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Transdiagnostic CBT for Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03810456
Recruitment Status : Active, not recruiting
First Posted : January 18, 2019
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Behavioral: Intensive Cognitive Behavior Therapy (iCBT) Behavioral: Standard Cognitive Behavior Therapy (sCBT) Phase 2 Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description: Persons completing follow-up assessments will be masked to the conditions to which patients were randomized.
Primary Purpose: Treatment
Official Title: Improving Veteran Functioning With Intensive Transdiagnostic CBT for Anxiety
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : August 31, 2021
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: iCBT
Patients in this arm will receive transdiagnostic CBT delivered in an intensive format over one weekend.
 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.
Active Comparator: sCBT
Patients in this arm will receive transdiagnostic CBT delivered in a standard weekly format for 12 weeks.
 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.
No Intervention: TAU
Patients in this arm will not receive transdiagnostic CBT but will receive treatment as usual.


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline Community Reintegration of Injured Service Members (CRIS) at 6 month follow-up [ Time Frame: 6-month follow-up ]
    The CRIS is a commonly used measure of community reintegration in service members following deployment. Three scales assess the extent of participation, perceived limitations in participation, and satisfaction with community reintegration. Scores on each subscale range from 10 - 70, with higher scores indicating higher degrees of community reintegration.

  2. Change from Baseline Short Form -12 Health Survey (SF-12) at 6 month follow-up [ Time Frame: 6-month follow-up ]
    The SF-12 measures eight domains related to physical and mental health, health perceptions, and the impact of physical or emotional problems on general functioning via self-report. Raw scores on the SF-12 range from 0-100, with higher scores reflecting higher levels of overall health and well-being.


Secondary Outcome Measures :
  1. Change from Baseline Beck Anxiety Inventory (BAI) at 6 month follow-up [ Time Frame: 6-month follow-up ]
    The 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.

  2. Change from Baseline Beck Depression Inventory - Second Edition (BDI-II) at 6 month follow-up [ Time Frame: 6-month follow-up ]
    The 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810456


Locations
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United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Ellen Teng, PhD Michael E. DeBakey VA Medical Center, Houston, TX
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03810456    
Other Study ID Numbers: D2160-R
5I01RX002160-02 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Cognitive Behavior Therapy
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders