Clinical trial NCT05959434: Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and PTSD
Official title: Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and Co-Occurring PTSD: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Posttraumatic Stress Disorder
Alcohol Use Disorder
Keywords: trauma or PTSD
alcohol use
Cognitive Processing Therapy
Relapse Prevention
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2023-07-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test the efficacy of a novel integrative cognitive-behavioral intervention in patients with posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD).

Specific Aim 1: Examine the efficacy of CPT-RP, as compared to RP alone, in reducing alcohol frequency (percent days drinking) and quantity (drinks per drinking day) as measured by the Timeline Follow-Back (TLFB).

Specific Aim 2: Examine the efficacy of CPT-RP, as compared to RP alone, in reducing PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5).

Specific Aim 3: Use ecological momentary assessment (EMA) to evaluate intervention effects on daily alcohol-related cognitions and behaviors through real-time associations with PTSD symptomatology and distress tolerance.

Researchers will compare integrative CPT+RP with RP-alone to see if CPT+RP is more efficacious in reducing alcohol use and PTSD symptom severity.

Detailed description: A substantial proportion of individuals with alcohol use disorder (AUD) also meet criteria for posttraumatic stress disorder (PTSD). The co-occurrence of AUD/PTSD is characterized by more severe symptomatology, greater functional impairment, increased suicide risk, and poorer treatment outcomes as compared to either disorder alone. Trauma-focused, cognitive-behavioral interventions delivered alongside interventions for substance use disorders are most effective in reducing PTSD severity and substance use. Cognitive Processing Therapy (CPT) for PTSD and Relapse Prevention (RP) for AUD are two of the most widely used and efficacious behavioral treatments for these conditions. The investigators successfully developed and pilot tested a therapy manual that combines CPT with RP. The preliminary data demonstrate safety, feasibility, high rates of retention (80.0%) and patient satisfaction. Moreover, our data from a recent national survey of frontline mental health providers indicate that CPT is the most commonly used trauma-focused treatment for PTSD and providers are highly interested in an integrative CPT-RP intervention, conferring strong potential for uptake in real-world practice settings. In fact, due to the lack of an available, empirically developed, manualized CPT-RP treatment, 84.0% of frontline providers report attempting on their own to create such a treatment to use with their patients. This may result in highly variable and suboptimal implementation and outcomes. In response to provider input and positive preliminary data, the proposed study directly addresses this critical need by evaluating a new integrative CPT-RP treatment for individuals with co-occurring AUD and PTSD. At present, only one trauma-focused, integrative intervention is available for AUD/PTSD and it uses Prolonged Exposure (PE) to reduce PTSD symptoms. In comparison to PE, CPT is more widely used, often preferred by clinicians, equally as effective in reducing PTSD symptoms, and associated with lower dropout rates. Thus, the new CPT-RP intervention could have wider reach and greater acceptability than exposure-based treatments. Treatment choice is related to improved treatment outcomes, and therefore, there is an immediate need to add to the portfolio of evidence-based, trauma-focused, integrative treatments for AUD/PTSD. The primary objective of this Stage II study is to examine the efficacy of CPT-RP, as compared to RP alone, in reducing (1) alcohol use frequency and quantity and (2) PTSD symptom severity among individuals with current AUD/PTSD. To accomplish this, a randomized study design, manualized intervention, and standardized repeated dependent measures of clinical outcomes at multiple time points will be employed. Putative mechanisms of behavior change will be evaluated via daily monitoring. The proposed study aligns closely with the mission of NIAAA in that it aims to produce maximally efficacious behavioral interventions for AUD and comorbid psychiatric disorders such as PTSD. The findings from this study will provide new information to advance the science of AUD/PTSD comorbidity and innovate clinical practice.

Eligibility criteria: Inclusion Criteria:

1. Any gender identity, any race or ethnicity, aged 18-70 years.
2. Able to provide written informed consent.
3. Ability to understand English.
4. Meet DSM-5 diagnostic criteria for current (past month) moderate to severe alcohol use disorder (\> 4 criteria).
5. At least 2 heavy drinking days per week (4 or more drinks for a woman, 5 or more drinks for a man) in the last 30 days, or \>14 drinks per week for females or \> 21 drinks per week for males for at least 2 weeks in the last 30 days.
6. Meet DSM-5 diagnostic criteria for current (past month) PTSD as assessed by the CAPS-5 (score of \> 25).
7. Participants may also meet criteria for a mood disorder (except bipolar affective disorder, see Exclusion Criteria) or anxiety disorders. The inclusion of participants with affective and anxiety disorders is essential because of the marked frequency of the co-existence of mood and anxiety disorders among patients with AUD and PTSD. Concurrent substance use disorders are acceptable provided alcohol is the participant's primary substance of choice.
8. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation.

Exclusion Criteria:

1. Meeting DSM-5 criteria for a history of or current psychotic disorder or bipolar disorder, or imminent risk of suicidal or homicidal behavior. The intervention may be insufficient, and those participants will be referred clinically for a higher level of care.
2. Participants on psychotropic medications which have been initiated during the past 4 weeks.
3. Acute alcohol withdrawal as indicated by CIWA-Ar scores \>8. Those participants will be referred clinically for medically supervised detoxification. They may be re-evaluated for eligibility after detoxification.
4. Pregnancy or breastfeeding for women.
5. Currently enrolled in evidence-based behavioral treatment for AUD or PTSD. Attendance at therapeutic activities (e.g., Alcoholics Anonymous) other than study sessions will be closely monitored using the Treatment Services Review.

Primary outcomes:
measure: Change in Alcohol Use
timeFrame: through study treatment completion, an average of 12 weeks
measure: Change in Posttraumatic Stress Disorder (PTSD) Symptoms
timeFrame: through study treatment completion, an average of 12 weeks
Secondary outcomes:
measure: Change in Alcohol Use
timeFrame: At 3 months, 6 months, and 12 months following study treatment completion
measure: Change in Posttraumatic Stress Disorder (PTSD) Symptoms
timeFrame: At 3 months, 6 months, and 12 months following study treatment completion
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: College Station
country: United States
facility: Texas A&M University
state: Texas
Study officials:
affiliation: Texas A&M University
name: Anka A Vujanovic, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Sudie E Back, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: