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| Sponsor: | Elizabeth Ralevski |
|---|---|
| Information provided by (Responsible Party): | Elizabeth Ralevski, Yale University |
| ClinicalTrials.gov Identifier: | NCT00622921 |
Purpose
Purpose: Phase I focus groups with clinicians and patients will gather qualitative data to focus and inform the content of Phase II. In Phase II, 12 weeks of psychotherapy will be offered to evaluate feasibility and potential efficacy of a couples-based, integrated treatment for men with PTSD and alcohol dependence.
Hypotheses: We predict that this experimental psychotherapy, Partners Encouraging Abstinence and Coping with Emotions (PEACE), will reduce patient drinking, reduce PTSD symptoms, and improve relationship functioning.
| Condition | Intervention | Phase |
|---|---|---|
|
PTSD Alcohol Dependence |
Behavioral: Couples-based behavioral psychotherapy |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Couples-based Behavioral Psychotherapy for Male Patients With Posttraumatic Stress Disorder and Alcohol Dependence |
| Enrollment: | 0 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Couples-based behavioral psychotherapy
|
Behavioral: Couples-based behavioral psychotherapy
12 weeks of Couples-based behavioral psychotherapy
|
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Connecticut | |
| VA Connecticut Healthcare System | |
| West Haven, Connecticut, United States, 06516 | |
| Principal Investigator: | Ismene L Petrakis, MD | Yale University |
More Information
| Responsible Party: | Elizabeth Ralevski, Assistant Professor, Yale University |
| ClinicalTrials.gov Identifier: | NCT00622921 History of Changes |
| Other Study ID Numbers: | IP0031, 0711003228 |
| Study First Received: | February 13, 2008 |
| Last Updated: | January 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
PTSD alcohol dependence |
|
Alcoholism Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Alcohol-Related Disorders |
Substance-Related Disorders Mental Disorders Anxiety Disorders |