Transdiagnostic Behavior Therapy Vs TAU for Adjustment Disorder Following Traumatic Event Exposure
- Conditions
- Adjustment DisordersMental Disorder
- Interventions
- Behavioral: Transdiagnostic Behavior Therapy (TBT)Behavioral: Treatment as Usual-Problem Solving Therapy (TAU-PST)
- Registration Number
- NCT06433271
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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
- Active psychosis
- Suicidal ideation with clear intent
- Severe substance use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transdiagnostic Behavior Therapy (TBT) Transdiagnostic Behavior Therapy (TBT) Participants will receive 6, 30-45-minute, manualized, individual therapy sessions. Active Comparator: Treatment as Usual-Problem Solving Therapy (TAU-PST) Treatment as Usual-Problem Solving Therapy (TAU-PST) Participants will receive 6, 30-45-minute, manualized, individual therapy sessions.
- Primary Outcome Measures
Name Time Method Adjustment Disorder New Module Self Report 6 months post treatment The ADNM is a 20-item self-report measure of AjD that first asks participants to select from a list of past year stressors and to identify which was the most prominent or distressing. The second section comprises 20 items, which form six subscales in accordance with ICD-11 criteria relating to pre-occupation, failure to adapt, avoidance, depressive mood, anxiety, and impulse disturbance (Lorenz et al., 2016). Participants rate on a 4-point Likert scale how often they have experienced particular symptoms during the past two weeks, and overall symptom severity is calculated as a sum of all item scores. Total score ranges from 20-80, with a higher score indicating a higher risk of developing adjustment disorder.
Generalized Anxiety Disorder Questionnaire - 7 6 months post treatment The Generalized Anxiety Disorder Questionnaire (GAD-7; Spitzer et al., 2006) consists of seven items measuring worry and anxiety symptoms. Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21 with higher scores reflecting greater anxiety severity.of Mental Disorders, Fifth Edition (DSM-5) (PCL-5) (Weathers et al., 2013) is structured to correspond to the DSM-5 PTSD criteria. The 20-items are scored on a 0-4 Likert scale for each symptom corresponding to "Not at all" to "Extremely". Total score ranges from 0 to 80, with a higher score indicating greater PTSD symptom severity.
Patient Health Questionnaire-9 6 months post treatment The PHQ-9 (Kroenke et al., 2001) is a widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron et al, 2008) and is correlated strongly with other depression measures. Its nine items assess affective and somatic symptoms and correspond to diagnostic criteria for MDD. This measure will also be collected every other week during treatment. Total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).
- Secondary Outcome Measures
Name Time Method Medical Outcome Study Short Form-36 Health Survey 6 months post treatment The SF-36 (Ware \& Sherbourne, 1992) is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. Total score ranges from 0 to 100, with a higher score indicating better health status.
Insomnia Severity Index 6 months post treatment The ISI self-report measure captures a respondent's perception of his or her current insomnia. The ISI includes seven items that assess severity of sleep onset, sleep maintenance, and early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. Each item is rated on a 4-point Likert scale and the total score ranges from 0 to 28. A higher score suggests more severe insomnia.
Dose Received 14 weeks after treatment starts Number of treatment sessions completed.
Trial Locations
- Locations (1)
Ralph H. Johnson VA Health Care System
🇺🇸Charleston, South Carolina, United States