Reviewer's report
Title:Delivering internet-based exposure treatment for irritable bowel syndrome
in a clinical setting: a randomized controlled trial.
Version: 1Date:7 March 2011
Reviewer: Yanda van Rood
Reviewer's report:
Major Compulsory Revisions
1. The authors state: "Our aim was to investigate the feasibility and effectiveness
of ICBT within regular clinical practice." However, only data on the effectiveness
of ICBT are presented. Since, ICBT has already been shown to be more effective
for IBS than waiting list, data on the feasibility (and cost effectiveness) of ICBT
would be of more interest.
2. Abstract. An abstract is missing.
3. Background. Page 2 "Recent studies that have included extensive self-help
material combined with qualified therapist contact through telephone [13], the
internet [14], or a reduced number of sessions [15] have demonstrated effects at
par with face-to-face treatments." Please include references demonstrating that
these interventions are as effective as face-to-face treatments.
4. "This study is reported in accordance with the CONSORT statement for
nonpharmacological trials [20]." However, there is no mention of trial registration.
Please include the registration number if the trial has been registered.
5. Exclusion criteria. The reasons for including exclusion criteria g and k need to
be explicated. Specifically, the authors should explain what makes patients highly
unsuitable for ICBT other than not having access to internet, and not reading or
write Swedish. In total 7 patients were not suitable for ICBT, i.e. 5% this needs
explanation.
6. By excluding all patients with severe diarrhea, the IBS patient group is not any
more representative for IBS patients in general. Patients type of IBS, diarrhea,
constipation or mixed according to the ROME III criteria should be described in
table 1. In the discussion this limitation should be described.
7. The authors violate their own inclusion criteria by including 2 patients who first
visited the clinic outside the specified period. These patients should not have
been included.
8. Please explain how 5 patients could be unreachable if they visited the clinic in
the specified period. If patients were phoned after their first visit this should be
described in the recruitment procedure.
9. The following sentence is not clear. "GSA is defined as ‘‘the cognitive,
affective, and behavioral response stemming from fear of gastrointestinal
sensations, symptoms, and the context in which these visceral sensations and
symptoms occur” [21] and is proposed to be a maintaining and exacerbating
factor in IBS." GSA is already anxiety, i.e. an affect. The cognitive, affective and
behavioral response are part of the fear response. They do not stem from it.
10. "Dysfunctional behavioral responses to IBS, such as excessive symptom
controlling or avoidance behaviors, can also increase the awareness of
symptoms and lead to a decreased quality of life, which further worsens the
symptoms [22, 24]." Selective attention, anxiety, muscle tension all can increase
or maintain symptoms directly. Please explain how a decrease in quality of life
might worsen the symptoms.
11. Symptom reduction and increase of quality of life are presented as primary
goals. The authors might want to describe the increase of quality of life in line
with the outcome measures as a secondary goal, i.e. if symptoms are reduced
the quality of life will increase.
"In the long run, acceptance of symptoms instead of control or avoidance
behaviors will increase quality of life. Together with the change in GSA this will
lead to a decreased burden of IBS symptoms." The primary goal of treatment
now seems to be an increase in quality of life, whereas before symptom
reduction was the primary aim of treatment. The authors might want to check the
text for consistency on this matter.
12. "Exposure can be defined as exposing oneself to an aversive stimulus and
simultaneously engaging in a behavior that is inconsistent with the emotion that
the stimulus elicits. This serves to reduce the strength of the emotional reaction
when exposed to the stimulus in the future [25]." The authors give a unusual
definition of exposure. What they describe is usually known as systematic
desensitization or counterconditioning. In both techniques an aversive stimulus is
associated with a new neutral or positive stimulus. A stimulus which elicits an
emotion which is not consistent with the emotion elicited by the aversive
stimulus. Mindful acceptance is, as is the relaxation response, not compatible
with anxiety and can be used to change the acquired negative valence of the
stimulus (i.e. gastrointestinal sensations and symptoms). Exposure with or
without response prevention can be used to falsify catastrophic expectations or
to extinguish the fear response, depending on the working mechanisms that are
supposed to play a role. This form of exposure is indeed an integral part of most
CBT treatments. Counterconditioning techniques are much less often explicitly
mentioned.
13. It is not clear how mindfulness exercises are used in the exposure exercises
and what rationale is given to patients to motivate them for treatment. A table in
which the content of the sessions is presented would be most welcome.
14. Exposure can be very effective, however in clinical practice many patients do
not start treatment or drop out during treatment because they find the exercises
to challenging. This might be brought forward in the discussion.
Exposure exercises need to be tailored to the patient. How was this done?
Where there individual goals set and if so, how many patients reached all their
therapeutic goals.
15. Patients were encouraged to send at least one message per week. The
intensity of the contact, i.e. how active the patient was in treatment might explain
the observed effect. In the results section the authors might want to describe how
many contacts the patients on average did seek per week as well as the range.
This is at least as interesting as the amount of therapist time spent per week.
Here the range is of interest too.
16. Treatment consists of different steps and patients only could go to a next step
if they finished the last one. This is an important aspect of the treatment and the
authors might want to consider to present the statistics (average and range). The
same holds for the number of steps in the treatment and the number of patients
that finished all treatment steps.
17. As the authors point out in their discussion a major limitation of the study is
the use of a waiting list control condition. To control for the placebo effect which
is known to be large in IBS patients the control condition needs to include an
activity that is as credible to the patient as the activity in the experimental
condition and the time spend on the activity must me comparable to control for
attention. Not only do they not control for the placebo effect, but waiting for
treatment when one expects to be treated (as is the case in normal clinical care)
may have a negative effect on symptom severity. Indeed patients in the waiting
list condition deteriorate on the MADRS-S, GSRS-IBS and IBS-QOL. It can not
be ruled out that the group by time effect is significant for GSRS-IBS and
IBS-QOL as a result of a worsening of symptoms of patients in the waiting list
condition. The authors might want to include this aspect in the discussion.
18. A psychiatric assessment was conducted before randomization. Please
explain at what time, by whom and for what reason in the recruitment procedure
the psychiatric assessment took place. If it was used to check on exclusion
criteria this should be described in the paragraphs on exclusion and inclusion. If
the psychiatric assessment was carried out with the aim to collect data, e.g.
psychiatric diagnosis, than the results should also be presented.
19. 2 patients were included who were seen outside the time frame reserved for
inclusion. The data have to be analyzed again with 131 patients.
20. "Since IBS symptoms are known to vary considerably over time [36], the
mean score of four weekly assessments of GSRS-IBS was used to get reliable
estimates of the participants’ symptom levels at each assessment point." If
patients filled in the GSRS-IBS at the first visit and every week for three weeks
after that before they started ICBT this might be stated in the method section.
21. The IBS-QOL and the SDS both assess symptom induced disability /
interference. Why are both included in the study? Why did the authors include an
instrument for depressive symptoms. Generally IBS patients are not depressive.
The scores indicate that most patients indeed were not depressed. Another point
of consideration is that the correlation between MADRS-S and physicians'
MADRS is moderate (r = 0.54, p < 0.001) indicating that MADRS-S is
complementary rather than redundant to the MADRS (ref: The self-reported
Montgomery-Asberg Depression Rating Scale is a useful evaluative tool in Major
Depressive Disorder. Fantino B, Moore N. BMC Psychiatry. 2009 May 27;9:26.).
So it can not be used for the diagnosis of depressive disorder. Since no specific
hypothesis was formulated concerning the outcome on the MADRS-S and taking
into account the above point, the authors might want to consider to eliminate the
data on the MADRS.
22. Follow-up: the scores on the MADRS-S increased during follow-up. Please
present the p-values and other relevant statistics for all follow-up measurements.
23. In the first sentence of the discussion an other aspect of the study not
explicitly mentioned before is highlighted, i.e. that before it was an self-selected
sample and now it is a consecutively recruited sample. If this is the most
important difference with the study done before it should be mentioned in the
background paragraph. How the clinical usefulness might be evaluated has not
been defined. This should be done and the results need to be reported.
24. "Clinical guidelines recommend that IBS patients should be referred to
psychological treatments primarily if they show depressive symptoms, anxiety, or
poor coping strategies and wish to undergo such a treatment [7, 48]. However, in
this study we deliberately did not let the gastroenterologists select the patients
that they deemed would benefit from a psychological treatment." These points
are unrelated. It is unlikely that the selection criteria used by gastroenterologists
are the same as the mentioned criteria (depressive symptoms, anxiety, or poor
coping strategies and wish to undergo such a treatment).
25. On page 16 the authors give as a possible explanation for the lower effect
sizes than they observed in their earlier study the supposedly lower motivation of
these patients. The authors might want to objectify this by reporting the number
of patients that completed all steps of the treatment.
26. The discussion might be extended by including the negative effect of being
on a waiting list, the non-representativeness of the IBS patients, and the
unacceptability of exposure exercises as another possible explanation for the
high number of drop outs.
27. The title in it self is contradictory, suggesting that one can have a RCT in
clinical practice (without changing clinical practice).
28. Conclusions. "These results might indicate that a larger proportion of IBS
patients than is usually presumed might benefit from psychological treatment."
On what grounds do the authors draw this conclusion? If this is indeed a
conclusion data supporting this should be presented and discussed in discussion
section.
Minor Essential Revisions
1. Page 4. Power calculation. The authors state: "We aimed at having a power of
at 85% to detect a standardized mean difference between the active treatment
and waiting list of 0.8, which gave a sample of at least 60 participants." Words
seem to be missing; i.e. the outcome measures used to calculate the necessary
number of patients.
2. Page 4. Inclusion criteria. Criterion c precedes b and the order might be
changed accordingly.
3. Page 5 first sentences breaks between ‘in’ and ‘Stockholm’
Page 5. "However, if the gastroenterologists judged ……. Etc" is one of the
exclusion criteria and has been explained already. Sentence may be deleted.
4. Page 5. "To ensure that the effects of this basic IBS management ….. , we
applied at least a one-month “washout” period …." The word “washout” is
confusing because it refers to medication use. Please clearly explain what was
done.
5. Page 6. "However, for 16 eligible patients……" This sentence should follow
after the following sentence …".. period, and 131 of these were eligible according
to their medical record."
6. Page 7. "GSA is defined as ‘‘the cognitive, affective, and behavioral response
stemming from fear of gastrointestinal sensations, [and] symptoms, and the
context in which these visceral sensations and symptoms occur” [21] and is
proposed to be a maintaining and exacerbating factor in IBS." Delete punctuation
mark and insert and.
7. Page 8. "In ICBT the patients learn about the treatment interventions by
reading self-help texts that contain both educational material and instructions on
how to perform the exercises that constitute the treatment. The general principle
is that the treatment should reflect face-to-face therapy in terms of content, but
using an online therapist to guide the participants through the course of the
treatment. The format allows for large patient volumes to be treated and an
increasing number of controlled studies indicate that for common psychiatric
disorders ICBT is as effective as face-to-face delivered treatment [30]." The
authors might want to consider to place this paragraph in the introduction, page 2
last sentence.
8. Page 10. "The waiting list completed assessments immediately after and 12
months after having been crossed over to and finishing treatment and a
psychiatric assessment of all patients was conducted before the randomization
and at 12-month follow-up." This sentence is not clear. Suggestion: The waiting
list completed assessments immediately after and 12 months after having been
crossed over to and finishing treatment. A psychiatric assessment of all patients
was conducted before the randomization and at 12-month follow-up.
9. Page 13. "Of the 30 patients in the ICBT group, 20 (67%) completed the
12-month follow-up assessment. One of these patients had not completed the
post-treatment assessment and one patient completed all follow-up
questionnaires but GSRS-IBS. Thus 24 patients were included in the analyses of
change between post-treatment and follow-up, with 5 patients having missing
data." Confusing sentence. Suggestion: One of the patients who completed the
12-month follow-up assessment did not complete the post-treatment
assessment, but was included in the analysis of change between post-treatment
and follow-up resulting in 24 patients in this analysis. Of these 24 patients 5 had
missing data.
10. "…. and one patient completed all follow-up questionnaires but GSRS-IBS."
No information is given on the other patients with missing data. The authors
might want to consider to leave this information out here.
11. Page 16 ".…. with a few exceptions relating primarily to age [include: of
onset], presence of inflammatory bowel disease, severe diarrhea, poor language
skills, and patient willingness." Patient willingness however was not defined as a
inclusion criterion.
12. Page 16 From … "It has been difficult to empirically determine which patient
characteristics ….[to the end of the paragraph]" might be placed after "Of 131
eligible patients 77 (59%) were included in the study. An inclusion rate of 59%
stands in contrast to the estimated 25% of IBS patients that will benefit from a
psychological treatment [48]."
13. According to the instructions to the authors, tables should not be submitted
as figures but should be included in the main manuscript file.
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
'I declare that I have no competing interests'
Reviewer's report
Title:Delivering internet-based exposure treatment for irritable bowel syndrome
in a clinical setting: a randomized controlled trial.
Version: 1Date:7 March 2011
Reviewer: Yanda van Rood
Reviewer's report:
Major Compulsory Revisions
1. The authors state: "Our aim was to investigate the feasibility and effectiveness
of ICBT within regular clinical practice." However, only data on the effectiveness
of ICBT are presented. Since, ICBT has already been shown to be more effective
for IBS than waiting list, data on the feasibility (and cost effectiveness) of ICBT
would be of more interest.
2. Abstract. An abstract is missing.
3. Background. Page 2 "Recent studies that have included extensive self-help
material combined with qualified therapist contact through telephone [13], the
internet [14], or a reduced number of sessions [15] have demonstrated effects at
par with face-to-face treatments." Please include references demonstrating that
these interventions are as effective as face-to-face treatments.
4. "This study is reported in accordance with the CONSORT statement for
nonpharmacological trials [20]." However, there is no mention of trial registration.
Please include the registration number if the trial has been registered.
5. Exclusion criteria. The reasons for including exclusion criteria g and k need to
be explicated. Specifically, the authors should explain what makes patients highly
unsuitable for ICBT other than not having access to internet, and not reading or
write Swedish. In total 7 patients were not suitable for ICBT, i.e. 5% this needs
explanation.
6. By excluding all patients with severe diarrhea, the IBS patient group is not any
more representative for IBS patients in general. Patients type of IBS, diarrhea,
constipation or mixed according to the ROME III criteria should be described in
table 1. In the discussion this limitation should be described.
7. The authors violate their own inclusion criteria by including 2 patients who first
visited the clinic outside the specified period. These patients should not have
been included.
8. Please explain how 5 patients could be unreachable if they visited the clinic in
the specified period. If patients were phoned after their first visit this should be
described in the recruitment procedure.
9. The following sentence is not clear. "GSA is defined as ‘‘the cognitive,
affective, and behavioral response stemming from fear of gastrointestinal
sensations, symptoms, and the context in which these visceral sensations and
symptoms occur” [21] and is proposed to be a maintaining and exacerbating
factor in IBS." GSA is already anxiety, i.e. an affect. The cognitive, affective and
behavioral response are part of the fear response. They do not stem from it.
10. "Dysfunctional behavioral responses to IBS, such as excessive symptom
controlling or avoidance behaviors, can also increase the awareness of
symptoms and lead to a decreased quality of life, which further worsens the
symptoms [22, 24]." Selective attention, anxiety, muscle tension all can increase
or maintain symptoms directly. Please explain how a decrease in quality of life
might worsen the symptoms.
11. Symptom reduction and increase of quality of life are presented as primary
goals. The authors might want to describe the increase of quality of life in line
with the outcome measures as a secondary goal, i.e. if symptoms are reduced
the quality of life will increase.
"In the long run, acceptance of symptoms instead of control or avoidance
behaviors will increase quality of life. Together with the change in GSA this will
lead to a decreased burden of IBS symptoms." The primary goal of treatment
now seems to be an increase in quality of life, whereas before symptom
reduction was the primary aim of treatment. The authors might want to check the
text for consistency on this matter.
12. "Exposure can be defined as exposing oneself to an aversive stimulus and
simultaneously engaging in a behavior that is inconsistent with the emotion that
the stimulus elicits. This serves to reduce the strength of the emotional reaction
when exposed to the stimulus in the future [25]." The authors give a unusual
definition of exposure. What they describe is usually known as systematic
desensitization or counterconditioning. In both techniques an aversive stimulus is
associated with a new neutral or positive stimulus. A stimulus which elicits an
emotion which is not consistent with the emotion elicited by the aversive
stimulus. Mindful acceptance is, as is the relaxation response, not compatible
with anxiety and can be used to change the acquired negative valence of the
stimulus (i.e. gastrointestinal sensations and symptoms). Exposure with or
without response prevention can be used to falsify catastrophic expectations or
to extinguish the fear response, depending on the working mechanisms that are
supposed to play a role. This form of exposure is indeed an integral part of most
CBT treatments. Counterconditioning techniques are much less often explicitly
mentioned.
13. It is not clear how mindfulness exercises are used in the exposure exercises
and what rationale is given to patients to motivate them for treatment. A table in
which the content of the sessions is presented would be most welcome.
14. Exposure can be very effective, however in clinical practice many patients do
not start treatment or drop out during treatment because they find the exercises
to challenging. This might be brought forward in the discussion.
Exposure exercises need to be tailored to the patient. How was this done?
Where there individual goals set and if so, how many patients reached all their
therapeutic goals.
15. Patients were encouraged to send at least one message per week. The
intensity of the contact, i.e. how active the patient was in treatment might explain
the observed effect. In the results section the authors might want to describe how
many contacts the patients on average did seek per week as well as the range.
This is at least as interesting as the amount of therapist time spent per week.
Here the range is of interest too.
16. Treatment consists of different steps and patients only could go to a next step
if they finished the last one. This is an important aspect of the treatment and the
authors might want to consider to present the statistics (average and range). The
same holds for the number of steps in the treatment and the number of patients
that finished all treatment steps.
17. As the authors point out in their discussion a major limitation of the study is
the use of a waiting list control condition. To control for the placebo effect which
is known to be large in IBS patients the control condition needs to include an
activity that is as credible to the patient as the activity in the experimental
condition and the time spend on the activity must me comparable to control for
attention. Not only do they not control for the placebo effect, but waiting for
treatment when one expects to be treated (as is the case in normal clinical care)
may have a negative effect on symptom severity. Indeed patients in the waiting
list condition deteriorate on the MADRS-S, GSRS-IBS and IBS-QOL. It can not
be ruled out that the group by time effect is significant for GSRS-IBS and
IBS-QOL as a result of a worsening of symptoms of patients in the waiting list
condition. The authors might want to include this aspect in the discussion.
18. A psychiatric assessment was conducted before randomization. Please
explain at what time, by whom and for what reason in the recruitment procedure
the psychiatric assessment took place. If it was used to check on exclusion
criteria this should be described in the paragraphs on exclusion and inclusion. If
the psychiatric assessment was carried out with the aim to collect data, e.g.
psychiatric diagnosis, than the results should also be presented.
19. 2 patients were included who were seen outside the time frame reserved for
inclusion. The data have to be analyzed again with 131 patients.
20. "Since IBS symptoms are known to vary considerably over time [36], the
mean score of four weekly assessments of GSRS-IBS was used to get reliable
estimates of the participants’ symptom levels at each assessment point." If
patients filled in the GSRS-IBS at the first visit and every week for three weeks
after that before they started ICBT this might be stated in the method section.
21. The IBS-QOL and the SDS both assess symptom induced disability /
interference. Why are both included in the study? Why did the authors include an
instrument for depressive symptoms. Generally IBS patients are not depressive.
The scores indicate that most patients indeed were not depressed. Another point
of consideration is that the correlation between MADRS-S and physicians'
MADRS is moderate (r = 0.54, p < 0.001) indicating that MADRS-S is
complementary rather than redundant to the MADRS (ref: The self-reported
Montgomery-Asberg Depression Rating Scale is a useful evaluative tool in Major
Depressive Disorder. Fantino B, Moore N. BMC Psychiatry. 2009 May 27;9:26.).
So it can not be used for the diagnosis of depressive disorder. Since no specific
hypothesis was formulated concerning the outcome on the MADRS-S and taking
into account the above point, the authors might want to consider to eliminate the
data on the MADRS.
22. Follow-up: the scores on the MADRS-S increased during follow-up. Please
present the p-values and other relevant statistics for all follow-up measurements.
23. In the first sentence of the discussion an other aspect of the study not
explicitly mentioned before is highlighted, i.e. that before it was an self-selected
sample and now it is a consecutively recruited sample. If this is the most
important difference with the study done before it should be mentioned in the
background paragraph. How the clinical usefulness might be evaluated has not
been defined. This should be done and the results need to be reported.
24. "Clinical guidelines recommend that IBS patients should be referred to
psychological treatments primarily if they show depressive symptoms, anxiety, or
poor coping strategies and wish to undergo such a treatment [7, 48]. However, in
this study we deliberately did not let the gastroenterologists select the patients
that they deemed would benefit from a psychological treatment." These points
are unrelated. It is unlikely that the selection criteria used by gastroenterologists
are the same as the mentioned criteria (depressive symptoms, anxiety, or poor
coping strategies and wish to undergo such a treatment).
25. On page 16 the authors give as a possible explanation for the lower effect
sizes than they observed in their earlier study the supposedly lower motivation of
these patients. The authors might want to objectify this by reporting the number
of patients that completed all steps of the treatment.
26. The discussion might be extended by including the negative effect of being
on a waiting list, the non-representativeness of the IBS patients, and the
unacceptability of exposure exercises as another possible explanation for the
high number of drop outs.
27. The title in it self is contradictory, suggesting that one can have a RCT in
clinical practice (without changing clinical practice).
28. Conclusions. "These results might indicate that a larger proportion of IBS
patients than is usually presumed might benefit from psychological treatment."
On what grounds do the authors draw this conclusion? If this is indeed a
conclusion data supporting this should be presented and discussed in discussion
section.
Minor Essential Revisions
1. Page 4. Power calculation. The authors state: "We aimed at having a power of
at 85% to detect a standardized mean difference between the active treatment
and waiting list of 0.8, which gave a sample of at least 60 participants." Words
seem to be missing; i.e. the outcome measures used to calculate the necessary
number of patients.
2. Page 4. Inclusion criteria. Criterion c precedes b and the order might be
changed accordingly.
3. Page 5 first sentences breaks between ‘in’ and ‘Stockholm’
Page 5. "However, if the gastroenterologists judged ……. Etc" is one of the
exclusion criteria and has been explained already. Sentence may be deleted.
4. Page 5. "To ensure that the effects of this basic IBS management ….. , we
applied at least a one-month “washout” period …." The word “washout” is
confusing because it refers to medication use. Please clearly explain what was
done.
5. Page 6. "However, for 16 eligible patients……" This sentence should follow
after the following sentence …".. period, and 131 of these were eligible according
to their medical record."
6. Page 7. "GSA is defined as ‘‘the cognitive, affective, and behavioral response
stemming from fear of gastrointestinal sensations, [and] symptoms, and the
context in which these visceral sensations and symptoms occur” [21] and is
proposed to be a maintaining and exacerbating factor in IBS." Delete punctuation
mark and insert and.
7. Page 8. "In ICBT the patients learn about the treatment interventions by
reading self-help texts that contain both educational material and instructions on
how to perform the exercises that constitute the treatment. The general principle
is that the treatment should reflect face-to-face therapy in terms of content, but
using an online therapist to guide the participants through the course of the
treatment. The format allows for large patient volumes to be treated and an
increasing number of controlled studies indicate that for common psychiatric
disorders ICBT is as effective as face-to-face delivered treatment [30]." The
authors might want to consider to place this paragraph in the introduction, page 2
last sentence.
8. Page 10. "The waiting list completed assessments immediately after and 12
months after having been crossed over to and finishing treatment and a
psychiatric assessment of all patients was conducted before the randomization
and at 12-month follow-up." This sentence is not clear. Suggestion: The waiting
list completed assessments immediately after and 12 months after having been
crossed over to and finishing treatment. A psychiatric assessment of all patients
was conducted before the randomization and at 12-month follow-up.
9. Page 13. "Of the 30 patients in the ICBT group, 20 (67%) completed the
12-month follow-up assessment. One of these patients had not completed the
post-treatment assessment and one patient completed all follow-up
questionnaires but GSRS-IBS. Thus 24 patients were included in the analyses of
change between post-treatment and follow-up, with 5 patients having missing
data." Confusing sentence. Suggestion: One of the patients who completed the
12-month follow-up assessment did not complete the post-treatment
assessment, but was included in the analysis of change between post-treatment
and follow-up resulting in 24 patients in this analysis. Of these 24 patients 5 had
missing data.
10. "…. and one patient completed all follow-up questionnaires but GSRS-IBS."
No information is given on the other patients with missing data. The authors
might want to consider to leave this information out here.
11. Page 16 ".…. with a few exceptions relating primarily to age [include: of
onset], presence of inflammatory bowel disease, severe diarrhea, poor language
skills, and patient willingness." Patient willingness however was not defined as a
inclusion criterion.
12. Page 16 From … "It has been difficult to empirically determine which patient
characteristics ….[to the end of the paragraph]" might be placed after "Of 131
eligible patients 77 (59%) were included in the study. An inclusion rate of 59%
stands in contrast to the estimated 25% of IBS patients that will benefit from a
psychological treatment [48]."
13. According to the instructions to the authors, tables should not be submitted
as figures but should be included in the main manuscript file.
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
'I declare that I have no competing interests'
Please review this paper.
user
Reviewer's report
Title:Delivering internet-based exposure treatment for irritable bowel syndrome
in a clinical setting: a randomized controlled trial.
Version: 1Date:7 March 2011
Reviewer: Yanda van Rood
Reviewer's report:
Major Compulsory Revisions
1. The authors state: "Our aim was to investigate the feasibility and effectiveness
of ICBT within regular clinical practice." However, only data on the effectiveness
of ICBT are presented. Since, ICBT has already been shown to be more effective
for IBS than waiting list, data on the feasibility (and cost effectiveness) of ICBT
would be of more interest.
2. Abstract. An abstract is missing.
3. Background. Page 2 "Recent studies that have included extensive self-help
material combined with qualified therapist contact through telephone [13], the
internet [14], or a reduced number of sessions [15] have demonstrated effects at
par with face-to-face treatments." Please include references demonstrating that
these interventions are as effective as face-to-face treatments.
4. "This study is reported in accordance with the CONSORT statement for
nonpharmacological trials [20]." However, there is no mention of trial registration.
Please include the registration number if the trial has been registered.
5. Exclusion criteria. The reasons for including exclusion criteria g and k need to
be explicated. Specifically, the authors should explain what makes patients highly
unsuitable for ICBT other than not having access to internet, and not reading or
write Swedish. In total 7 patients were not suitable for ICBT, i.e. 5% this needs
explanation.
6. By excluding all patients with severe diarrhea, the IBS patient group is not any
more representative for IBS patients in general. Patients type of IBS, diarrhea,
constipation or mixed according to the ROME III criteria should be described in
table 1. In the discussion this limitation should be described.
7. The authors violate their own inclusion criteria by including 2 patients who first
visited the clinic outside the specified period. These patients should not have
been included.
8. Please explain how 5 patients could be unreachable if they visited the clinic in
the specified period. If patients were phoned after their first visit this should be
described in the recruitment procedure.
9. The following sentence is not clear. "GSA is defined as ‘‘the cognitive,
affective, and behavioral response stemming from fear of gastrointestinal
sensations, symptoms, and the context in which these visceral sensations and
symptoms occur” [21] and is proposed to be a maintaining and exacerbating
factor in IBS." GSA is already anxiety, i.e. an affect. The cognitive, affective and
behavioral response are part of the fear response. They do not stem from it.
10. "Dysfunctional behavioral responses to IBS, such as excessive symptom
controlling or avoidance behaviors, can also increase the awareness of
symptoms and lead to a decreased quality of life, which further worsens the
symptoms [22, 24]." Selective attention, anxiety, muscle tension all can increase
or maintain symptoms directly. Please explain how a decrease in quality of life
might worsen the symptoms.
11. Symptom reduction and increase of quality of life are presented as primary
goals. The authors might want to describe the increase of quality of life in line
with the outcome measures as a secondary goal, i.e. if symptoms are reduced
the quality of life will increase.
"In the long run, acceptance of symptoms instead of control or avoidance
behaviors will increase quality of life. Together with the change in GSA this will
lead to a decreased burden of IBS symptoms." The primary goal of treatment
now seems to be an increase in quality of life, whereas before symptom
reduction was the primary aim of treatment. The authors might want to check the
text for consistency on this matter.
12. "Exposure can be defined as exposing oneself to an aversive stimulus and
simultaneously engaging in a behavior that is inconsistent with the emotion that
the stimulus elicits. This serves to reduce the strength of the emotional reaction
when exposed to the stimulus in the future [25]." The authors give a unusual
definition of exposure. What they describe is usually known as systematic
desensitization or counterconditioning. In both techniques an aversive stimulus is
associated with a new neutral or positive stimulus. A stimulus which elicits an
emotion which is not consistent with the emotion elicited by the aversive
stimulus. Mindful acceptance is, as is the relaxation response, not compatible
with anxiety and can be used to change the acquired negative valence of the
stimulus (i.e. gastrointestinal sensations and symptoms). Exposure with or
without response prevention can be used to falsify catastrophic expectations or
to extinguish the fear response, depending on the working mechanisms that are
supposed to play a role. This form of exposure is indeed an integral part of most
CBT treatments. Counterconditioning techniques are much less often explicitly
mentioned.
13. It is not clear how mindfulness exercises are used in the exposure exercises
and what rationale is given to patients to motivate them for treatment. A table in
which the content of the sessions is presented would be most welcome.
14. Exposure can be very effective, however in clinical practice many patients do
not start treatment or drop out during treatment because they find the exercises
to challenging. This might be brought forward in the discussion.
Exposure exercises need to be tailored to the patient. How was this done?
Where there individual goals set and if so, how many patients reached all their
therapeutic goals.
15. Patients were encouraged to send at least one message per week. The
intensity of the contact, i.e. how active the patient was in treatment might explain
the observed effect. In the results section the authors might want to describe how
many contacts the patients on average did seek per week as well as the range.
This is at least as interesting as the amount of therapist time spent per week.
Here the range is of interest too.
16. Treatment consists of different steps and patients only could go to a next step
if they finished the last one. This is an important aspect of the treatment and the
authors might want to consider to present the statistics (average and range). The
same holds for the number of steps in the treatment and the number of patients
that finished all treatment steps.
17. As the authors point out in their discussion a major limitation of the study is
the use of a waiting list control condition. To control for the placebo effect which
is known to be large in IBS patients the control condition needs to include an
activity that is as credible to the patient as the activity in the experimental
condition and the time spend on the activity must me comparable to control for
attention. Not only do they not control for the placebo effect, but waiting for
treatment when one expects to be treated (as is the case in normal clinical care)
may have a negative effect on symptom severity. Indeed patients in the waiting
list condition deteriorate on the MADRS-S, GSRS-IBS and IBS-QOL. It can not
be ruled out that the group by time effect is significant for GSRS-IBS and
IBS-QOL as a result of a worsening of symptoms of patients in the waiting list
condition. The authors might want to include this aspect in the discussion.
18. A psychiatric assessment was conducted before randomization. Please
explain at what time, by whom and for what reason in the recruitment procedure
the psychiatric assessment took place. If it was used to check on exclusion
criteria this should be described in the paragraphs on exclusion and inclusion. If
the psychiatric assessment was carried out with the aim to collect data, e.g.
psychiatric diagnosis, than the results should also be presented.
19. 2 patients were included who were seen outside the time frame reserved for
inclusion. The data have to be analyzed again with 131 patients.
20. "Since IBS symptoms are known to vary considerably over time [36], the
mean score of four weekly assessments of GSRS-IBS was used to get reliable
estimates of the participants’ symptom levels at each assessment point." If
patients filled in the GSRS-IBS at the first visit and every week for three weeks
after that before they started ICBT this might be stated in the method section.
21. The IBS-QOL and the SDS both assess symptom induced disability /
interference. Why are both included in the study? Why did the authors include an
instrument for depressive symptoms. Generally IBS patients are not depressive.
The scores indicate that most patients indeed were not depressed. Another point
of consideration is that the correlation between MADRS-S and physicians'
MADRS is moderate (r = 0.54, p < 0.001) indicating that MADRS-S is
complementary rather than redundant to the MADRS (ref: The self-reported
Montgomery-Asberg Depression Rating Scale is a useful evaluative tool in Major
Depressive Disorder. Fantino B, Moore N. BMC Psychiatry. 2009 May 27;9:26.).
So it can not be used for the diagnosis of depressive disorder. Since no specific
hypothesis was formulated concerning the outcome on the MADRS-S and taking
into account the above point, the authors might want to consider to eliminate the
data on the MADRS.
22. Follow-up: the scores on the MADRS-S increased during follow-up. Please
present the p-values and other relevant statistics for all follow-up measurements.
23. In the first sentence of the discussion an other aspect of the study not
explicitly mentioned before is highlighted, i.e. that before it was an self-selected
sample and now it is a consecutively recruited sample. If this is the most
important difference with the study done before it should be mentioned in the
background paragraph. How the clinical usefulness might be evaluated has not
been defined. This should be done and the results need to be reported.
24. "Clinical guidelines recommend that IBS patients should be referred to
psychological treatments primarily if they show depressive symptoms, anxiety, or
poor coping strategies and wish to undergo such a treatment [7, 48]. However, in
this study we deliberately did not let the gastroenterologists select the patients
that they deemed would benefit from a psychological treatment." These points
are unrelated. It is unlikely that the selection criteria used by gastroenterologists
are the same as the mentioned criteria (depressive symptoms, anxiety, or poor
coping strategies and wish to undergo such a treatment).
25. On page 16 the authors give as a possible explanation for the lower effect
sizes than they observed in their earlier study the supposedly lower motivation of
these patients. The authors might want to objectify this by reporting the number
of patients that completed all steps of the treatment.
26. The discussion might be extended by including the negative effect of being
on a waiting list, the non-representativeness of the IBS patients, and the
unacceptability of exposure exercises as another possible explanation for the
high number of drop outs.
27. The title in it self is contradictory, suggesting that one can have a RCT in
clinical practice (without changing clinical practice).
28. Conclusions. "These results might indicate that a larger proportion of IBS
patients than is usually presumed might benefit from psychological treatment."
On what grounds do the authors draw this conclusion? If this is indeed a
conclusion data supporting this should be presented and discussed in discussion
section.
Minor Essential Revisions
1. Page 4. Power calculation. The authors state: "We aimed at having a power of
at 85% to detect a standardized mean difference between the active treatment
and waiting list of 0.8, which gave a sample of at least 60 participants." Words
seem to be missing; i.e. the outcome measures used to calculate the necessary
number of patients.
2. Page 4. Inclusion criteria. Criterion c precedes b and the order might be
changed accordingly.
3. Page 5 first sentences breaks between ‘in’ and ‘Stockholm’
Page 5. "However, if the gastroenterologists judged ……. Etc" is one of the
exclusion criteria and has been explained already. Sentence may be deleted.
4. Page 5. "To ensure that the effects of this basic IBS management ….. , we
applied at least a one-month “washout” period …." The word “washout” is
confusing because it refers to medication use. Please clearly explain what was
done.
5. Page 6. "However, for 16 eligible patients……" This sentence should follow
after the following sentence …".. period, and 131 of these were eligible according
to their medical record."
6. Page 7. "GSA is defined as ‘‘the cognitive, affective, and behavioral response
stemming from fear of gastrointestinal sensations, [and] symptoms, and the
context in which these visceral sensations and symptoms occur” [21] and is
proposed to be a maintaining and exacerbating factor in IBS." Delete punctuation
mark and insert and.
7. Page 8. "In ICBT the patients learn about the treatment interventions by
reading self-help texts that contain both educational material and instructions on
how to perform the exercises that constitute the treatment. The general principle
is that the treatment should reflect face-to-face therapy in terms of content, but
using an online therapist to guide the participants through the course of the
treatment. The format allows for large patient volumes to be treated and an
increasing number of controlled studies indicate that for common psychiatric
disorders ICBT is as effective as face-to-face delivered treatment [30]." The
authors might want to consider to place this paragraph in the introduction, page 2
last sentence.
8. Page 10. "The waiting list completed assessments immediately after and 12
months after having been crossed over to and finishing treatment and a
psychiatric assessment of all patients was conducted before the randomization
and at 12-month follow-up." This sentence is not clear. Suggestion: The waiting
list completed assessments immediately after and 12 months after having been
crossed over to and finishing treatment. A psychiatric assessment of all patients
was conducted before the randomization and at 12-month follow-up.
9. Page 13. "Of the 30 patients in the ICBT group, 20 (67%) completed the
12-month follow-up assessment. One of these patients had not completed the
post-treatment assessment and one patient completed all follow-up
questionnaires but GSRS-IBS. Thus 24 patients were included in the analyses of
change between post-treatment and follow-up, with 5 patients having missing
data." Confusing sentence. Suggestion: One of the patients who completed the
12-month follow-up assessment did not complete the post-treatment
assessment, but was included in the analysis of change between post-treatment
and follow-up resulting in 24 patients in this analysis. Of these 24 patients 5 had
missing data.
10. "…. and one patient completed all follow-up questionnaires but GSRS-IBS."
No information is given on the other patients with missing data. The authors
might want to consider to leave this information out here.
11. Page 16 ".…. with a few exceptions relating primarily to age [include: of
onset], presence of inflammatory bowel disease, severe diarrhea, poor language
skills, and patient willingness." Patient willingness however was not defined as a
inclusion criterion.
12. Page 16 From … "It has been difficult to empirically determine which patient
characteristics ….[to the end of the paragraph]" might be placed after "Of 131
eligible patients 77 (59%) were included in the study. An inclusion rate of 59%
stands in contrast to the estimated 25% of IBS patients that will benefit from a
psychological treatment [48]."
13. According to the instructions to the authors, tables should not be submitted
as figures but should be included in the main manuscript file.
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
'I declare that I have no competing interests'
assistant