Posttraumatic Stress Disorder study: Relapse Prevention
Official title Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and PTSD
ClinicalTrials.gov ID: NCT05959434
What this study is testing
- What it's testing
- The study compares a new combined therapy (CPT plus relapse prevention) with relapse prevention alone to see if it lowers how often and how much participants drink, and to reduce PTSD symptoms.
- Who it's for
- Adults who have both PTSD and alcohol use disorder.
- What's involved
- Participants will receive either the combined therapy or relapse prevention alone, attend therapy sessions, and complete daily surveys and questionnaires about drinking and PTSD symptoms.
- Time commitment
- The study lasts several months, with regular therapy visits and daily online surveys to track drinking and PTSD symptoms.
- Phase 2: a mid-size study of how well it works
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Any gender identity, any race or ethnicity, 18 years of age or older.
- Able to provide written informed consent.
- Ability to understand English.
- Meet DSM-5 diagnostic criteria for current (past month) moderate to severe alcohol use disorder ( \>= 4 criteria).
- 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...
You likely can't join if
- ) or anxiety disorders. The inclusion of participants with affective and anxiety disorders is essential because of the marked frequency of the...
- Meeting DSM-5 criteria for a history of or current psychotic disorder or bipolar disorder, or imminent risk of suicidal or homicidal behavior.
- Participants on psychotropic medications which have been initiated during the past 4 weeks.
- Acute alcohol withdrawal as indicated by CIWA-Ar scores \>8. Those participants will be referred clinically for medically supervised detoxification.
- Pregnancy or breastfeeding for women.
- Currently enrolled in evidence-based behavioral treatment for AUD or PTSD.
See the full eligibility criteria
- Any gender identity, any race or ethnicity, 18 years of age or older.
- Able to provide written informed consent.
- Ability to understand English.
- Meet DSM-5 diagnostic criteria for current (past month) moderate to severe alcohol use disorder ( \>= 4 criteria).
- 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...
- Meet DSM-5 diagnostic criteria for current (past month) PTSD as assessed by the CAPS-5.
- Participants may also meet criteria for a mood disorder (except bipolar affective disorder, see
- ) 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.
- Meeting DSM-5 criteria for a history of or current psychotic disorder or bipolar disorder, or imminent risk of suicidal or homicidal behavior.
- Participants on psychotropic medications which have been initiated during the past 4 weeks.
- 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.
- Pregnancy or breastfeeding for women.
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Charleston, South Carolina, United States
- College Station, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Charleston, South Carolina, United States; College Station, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.