Phase 3
N=265
Transdiagnostic Cognitive Behavioral Treatment for Anxiety
Anxiety Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03810456 ↗Enrolled (actual)
265
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups — 4.21; 4.18; 4.17; 4.52 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Intensive Cognitive Behavior Therapy (iCBT) (Behavioral); Standard Cognitive Behavior Therapy (sCBT) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups |
4.21; 4.18; 4.17; 4.52; 4.44; 4.18 | — |
| PRIMARY CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups |
4.40; 4.34; 4.36; 4.52; 4.44; 4.18 | — |
| PRIMARY CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups |
4.28; 4.26; 4.15; 4.80; 4.51; 4.31 | — |
| PRIMARY BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups |
31.8; 31.7; 32.0; 24.0; 25.9; 26.3 | — |
| SECONDARY 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 |
34.4; 34.8; 33.6; 42.9; 40.7; 37.4 | — |
| SECONDARY BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups |
31.0; 31.0; 32.7; 23.5; 24.6; 29.8 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Veterans enrolled to receive VA medical care
- Current diagnosis of at least one anxiety-based disorder
- Moderate-to-poor life enjoyment and satisfaction
- Stable on psychotropic medication 4 weeks prior to participation
- Willing to be randomized to treatment condition
Exclusion Criteria
- Active symptoms of mania or psychosis at baseline
- Depression with active suicidal ideation/intent
- Moderate-to-severe cognitive impairment
- Active drug/alcohol abuse during initial 3 months of study enrollment
- Undergoing concurrent transdiagnostic CBT for anxiety
Data sourced from ClinicalTrials.gov (NCT03810456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.