Efficacy and Neural Mediators of Response to Trauma Management Therapy for PTSD

Social difficulties are serious and frequent complicating factors in the treatment of post-traumatic stress disorder (PTSD). To better understand how treatment of post-traumatic stress disorder impacts neural mechanisms of social cognition, the investigators are examining behavior and brain processes associated with response to Trauma Management Therapy. Understanding the behavioral and neural impact of psychotherapy may contribute to development of more effective treatments for PTSD.

Study Overview

• Status: Completed
• Conditions: PTSD
• Intervention / Treatment: Other: Trauma Management Therapy; Other: Exposure Therapy with Psychotherapy group

Detailed Description

PTSD is associated with significant interpersonal difficulties that interfere with functioning. As such, this work is intended to evaluate the empirical support for a novel treatment that fills a significant gap in the treatment options available to Veterans with PTSD who suffer with interpersonal difficulties. In this study the investigators will (i) evaluate the efficacy of Trauma Management Therapy (TMT) for treating PTSD-related interpersonal dysfunction, as well as PTSD-related fear and anxiety, and (ii) evaluate neural mediators of clinical improvements associated with TMT.

This work will provide insights into the mechanisms by which treatments may lead to improvements in social functioning, informing both the biological basis of psychotherapy and the development and refinement of alternative therapeutic interventions targeting social impairments.

Treatment seeking Veterans with PTSD will be randomized to one of two treatments: (i) Trauma Management Therapy, consisting of 12 sessions of individualized exposure therapy followed by 24 sessions of group-based social and emotional rehabilitation, or (ii) Exposure + Comparison Treatment Group consisting of 12 sessions of individualized exposure therapy followed by 24 sessions of group-based psychotherapy. Veterans enrolled in both the TMT and EXP+GRP arms will undergo functional neuroimaging as they engage in an emotional image viewing task, as well as two social interaction tasks. Neurobehavioral assessments will be made prior to and following completion of treatment.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Salem, Virginia, United States, 24153
      • Salem VA Medical Center, Salem, VA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male and female veterans of all ethnicities
• Meet diagnostic criteria for post-traumatic stress disorder (assessed by study staff)
• Fluent in English
• Able to see computer display clearly
• Able to provide informed consent
• Able to follow written or verbal instructions

Exclusion Criteria:

• history of seizures
• history of stroke
• Cushing's syndrome
• history of moderate to severe traumatic brain injury
• electroconvulsive therapy within 5 years
• history of chemotherapy for cancer
• contraindications to fMRI
• pregnancy
• diagnosis of schizophrenia, schizoaffective disorder, delusional disorder and/or organic psychosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trauma Management Therapy; Trauma Management Therapy (TMT) consists of a combination of 12 sessions of individualized exposure therapy and 24 sessions of group-based social and emotion rehabilitation.	Other: Trauma Management Therapy; Trauma Management Therapy (TMT) consists of a combination of 12 sessions of individualized exposure therapy and 24 sessions of group-based social and emotion rehabilitation.; Other Names: TMT
Active Comparator: Exposure Therapy with Psychoeducation; Exposure Therapy with Psychoeducation (EXP+EDU) consists of a combination of 12 sessions of individualized exposure therapy and 24 session of group-based psychoeducation.	Other: Exposure Therapy with Psychotherapy group; Exposure Therapy with Psychoeducation (EXP+EDU) consists of a combination of 12 sessions of individualized exposure therapy and 24 session of group-based psychoeducation.; Other Names: EXP+GRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Social Adjustment Scale - Self-Report	The Social Adjustment Scale (SAS; Weissman & Bothwell, 1976) is a 54 item self-report measure that assesses social adjustment in six social areas of functioning including work, social and leisure activities, extended family, marital, parental, and family. Each item is rated on a five point scale, and within each of domain items are averaged. Thus, scores in each domain can range between 1 (high social adjustment) and 5 (low social adjustment). [edited 2/24/24 Higher scores mean a worse outcome.]	SAS will be assessed at two time-points: before starting treatment i.e. pre-treatment (week 0) and at completion of treatment, i.e. post-treatment (week 8).
Change in PTSD Checklist for DSM-5	The PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013; Bovin et al., 2016) is a 20 item self-report measure assessing DSM-5 PTSD symptom severity. Each DSM-5 item is rated on a 0 (absent) to 4 (extreme/incapacitating) scale, and total score is calculated by summing severity scores across items. Total CAPS-5 severity can range from 0 to 80. Higher scores mean a worse outcome.	The PCL-5 will be assessed at two time-points: before starting treatment i.e. pre-treatment (week 0) and at completion of treatment, i.e. post-treatment (week 8).
Change in Clinician-Administered PTSD Scale for DSM-5	The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al. 2013; 2017) is a 20 item semi-structured instrument for the diagnosis and assessment of severity of posttraumatic stress disorder (PTSD). Each DSM-5 item is rated on a 0 (absent) to 4 (extreme/incapacitating) scale, and total score is calculated by summing severity scores across items. Total CAPS-5 severity can range from 0 to 80. [edited 2/24/24: Higher scores mean a worse outcome.]	CAPS-5 will be assessed at two time-points per participant: before starting treatment i.e. pre-treatment (week 0) and at completion of treatment, i.e. post-treatment (week 8).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Aggression Questionnaire	Change in Aggression Questionnaire (AQ; Buss & Warren, 2000) is a 34 item self-report measure that assesses severity of self-perceived aggression and anger. Each item is rated on a 1 (Not at all like me) to 5 (Completely like me) scale, and scores of all items are summed. Scores can range from 34 to 170. Higher scores mean a worse outcome.	AQ will be assessed at two time-points: before starting treatment i.e. pre-treatment (week 0) and at completion of treatment, i.e. post-treatment (week 8).
Change in Interpersonal Trust Scale	Change in Interpersonal Trust Scale (ITS; Rotter, 1967) is a 25 item self-report measure that assesses trust within relationships. Each item is rated on a 1 (low trust) to 5 (high trust) scale, and total scores can range from 25 to 125. [edited 2/24/24: Higher scores mean a better outcome.]	ITS will be assessed at two time-points: before starting treatment i.e. pre-treatment (week 0) and at completion of treatment, i.e. post-treatment (week 8).

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Brooks King-Casas, PhD, Salem VA Medical Center, Salem, VA

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: PTSD; treatment; neuroimaging; fMRI; exposure therapy; veterans
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: D2354-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No