Integrated Alcohol Disorder and PTSD Treatment

August 5, 2019 updated by: VA Office of Research and Development
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives. Co-occurrence of alcohol use disorder (AD) and posttraumatic stress disorder (PTSD) is common. Research supports exposure therapy as the front line treatment for PTSD as this approach is most likely to lead to sustained recovery from the disorder. However, individuals with AD are generally not offered exposure therapies because of beliefs that exposure would lead to engagement in greater alcohol use and other dangerous behaviors. Most research and clinical treatment for comorbid AD and PTSD (AD/PTSD) have involved coping skills based therapies that have generally not shown sustained reductions in alcohol use and PTSD symptoms. A growing body of evidence suggests these individuals with AD/PTSD are able to handle and benefit from exposure. This proposed trial will compare an integrated exposure psychotherapy to an integrated coping skills psychotherapy for the treatment of AD/PTSD. In addition, mechanisms of change for Veterans with AD/PTSD in both treatment conditions, including therapy process variables, changes in negative affect, and sleep problems, will be explored. This project addresses a critical barrier in the field - the widely held belief that individuals with AD and PTSD cannot tolerate exposure therapy, although it is the best practice treatment for PTSD. The fundamental rationale is to improve the evidence base that informs how patients with AD/PTSD can attain sustained recovery. The investigators propose a randomized controlled trial to evaluate an integrated exposure-based treatment for concurrent AD and PTSD. The primary aim will be to conduct a randomized controlled trial to evaluate the effects of integrated exposure psychotherapy when compared to a present-focused coping skills based intervention (Seeking Safety; SS) in 148 male and female Veterans who have AD and PTSD. The hypotheses are that at post-treatment both groups will show reductions in alcohol use, but the integrated exposure group will demonstrate greater reductions in PTSD symptoms than SS. At 5- and 8-month post-baseline follow-up, the integrated exposure group will have significantly fewer percent drinking days and fewer PTSD symptoms than SS. In addition, mechanisms of change in both treatment conditions will be examined.

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • VA San Diego Healthcare System, San Diego, CA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1: Integrated Prolonged Exposure Therapy
Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder)
Behavioral: Integrated Prolonged Exposure Therapy
Prolonged exposure (PE) therapy is an evidence based practice for the treatment of PTSD. Components of PE included education about PTSD and exposure to avoided reminders of trauma.
Other Names:
  • I-PE
ACTIVE_COMPARATOR: Arm 2: Seeking Safety
Seeking Safety
Behavioral: Seeking Safety
Seeking Safety (SS) teaching coping skills in behavioral, cognitive, and interpersonal domains so that people are able to make safe choices rather than drinking or PTSD-related behaviors such as avoidance.
Other Names:
  • SS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician Administered PTSD Scale (CAPS)
Time Frame: baseline through 6 month follow-up
The CAPS-5 (score range, 0-80, with 0 indicating no PTSD symptoms and 80 indicating extreme ratings across all symptoms), a 30-item structured interview considered to be the criterion standard for PTSD, was the primary measure of PTSD symptoms and diagnosis. Diagnosis was determined using the rule of a severity score of 2 or higher, which follows DSM-5 PTSD criteria.
baseline through 6 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timeline Follow-Back Procedure (TLFB) for Alcohol Use
Time Frame: baseline to 6-month follow-up
Frequency and quantity of alcohol use were assessed using the Timeline Follow-Back, a calendar-assisted structured clinical interview that displays good psychometric properties. The PHDD was calculated by dividing the number of days in which 5 or more drinks for men or 4 or more drinks for women were consumed by the total number of days in the reference period.
baseline to 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 21, 2013

Primary Completion (ACTUAL)

March 30, 2018

Study Completion (ACTUAL)

March 30, 2018

Study Registration Dates

First Submitted

February 28, 2012

First Submitted That Met QC Criteria

May 15, 2012

First Posted (ESTIMATE)

May 17, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NURA-011-11F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not in our approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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