Clinical trial NCT06433271: Transdiagnostic Behavior Therapy Vs TAU for Adjustment Disorder Following Traumatic Event Exposure
Official title: Comparative Effectiveness of Transdiagnostic Behavior Therapy Vs TAU for Adjustment Disorder Following Traumatic Event Exposure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adjustment Disorders
Mental Disorder
Keywords: Veterans
Military Personnel
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Ralph H. Johnson VA Medical Center
name: U.S. Army Medical Research and Development Command
First posted: 2024-05-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Adjustment Disorder New Module Self Report
timeFrame: Baseline
measure: Adjustment Disorder New Module Self Report
timeFrame: 1 week post treatment
measure: Adjustment Disorder New Module Self Report
timeFrame: 3 months post treatment
measure: Adjustment Disorder New Module Self Report
timeFrame: 6 months post treatment
measure: Generalized Anxiety Disorder Questionnaire - 7
timeFrame: Baseline
measure: Generalized Anxiety Disorder Questionnaire - 7
timeFrame: 1 week post treatment
measure: Generalized Anxiety Disorder Questionnaire - 7
timeFrame: 3 months post treatment
measure: Generalized Anxiety Disorder Questionnaire - 7
timeFrame: 6 months post treatment
measure: Patient Health Questionnaire-9
timeFrame: Baseline
measure: Patient Health Questionnaire-9
timeFrame: 1 week post treatment
measure: Patient Health Questionnaire-9
timeFrame: 3 months post treatment
measure: Patient Health Questionnaire-9
timeFrame: 6 months post treatment
Secondary outcomes:
measure: Insomnia Severity Index
timeFrame: Baseline
measure: Insomnia Severity Index
timeFrame: 1 week post treatment
measure: Insomnia Severity Index
timeFrame: 3 months post treatment
measure: Insomnia Severity Index
timeFrame: 6 months post treatment
measure: Medical Outcome Study Short Form-36 Health Survey
timeFrame: Baseline
measure: Medical Outcome Study Short Form-36 Health Survey
timeFrame: 1 week post treatment
measure: Medical Outcome Study Short Form-36 Health Survey
timeFrame: 3 months post treatment
measure: Medical Outcome Study Short Form-36 Health Survey
timeFrame: 6 months post treatment
measure: Dose Received
timeFrame: 14 weeks after treatment starts
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Health Care System
state: South Carolina
Study officials:
affiliation: McGovern Medical School at UTHealth Houston
name: Ron Acierno, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gros DF. Development and initial evaluation of Transdiagnostic Behavior Therapy (TBT) for veterans with affective disorders. Psychiatry Res. 2014 Dec 15;220(1-2):275-82. doi: 10.1016/j.psychres.2014.08.018. Epub 2014 Aug 15.
citation: Gros DF, Allan NP. A randomized controlled trial comparing Transdiagnostic Behavior Therapy (TBT) and behavioral activation in veterans with affective disorders. Psychiatry Res. 2019 Nov;281:112541. doi: 10.1016/j.psychres.2019.112541. Epub 2019 Aug 29.
citation: Gros DF, Merrifield C, Rowa K, Szafranski DD, Young L, McCabe RE. A Naturalistic Comparison of Group Transdiagnostic Behaviour Therapy (TBT) and Disorder-Specific Cognitive Behavioural Therapy Groups for the Affective Disorders. Behav Cogn Psychother. 2019 Jan;47(1):39-51. doi: 10.1017/S1352465818000309. Epub 2018 May 29.
citation: Gros DF, Szafranski DD, Shead SD. A real world dissemination and implementation of Transdiagnostic Behavior Therapy (TBT) for veterans with affective disorders. J Anxiety Disord. 2017 Mar;46:72-77. doi: 10.1016/j.janxdis.2016.04.010. Epub 2016 Apr 27.