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Psychotherapy for PTSD and Substance Use Disorders (COMPASS Trial)

N/A
Waitlist Available
Led By Shannon Kehle-Forbes, PhD
Research Sponsored by Center for Veterans Research and Education
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meet DSM-5 criteria for PTSD
Meet DSM-5 criteria for a current SUD (Tobacco Use Disorder alone is not sufficient for inclusion).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months after treatment
Awards & highlights

COMPASS Trial Summary

This trial will compare two types of psychotherapy, one focused on the trauma and one not, to see which is better for treating PTSD in patients who also have substance use disorders.

Who is the study for?
This trial is for veterans with PTSD who are also getting treatment for substance use disorders (excluding tobacco use disorder alone). They must have used substances in the last 30 days and agree not to get other PTSD therapies during the study. Those with severe cognitive issues, current dangerous intentions, or unstable psychotic symptoms can't join.Check my eligibility
What is being tested?
The study compares two types of psychotherapy: Trauma-Focused Therapy (TFT) like Prolonged Exposure or Cognitive Processing Therapy, and Non-Trauma-Focused Therapy (NTFT), specifically Present Centered Therapy. Participants will be randomly assigned to one type while continuing their substance use disorder treatment.See study design
What are the potential side effects?
Psychotherapies may bring up distressing memories which could temporarily increase stress levels. TFT might be challenging to complete for some due to its focus on trauma. NTFT focuses more on present issues and may be easier to finish but its effectiveness compared to TFT is being studied.

COMPASS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with PTSD.
Select...
You currently have a substance use disorder, which means you have a problem with drugs or alcohol (excluding tobacco use disorder alone).
Select...
You need to disclose if you have used drugs or alcohol in the last 30 days or before entering a controlled environment, if you are leaving that environment at the time of enrollment.

COMPASS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PTSD Treatment Non-completion
Secondary outcome measures
% Days with drug use or heavy drinking over prior 28 days
Brief Inventory of Psychosocial Functioning (BIPF)
Client Satisfaction Questionnaire - 8 (CSQ-8)
+7 more

COMPASS Trial Design

2Treatment groups
Experimental Treatment
Group I: Trauma-Focused TherapyExperimental Treatment2 Interventions
Patients 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.
Group II: Non-Trauma-Focused TherapyExperimental Treatment1 Intervention
Those 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prolonged Exposure Therapy
2008
Completed Phase 4
~860
Cognitive Processing Therapy
2016
N/A
~3400
Present Centered Therapy
2015
Completed Phase 3
~930

Find a Location

Who is running the clinical trial?

Minneapolis Veterans Affairs Medical CenterFED
71 Previous Clinical Trials
14,482 Total Patients Enrolled
Center for Veterans Research and EducationLead Sponsor
11 Previous Clinical Trials
1,087 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
548 Previous Clinical Trials
29,996,167 Total Patients Enrolled

Media Library

Cognitive Processing Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04581434 — N/A
Substance Use Disorder Research Study Groups: Trauma-Focused Therapy, Non-Trauma-Focused Therapy
Substance Use Disorder Clinical Trial 2023: Cognitive Processing Therapy Highlights & Side Effects. Trial Name: NCT04581434 — N/A
Cognitive Processing Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04581434 — N/A
Substance Use Disorder Patient Testimony for trial: Trial Name: NCT04581434 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please provide an estimate of the number of locations currently engaged in this research trial?

"Currently, 14 different facilities are enrolling participants for this research. These locations span across Salt Lake City, Cleveland and Seattle; with many other centres available to choose from in order to reduce the need for travel when participating in the study."

Answered by AI

How extensive is the population enrolled in this research endeavor?

"This clinical trial demands 420 eligible participants that abide by the inclusion criteria. Salt Lake City VA Healthcare System and Louis Stokes Cleveland VA Medical Center are two of many participating sites located in different cities."

Answered by AI

Are there still spots available for this research trial?

"According to the information available from clinicaltrials.gov, recruitment for this trial is taking place now. It was first posted on December 8th 2020 and has had its parameters updated as recently as April 30th 2021."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Pennsylvania
Texas
Other
What site did they apply to?
San Diego VA Healthcare System
Minneapolis VA Medical Center
Southeast Louisiana Veterans Health Care System
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
3+
0

What questions have other patients asked about this trial?

Is there a BMI limit? How long do vistis take? What form of treatment is it?
PatientReceived 2+ prior treatments
How many times will I be required in Philly?
PatientReceived no prior treatments

Why did patients apply to this trial?

Mention a Focus group. My sister recommended it to me. To get relief from stress and depression.
PatientReceived 1 prior treatment
I could really use some help with my PTSD. A desire to help myself and people like myself.
PatientReceived 1 prior treatment
Recent research and studies
~99 spots leftby Mar 2025