Trial Outcomes & Findings for Self Administered Cognitive Behavior Therapy for Irritable Bowel Syndrome (NCT NCT00738920)
NCT ID: NCT00738920
Last Updated: 2022-08-05
Results Overview
The CGI-I is a single-item, 7-point centered scale that integrates symptom severity and improvement since the start of treatment. Specific IBS-based anchor points were used, as is the convention for multi-symptom disease states. Response range from 1 (very much worse) to 7 (very much improved), with higher scores indicating greater symptom improvement. Participants who respond 6 (much improved) or 7 (very much improved) are classified as treatment responders.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
436 participants
Primary outcome timeframe
2-Week Follow-Up, 3-Month Follow-Up, 6-Month Follow-Up, 9-Month Follow-Up and 12-Month Follow-Up
Results posted on
2022-08-05
Participant Flow
Participant milestones
| Measure |
MC-CBT
Self Administered Cognitive Behavior Therapy
Self Administered Cognitive Behavior Therapy: This 4 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
|
Standard-CBT
Therapist Administered Cognitive Behavior Therapy
Therapist Administered Cognitive Behavior Therapy: This 10 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
|
Education/Support
Behavioral Patient Education/Counseling
Behavioral Education and Supportive Therapy: This 4 session treatment aims at controlling symptoms through support and the provision of information about IBS symptoms, how it is diagnosed, its causes, and treatment options and a collaborative, relationship between the patient and doctor
|
|---|---|---|---|
|
Baseline to 2-Week Follow-Up
STARTED
|
145
|
146
|
145
|
|
Baseline to 2-Week Follow-Up
COMPLETED
|
129
|
123
|
130
|
|
Baseline to 2-Week Follow-Up
NOT COMPLETED
|
16
|
23
|
15
|
|
2-Week Follow-Up to 3-Month Follow-Up
STARTED
|
129
|
123
|
130
|
|
2-Week Follow-Up to 3-Month Follow-Up
COMPLETED
|
121
|
111
|
118
|
|
2-Week Follow-Up to 3-Month Follow-Up
NOT COMPLETED
|
8
|
12
|
12
|
|
3-Month Follow-Up to 6-Month Follow-Up
STARTED
|
121
|
111
|
118
|
|
3-Month Follow-Up to 6-Month Follow-Up
COMPLETED
|
117
|
111
|
115
|
|
3-Month Follow-Up to 6-Month Follow-Up
NOT COMPLETED
|
4
|
0
|
3
|
|
6-Month Follow-Up to 9-Month Follow-Up
STARTED
|
117
|
111
|
115
|
|
6-Month Follow-Up to 9-Month Follow-Up
COMPLETED
|
113
|
104
|
103
|
|
6-Month Follow-Up to 9-Month Follow-Up
NOT COMPLETED
|
4
|
7
|
12
|
|
9-Month Follow-Up to 12-Month Follow-Up
STARTED
|
113
|
104
|
103
|
|
9-Month Follow-Up to 12-Month Follow-Up
COMPLETED
|
112
|
103
|
102
|
|
9-Month Follow-Up to 12-Month Follow-Up
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
MC-CBT
Self Administered Cognitive Behavior Therapy
Self Administered Cognitive Behavior Therapy: This 4 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
|
Standard-CBT
Therapist Administered Cognitive Behavior Therapy
Therapist Administered Cognitive Behavior Therapy: This 10 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
|
Education/Support
Behavioral Patient Education/Counseling
Behavioral Education and Supportive Therapy: This 4 session treatment aims at controlling symptoms through support and the provision of information about IBS symptoms, how it is diagnosed, its causes, and treatment options and a collaborative, relationship between the patient and doctor
|
|---|---|---|---|
|
Baseline to 2-Week Follow-Up
Lost to Follow-up
|
8
|
9
|
8
|
|
Baseline to 2-Week Follow-Up
Withdrawal by Subject
|
8
|
14
|
7
|
|
2-Week Follow-Up to 3-Month Follow-Up
Withdrawal by Subject
|
3
|
5
|
6
|
|
2-Week Follow-Up to 3-Month Follow-Up
Lost to Follow-up
|
5
|
7
|
6
|
|
3-Month Follow-Up to 6-Month Follow-Up
Lost to Follow-up
|
3
|
0
|
2
|
|
3-Month Follow-Up to 6-Month Follow-Up
Withdrawal by Subject
|
1
|
0
|
1
|
|
6-Month Follow-Up to 9-Month Follow-Up
Lost to Follow-up
|
2
|
4
|
7
|
|
6-Month Follow-Up to 9-Month Follow-Up
Withdrawal by Subject
|
2
|
3
|
5
|
|
9-Month Follow-Up to 12-Month Follow-Up
Lost to Follow-up
|
1
|
0
|
1
|
|
9-Month Follow-Up to 12-Month Follow-Up
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Self Administered Cognitive Behavior Therapy for Irritable Bowel Syndrome
Baseline characteristics by cohort
| Measure |
MC-CBT
n=145 Participants
Self Administered Cognitive Behavior Therapy
Self Administered Cognitive Behavior Therapy: This 4 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
|
Standard-CBT
n=146 Participants
Therapist Administered Cognitive Behavior Therapy
Therapist Administered Cognitive Behavior Therapy: This 10 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
|
Education/Support
n=145 Participants
Behavioral Patient Education/Counseling
Behavioral Education and Supportive Therapy: This 4 session treatment aims at controlling symptoms through support and the provision of information about IBS symptoms, how it is diagnosed, its causes, and treatment options and a collaborative, relationship between the patient and doctor
|
Total
n=436 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
42.2 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 14.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
350 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
131 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
383 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Predominant IBS Bowel Type
Constipation
|
43 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
|
Predominant IBS Bowel Type
Diarrhea
|
59 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
188 Participants
n=4 Participants
|
|
Predominant IBS Bowel Type
Mixed
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Predominant IBS Bowel Type
Undifferentiated
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Duration of IBS symptoms
|
15.7 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
17.7 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
17.7 years
STANDARD_DEVIATION 16.4 • n=5 Participants
|
17.1 years
STANDARD_DEVIATION 14.4 • n=4 Participants
|
|
Medication Use for IBS Symptoms
Pain medication
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Medication Use for IBS Symptoms
Bowel medication
|
86 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
271 Participants
n=4 Participants
|
|
Medication Use for IBS Symptoms
Multisymptom medication
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Medication Use for IBS Symptoms
Psychiatric medication
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Medication Use for IBS Symptoms
None
|
36 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2-Week Follow-Up, 3-Month Follow-Up, 6-Month Follow-Up, 9-Month Follow-Up and 12-Month Follow-UpPopulation: Per protocol
The CGI-I is a single-item, 7-point centered scale that integrates symptom severity and improvement since the start of treatment. Specific IBS-based anchor points were used, as is the convention for multi-symptom disease states. Response range from 1 (very much worse) to 7 (very much improved), with higher scores indicating greater symptom improvement. Participants who respond 6 (much improved) or 7 (very much improved) are classified as treatment responders.
Outcome measures
| Measure |
MC-CBT
n=131 Participants
Self Administered Cognitive Behavior Therapy
Self Administered Cognitive Behavior Therapy: This 4 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
|
Standard-CBT
n=125 Participants
Therapist Administered Cognitive Behavior Therapy
Therapist Administered Cognitive Behavior Therapy: This 10 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
|
Education/Support
n=133 Participants
Behavioral Patient Education/Counseling
Behavioral Education and Supportive Therapy: This 4 session treatment aims at controlling symptoms through support and the provision of information about IBS symptoms, how it is diagnosed, its causes, and treatment options and a collaborative, relationship between the patient and doctor
|
|---|---|---|---|
|
Clinical Global Impressions - Improvement Scale (CGI-I; Patient Version)
6-Month Follow-Up
|
63.9 percentage of treatment responders
|
58.1 percentage of treatment responders
|
51.0 percentage of treatment responders
|
|
Clinical Global Impressions - Improvement Scale (CGI-I; Patient Version)
9-Month Follow-Up
|
64.9 percentage of treatment responders
|
62.2 percentage of treatment responders
|
48.9 percentage of treatment responders
|
|
Clinical Global Impressions - Improvement Scale (CGI-I; Patient Version)
12-Month Follow-Up
|
70.0 percentage of treatment responders
|
68.4 percentage of treatment responders
|
51.7 percentage of treatment responders
|
|
Clinical Global Impressions - Improvement Scale (CGI-I; Patient Version)
2-Week Follow-Up
|
68.1 percentage of treatment responders
|
64.6 percentage of treatment responders
|
46.7 percentage of treatment responders
|
|
Clinical Global Impressions - Improvement Scale (CGI-I; Patient Version)
3-Month Follow-Up
|
64.0 percentage of treatment responders
|
64.6 percentage of treatment responders
|
49.5 percentage of treatment responders
|
SECONDARY outcome
Timeframe: Baseline, 2-Week Follow-Up, 3-Month Follow-Up, 6-Month Follow-Up, 9-Month Follow-Up and 12-Month Follow-UpPopulation: Per protocol population
The IBS-SSS is a 5-item instrument used to measure severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with QOL. For four of the items, respondents mark a point on a 101 mm visual analogue scale to indicate their response to that item. The proportional distance from zero is the score (ranging from 0 to 100) assigned for that scale. The other item asks the number of days out of 10 the patient experiences abdominal pain and the answer is multiplied by 10 to create a 0 to 100 metric. The five items are summed and the total scores range from 0-500, with higher scores signifying more severe symptoms \[mild (\<175), moderate (175-300), severe (\>300)\]. A decrease of 50 points on the IBS-SSS is considered clinically significant.
Outcome measures
| Measure |
MC-CBT
n=131 Participants
Self Administered Cognitive Behavior Therapy
Self Administered Cognitive Behavior Therapy: This 4 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
|
Standard-CBT
n=125 Participants
Therapist Administered Cognitive Behavior Therapy
Therapist Administered Cognitive Behavior Therapy: This 10 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
|
Education/Support
n=133 Participants
Behavioral Patient Education/Counseling
Behavioral Education and Supportive Therapy: This 4 session treatment aims at controlling symptoms through support and the provision of information about IBS symptoms, how it is diagnosed, its causes, and treatment options and a collaborative, relationship between the patient and doctor
|
|---|---|---|---|
|
Change From Baseline on the IBS Symptom Severity Scale (IBS-SSS)
Change from Baseline to 2-Week Follow-Up
|
-89.4 units on a scale
Standard Deviation 17.0
|
81.0 units on a scale
Standard Deviation 17.0
|
84.4 units on a scale
Standard Deviation 14.6
|
|
Change From Baseline on the IBS Symptom Severity Scale (IBS-SSS)
Change from Baseline to 3-Month Follow-Up
|
-105.9 units on a scale
Standard Deviation 17.7
|
-103.2 units on a scale
Standard Deviation 16.4
|
-88.5 units on a scale
Standard Deviation 14.6
|
|
Change From Baseline on the IBS Symptom Severity Scale (IBS-SSS)
Change from Baseline to 6-Month Follow-Up
|
-111.3 units on a scale
Standard Deviation 17.9
|
-103.5 units on a scale
Standard Deviation 17.7
|
-97.93 units on a scale
Standard Deviation 15.4
|
|
Change From Baseline on the IBS Symptom Severity Scale (IBS-SSS)
Change from Baseline to 9-Month Follow-Up
|
-111.2 units on a scale
Standard Deviation 17.7
|
-104.6 units on a scale
Standard Deviation 17.0
|
-94.9 units on a scale
Standard Deviation 17.1
|
|
Change From Baseline on the IBS Symptom Severity Scale (IBS-SSS)
Change from Baseline to 12-Month Follow-Up
|
-120.1 units on a scale
Standard Deviation 17.9
|
-112.9 units on a scale
Standard Deviation 18.4
|
-103.4 units on a scale
Standard Deviation 18.6
|
SECONDARY outcome
Timeframe: 2-Week Follow-UpPopulation: Per protocol
The CSQ is an 8-item questionnaire that measures patient satisfaction with treatment. Scores range from 8 to 32 with higher scores indicating greater satisfaction with treatment.
Outcome measures
| Measure |
MC-CBT
n=129 Participants
Self Administered Cognitive Behavior Therapy
Self Administered Cognitive Behavior Therapy: This 4 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
|
Standard-CBT
n=123 Participants
Therapist Administered Cognitive Behavior Therapy
Therapist Administered Cognitive Behavior Therapy: This 10 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
|
Education/Support
n=130 Participants
Behavioral Patient Education/Counseling
Behavioral Education and Supportive Therapy: This 4 session treatment aims at controlling symptoms through support and the provision of information about IBS symptoms, how it is diagnosed, its causes, and treatment options and a collaborative, relationship between the patient and doctor
|
|---|---|---|---|
|
Client Satisfaction Questionnaire (CSQ)
|
28.9 units on a scale
Interval 28.3 to 29.5
|
28.4 units on a scale
Interval 27.7 to 29.1
|
26.6 units on a scale
Interval 25.7 to 27.5
|
Adverse Events
MC-CBT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard-CBT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Education/Support
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MC-CBT
n=145 participants at risk
Self Administered Cognitive Behavior Therapy
Self Administered Cognitive Behavior Therapy: This 4 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
|
Standard-CBT
n=146 participants at risk
Therapist Administered Cognitive Behavior Therapy
Therapist Administered Cognitive Behavior Therapy: This 10 session treatment is aimed at controlling symptoms by changing specific behaviors found to aggravate IBS
|
Education/Support
n=145 participants at risk
Behavioral Patient Education/Counseling
Behavioral Education and Supportive Therapy: This 4 session treatment aims at controlling symptoms through support and the provision of information about IBS symptoms, how it is diagnosed, its causes, and treatment options and a collaborative, relationship between the patient and doctor
|
|---|---|---|---|
|
Social circumstances
Attempted suicide
|
0.00%
0/145 • 1 year
|
0.00%
0/146 • 1 year
|
0.69%
1/145 • Number of events 1 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place