Integrated Alcohol Disorder and PTSD Treatment

PTSD Clinical Trial

Official title:

Integrated Alcohol Disorder and PTSD Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601067
• Other study ID #: NURA-011-11F
• Status: Completed
• Phase: Phase 2
• Start date: January 21, 2013
• Est. completion date: March 30, 2018

Study information

• Verified date: August 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol-Related Disorders
• Alcoholism
• PTSD

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale (CAPS)	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	Timeline Follow-Back Procedure (TLFB) for Alcohol Use	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