Clinical trial NCT03449576: Efficacy and Neural Mediators of Response to Trauma Management Therapy for PTSD
Official title: Efficacy and Neural Mediators of Response to Trauma Management Therapy for PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: PTSD
neuroimaging
fMRI
veterans
exposure therapy
treatment
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-02-28
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Clinician-Administered PTSD Scale for DSM-5
timeFrame: 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).
measure: Change in Social Adjustment Scale - Self-Report
timeFrame: 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).
measure: Change in PTSD Checklist for DSM-5
timeFrame: 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).
Secondary outcomes:
measure: Change in Aggression Questionnaire
timeFrame: 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).
measure: Change in Interpersonal Trust Scale
timeFrame: 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).
Other outcomes:
Locations:
city: Salem
country: United States
facility: Salem VA Medical Center, Salem, VA
state: Virginia
Study officials:
affiliation: Salem VA Medical Center, Salem, VA
name: Brooks King-Casas, PhD
role: PRINCIPAL_INVESTIGATOR
References: