Skip to content

Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and PTSD

Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and Co-Occurring PTSD: A Randomized Clinical Trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05959434
Acronym
CPT+RP
Enrollment
200
Registered
2023-07-25
Start date
2024-04-01
Completion date
2028-07-31
Last updated
2025-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder, Alcohol Use Disorder

Keywords

trauma or PTSD, alcohol use, Cognitive Processing Therapy, Relapse Prevention

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.

Interventions

BEHAVIORALCognitive Processing Therapy + Relapse Prevention

Cognitive-Behavioral Therapy that integrates Cognitive Processing Therapy for PTSD with Relapse Prevention for alcohol use disorder

Cognitive-Behavioral Therapy that targets alcohol use, specifically

Sponsors

Texas A&M University
Lead SponsorOTHER
Medical University of South Carolina
CollaboratorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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 3 to 4 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. 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Alcohol Usethrough study treatment completion, an average of 12 weeksComposite of alcohol use frequency (percent days drinking) and quantity (drinks per drinking day), as measured by the Timeline Follow-Back
Change in Posttraumatic Stress Disorder (PTSD) Symptomsthrough study treatment completion, an average of 12 weeksPTSD symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

Secondary

MeasureTime frameDescription
Change in Alcohol UseAt 3 months, 6 months, and 12 months following study treatment completionComposite of alcohol use frequency (percent days drinking) and quantity (drinks per drinking day), as measured by the Timeline Follow-Back
Change in Posttraumatic Stress Disorder (PTSD) SymptomsAt 3 months, 6 months, and 12 months following study treatment completionPTSD symptoms as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

Countries

United States

Contacts

Primary ContactAnka A Vujanovic, Ph.D.
avujanovic@tamu.edu979-862-6538
Backup ContactSudie E Back, Ph.D.
backs@musc.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026