Transdiagnostic Cognitive Behavioral Treatment for Anxiety

Anxiety Disorders Clinical Trial

Official title:

Improving Veteran Functioning With Intensive Transdiagnostic CBT for Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810456
• Other study ID #: D2160-R
• Secondary ID: 5I01RX002160-02
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 1, 2018
• Est. completion date: August 31, 2022

Study information

• Verified date: October 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 359
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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.	Baseline, 1 Month, 3 Month, 6 Month Follow Ups
Primary	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.	Baseline, 1 Month, 3 Month, 6 Month Follow Ups
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	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.	Baseline, 1 Month, 3 Month, 6 Month Follow Ups
Primary	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.	Baseline, 1 Month, 3 Month, 6 Month Follow Ups
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	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.	Baseline, 1 Month, 3 Month, 6 Month Follow Ups
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	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.	Baseline, 1 Month, 3 Month, 6 Month Follow Ups