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

Overview

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.

Interventions

• Behavioral 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).
• Behavioral 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 measures

• 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]

Secondary outcome measures (9)

• Insomnia Severity Index [Time frame: Baseline]
• Insomnia Severity Index [Time frame: 1 week post treatment]
• Insomnia Severity Index [Time frame: 3 months post treatment]
• Insomnia Severity Index [Time frame: 6 months post treatment]
• Medical Outcome Study Short Form-36 Health Survey [Time frame: Baseline]
• Medical Outcome Study Short Form-36 Health Survey [Time frame: 1 week post treatment]
• Medical Outcome Study Short Form-36 Health Survey [Time frame: 3 months post treatment]
• Medical Outcome Study Short Form-36 Health Survey [Time frame: 6 months post treatment]
• Dose Received [Time frame: 14 weeks after treatment starts]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Ralph H. Johnson VA Health Care System — Charleston

Publications

• 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. PMID 25193379
• 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. PMID 31514043
• 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. PMID 29807553
• 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. PMID 27158076

Identifiers

NCT: NCT06433271 · Pro00134707 · PR230007

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗