Transdiagnostic Cognitive Behavioral Treatment for Anxiety

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Improving Veteran Functioning With Intensive Transdiagnostic CBT for Anxiety

ClinicalTrials.gov ID

NCT03810456

Acronym / sponsor ID

D2160-R

Conditions

Anxiety Disorders

Keywords

Cognitive Behavior Therapy

Phase

Phase 2/3

Study type

Interventional

Recruitment status

Completed

Enrolment

359 participants (actual)

Lead sponsor

VA Office of Research and DevelopmentUS federal agency

Study start

1 Aug 2018 (actual)

Primary completion

31 Aug 2021 (actual)

Study completion

31 Aug 2022 (actual)

First posted

18 Jan 2019 (actual)

Results

Posted 28 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Single blind (outcomes assessor)

Number of arms

3

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.

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. CRIS-EPS: Comparison of Extent of Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups

   Time frame: Baseline, 1 Month, 3 Month, 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.

2. CRIS-PLS: Comparison of Perceived Limitation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups

   Time frame: Baseline, 1 Month, 3 Month, 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.

3. CRIS-SPS: Comparison of Satisfaction With Participation Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups

   Time frame: Baseline, 1 Month, 3 Month, 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.

4. BAI: Comparison of Beck Anxiety Inventory Scores Among iCBT, sCBT, and TAU Groups From Baseline to 1, 3, and 6 Month Follow Ups

   Time frame: Baseline, 1 Month, 3 Month, 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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

1 site in 1 country: see every site and its status.