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Behavioral Intervention

Integrated Cognitive Processing Therapy and Relapse Prevention (CPT+RP) for Post-Traumatic Stress Disorder (CPT+RP Trial)

Phase 2

Recruiting

Led By Anka A Vujanovic, Ph.D.

Research Sponsored by University of Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3 months, 6 months, and 12 months following study treatment completion

Awards & highlights

CPT+RP Trial Summary

"This trial aims to test a new therapy for individuals with both posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD). The study will compare the effectiveness of a combined therapy (C

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include emotional distress due to discussing traumatic events during therapy sessions, which could temporarily worsen PTSD symptoms.

CPT+RP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3 months, 6 months, and 12 months following study treatment completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3 months, 6 months, and 12 months following study treatment completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 months, 6 months, and 12 months following study treatment completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change in Alcohol Use

Change in Posttraumatic Stress Disorder (PTSD) Symptoms

CPT+RP Trial Design

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of HoustonLead Sponsor

147 Previous Clinical Trials

47,278 Total Patients Enrolled

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

806 Previous Clinical Trials

1,157,849 Total Patients Enrolled

Medical University of South CarolinaOTHER

934 Previous Clinical Trials

7,394,596 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being recruited for participation in this medical research study?

"Indeed, the details on clinicaltrials.gov confirm that this research study is actively seeking eligible individuals. The trial was initially shared on April 1st, 2024 and last revised on April 16th, 2024. Enrollment aims to encompass a total of 200 participants distributed across two distinct sites."

Answered by AI

Are there any available vacancies for patient participation in this clinical trial?

"Affirmative. Records on clinicaltrials.gov reveal that this research study is currently seeking volunteers. Originally listed on April 1st, 2024, the trial was last modified on April 16th, 2024. The aim is to enroll a total of 200 participants across two designated sites."

Answered by AI

Can individuals enroll themselves in this medical research study?

"Individuals aged between 18 and 70 years with a confirmed diagnosis of post-traumatic stress disorder (PTSD) are sought for enrollment in this clinical trial, which aims to recruit approximately 200 participants."

Answered by AI

Has the FDA given its approval for Integrated Cognitive Processing Therapy and Relapse Prevention (CPT+RP)?

"The safety rating for Integrated Cognitive Processing Therapy and Relapse Prevention (CPT+RP) is a 2 on the scale of 1 to 3, as per our evaluation at Power. This assessment aligns with it being a Phase 2 trial, indicating minimal data supporting efficacy but some backing its safety profile."

Answered by AI