Transdiagnostic Cognitive Behavioral Treatment for Anxiety

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

359 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2022-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Persons completing follow-up assessments will be masked to the conditions to which patients were randomized.

Study Groups

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iCBT

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

Group Type ACTIVE_COMPARATOR

Intensive Cognitive Behavior Therapy (iCBT)

Intervention Type 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.

sCBT

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

Group Type ACTIVE_COMPARATOR

Standard Cognitive Behavior Therapy (sCBT)

Intervention Type 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.

TAU

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No