Phase 2
N=119
Integrated Alcohol Disorder and PTSD Treatment
PTSD · Alcoholism
Bottom Line
View on ClinicalTrials.gov: NCT01601067 ↗Enrolled (actual)
119
Serious AEs
1.7%
Results posted
Aug 2019
Primary outcome: Primary: Clinician Administered PTSD Scale (CAPS) — 43.2; 42.1; 25.8; 32.9 score on a scale — p=.002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Integrated Prolonged Exposure Therapy (Behavioral); Seeking Safety (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician Administered PTSD Scale (CAPS) |
43.2; 42.1; 25.8; 32.9; 26.4; 31.0 | .002 sig |
| SECONDARY Timeline Follow-Back Procedure (TLFB) for Alcohol Use |
52.5; 50.4; 21.0; 17.4; 14.2; 15.0 | .91 |
Summary
Comorbidity of alcohol use disorder (AD) and posttraumatic stress disorder (PTSD) is common. Currently available treatments often do not lead to sustained recovery from these disorders, possibly because they typically do not include exposure therapy which is considered best practice treatments for PTSD. This study compares exposure-based integrated treatment to integrated coping skills psychotherapy (a well disseminated practice) for comorbid AD and PTSD with the hypothesis that exposure therapy will allow those with PTSD to better sustain PTSD symptom reduction and reduction in alcohol use. The aim of this grant is to change common treatment practices for comorbid AD and PTSD by increasing the availability of evidence-based PTSD treatment for those with AD.
Eligibility Criteria
Inclusion Criteria
- Veterans who were victims of psychological trauma that occurred in childhood or adulthood.
- At least one month post-trauma.
- Age 18 or older.
- Meeting diagnostic criteria for current alcohol dependence and PTSD.
- Literate in English.
- Intend to stay in San Diego during study participation.
- Willing to attend psychotherapy and measurement sessions.
- Willing to stay cut down alcohol use significantly during treatment.
Exclusion Criteria
- Moderate or severe cognitive impairment on the Brief Neuropsychological (NP) Assessment Battery as this may interfere with ability to benefit from treatment.
- Acutely suicidal individuals will be referred for more appropriate treatment.
- Histories of psychosis or mania independent of substance use will be excluded because the presence of these disorders can impede therapy progress.
- Individuals who use intravenous drugs will be excluded.
- Participants who do not have adequate memory of the trauma will be excluded because such memory is necessary for exposure therapy.
- Only Veterans residing within 50 miles of the site will be included.
- Those with life threatening or unstable medical illness, documented neurological disorder, or inability to read will be excluded.
Data sourced from ClinicalTrials.gov (NCT01601067). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.