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

NCT03449576 | Completed Results

• 1 other identifier: D2354-R
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD

Keywords

PTSD; neuroimaging; fMRI; veterans; exposure therapy; treatment

Outcome Measures

Primary Outcomes (3)

• 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).

• 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).

Secondary Outcomes (2)

• Change in Aggression Questionnaire

  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

  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).

Study Arms (2)

Trauma Management Therapy

EXPERIMENTAL

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

Exposure Therapy with Psychoeducation

ACTIVE COMPARATOR

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

Interventions

Trauma Management Therapy 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.

Also known as: TMT

Trauma Management Therapy

Exposure Therapy with Psychotherapy group 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.

Also known as: EXP+GRP

Exposure Therapy with Psychoeducation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Salem VA Medical Center, Salem, VA

Salem, Virginia, 24153, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Implosive Therapy; Psychotherapy, Group

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Socioenvironmental Therapy

Results Point of Contact

• Title: Dr. Shirley Groer (Scientific Program Manager)
• Organization: Rehabilitation Research & Development

shirley.groer@va.gov

202-553-9899

Study Officials

• Brooks King-Casas, PhD

  Salem VA Medical Center, Salem, VA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 28, 2018
• Study Start: January 1, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 24, 2024
• Results First Posted: July 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)