Transdiagnostic Cognitive Behavioral Treatment for Anxiety

NCT03810456 | Completed Phase 2 Results

• 2 other identifiers: D2160-R5I01RX002160-02
• Study Type: interventional
• Target: 359
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety Disorders

Keywords

Cognitive Behavior Therapy

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• 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, 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

  Baseline, 1 Month, 3 Month, 6 Month Follow Ups

Study Arms (3)

iCBT

ACTIVE COMPARATOR

Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.

Behavioral: Intensive Cognitive Behavior Therapy (iCBT)

sCBT

ACTIVE COMPARATOR

Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.

Behavioral: Standard Cognitive Behavior Therapy (sCBT)

TAU

NO INTERVENTION

Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.

Interventions

Intensive Cognitive Behavior Therapy (iCBT) BEHAVIORAL

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.

iCBT

Standard Cognitive Behavior Therapy (sCBT) BEHAVIORAL

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.

sCBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Limitations and Caveats

Due to the COVID-19 pandemic, all research was placed on hold for several months. All study procedures for this project had to be converted to virtual telehealth delivery. This change in modality (including intervention delivery) may have impacted study outcomes and resulted in underpowered analyses.

Results Point of Contact

• Title: Dr. Ellen Teng
• Organization: Michael E. DeBakey VA Medical Center

Ellen.Teng@va.gov

(713) 578-5513

Study Officials

• Ellen Teng, PhD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Persons completing follow-up assessments will be masked to the conditions to which patients were randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 18, 2019
• Study Start: August 1, 2018
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2022
• Last Updated: August 28, 2023
• Results First Posted: August 28, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)