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Transdiagnostic Cognitive Behavioral Treatment for Anxiety

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intensive Cognitive Behavior Therapy (iCBT)
Standard Cognitive Behavior Therapy (sCBT)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Cognitive Behavior Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Michael E. DeBakey VA Medical Center, Houston, TX

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

iCBT

sCBT

TAU

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 16, 2019
Last Updated
October 7, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03810456
Brief Title
Transdiagnostic Cognitive Behavioral Treatment for Anxiety
Official Title
Improving Veteran Functioning With Intensive Transdiagnostic CBT for Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Cognitive Behavior Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
Persons completing follow-up assessments will be masked to the conditions to which patients were randomized.
Allocation
Randomized
Enrollment
359 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iCBT
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.
Arm Title
sCBT
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.
Arm Title
TAU
Arm Type
No Intervention
Arm Description
Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Cognitive Behavior Therapy (iCBT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Cognitive Behavior Therapy (sCBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
Description
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
Title
CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
Description
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
Title
CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
Description
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
Title
BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
Description
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
Secondary Outcome Measure Information:
Title
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
Description
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
Title
BDI-II: Comparison of Beck Depression Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Teng, PhD
Organizational Affiliation
Michael E. DeBakey VA Medical Center, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Transdiagnostic Cognitive Behavioral Treatment for Anxiety

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