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

NCT ID: NCT03449576

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-07-01

Brief Summary

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.

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.

Conditions

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Trauma Management Therapy

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Exposure Therapy with Psychotherapy group

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

TMT; EXP+GRP

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brooks King-Casas, PhD

Role: PRINCIPAL_INVESTIGATOR

Salem VA Medical Center, Salem, VA

Locations

Salem VA Medical Center, Salem, VA

Salem, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

D2354-R

Identifier Type: -

Identifier Source: org_study_id