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.
What data supports the idea that Combined Therapy for Alcohol Use Disorder and PTSD is an effective treatment?The available research shows that Combined Therapy for Alcohol Use Disorder and PTSD, which integrates cognitive processing therapy with relapse prevention, is effective. One study highlighted a case where a combat veteran with PTSD and alcohol dependence showed significant improvement in both PTSD symptoms and alcohol-related problems after a 12-week course of enhanced cognitive processing therapy. Another case study demonstrated that a similar integrated approach reduced PTSD symptoms and substance use in a woman with PTSD and alcohol dependence. These findings suggest that combining therapies can be more effective than treating each condition separately.13458
What safety data is available for combined therapy for PTSD and alcohol use disorder?The available research indicates that integrated treatments like Cognitive Processing Therapy (CPT) and Relapse Prevention (RP) are effective for individuals with comorbid PTSD and alcohol use disorder. A randomized clinical trial compared CPT and RP, showing promise for these treatments. A case report on CPT-C, enhanced for heavy alcohol use, demonstrated significant improvement in PTSD and alcohol-related symptoms. However, dropout rates are a concern, and identifying within-treatment risk factors for dropout is crucial. Overall, these studies suggest that combined therapy is promising, but more research is needed to fully understand its safety and efficacy.13678
Is Cognitive Processing Therapy + Relapse Prevention a promising treatment for people with both PTSD and alcohol use disorder?Yes, Cognitive Processing Therapy + Relapse Prevention is a promising treatment for people with both PTSD and alcohol use disorder. It combines effective methods for treating PTSD and alcohol problems, showing significant improvements in both areas.12468
Do I have to stop taking my current medications to join the trial?The trial requires that if you are taking psychotropic medications, you must 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 cannot participate.
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.Exclusion Criteria
I am not pregnant or breastfeeding.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Integrated Cognitive Processing Therapy and Relapse Prevention (CPT+RP)Experimental Treatment1 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 Control1 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 nearbySelect from list below to view details:
Texas A&M UniversityCollege Station, TX
Medical University of South CarolinaCharleston, SC
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Who is running the clinical trial?
University of HoustonLead Sponsor
Texas A&M UniversityLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
Medical University of South CarolinaCollaborator
References
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.
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.
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.
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.
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.
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.
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.
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.