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

The University of Texas System (UT)

Status: Enrolling

Conditions: Mental Disorder; Adjustment Disorders

Treatments: Behavioral: Treatment as Usual-Problem Solving Therapy (TAU-PST); Behavioral: Transdiagnostic Behavior Therapy (TBT)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06433271

PR230007 (Other Grant/Funding Number)

Pro00134707

Details and patient eligibility

About

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.

Full description

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.

Currently, the VA suggests a problem solving cognitive behavioral therapy, but this recommendation is not based on replicated, randomized controlled trials. Transdiagnostic Behavior Therapy (TBT), is based on key 'active components' of existing evidence based treatments such as Prolonged Exposure and Behavioral Activation, has been designed by this research team to be easily trained and inexpensively disseminated, and has been evaluated in a series of pilots with anxiety and depression disorders that, importantly, represent the key symptom classes of adjustment disorder.

Thus, the rationale for the proposed trial is that the research team has done preliminary efficacy testing of an easily exportable intervention that has impact on the key symptoms of adjustment disorder, and the standard of evidence demands replicated, randomized controlled trials to determine if initial signals of positive effect are sustained.

The study will use a 2 group repeated measures randomized controlled design to evaluate effectiveness of TBT for AjD compared to treatment as usual (TAU-PST). Participants will be randomly assigned in equal numbers (n = 75; N = 150) to one of two treatment arms: (1) TBT or (2) TAU-PST. Participants assigned to TBT will receive 6, 30-45-minute, manualized, individual therapy sessions. Participants assigned to TAU-PST will receive 6, 30-45-minute sessions of Problem-Solving Therapy. Dependent measures will include Department of Defense (DoD) specified common data elements and specific measures of AjD, PTSD, anxiety, depression, and functioning collected by blinded assessors at baseline, post-treatment, 3-month, and 6-month follow-up.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Transdiagnostic Behavior Therapy (TBT)

Experimental group

Description:

Participants will receive 6, 30-45-minute, manualized, individual therapy sessions.

Treatment:

Behavioral: Transdiagnostic Behavior Therapy (TBT)

Active Comparator: Treatment as Usual-Problem Solving Therapy (TAU-PST)

Active Comparator group

Description:

Participants will receive 6, 30-45-minute, manualized, individual therapy sessions.

Treatment:

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