N/A
N=80
Reducing Alcohol Use & Post-traumatic Stress Disorder (PTSD) With Cognitive Restructuring & Experiential Acceptance
Alcoholism · Stress Disorders, Post-Traumatic
Bottom Line
View on ClinicalTrials.gov: NCT00760994 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Average Drinks Per Day Assessed Using Daily Interactive Voice Response (IVR) — 3.6; 1.8; 3.1 drinks per day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Experiential acceptance (Behavioral); Cognitive restructuring (Behavioral); No-intervention control: Nutrition information (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Seattle Institute for Biomedical and Clinical Research
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Drinks Per Day Assessed Using Daily Interactive Voice Response (IVR) |
3.6; 1.8; 3.1 | — |
| SECONDARY Average Post-Traumatic Stress Disorder (PTSD) Scores Per Day Assessed Using Daily Interactive Voice Response (IVR) |
2.7; 3.1; 3.0 | — |
Summary
The purpose of this study is to determine whether an experiential acceptance therapy intervention is effective in the treatment of alcohol dependency and post-traumatic stress disorder (PTSD) symptoms in individuals who suffer from PTSD.
Eligibility Criteria
Inclusion Criteria
- age at least 18 years
- current DSM-IV diagnosis of alcohol dependence (AD) with some alcohol use in the last month
- current DSM-IV diagnosis of post-traumatic stress disorder (PTSD)
- capacity to provide informed consent
- English fluency
- no planned absences that they would be unable to complete 6 weeks of daily monitoring and study sessions
- access to a telephone
- desire to decrease or stop alcohol drinking behavior
Exclusion Criteria
- a history of delirium tremens
- seizures, in order to ensure that participants will be medically safe to decrease alcohol use
- opiate abuse or dependence use or chronic treatment with any opioid- containing medications during the previous month
- currently taking or planning to start taking either antabuse or naltrexone (due to their pharmacological impact on alcohol cravings and use)
- exhibits signs or symptoms of alcohol withdrawal at the time of initial consent
- acutely suicidal with intent/plan or present an imminent danger to others
- a current psychotic disorder
For ethical reasons and because of the preliminary nature of this study, participants may be in ongoing substance abuse or mental health treatment (MH) or may initiate counseling or medications (other than those noted in exclusion criteria) during the course of the study. Mental health treatment involvement will be used as a covariate if it is related to study dependent variables.
Data sourced from ClinicalTrials.gov (NCT00760994). 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.