A Phase 2/3 interventional study of Intensive Cognitive Behavior Therapy (iCBT) and Standard Cognitive Behavior Therapy (sCBT) in Anxiety Disorders, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-28.
Sponsored by VA Office of Research and Development · Phase 2/3, Interventional, and Treatment
This study is a randomized controlled trial examining the effectiveness of a transdiagnostic cognitive behavioral treatment (CBT) in improving Veterans' community reintegration and quality of life. Veterans with anxiety-based disorders, including posttraumatic stress, panic, social anxiety, and generalized anxiety disorders (with or without co-occurring depression) will be randomized to an intensive CBT (iCBT) treatment delivered over one weekend, standard CBT (sCBT) delivered over 12 weeks or treatment as usual (TAU). The study will also evaluate the potential of the compressed weekend format of iCBT in producing more rapid improvement in outcomes and increasing psychotherapy engagement compared with a standard psychotherapy format. Qualitative interviews will be conducted with Veterans who receive iCBT and their family members to examine how iCBT and environmental factors impacted their process of recovery.
The current project proposes to evaluate a brief but intensive transdiagnostic CBT that simultaneously targets multiple anxiety disorders with or without co-occurring depression. This will be accomplished by evaluating an innovative treatment delivery method that directly addresses barriers associated with standard psychotherapy delivery. The main objectives are to (1) determine if an intensive CBT protocol (iCBT) delivered over one weekend can improve community reintegration, quality of life, and emotional functioning compared with standard CBT (sCBT) and treatment as usual (TAU); (2) examine the rates of psychotherapy engagement in iCBT compared with sCBT; and (3) obtain a deeper understanding, through qualitative interviews with Veterans and their family members, of how iCBT and environmental factors may impact the process of reintegration and quality of life.
The proposed study is a randomized controlled trial with 3 treatment arms. A transdiagnostic group CBT protocol will be compared in a compressed weekend format (iCBT) with a standard group delivery format involving 3 months of weekly sessions (sCBT). A treatment as usual (TAU) condition will be included to compare outcomes. Veterans with one or more anxiety-based disorder(s) (with or without co-occurring depression) will be randomized to one of the three treatment arms. Veterans will be asked to attend a total of four assessments during the study including a baseline evaluation, 1-month, 3-month, and 6-month follow-ups. Qualitative interviews will be conducted with Veterans who completed iCBT and family members.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 359 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
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Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
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Exclusion Criteria:
Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.
Behavioral: Intensive Cognitive Behavior Therapy (iCBT)
Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.
Behavioral: Standard Cognitive Behavior Therapy (sCBT)
Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.
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.
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.
CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
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.
Time frame: Baseline, 1 Month, 3 Month, 6 Month Follow Ups
CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
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.
Time frame: Baseline, 1 Month, 3 Month, 6 Month Follow Ups
CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
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.
Time frame: Baseline, 1 Month, 3 Month, 6 Month Follow Ups
BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
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.
Time frame: Baseline, 1 Month, 3 Month, 6 Month Follow Ups
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
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.
Time frame: Baseline, 1 Month, 3 Month, 6 Month Follow Ups
BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
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.
Time frame: Baseline, 1 Month, 3 Month, 6 Month Follow Ups
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.
| Milestone | iCBT (Intensive Cognitive Behavioral Therapy) | sCBT (Standard Cognitive Behavioral Therapy) | TAU (Treatment as Usual) |
|---|---|---|---|
| Started | 99 | 99 | 67 |
| Completed | 69 | 79 | 67 |
| Not completed | 30 | 20 | 0 |
| Milestone | iCBT (Intensive Cognitive Behavioral Therapy) | sCBT (Standard Cognitive Behavioral Therapy) | TAU (Treatment as Usual) |
|---|---|---|---|
| Started | 69 | 79 | 67 |
| Completed | 66 | 55 | 67 |
| Not completed | 3 | 24 | 0 |
| Withdrew: Urgent family matters | 3 | 0 | 0 |
| Withdrew: Scheduling conflicts | 0 | 11 | 0 |
| Withdrew: No longer interested | 0 | 12 | 0 |
| Withdrew: Transportation issues | 0 | 1 | 0 |
| Milestone | iCBT (Intensive Cognitive Behavioral Therapy) | sCBT (Standard Cognitive Behavioral Therapy) | TAU (Treatment as Usual) |
|---|---|---|---|
| Started | 66 | 55 | 67 |
| Completed | 57 | 51 | 51 |
| Not completed | 9 | 4 | 16 |
| Withdrew: Lost to follow-up | 7 | 4 | 15 |
| Withdrew: Relocated to different state | 1 | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Milestone | iCBT (Intensive Cognitive Behavioral Therapy) | sCBT (Standard Cognitive Behavioral Therapy) | TAU (Treatment as Usual) |
|---|---|---|---|
| Started | 66 | 55 | 67 |
| Completed | 54 | 44 | 53 |
| Not completed | 12 | 11 | 14 |
| Withdrew: Lost to follow-up | 11 | 11 | 14 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Milestone | iCBT (Intensive Cognitive Behavioral Therapy) | sCBT (Standard Cognitive Behavioral Therapy) | TAU (Treatment as Usual) |
|---|---|---|---|
| Started | 66 | 55 | 67 |
| Completed | 53 | 46 | 49 |
| Not completed | 13 | 9 | 18 |
| Withdrew: Lost to follow-up | 12 | 9 | 18 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
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.
| score on a scale | iCBT (Intensive Cognitive Behavioral Therapy) | sCBT (Standard Cognitive Behavioral Therapy) | TAU (Treatment as Usual) |
|---|---|---|---|
| Baseline | 4.21 ± 0.7 | 4.18 ± 0.6 | 4.17 ± 0.8 |
| 1 Month Follow Up | 4.52 ± 0.9 | 4.44 ± .8 | 4.18 ± 0.8 |
| 3 Month Follow Up | 4.57 ± .7 | 4.54 ± .9 | 4.34 ± 0.8 |
| 6 Month Follow Up | 4.70 ± 0.7 | 4.52 ± 0.8 | 4.36 ± 0.8 |
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.
| score on a scale | iCBT (Intensive Cognitive Behavioral Therapy) | sCBT (Standard Cognitive Behavioral Therapy) | TAU (Treatment as Usual) |
|---|---|---|---|
| Baseline | 4.40 ± 0.8 | 4.34 ± 0.7 | 4.36 ± 0.9 |
| 1 Month Follow Up | 4.52 ± 0.9 | 4.44 ± 0.8 | 4.18 ± 0.8 |
| 3 Month Follow Up | 4.86 ± 0.9 | 4.52 ± 0.9 | 4.40 ± 0.9 |
| 6 Month Follow Up | 4.70 ± 0.7 | 4.52 ± 0.8 | 4.36 ± 0.8 |
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.
| score on a scale | iCBT (Intensive Cognitive Behavioral Therapy) | sCBT (Standard Cognitive Behavioral Therapy) | TAU (Treatment as Usual) |
|---|---|---|---|
| Baseline | 4.28 ± 1.0 | 4.26 ± 1.2 | 4.15 ± 1.0 |
| 1 Month Follow Up | 4.80 ± 1.1 | 4.51 ± 1.0 | 4.31 ± 1.0 |
| 3 Month Follow Up | 4.86 ± 0.9 | 4.60 ± 1.0 | 4.40 ± 0.9 |
| 6 Month Follow Up | 4.96 ± 0.8 | 4.63 ± 1.0 | 4.45 ± 0.9 |
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.
| score on a scale | iCBT (Intensive Cognitive Behavioral Therapy) | sCBT (Standard Cognitive Behavioral Therapy) | TAU (Treatment as Usual) |
|---|---|---|---|
| Baseline | 31.8 ± 11.2 | 31.7 ± 10.9 | 32.0 ± 12.1 |
| 1 Month Follow Up | 24.0 ± 12.6 | 25.9 ± 10.3 | 26.3 ± 12.6 |
| 3 Month Follow Up | 24.3 ± 12.2 | 25.6 ± 11.8 | 26.7 ± 12.4 |
| 6 Month Follow Up | 21.6 ± 11.6 | 24.1 ± 11.4 | 27.0 ± 12.1 |
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.
| score on a scale | iCBT (Intensive Cognitive Behavioral Therapy) | sCBT (Standard Cognitive Behavioral Therapy) | TAU (Treatment as Usual) |
|---|---|---|---|
| Baseline | 34.4 ± 7.0 | 34.8 ± 5.5 | 33.6 ± 7.0 |
| 1 Month Follow Up | 42.9 ± 9.7 | 40.7 ± 8.4 | 37.4 ± 8.3 |
| 3 Month Follow Up | 42.9 ± 10.6 | 42.0 ± 8.9 | 38.3 ± 9.6 |
| 6 Month Follow Up | 43.7 ± 10.1 | 42.5 ± 8.8 | 38.0 ± 8.0 |
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.
| score on a scale | iCBT (Intensive Cognitive Behavioral Therapy) | sCBT (Standard Cognitive Behavioral Therapy) | TAU (Treatment as Usual) |
|---|---|---|---|
| Baseline | 31.0 ± 10.7 | 31.0 ± 10.6 | 32.7 ± 11.1 |
| 1 Month Follow Up | 23.5 ± 13.4 | 24.6 ± 11.8 | 29.8 ± 12.9 |
| 3 Month Follow Up | 25.1 ± 12.7 | 24.8 ± 13.2 | 28.5 ± 13.1 |
| 6 Month Follow Up | 22.5 ± 12.0 | 24.4 ± 13.5 | 28.8 ± 12.8 |
Collected over 3 years, 7 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| iCBT (Intensive Cognitive Behavioral Therapy) | 0/99 (0%) | 0/99 (0%) | 0/99 (0%) |
| sCBT (Standard Cognitive Behavioral Therapy) | 0/98 (0%) | 0/98 (0%) | 0/98 (0%) |
| TAU (Treatment as Usual) | 0/67 (0%) | 0/67 (0%) | 0/67 (0%) |
One participant randomized to the sCBT arm was excluded from analyses due to not meeting study inclusion criteria.
| Age, Continuous(Years) | iCBT (Intensive Cognitive Behavioral Therapy) | sCBT (Standard Cognitive Behavioral Therapy) | TAU (Treatment a Usual) | Total |
|---|---|---|---|---|
| Mean | 42.7 ± 11.2 | 43.9 ± 12.2 | 43.6 ± 11.9 | 43.4 ± 11.7 |
| Sex: Female, Male(Participants) | iCBT (Intensive Cognitive Behavioral Therapy) | sCBT (Standard Cognitive Behavioral Therapy) | TAU (Treatment a Usual) | Total |
|---|---|---|---|---|
| Female | 35 | 34 | 23 | 92 |
| Male | 64 | 64 | 44 | 172 |
| Ethnicity (NIH/OMB)(Participants) | iCBT (Intensive Cognitive Behavioral Therapy) | sCBT (Standard Cognitive Behavioral Therapy) | TAU (Treatment a Usual) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 25 | 24 | 14 | 63 |
| Not Hispanic or Latino | 73 | 72 | 50 | 195 |
| Unknown or Not Reported | 1 | 2 | 3 | 6 |
| Race (NIH/OMB)(Participants) | iCBT (Intensive Cognitive Behavioral Therapy) | sCBT (Standard Cognitive Behavioral Therapy) | TAU (Treatment a Usual) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 2 | 2 | 0 | 4 |
| Asian | 2 | 3 | 0 | 5 |
| Native Hawaiian or Other Pacific Islander | 6 | 1 | 0 | 7 |
| Black or African American | 46 | 46 | 37 | 129 |
| White | 35 | 36 | 24 | 95 |
| More than one race | 5 | 6 | 2 | 13 |
| Unknown or Not Reported | 3 | 4 | 4 | 11 |
| Region of Enrollment(Participants) | iCBT (Intensive Cognitive Behavioral Therapy) | sCBT (Standard Cognitive Behavioral Therapy) | TAU (Treatment a Usual) | Total |
|---|---|---|---|---|
| United States | 99 | 98 | 67 | 264 |
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