Clinical trial NCT04581434: Psychotherapy for PTSD Among Veterans Also Receiving Drug or Alcohol Treatment
Official title: Comparative Effectiveness of Trauma-Focused and Non-Trauma-Focused Treatment Strategies for PTSD Among Those With Co-Occurring SUD (COMPASS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Substance Use Disorders
Keywords: PTSD
Substance Use Disorders
Psychotherapy
Randomized Clinical Trial
Comparative Effectiveness
Lead sponsor: Center for Veterans Research and Education
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Minneapolis Veterans Affairs Medical Center
First posted: 2020-10-09
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinician Administered Scale for PTSD -5 (CAPS-5) Severity Score
timeFrame: Immediately after ending treatment
measure: PTSD Treatment Non-completion
timeFrame: Immediately after ending treatment
Secondary outcomes:
measure: PTSD Checklist-5 (PCL-5)
timeFrame: Immediately after ending treatment
measure: PTSD Checklist-5 (PCL-5)
timeFrame: 3-months after ending treatment
measure: PTSD Checklist-5 (PCL-5)
timeFrame: 6-months after ending treatment
measure: % Days with drug use or heavy drinking over prior 28 days
timeFrame: Immediately after ending treatment
measure: % Days with drug use or heavy drinking over prior 28 days
timeFrame: 3 months after ending treatment
measure: % Days with drug use or heavy drinking over prior 28 days
timeFrame: 6 months after ending treatment
measure: Clinician Administered Scale for PTSD -5 (CAPS-5) Severity Score
timeFrame: 3 months after treatment
measure: Clinician Administered Scale for PTSD -5 (CAPS-5) Severity Score
timeFrame: 6 months after treatment
measure: Short Inventory of Problems, Revised (SIP-R)
timeFrame: Immediately after treatment
measure: Short Inventory of Problems, Revised (SIP-R)
timeFrame: 3-months after treatment
measure: Short Inventory of Problems, Revised (SIP-R)
timeFrame: 6-months after treatment
measure: Brief Inventory of Psychosocial Functioning (BIPF)
timeFrame: Immediately after treatment
measure: Brief Inventory of Psychosocial Functioning (BIPF)
timeFrame: 3 months after treatment
measure: Brief Inventory of Psychosocial Functioning (BIPF)
timeFrame: 6 months after treatment
measure: Insomnia Severity Index
timeFrame: Immediately after treatment
measure: Insomnia Severity Index
timeFrame: 3 months after treatment
measure: Insomnia Severity Index
timeFrame: 6 months after treatment
measure: Dimensions of Anger Reactions (DAR)
timeFrame: Immediately after treatment
measure: Dimensions of Anger Reactions (DAR)
timeFrame: 3 months after treatment
measure: Dimensions of Anger Reactions (DAR)
timeFrame: 6 months after treatment
measure: WHO Quality of Life, Brief (WHOQOL-BREF)
timeFrame: Immediately after treatment
measure: WHO Quality of Life, Brief (WHOQOL-BREF)
timeFrame: 3 months after treatment
measure: WHO Quality of Life, Brief (WHOQOL-BREF)
timeFrame: 6 months after treatment
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Immediately after treatment
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Three months after treatment
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Six months after treatment
measure: Client Satisfaction Questionnaire - 8 (CSQ-8)
timeFrame: Immediately after treatment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego VA Healthcare System
state: California
city: Tampa
country: United States
facility: Tampa VA Medical Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Hines
country: United States
facility: Edward Hines, Jr. VA Hospital
state: Illinois
city: New Orleans
country: United States
facility: Southeast Louisiana Veterans Health Care System
state: Louisiana
city: Minneapolis
country: United States
facility: Minneapolis VA Medical Center
state: Minnesota
city: Syracuse
country: United States
facility: Syracuse VA Medical Center
state: New York
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati VA Healthcare System
state: Ohio
city: Cleveland
country: United States
facility: Louis Stokes Cleveland VA Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Philadelphia VA Medical Center
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Salt Lake City VA Healthcare System
state: Utah
city: Seattle
country: United States
facility: Puget Sound VA Healthcare System
state: Washington
city: Madison
country: United States
facility: Madison VA Medical Center
state: Wisconsin
Study officials:
affiliation: Minneapolis VA Healthcare System
name: Shannon Kehle-Forbes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Minneapolis VA Healthcare System
name: Hildi Hagedorn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kehle-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.