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

VA Office of Research and Development

Status: Completed

Conditions: PTSD

Treatments: Other: Exposure Therapy with Psychotherapy group; Other: Trauma Management Therapy

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03449576

D2354-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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69 participants in 2 patient groups

Trauma Management Therapy

Experimental group

Description:

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.

Treatment:

Other: Trauma Management Therapy

Exposure Therapy with Psychoeducation

Active Comparator group

Description:

Exposure Therapy with Psychoeducation (EXP+EDU) consists of a combination of 12 sessions of individualized exposure therapy and 24 session of group-based psychoeducation.

Treatment:

Other: Exposure Therapy with Psychotherapy group