Comparative Effectiveness of Two Treatments for Veterans With PTSD

NCT02586064 | Completed Results DMC

• 2 other identifiers: D1783-RI01RX001783
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 2

Brief Summary

Interpersonal problems such as relationship conflict and social isolation are common among Veterans with PTSD and serve as barriers to successful posttraumatic adjustment. The main interventions for PTSD at VA facilities, i.e., Prolonged Exposure, Cognitive Processing Therapy, and Trauma-Focused CBT, do not directly target these relationship difficulties and many Veterans do not complete these treatments. Couple and family approaches for PTSD address relationship problems, but logistical problems make it difficult for couples to attend sessions and these approaches do not involve Veterans who are socially isolated or unmarried. There is accumulating evidence that Interpersonal Psychotherapy (IPT) for PTSD may be effective in reducing symptoms and improving interpersonal functioning. This study, a randomized controlled trial, aims to provide evidence regarding whether IPT for PTSD could be a useful addition to current treatments delivered at the VA.

Conditions

Posttraumatic Stress Disorder

Keywords

posttraumatic stress disorder; Veterans; Psychotherapy; Randomized Controlled Trial; Treatment

Outcome Measures

Primary Outcomes (2)

• Change in Clinician Administered PTSD Scale (CAPS-5)

  Structured interview for assessment of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome.

  Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks

• Change in Inventory of Interpersonal Functioning (IIP-32)

  Self-report measure of Veterans' interpersonal difficulties. Scores range from a minimum value of 0 to a maximum value of 128, higher scores mean a worse outcome.

  Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks

Secondary Outcomes (12)

• Change in PTSD Checklist for DSM-5 Military Version (PCL-M)

  Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks

• Change in Patient Health Questionnaire (PHQ)

  Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks

• Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other

  Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks

• Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family

  Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks

• Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends

  Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks

Study Arms (2)

Interpersonal Psychotherapy for PTSD

EXPERIMENTAL

Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions

Behavioral: Interpersonal Therapy for PTSD

Prolonged Exposure

ACTIVE COMPARATOR

Exposure based intervention including exposure to memories and avoided places and activities

Behavioral: Prolonged Exposure

Interventions

Interpersonal Therapy for PTSD BEHAVIORAL

Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.

Interpersonal Psychotherapy for PTSD

Prolonged Exposure BEHAVIORAL

Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).

Prolonged Exposure

Eligibility Criteria

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

You may qualify if:

• Veterans age 18 or older
• Experienced trauma while deployed to a war zone
• Meet DSM-5 criteria for PTSD and a minimum CAPS-5 score of 23
• Have at least one area of relationship dysfunction
• Consent to be randomized

You may not qualify if:

• Current severe substance use disorder
• Current psychotic symptoms
• Current mania or un-medicated Bipolar Disorder
• Imminent threat of suicide or homicide
• Victim or perpetrator of severe domestic violence in the past 12 months
• Currently receiving Cognitive Behavioral Therapy for PTSD
• Psychotropic medication start or dosage change within the prior 4 weeks

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Georgetown University: collaborator
• Southeast Louisiana Veterans Health Care System: collaborator

Study Sites (2)

Southeast Louisiana Veterans Health Care System, New Orleans, LA

New Orleans, Louisiana, 70112, United States

Location

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Tracie Shea
• Organization: Providence VA Medical Center

MaryTracie.Shea@va.gov

401-273-7100

Study Officials

• Tracie M. Shea, PhD

  Providence VA Medical Center, Providence, RI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 26, 2015
• Study Start: September 1, 2016
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: July 7, 2021
• Results First Posted: July 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Following publication of primary and secondary study findings
• Access Criteria: uncertain at this point

Locations

US (2)