Combined Therapy for Alcohol Use Disorder and PTSD

(CPT+RP Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Anka A Vujanovic, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Houston

Must be taking: Psychotropic medications

Must not be taking: Psychotropic medications

Disqualifiers: Psychotic disorder, Bipolar, Pregnancy, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are taking psychotropic medications, you need to be on a stable dose for at least 4 weeks before starting the study. If your medications were started in the past 4 weeks, you may not be eligible to participate.

What data supports the effectiveness of the treatment for Alcohol Use Disorder and PTSD?

Research shows that Cognitive Processing Therapy (CPT) is effective for PTSD, and when enhanced to address alcohol use, it can significantly improve both PTSD symptoms and alcohol-related problems. Integrated treatments combining cognitive-behavioral therapy for PTSD and substance use disorders have shown promise in reducing symptoms of both conditions. ^{1 2 3 4 5}

Is the combined therapy for Alcohol Use Disorder and PTSD safe for humans?

The research suggests that integrated treatments like Cognitive Processing Therapy (CPT) and Relapse Prevention (RP) are generally safe for individuals with PTSD and Alcohol Use Disorder, as they have been used effectively without major safety concerns reported. ^{1 2 4 6 7}

How is the treatment Cognitive Processing Therapy + Relapse Prevention unique for treating PTSD and Alcohol Use Disorder?

This treatment is unique because it combines Cognitive Processing Therapy, which is effective for PTSD, with Relapse Prevention, which is used for Alcohol Use Disorder, into an integrated approach that addresses both conditions simultaneously, potentially improving outcomes for individuals with both PTSD and AUD. ^{1 2 3 7 8}

Research Team

Sudie Back, PhD

Principal Investigator

Medical University of South Carolina

Anka A Vujanovic, Ph.D.

Principal Investigator

Texas A&M University

Eligibility Criteria

This trial is for adults aged 18-70 with both PTSD and moderate to severe alcohol use disorder, who can consent and understand English. It's not for those with bipolar disorder or other specific conditions. Participants should have a recent history of heavy drinking as defined in the study.

Inclusion Criteria

Meet DSM-5 diagnostic criteria for current (past month) moderate to severe alcohol use disorder (> 4 criteria)

Participants may also meet criteria for a mood disorder or anxiety disorders. Concurrent substance use disorders are acceptable provided alcohol is the participant's primary substance of choice

Ability to understand English

Exclusion Criteria

Acute alcohol withdrawal as indicated by CIWA-Ar scores >8

Meeting DSM-5 criteria for a history of or current psychotic disorder or bipolar disorder, or imminent risk of suicidal or homicidal behavior

I am not pregnant or breastfeeding.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12, 90-minute individual sessions of CPT+RP or RP alone, delivered twice-weekly

6-9 weeks

12 visits (in-person)

Follow-up

Participants are monitored for changes in alcohol use and PTSD symptoms

12 months

Assessments at 3, 6, and 12 months

Treatment Details

Interventions

• Cognitive Processing Therapy + Relapse Prevention (Behavioral Intervention)
• Relapse Prevention (Behavioral Intervention)

Trial Overview The study tests if Cognitive Processing Therapy combined with Relapse Prevention (CPT+RP) is better than just Relapse Prevention (RP) at reducing how often and how much participants drink, as well as easing PTSD symptoms.

Participant Groups

Group I: Integrated Cognitive Processing Therapy and Relapse Prevention (CPT+RP) Experimental Treatment 1 Intervention

Participants will receive 12, 90-minute individual sessions of CPT+RP delivered twice-weekly. We will offer some flexibility (e.g., due to illness or scheduling conflicts) and allow up to 9 weeks to complete all 12 sessions if needed. During CPT+RP, patients receive psychoeducation pertaining to the interconnectedness of AUD and PTSD and learn techniques to identify and manage triggers for alcohol use, cope with cravings, address problem thoughts about drinking, and enhance social support. These skills address core functional outcomes relevant to addiction, including executive functioning, incentive salience, and negative emotionality. The PTSD treatment component of CPT+RP reduces PTSD symptoms via identifying and targeting maladaptive trauma-related cognitions, beliefs, and Stuck Points via cognitive restructuring exercises, such as Socratic questioning. RP skills are integrated within each session.

Group II: Relapse Prevention (RP) Active Control 1 Intervention

Participants will receive 12, 90-minute individual sessions of RP delivered twice-weekly as consistent with the experimental condition. The RP manual is adapted from the NIAAA Project MATCH Cognitive-Behavioral Coping Skills Therapy Manual and has been used in prior NIH-funded trials of integrated, trauma-focused treatment. Session topics include, for example, Triggers for Alcohol Use, Coping with Cravings and Urges to Drink (e.g., avoid alcohol cues, distracting activities, talk to friends/family, urge surfing), Managing Thoughts about Alcohol and Drinking by challenging and changing thoughts, Planning for Emergencies and Coping with a Lapse, Drink Refusal Skills, Increasing Pleasant Activities and Enhancing Social Support.

Cognitive Processing Therapy + Relapse Prevention is already approved in United States for the following indications:

🇺🇸 Approved in United States as CPT-RP for:

• Posttraumatic Stress Disorder (PTSD)
• Alcohol Use Disorder (AUD)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Texas A&M University College Station, TX

Medical University of South Carolina Charleston, SC

Who Is Running the Clinical Trial?

University of Houston

Lead Sponsor

Trials

155

Patients Recruited

48,600+

Texas A&M University

Lead Sponsor

Trials

156

Patients Recruited

28,900+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Patients Recruited

1,091,000+

Medical University of South Carolina

Collaborator

Trials

994

Patients Recruited

7,408,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Cognitive Processing Therapy or Relapse Prevention for comorbid Posttraumatic Stress Disorder and Alcohol Use Disorder: A randomized clinical trial. [2023] To compare a Posttraumatic Stress Disorder (PTSD) treatment (Cognitive Processing Therapy; CPT), an Alcohol Use Disorder (AUD) treatment (Relapse Prevention; RP), and assessment-only (AO) for those meeting diagnostic criteria for both PTSD and AUD.

2. United States pubmed.ncbi.nlm.nih.gov

Case report on the use of cognitive processing therapy-cognitive, enhanced to address heavy alcohol use. [2022] There is a high rate of co-occurring alcohol dependence (AD) in individuals with posttraumatic stress disorder (PTSD). Cognitive processing therapy (CPT) is an effective treatment for individuals diagnosed with PTSD. CPT-Cognitive (CPT-C) is a modified form of CPT. This case report describes a 12-week course of CPT-C treatment, enhanced to address heavy alcohol use, in a combat veteran with PTSD and co-occurring AD. By treatment end, the veteran demonstrated clinically significant improvement in both PTSD symptoms and alcohol-related problems and sustained these gains 12-weeks posttreatment. The results indicate promise for the use of CPT-C, enhanced for heavy alcohol use, for individuals diagnosed with PTSD and AD.

3. United States pubmed.ncbi.nlm.nih.gov

Behavioral Treatments for Alcohol Use Disorder and Post-Traumatic Stress Disorder. [2023] Alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) are highly prevalent and debilitating psychiatric conditions that commonly co-occur. Individuals with comorbid AUD and PTSD incur heightened risk for other psychiatric problems (e.g., depression and anxiety), impaired vocational and social functioning, and poor treatment outcomes. This review describes evidence-supported behavioral interventions for treating AUD alone, PTSD alone, and comorbid AUD and PTSD. Evidence-based behavioral interventions for AUD include relapse prevention, contingency management, motivational enhancement, couples therapy, 12-step facilitation, community reinforcement, and mindfulness. Evidence-based PTSD interventions include prolonged exposure therapy, cognitive processing therapy, eye movement desensitization and reprocessing, psychotherapy incorporating narrative exposure, and present-centered therapy. The differing theories behind sequential versus integrated treatment of comorbid AUD and PTSD are presented, as is evidence supporting the use of integrated treatment models. Future research on this complex, dual-diagnosis population is necessary to improve understanding of how individual characteristics, such as gender and treatment goals, affect treatment outcome.

4. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of treatments for co-occurring substance use disorders and post-traumatic stress disorder. [2022] Post-traumatic stress disorder (PTSD) is common among people with substance use disorders, and the comorbidity is associated with negative outcomes. We report on a randomized controlled trial comparing the effect of integrated cognitive-behavioral therapy (ICBT) plus standard care, individual addiction counseling plus standard care and standard care alone on substance use and PTSD symptoms.

5. United States pubmed.ncbi.nlm.nih.gov

A Novel, Integrated Cognitive-Behavioral Therapy for Co-Occurring Posttraumatic Stress and Substance Use Disorders: A Case Study. [2020] Posttraumatic stress disorder (PTSD) and substance use disorders (SUD) are complex psychiatric conditions that commonly co-occur. No preferred, evidence-based treatments for PTSD/SUD comorbidity are presently available. Promising integrated treatments have combined prolonged exposure therapy with cognitive-behavioral relapse prevention therapy for SUD. We describe a case study that showcases a novel, integrated cognitive-behavioral treatment approach for PTSD/SUD, entitled Treatment of Integrated Posttraumatic Stress and Substance Use (TIPSS). The TIPSS program integrates cognitive processing therapy with cognitive-behavioral therapy for SUD for the treatment of co-occurring PTSD/SUD. The present case report, based upon a woman with PTSD comorbid with both cocaine and alcohol dependence, demonstrates that TIPSS has the potential to effectively reduce PTSD symptoms as well as substance use.

6. United States pubmed.ncbi.nlm.nih.gov

Treatment responder status and time to response as a function of hazardous drinking among active-duty military receiving variable-length cognitive processing therapy for posttraumatic stress disorder. [2023] A common concern is whether individuals with posttraumatic stress disorder (PTSD) and hazardous drinking will respond to PTSD treatment or need a higher dose. In a sample of active-duty military, we examined the impact of hazardous drinking on cognitive processing therapy (CPT) outcomes and whether number of sessions to reach good end-state or dropout differed by drinking status.

7. Ireland pubmed.ncbi.nlm.nih.gov

Within-treatment clinical markers of dropout risk in integrated treatments for comorbid PTSD and alcohol use disorder. [2023] Integrated interventions for comorbid posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) are effective, but many patients prematurely drop out from treatment. Little is known about within-treatment risk factors for dropout, limiting the ability during therapy to identify patients at risk for attrition.

8. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of cognitive behaviour therapy for comorbid post-traumatic stress disorder and alcohol use disorders. [2019] Aims This study aimed to test the efficacy of integrated cognitive behaviour therapy (CBT) for coexisting post traumatic stress disorder (PTSD) and alcohol use disorders (AUD). Setting Clinics across Sydney, Australia.Design Randomized controlled trial of 12 once-weekly individual sessions of either integrated CBT for PTSD and AUD(integrated therapy, IT; n = 33) or CBT for AUD plus supportive counselling (alcohol-support, AS; n = 29). Blind assessments were conducted at baseline and post-treatment and at 5 [standard deviation (SD) = 2.25] and 9.16(SD = 3.45) months post-treatment. Participants Sixty-two adults with concurrent PTSD and AUD. Measurements Outcomes included changes in alcohol consumption (time-line follow-back), PTSD severity [clinician-administered PTSD scale (CAPS)], alcohol dependence and problems, and depression and anxiety. Findings Reductions in PTSD severity were evident in both groups. IT participants who had received one or more sessions of exposure therapy exhibited a twofold greater rate of clinically significant change in CAPS severity at follow-up than AS participants [IT60%, AS 39%, odds ratio (OR): 2.31, 95% confidence interval (CI): 1.06, 5.01]. AS participants exhibited larger reductions than IT participants in alcohol consumption, dependence and problems within the context of greater treatment from other services during follow-up. Results lend support to a mutually maintaining effect between AUD and PTSD. Conclusions Individuals with severe and complex presentations of coexisting post-traumatic stress disorder(PTSD) and alcohol use disorders (AUD) can derive substantial benefit from cognitive behaviour therapy targeting AUD, with greater benefits associated with exposure for PTSD. Among individuals with dual disorders, these therapies can generate significant, well-maintained treatment effects on PTSD, AUD and psychopathology.