Psychotherapy for PTSD Among Veterans Also Receiving Drug or Alcohol Treatment

Substance Use Disorders Clinical Trial

— COMPASS  

Official title:

Comparative Effectiveness of Trauma-Focused and Non-Trauma-Focused Treatment Strategies for PTSD Among Those With Co-Occurring SUD (COMPASS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04581434
• Other study ID #: #PTSD-2019C1-16009
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 8, 2020
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2023
• Source: Center for Veterans Research and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Background and Significance: Posttraumatic stress disorder (PTSD) and substance use disorder (SUD) comorbidity is common. The Veterans Affairs (VA)/Department of Defense Clinical Practice Guideline for PTSD strongly recommends providing guideline-concurrent care for PTSD alongside SUD treatment, but there is insufficient evidence about which guideline-recommended treatments for PTSD work best in this population. Trauma-focused therapy (TFT) is a frontline treatment approach; yet its effectiveness is less well-established among patients with co-occurring SUD, and TFT dropout rates are uniquely high in this population. Multiple guidelines suggest non-trauma-focused treatment (NTFT) as a second-line treatment approach for PTSD; higher completion rates for some NTFT (e.g., Present Centered Therapy) may make this strategy particularly effective for those with comorbid SUD. Despite providers' desire for an NTFT option for patients with PTSD/SUD, no guideline-recommended NTFTs have been evaluated in those with the comorbidity

Study Aims: Our long-term objective is to improve the lives of patients with co-occurring PTSD and SUD. To meet this objective, we will conduct a pragmatic randomized clinical trial that will yield decisive data regarding the comparative effectiveness of two evidence-based approaches for the treatment of PTSD in this understudied patient population: trauma-focused and non-trauma-focused psychotherapy. The major aims are: (1) Determine whether TFT differs at a clinically-meaningful magnitude from NTFT in its effects on posttreatment PTSD symptoms among patients with co-occurring PTSD and SUD (2) Determine whether patients with co-occurring PTSD and SUD randomized to TFT drop out of PTSD treatment more often than those randomized to NTFT, and (3) Determine if TFT differs at a clinically-meaningful level from NTFT in PTSD symptom reduction and number of PTSD therapy sessions attended in patients with varying (a) levels of baseline SUD severity, (b) classes of misused substances, and (c) treatment preferences.

Study Description: We propose a prospective, pragmatic randomized comparative effectiveness trial at 14 VA Medical Center sites (11 confirmed). Randomization will occur at the patient level and will assign participants to either (1) TFT (Prolonged Exposure or Cognitive Processing Therapy) or 2) NTFT (Present Centered Therapy). All participants will also receive concurrent SUD treatment-as-usual. Participants will complete self-report measures and a clinician-administered interview pretreatment, posttreatment, and six-months posttreatment. 420 participants (210 per arm) will be veterans seeking outpatient SUD treatment in an enrolled clinic who meet DSM-5 criteria for a current SUD and PTSD. The sample will be diverse in sex, race, age, and geography. Main outcomes will be PTSD symptom severity measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5), and PTSD treatment dropout (dichotomous indicator of completion of all PTSD treatment sessions). Major Aim 1 will be tested using a linear mixed model using study intervention, assessment point, and their interaction as fixed effects and including random effects for participant, clinician, and study site. Major Aim 2 will be testing using a random effects logistic regression of therapy retention on intervention and baseline CAPS incorporating random effects for clinician and site.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 420
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA:

1. Initiate an episode of outpatient SUD treatment at an enrolled facility.

2. meet DSM-5 criteria for a current SUD (Tobacco Use Disorder alone is not sufficient for inclusion).

3. 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)

4. meet DSM-5 criteria for PTSD

5. provide informed consent and be willing to be randomized to PTSD treatment condition

6. agree to not receive non-study, active psychotherapy for PTSD during study treatment

EXCLUSION CRITERIA:

1. Severe cognitive impairment

2. Current suicidal or homicidal intent with a specific plan

3. Unstable psychotic or manic symptoms not attributable to SUD

4. 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

Related Conditions & MeSH terms

• Disease
• Stress Disorders, Post-Traumatic
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Prolonged Exposure Therapy
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
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
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

Locations

Country	Name	City	State
United States	Atlanta VA Medical Center	Atlanta	Georgia
United States	Cincinnati VA Healthcare System	Cincinnati	Ohio
United States	Louis Stokes Cleveland VA Medical Center	Cleveland	Ohio
United States	Durham VA Medical Center	Durham	North Carolina
United States	Edward Hines, Jr. VA Hospital	Hines	Illinois
United States	Madison VA Medical Center	Madison	Wisconsin
United States	Minneapolis VA Medical Center	Minneapolis	Minnesota
United States	Southeast Louisiana Veterans Health Care System	New Orleans	Louisiana
United States	Philadelphia VA Medical Center	Philadelphia	Pennsylvania
United States	Salt Lake City VA Healthcare System	Salt Lake City	Utah
United States	San Diego VA Healthcare System	San Diego	California
United States	Puget Sound VA Healthcare System	Seattle	Washington
United States	Syracuse VA Medical Center	Syracuse	New York
United States	Tampa VA Medical Center	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Center for Veterans Research and Education	Minneapolis Veterans Affairs Medical Center, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	PTSD Treatment Non-completion	Proportion of veterans who do not complete a full course of assigned PTSD treatment	Immediately after ending treatment
Secondary	PTSD Checklist-5 (PCL-5)	PTSD Symptom Severity - Self-Reported; Range = 0-80; higher scores = more severe symptoms	Immediately after ending treatment
Secondary	PTSD Checklist-5 (PCL-5)	PTSD Symptom Severity - Self-Reported; Range = 0-80; higher scores = more severe symptoms	3-months after ending treatment
Secondary	PTSD Checklist-5 (PCL-5)	PTSD Symptom Severity - Self-Reported; Range = 0-80; higher scores = more severe symptoms	6-months after ending treatment
Secondary	% Days with drug use or heavy drinking over prior 28 days	Substance use as measured by the Timeline Follow-Back Interview (TLFB)	Immediately after ending treatment
Secondary	% Days with drug use or heavy drinking over prior 28 days	Substance use as measured by the Timeline Follow-Back Interview (TLFB)	3 months after ending treatment
Secondary	% Days with drug use or heavy drinking over prior 28 days	Substance use as measured by the Timeline Follow-Back Interview (TLFB)	6 months after ending treatment
Secondary	Clinician Administered Scale for PTSD -5 (CAPS-5) Severity Score	PTSD Symptom Severity - Clinician Assessed; range 0-80; higher scores = greater severity.	3 months after treatment
Secondary	Clinician Administered Scale for PTSD -5 (CAPS-5) Severity Score	PTSD Symptom Severity - Clinician Assessed; range 0-80; higher scores = greater severity.	6 months after treatment
Secondary	Short Inventory of Problems, Revised (SIP-R)	Problems associated with drug or alcohol use; range = 0-51, higher scores = more severe	Immediately after treatment
Secondary	Short Inventory of Problems, Revised (SIP-R)	Problems associated with drug or alcohol use; range = 0-51, higher scores = more severe	3-months after treatment
Secondary	Short Inventory of Problems, Revised (SIP-R)	Problems associated with drug or alcohol use; range = 0-51, higher scores = more severe	6-months after treatment
Secondary	Brief Inventory of Psychosocial Functioning (BIPF)	PTSD-related psychosocial functioning; higher scores = more severe	Immediately after treatment
Secondary	Brief Inventory of Psychosocial Functioning (BIPF)	PTSD-related psychosocial functioning; higher scores = more severe	3 months after treatment
Secondary	Brief Inventory of Psychosocial Functioning (BIPF)	PTSD-related psychosocial functioning; higher scores = more severe	6 months after treatment
Secondary	Insomnia Severity Index	Self-reported sleep disturbances; range 0-28; higher scores = more severe	Immediately after treatment
Secondary	Insomnia Severity Index	Self-reported sleep disturbances; range 0-28; higher scores = more severe	3 months after treatment
Secondary	Insomnia Severity Index	Self-reported sleep disturbances; range 0-28; higher scores = more severe	6 months after treatment
Secondary	Dimensions of Anger Reactions (DAR)	Self-reporter anger; range = 2-25; higher scores = more severe	Immediately after treatment
Secondary	Dimensions of Anger Reactions (DAR)	Self-reporter anger; range = 2-25; higher scores = more severe	3 months after treatment
Secondary	Dimensions of Anger Reactions (DAR)	Self-reporter anger; range = 2-25; higher scores = more severe	6 months after treatment
Secondary	WHO Quality of Life, Brief (WHOQOL-BREF)	Self-reported quality of life; higher score = better quality of life	Immediately after treatment
Secondary	WHO Quality of Life, Brief (WHOQOL-BREF)	Self-reported quality of life; higher score = better quality of life	3 months after treatment
Secondary	WHO Quality of Life, Brief (WHOQOL-BREF)	Self-reported quality of life; higher score = better quality of life	6 months after treatment
Secondary	Patient Health Questionnaire-9 (PHQ-9)	Self-reported depression; range = 0-27; higher scores = more severe symptoms	Immediately after treatment
Secondary	Patient Health Questionnaire-9 (PHQ-9)	Self-reported depression; range = 0-27; higher scores = more severe symptoms	Three months after treatment
Secondary	Patient Health Questionnaire-9 (PHQ-9)	Self-reported depression; range = 0-27; higher scores = more severe symptoms	Six months after treatment
Secondary	Client Satisfaction Questionnaire - 8 (CSQ-8)	Treatment satisfaction; range = 8-32; higher scores = more severe symptoms	Immediately after treatment