Optimizing Treatment Response in VA Specialized Intensive/Inpatient PTSD Programs

PTSD Clinical Trial

Official title:

Pilot Study of Group Prolonged Exposure in Residential Treatment (CDA 15-251)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03533608
• Other study ID #: CDX 18-002
• Secondary ID: CDA 15-251
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: March 15, 2020

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prolonged Exposure therapy (PE) is a first-line treatment for posttraumatic stress disorder; however few VA patients receive this treatment. One of the barriers to PE receipt is that this treatment is only available in an individual (one-on-one) format, whereas many VA mental health clinics provide the majority of their psychotherapy services in group format. In particular, PTSD residential rehabilitation programs (RRTPs) offer most programming in group format. Thus, the current study was designed to pilot test a group format of PE in RRTPs.

Description:

Fifty Veterans who are currently receiving treatment in the PTSD RRTP at a Midwest VA will be recruited to participate in a Group PE protocol. Participants will engage in 12, 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms. PTSD symptoms will be measured via the PCL-5. The goal of this pilot study will be to determine whether or not it will be feasible to conduct a full-scale trial of Group PE in the current setting by testing the process, resources, management, and scientific basis of the planned trial. As such, the proposed study will primarily assess feasibility outcomes and not efficacy outcomes. The investigators will assess number of participants screened, number meeting inclusion criteria, adherence of participants to the proposed treatment (measured via number of sessions attended), standard deviation of the outcome measure (PCL-5), response rates to questionnaires, and loss to follow-up. The investigators will also measure clinicians' adherence to protocol and acceptability of the treatment to patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inclusion criteria are current engagement in treatment at the Battle Creek VA PTSD Residential Rehabilitation Treatment Program.

Exclusion Criteria:

• Exclusion criteria are severe cognitive impairment that in the judgment of the PI or the patient's clinical providers make it unlikely that the patient can adhere to the study protocol.

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Group PE
Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan
United States	Battle Creek VA Medical Center, Battle Creek, MI	Battle Creek	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PTSD Symptoms	PTSD symptoms will be measured via the PCL-5 at baseline, 6-week, and 2-months. The PCL-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Patients are asked to rate how bothered they are by each item in the past month on a 5-point likert scale ranging from 0-4 (not at all, a little bit, moderately, quite a bit, extremely). Items are summed together and a PCL-5 cut point score of 33 is used for provisional PTSD diagnosis. Change = (Week 6 score-Baseline score) and (2 month score-Baseline score).	Baseline, 6-week, and 2-months
Primary	Change in Depression Symptoms	Depressive symptoms will be measured via the PHQ-9 at baseline, 6-weeks, and 2-months. The PHQ-9 is a 9-item self-report measure that assesses the presence and severity of depressive symptoms. Patients are asked to rate the presence of symptoms over the past 2 weeks on a 4-point likert scale ranging from 0-3 (not at all, several days, more than half the days, nearly every day). Individual items are summed together and Total scores ranging from 5-9 indicate mild depression, 10-14 indicate moderate depression, 15-19 indicate moderately severe depression, and 20-27 indicate severe depression. Change = (Week 6 score-Baseline score) and (2 month score-Baseline score).	Baseline, 6 weeks, 2-months