Recruiting

TBT vs. TAU-PST

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06433271

Conditions

Adjustment Disorders

Mental Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transdiagnostic Behavior Therapy (TBT)

Treatment as Usual-Problem Solving Therapy (TAU-PST)

Study Details

Brief summary:

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.

Conditions

Adjustment Disorders

Mental Disorder

Study ID

NCT06433271

Start date

Oct 8, 2024

Status verified date

Dec, 2024

Completion date

Jan, 2029

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult male or female over the age of 18 that has served, or is currently serving, in the military.
  • Stable psychotropic medication for at least 4 weeks if applicable
  • Current DSM-5 diagnosis of Adjustment Disorder

Exclusion Criteria:

  • Active psychosis
  • Suicidal ideation with clear intent
  • Severe substance use

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Transdiagnostic Behavior Therapy (TBT)

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)

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.

Primary outcome measure

  • Adjustment Disorder New Module Self Report [ Time Frame: Baseline ]
  • Adjustment Disorder New Module Self Report [ Time Frame: 1 week post treatment ]
  • Adjustment Disorder New Module Self Report [ Time Frame: 3 months post treatment ]
  • Adjustment Disorder New Module Self Report [ Time Frame: 6 months post treatment ]
  • Generalized Anxiety Disorder Questionnaire - 7 [ Time Frame: Baseline ]
  • Generalized Anxiety Disorder Questionnaire - 7 [ Time Frame: 1 week post treatment ]
  • Generalized Anxiety Disorder Questionnaire - 7 [ Time Frame: 3 months post treatment ]
  • Generalized Anxiety Disorder Questionnaire - 7 [ Time Frame: 6 months post treatment ]
  • Patient Health Questionnaire-9 [ Time Frame: Baseline ]
  • Patient Health Questionnaire-9 [ Time Frame: 1 week post treatment ]
  • Patient Health Questionnaire-9 [ Time Frame: 3 months post treatment ]
  • Patient Health Questionnaire-9 [ Time Frame: 6 months post treatment ]

Central Contacts and Locations

Central contacts

Stephanie M Hart, MPH

8435775011stephanie.hart4@va.gov

Locations

Ralph H. Johnson VA Health Care System

Recruiting

Charleston, South Carolina, United States, 29401

Contacts

Stephanie M Hart, MPH

8433015799stephanie.hart4@va.gov

Michelle Pompei, MPH

843-471-4751michelle.pompei@va.gov

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Dec 6, 2024

Last verified

Dec, 2024

Keywords

  • Veterans
  • Military Personnel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2024-12-06.