Transdiagnostic Behavior Therapy Vs TAU for Adjustment Disorder Following Traumatic Event Exposure

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06433271
Status
Recruiting
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Conditions

  • Adjustment Disorders
  • Mental Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transdiagnostic Behavior Therapy (TBT) — BEHAVIORAL
    TBT manualized treatment incorporates daily exposure exercises from up to four categories of avoidance that are most characteristic of the emotional disorders (i.e., situational, interoceptive, imaginal, and positive emotional).
  • Treatment as Usual-Problem Solving Therapy (TAU-PST) — BEHAVIORAL
    PST is an evidence- based psychotherapy implemented in VA Primary Care - Mental Health Integration (PC-MHI), with hundreds of VA providers trained in the intervention nationally. The primary aim of PST is to improve a patient's ability to cope with stressful events by adopting an adaptive perspective to stressors and using goal-focused, problem-solving behaviors to manage the problems associated with the stressors.

Study Details

Adjustment Disorder (AjD) is the most common mental health condition diagnosed in Active Duty personnel, and is diagnosed following an extreme stress event such as traumatic loss of a comrade, serious accident or injury, or other intense stress event. Despite its high prevalence, no evidence based treatment for AjD has been subjected to randomized controlled trials. This study seeks to build on the research team's pilot work across several disorders study to benefit service members and Veterans with AjD, a highly prevalent but frequently inadequately treated condition. The investigators will compare the effects of Transdiagnostic Behavior Therapy (TBT) vs treatment as usual which is Moving Forward Problem Solving Therapy (TAU-PST) on AjD symptom outcomes. The investigators hypothesize that TBT will result in greater overall symptom reduction compared to TAU-PST.

Key Dates

Start date
Oct 8, 2024
Status verified
Dec 2024
Primary completion
Jul 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Transdiagnostic Behavior Therapy (TBT)
    Participants will receive 6, 30-45-minute, manualized, individual therapy sessions.
  • Active Comparator: Active Comparator: Treatment as Usual-Problem Solving Therapy (TAU-PST)
    Participants will receive 6, 30-45-minute, manualized, individual therapy sessions.

Primary Outcome Measure

Adjustment Disorder New Module Self Report [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ralph H. Johnson VA Health Care SystemCharlestonSouth Carolina29401
Stephanie M Hart, MPH
[email protected]
8433015799
Michelle Pompei, MPH
[email protected]
843-471-4751
Ron Acierno, PhD
Daniel Gros, PhD

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By research site
Ralph H. Johnson VA Health Care System· Charleston, SC

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