Psychotherapy for PTSD Among Veterans Also Receiving Drug or Alcohol Treatment
COMPASS
Comparative Effectiveness of Trauma-Focused and Non-Trauma-Focused Treatment Strategies for PTSD Among Those With Co-Occurring SUD (COMPASS)
1 other identifier
interventional
426
1 country
14
Brief Summary
Many people who have posttraumatic stress disorder (PTSD) also struggle with problematic alcohol or drug use (substance use disorders \[SUD\]). Patients with both conditions prefer PTSD be treated alongside SUD. However, clinicians don't know if treatments that have been found to help those with PTSD work as well for people who also have SUD. This often leads to delaying PTSD treatment or using psychotherapies without research support. Trauma-focused psychotherapy (TFT) is the type of psychotherapy for PTSD that has been studied most often among people with both PTSD and SUD. It reduces symptoms of PTSD and substance use, although it might not work as well in those who have SUD as those who do not. Further, many patients with both PTSD and SUD do not complete TFT. Another strategy for treating PTSD is non-trauma-focused psychotherapy (NTFT). One NTFT, Present Centered Therapy, has been found to reduce symptoms of PTSD and more patients are able to complete NTFT than are able to finish TFT. However, no one has studied how well Present Centered Therapy works among patients who also have SUD. We will test which approach (TFT of NTFT) is better for reducing symptoms of PTSD and which is more likely to be completed by patients with both PTSD and SUD at VA healthcare facilities. We will also test to see whether some participants did better than others, so we can learn how to individualize treatment recommendations to patients. Participants will be assigned by chance to either TFT of NTFT. Patients assigned to TFT will receive either Prolonged Exposure or Cognitive Processing Therapy; both are weekly psychotherapies focused on addressing thoughts and/or memories related to their trauma. Those assigned to NTFT will receive Present Centered Therapy, a weekly psychotherapy in which patients learn about how PTSD relates to their current difficulties and problem solve current life difficulties. All participants will also receive SUD treatment. Participants will answer questions about their symptoms and experience with treatment before, right after they finish, and three and six months after they finish PTSD treatment. At the end of the study we will compare which treatment approach worked better to decrease PTSD symptom severity and which treatment patients were better able to complete. We will also track other outcomes that are important to patients (e.g., how they are doing in their relationships).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2020
CompletedFirst Posted
Study publicly available on registry
October 9, 2020
CompletedStudy Start
First participant enrolled
December 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2024
CompletedJune 25, 2024
June 1, 2024
3.4 years
September 29, 2020
June 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinician Administered Scale for PTSD -5 (CAPS-5) Severity Score
PTSD Symptom Severity - Clinician Assessed; range 0-80; higher scores = greater severity.
Immediately after ending treatment
PTSD Treatment Non-completion
Proportion of veterans who do not complete a full course of assigned PTSD treatment
Immediately after ending treatment
Secondary Outcomes (27)
PTSD Checklist-5 (PCL-5)
Immediately after ending treatment
PTSD Checklist-5 (PCL-5)
3-months after ending treatment
PTSD Checklist-5 (PCL-5)
6-months after ending treatment
% Days with drug use or heavy drinking over prior 28 days
Immediately after ending treatment
% Days with drug use or heavy drinking over prior 28 days
3 months after ending treatment
- +22 more secondary outcomes
Study Arms (2)
Trauma-Focused Therapy
EXPERIMENTALPatients randomized to Trauma Focused Therapy will receive either Prolonged Exposure (PE) or Cognitive Processing Therapy (CPT). According to standard VA practice, assignment will be determined according to which trauma-focused therapy the assigned provider is verified to provide; if the assigned therapist is verified in both PE and CPT, the provider will decide which treatment to deliver. PE and CPT are both recommended as frontline treatments by all published PTSD guidelines. The standard treatment length will be 12 weekly sessions; however, patients and providers can collaboratively agree to early completion or extension as warranted.
Non-Trauma-Focused Therapy
EXPERIMENTALThose randomized to non-trauma-focused therapy will receive present centered therapy (PCT). Originally designed as a strong comparator for psychotherapy research that included the components of "good therapy," PCT is now a bona-fide PTSD treatment suggested at the second tier in multiple clinical practice guidelines. The standard treatment length will be 12 weekly sessions; however, patients and providers can collaboratively agree to early completion or extension as warranted.
Interventions
Prolonged Exposure Therapy is an individually-delivered treatment for PTSD that includes in vivo exposure to trauma reminders and imaginal exposure to the trauma memory delivered in 90-minute weekly sessions.
Cognitive Processing Therapy is an individually-delivered treatment for PTSD that focuses on challenging and modifying maladaptive beliefs related to the trauma, with an optional written trauma account during weekly 60-minute sessions
Present Centered Therapy is an individually-delivered treatment for PTSD that focuses on "current life problems as manifestations of PTSD" in weekly 60-minute sessions. It includes psychoeducation and normalization of responses to trauma, problem solving related to current life difficulties and stress identified by patients, and emotional support and validation
Eligibility Criteria
You may qualify if:
- Initiate an episode of outpatient SUD treatment at an enrolled facility.
- Report substance use in the past 30 days (or in the 30 days prior to entering a controlled environment if exiting said controlled environment at time of enrollment)
- meet DSM-5 criteria for PTSD
- provide informed consent and be willing to be randomized to PTSD treatment condition
- agree to not receive non-study, active psychotherapy for PTSD during study treatment
You may not qualify if:
- Severe cognitive impairment
- Current suicidal or homicidal intent with a specific plan
- Unstable psychotic or manic symptoms not attributable to SUD
- More than 30 days between index outpatient SUD intake/treatment planning appointment \& consent or more than 90 days between the index outpatient SUD visit and the first PTSD psychotherapy session
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
San Diego VA Healthcare System
San Diego, California, 92161, United States
Tampa VA Medical Center
Tampa, Florida, 33612, United States
Atlanta VA Medical Center
Atlanta, Georgia, 30033, United States
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141, United States
Southeast Louisiana Veterans Health Care System
New Orleans, Louisiana, 70119, United States
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417, United States
Syracuse VA Medical Center
Syracuse, New York, 13210, United States
Durham VA Medical Center
Durham, North Carolina, 27705, United States
Cincinnati VA Healthcare System
Cincinnati, Ohio, 45220, United States
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, 44106, United States
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, 19104, United States
Salt Lake City VA Healthcare System
Salt Lake City, Utah, 84148, United States
Puget Sound VA Healthcare System
Seattle, Washington, 98108, United States
Madison VA Medical Center
Madison, Wisconsin, 53705, United States
Related Publications (2)
Ackland PE, Hagedorn HJ, Kenny ME, Salameh HA, Kehle-Forbes SM, Gustavson AM, Karimzadeh LE, Meis LA. Using brief reflections to capture and evaluate end-user engagement: a case example using the COMPASS study. BMC Med Res Methodol. 2024 May 2;24(1):103. doi: 10.1186/s12874-024-02222-5.
PMID: 38698315DERIVEDKehle-Forbes SM, Nelson D, Norman SB, Schnurr PP, Shea MT, Ackland PE, Meis L, Possemato K, Polusny MA, Oslin D, Hamblen JL, Galovski T, Kenny M, Babajide N, Hagedorn H. Comparative effectiveness of trauma-focused and non-trauma-focused psychotherapy for PTSD among veterans with comorbid substance use disorders: Protocol & rationale for a randomized clinical trial. Contemp Clin Trials. 2022 Sep;120:106876. doi: 10.1016/j.cct.2022.106876. Epub 2022 Aug 18.
PMID: 35987487DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shannon Kehle-Forbes, PhD
Minneapolis VA Healthcare System
- PRINCIPAL INVESTIGATOR
Hildi Hagedorn, PhD
Minneapolis VA Healthcare System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2020
First Posted
October 9, 2020
Study Start
December 8, 2020
Primary Completion
April 26, 2024
Study Completion
April 26, 2024
Last Updated
June 25, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share