VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161, United States
NCT Number: NCT01601067
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
San Diego, California, 92161, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
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.
VA Office of Research and Development
Fed
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