Trial Outcomes & Findings for Transdiagnostic Cognitive Behavioral Treatment for Anxiety (NCT NCT03810456)
NCT ID: NCT03810456
Last Updated: 2023-08-28
Results Overview
The Community Reintegration of Service Members (CRIS) is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Extent of Participation Subscale (EPS) asks how often an individual experiences/participates in specific activities. Scores on this subscale range from 1 - 7, with higher scores indicating greater degrees of participation in life roles.
COMPLETED
PHASE2/PHASE3
359 participants
Baseline, 1 Month, 3 Month, 6 Month Follow Ups
2023-08-28
Participant Flow
Veterans at the Michael E. DeBakey VA Medical Center and affiliated community based outpatient clinics were enrolled in this study from 08/1/2018 to 05/31/2021. Veterans were recruited through direct referrals and advertisements.
Enrolled participants were excluded from the study prior to randomization if they did not meet study inclusion criteria.
Participant milestones
| Measure |
iCBT (Intensive Cognitive Behavioral Therapy)
Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.
Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
|
sCBT (Standard Cognitive Behavioral Therapy)
Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.
Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
|
TAU (Treatment as Usual)
Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.
|
|---|---|---|---|
|
Enrolled and Randomized
STARTED
|
99
|
99
|
67
|
|
Enrolled and Randomized
COMPLETED
|
69
|
79
|
67
|
|
Enrolled and Randomized
NOT COMPLETED
|
30
|
20
|
0
|
|
Treatment
STARTED
|
69
|
79
|
67
|
|
Treatment
COMPLETED
|
66
|
55
|
67
|
|
Treatment
NOT COMPLETED
|
3
|
24
|
0
|
|
1 Month Follow-Up
STARTED
|
66
|
55
|
67
|
|
1 Month Follow-Up
COMPLETED
|
57
|
51
|
51
|
|
1 Month Follow-Up
NOT COMPLETED
|
9
|
4
|
16
|
|
3 Month Follow-Up
STARTED
|
66
|
55
|
67
|
|
3 Month Follow-Up
COMPLETED
|
54
|
44
|
53
|
|
3 Month Follow-Up
NOT COMPLETED
|
12
|
11
|
14
|
|
6 Month Follow-Up
STARTED
|
66
|
55
|
67
|
|
6 Month Follow-Up
COMPLETED
|
53
|
46
|
49
|
|
6 Month Follow-Up
NOT COMPLETED
|
13
|
9
|
18
|
Reasons for withdrawal
| Measure |
iCBT (Intensive Cognitive Behavioral Therapy)
Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.
Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
|
sCBT (Standard Cognitive Behavioral Therapy)
Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.
Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
|
TAU (Treatment as Usual)
Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.
|
|---|---|---|---|
|
Treatment
Urgent Family Matters
|
3
|
0
|
0
|
|
Treatment
Scheduling Conflicts
|
0
|
11
|
0
|
|
Treatment
No Longer Interested
|
0
|
12
|
0
|
|
Treatment
Transportation Issues
|
0
|
1
|
0
|
|
1 Month Follow-Up
Lost to Follow-up
|
7
|
4
|
15
|
|
1 Month Follow-Up
Relocated to Different State
|
1
|
0
|
1
|
|
1 Month Follow-Up
Withdrawal by Subject
|
1
|
0
|
0
|
|
3 Month Follow-Up
Lost to Follow-up
|
11
|
11
|
14
|
|
3 Month Follow-Up
Withdrawal by Subject
|
1
|
0
|
0
|
|
6 Month Follow-Up
Lost to Follow-up
|
12
|
9
|
18
|
|
6 Month Follow-Up
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Transdiagnostic Cognitive Behavioral Treatment for Anxiety
Baseline characteristics by cohort
| Measure |
iCBT (Intensive Cognitive Behavioral Therapy)
n=99 Participants
Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.
Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
|
sCBT (Standard Cognitive Behavioral Therapy)
n=98 Participants
Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.
Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
|
TAU (Treatment a Usual)
n=67 Participants
Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.
|
Total
n=264 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.7 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
43.9 Years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
43.6 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
43.4 Years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
172 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
195 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
99 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
264 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 Month, 3 Month, 6 Month Follow UpsPopulation: The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.
The Community Reintegration of Service Members (CRIS) is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Extent of Participation Subscale (EPS) asks how often an individual experiences/participates in specific activities. Scores on this subscale range from 1 - 7, with higher scores indicating greater degrees of participation in life roles.
Outcome measures
| Measure |
sCBT (Standard Cognitive Behavioral Therapy)
n=98 Participants
Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.
Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
|
TAU (Treatment as Usual)
n=67 Participants
Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.
|
iCBT (Intensive Cognitive Behavioral Therapy)
n=99 Participants
Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.
Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
|
|---|---|---|---|
|
CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
1 Month Follow Up
|
4.44 score on a scale
Standard Deviation .8
|
4.18 score on a scale
Standard Deviation 0.8
|
4.52 score on a scale
Standard Deviation 0.9
|
|
CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
3 Month Follow Up
|
4.54 score on a scale
Standard Deviation .9
|
4.34 score on a scale
Standard Deviation 0.8
|
4.57 score on a scale
Standard Deviation .7
|
|
CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
6 Month Follow Up
|
4.52 score on a scale
Standard Deviation 0.8
|
4.36 score on a scale
Standard Deviation 0.8
|
4.70 score on a scale
Standard Deviation 0.7
|
|
CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
Baseline
|
4.18 score on a scale
Standard Deviation 0.6
|
4.17 score on a scale
Standard Deviation 0.8
|
4.21 score on a scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Baseline, 1 Month, 3 Month, 6 Month Follow UpsPopulation: The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.
The Community Reintegration in Service Members (CRIS) scale is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Perceived Limitations Subscale (PLS) asks an individual their perceived limitations in participation. Scores on this subscale range from 1 - 7, with higher scores indicating fewer limitations in participation.
Outcome measures
| Measure |
sCBT (Standard Cognitive Behavioral Therapy)
n=98 Participants
Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.
Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
|
TAU (Treatment as Usual)
n=67 Participants
Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.
|
iCBT (Intensive Cognitive Behavioral Therapy)
n=99 Participants
Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.
Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
|
|---|---|---|---|
|
CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
Baseline
|
4.34 score on a scale
Standard Deviation 0.7
|
4.36 score on a scale
Standard Deviation 0.9
|
4.40 score on a scale
Standard Deviation 0.8
|
|
CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
1 Month Follow Up
|
4.44 score on a scale
Standard Deviation 0.8
|
4.18 score on a scale
Standard Deviation 0.8
|
4.52 score on a scale
Standard Deviation 0.9
|
|
CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
3 Month Follow Up
|
4.52 score on a scale
Standard Deviation 0.9
|
4.40 score on a scale
Standard Deviation 0.9
|
4.86 score on a scale
Standard Deviation 0.9
|
|
CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
6 Month Follow Up
|
4.52 score on a scale
Standard Deviation 0.8
|
4.36 score on a scale
Standard Deviation 0.8
|
4.70 score on a scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Baseline, 1 Month, 3 Month, 6 Month Follow UpsPopulation: The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.
The Community Reintegration Service Members (CRIS) scale is a commonly used measure of community reintegration in service members and participation in life roles following deployment. The Satisfaction with Participation Subscale (SPS) asks an individual their degree of satisfaction with participation. Scores on this subscale range from 1 - 7, with higher scores indicating greater levels of satisfaction with their participation.
Outcome measures
| Measure |
sCBT (Standard Cognitive Behavioral Therapy)
n=98 Participants
Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.
Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
|
TAU (Treatment as Usual)
n=67 Participants
Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.
|
iCBT (Intensive Cognitive Behavioral Therapy)
n=99 Participants
Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.
Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
|
|---|---|---|---|
|
CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
Baseline
|
4.26 score on a scale
Standard Deviation 1.2
|
4.15 score on a scale
Standard Deviation 1.0
|
4.28 score on a scale
Standard Deviation 1.0
|
|
CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
1 Month Follow Up
|
4.51 score on a scale
Standard Deviation 1.0
|
4.31 score on a scale
Standard Deviation 1.0
|
4.80 score on a scale
Standard Deviation 1.1
|
|
CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
3 Month Follow Up
|
4.60 score on a scale
Standard Deviation 1.0
|
4.40 score on a scale
Standard Deviation 0.9
|
4.86 score on a scale
Standard Deviation 0.9
|
|
CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
6 Month Follow Up
|
4.63 score on a scale
Standard Deviation 1.0
|
4.45 score on a scale
Standard Deviation 0.9
|
4.96 score on a scale
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: Baseline, 1 Month, 3 Month, 6 Month Follow UpsPopulation: The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.
The Beck Anxiety Inventory (BAI) assesses the severity of anxiety symptoms across 21 items, minimizing those that overlap with depression. The BAI assesses cognitive and somatic components of anxiety. The cognitive subscale provides a measure of fearful thoughts and impaired cognitive functioning, whereas the somatic subscale measures the symptoms of physiological arousal. The total score on the BAI ranges from 0 - 63, with higher scores reflecting higher levels of anxiety.
Outcome measures
| Measure |
sCBT (Standard Cognitive Behavioral Therapy)
n=98 Participants
Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.
Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
|
TAU (Treatment as Usual)
n=67 Participants
Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.
|
iCBT (Intensive Cognitive Behavioral Therapy)
n=99 Participants
Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.
Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
|
|---|---|---|---|
|
BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
Baseline
|
31.7 score on a scale
Standard Deviation 10.9
|
32.0 score on a scale
Standard Deviation 12.1
|
31.8 score on a scale
Standard Deviation 11.2
|
|
BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
1 Month Follow Up
|
25.9 score on a scale
Standard Deviation 10.3
|
26.3 score on a scale
Standard Deviation 12.6
|
24.0 score on a scale
Standard Deviation 12.6
|
|
BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
3 Month Follow Up
|
25.6 score on a scale
Standard Deviation 11.8
|
26.7 score on a scale
Standard Deviation 12.4
|
24.3 score on a scale
Standard Deviation 12.2
|
|
BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
6 Month Follow Up
|
24.1 score on a scale
Standard Deviation 11.4
|
27.0 score on a scale
Standard Deviation 12.1
|
21.6 score on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Baseline, 1 Month, 3 Month, 6 Month Follow UpsPopulation: The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.
The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (QLES-Q-SF) measures subjective functioning and satisfaction across a range of life domains including work, leisure activities, social relationships, and physical health. Satisfaction scores on this measure range from 14 (very poor) to 70 (very good). Higher scores indicate greater overall life satisfaction/functioning.
Outcome measures
| Measure |
sCBT (Standard Cognitive Behavioral Therapy)
n=98 Participants
Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.
Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
|
TAU (Treatment as Usual)
n=67 Participants
Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.
|
iCBT (Intensive Cognitive Behavioral Therapy)
n=99 Participants
Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.
Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
|
|---|---|---|---|
|
QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
Baseline
|
34.8 score on a scale
Standard Deviation 5.5
|
33.6 score on a scale
Standard Deviation 7.0
|
34.4 score on a scale
Standard Deviation 7.0
|
|
QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
1 Month Follow Up
|
40.7 score on a scale
Standard Deviation 8.4
|
37.4 score on a scale
Standard Deviation 8.3
|
42.9 score on a scale
Standard Deviation 9.7
|
|
QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
3 Month Follow Up
|
42.0 score on a scale
Standard Deviation 8.9
|
38.3 score on a scale
Standard Deviation 9.6
|
42.9 score on a scale
Standard Deviation 10.6
|
|
QLES-SF: Comparison of Quality of Life Enjoyment and Satisfaction Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
6 Month Follow Up
|
42.5 score on a scale
Standard Deviation 8.8
|
38.0 score on a scale
Standard Deviation 8.0
|
43.7 score on a scale
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Baseline, 1 Month, 3 Month, 6 Month Follow UpsPopulation: The number of participants reported here differ from the numbers reported in the Participant Flow because some participants did not complete follow-up assessments at all time points. Also, some participants who completed a follow-up at a later time may not have completed a follow-up at an earlier time point.
The Beck Depression Inventory-II (BDI-II) is a well-validated 21-item measure that assesses symptoms of depression. The total score on the BDI-II ranges from 0 - 63, with higher scores reflecting higher levels of depression.
Outcome measures
| Measure |
sCBT (Standard Cognitive Behavioral Therapy)
n=98 Participants
Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.
Standard Cognitive Behavior Therapy (sCBT): Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
|
TAU (Treatment as Usual)
n=67 Participants
Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.
|
iCBT (Intensive Cognitive Behavioral Therapy)
n=99 Participants
Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.
Intensive Cognitive Behavior Therapy (iCBT): Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
|
|---|---|---|---|
|
BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
Baseline
|
31.0 score on a scale
Standard Deviation 10.6
|
32.7 score on a scale
Standard Deviation 11.1
|
31.0 score on a scale
Standard Deviation 10.7
|
|
BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
1 Month Follow Up
|
24.6 score on a scale
Standard Deviation 11.8
|
29.8 score on a scale
Standard Deviation 12.9
|
23.5 score on a scale
Standard Deviation 13.4
|
|
BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
3 Month Follow Up
|
24.8 score on a scale
Standard Deviation 13.2
|
28.5 score on a scale
Standard Deviation 13.1
|
25.1 score on a scale
Standard Deviation 12.7
|
|
BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
6 Month Follow Up
|
24.4 score on a scale
Standard Deviation 13.5
|
28.8 score on a scale
Standard Deviation 12.8
|
22.5 score on a scale
Standard Deviation 12.0
|
Adverse Events
iCBT (Intensive Cognitive Behavioral Therapy)
sCBT (Standard Cognitive Behavioral Therapy)
TAU (Treatment as Usual)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place