A Phase 2 interventional study of Integrated Prolonged Exposure Therapy and Seeking Safety in PTSD and Alcoholism, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-08.
Sponsored by VA Office of Research and Development · Phase 2, Interventional, and Treatment
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.
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 168 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder)
Behavioral: Integrated Prolonged Exposure Therapy
Seeking Safety
Behavioral: Seeking Safety
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.
Also known as: 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.
Also known as: SS
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.
Time frame: baseline through 6 month follow-up
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.
Time frame: baseline to 6-month follow-up
Participants contacted our study in response to 1) flyers posted in VA mental health, primary care, and alcohol and substance use treatment programs; 2) from advertisements in print and web-based media; and 3) by VA primary care, SAMI, PTSD, and other psychiatry clinics
| Milestone | Arm 1: Integrated Prolonged Exposure Therapy | Arm 2: Seeking Safety |
|---|---|---|
| Started | 63 | 56 |
| Completed | 30 | 34 |
| Not completed | 33 | 22 |
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.
| score on a scale | Arm 1: Integrated Prolonged Exposure Therapy | Arm 2: Seeking Safety |
|---|---|---|
| Baseline | 43.2 (40.0 to 46.4) | 42.1 (38.7 to 45.5) |
| After Treatment | 25.8 (22.1 to 29.6) | 32.9 (29.3 to 36.6) |
| 3 month follow-up | 26.4 (22.6 to 30.3) | 31.0 (27.0 to 35.1) |
| 6 month follow-up | 22.5 (18.2 to 26.8) | 29.8 (25.6 to 33.9) |
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.
| percentage of days | Arm 1: Integrated Prolonged Exposure Therapy | Arm 2: Seeking Safety |
|---|---|---|
| % Days heavy drinking - baseline | 52.5 (46.5 to 58.6) | 50.4 (44.1 to 56.7) |
| % Days heavy drinking -After treatment | 21.0 (13.4 to 28.6) | 17.4 (10.4 to 24.5) |
| % Days heavy drinking - 3 month follow up | 14.2 (6.9 to 21.4) | 15.0 (7.1 to 22.8) |
| % Days heavy drinking - 6-month follow-up | 20.2 (11.9 to 28.5) | 19.9 (12.1 to 27.6) |
| % Days abstinent - baseline | 34.3 (27.1 to 41.6) | 31.2 (23.5 to 38.8) |
| % Days abstinent - After treatment | 67.5 (58.9 to 76.1) | 63.1 (54.9 to 71.4) |
| % Days abstinent - 3-month follow up | 65.6 (57.0 to 74.2) | 68.4 (59.3 to 77.4) |
| % Days abstinent - 6-month follow-up | 66.2 (56.5 to 75.9) | 64.0 (54.8 to 73.3) |
Collected over Four years and seven months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: Integrated Prolonged Exposure Therapy | 0/63 (0%) | 2/63 (3.2%) | 0/63 (0%) |
| Arm 2: Seeking Safety | 0/56 (0%) | 0/56 (0%) | 0/56 (0%) |
| Event | Arm 1: Integrated Prolonged Exposure Therapy | Arm 2: Seeking Safety |
|---|---|---|
| hospitalization for alcohol intoxication and mood stabilizationPsychiatric disorders | 2/63 | 0/56 |
| Age, Continuous(years) | Arm 1: Integrated Prolonged Exposure Therapy | Arm 2: Seeking Safety | Total |
|---|---|---|---|
| Mean | 43.2 ± 13.5 | 39.7 ± 11.3 | 41.6 ± 12.6 |
| Sex: Female, Male(Participants) | Arm 1: Integrated Prolonged Exposure Therapy | Arm 2: Seeking Safety | Total |
|---|---|---|---|
| Female | 7 | 5 | 12 |
| Male | 56 | 51 | 107 |
| Race/Ethnicity, Customized(Participants) | Arm 1: Integrated Prolonged Exposure Therapy | Arm 2: Seeking Safety | Total |
|---|---|---|---|
| White | 41 | 37 | 78 |
| Black | 8 | 8 | 16 |
| Asian | 3 | 3 | 6 |
| Other | 11 | 7 | 18 |
| Unavailable | 0 | 1 | 1 |
| Region of Enrollment(Participants) | Arm 1: Integrated Prolonged Exposure Therapy | Arm 2: Seeking Safety | Total |
|---|---|---|---|
| United States | 63 | 56 | 119 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Not in our approval.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
VA Office of Research and Development