Integrated Alcohol Disorder and PTSD Treatment
1 other identifier
interventional
168
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2013
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2012
CompletedFirst Posted
Study publicly available on registry
May 17, 2012
CompletedStudy Start
First participant enrolled
January 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2018
CompletedResults Posted
Study results publicly available
August 8, 2019
CompletedAugust 8, 2019
August 1, 2019
5.2 years
February 28, 2012
June 6, 2019
August 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Timeline Follow-Back Procedure (TLFB) for Alcohol Use
baseline to 6-month follow-up
Study Arms (2)
Arm 1: Integrated Prolonged Exposure Therapy
EXPERIMENTALIntegrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder)
Arm 2: Seeking Safety
ACTIVE COMPARATORSeeking Safety
Interventions
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 (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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161, United States
Related Publications (6)
Lyons R, Helm J, Luciano M, Haller M, Norman SB. The role of posttraumatic cognitions in integrated treatments for co-occurring posttraumatic stress disorder and alcohol use disorder. Psychol Trauma. 2024 Dec;16(Suppl 3):S532-S539. doi: 10.1037/tra0001540. Epub 2023 Jun 29.
PMID: 37384482DERIVEDMarx BP, Lee DJ, Norman SB, Bovin MJ, Sloan DM, Weathers FW, Keane TM, Schnurr PP. Reliable and clinically significant change in the clinician-administered PTSD Scale for DSM-5 and PTSD Checklist for DSM-5 among male veterans. Psychol Assess. 2022 Feb;34(2):197-203. doi: 10.1037/pas0001098. Epub 2021 Dec 23.
PMID: 34941354DERIVEDTripp JC, Haller M, Trim RS, Straus E, Bryan CJ, Davis BC, Lyons R, Hamblen JL, Norman SB. Does exposure exacerbate symptoms in veterans with PTSD and alcohol use disorder? Psychol Trauma. 2021 Nov;13(8):920-928. doi: 10.1037/tra0000634. Epub 2020 Jul 16.
PMID: 32673006DERIVEDTripp JC, Angkaw A, Schnurr PP, Trim RS, Haller M, Davis BC, Norman SB. Residual Symptoms of Posttraumatic Stress Disorder and Alcohol Use Disorder Following Integrated Exposure Treatment Versus Coping Skills Treatment. J Trauma Stress. 2020 Aug;33(4):477-487. doi: 10.1002/jts.22552. Epub 2020 Jun 18.
PMID: 32557843DERIVEDCapone C, Tripp JC, Trim RS, Davis BC, Haller M, Norman SB. Comparing Exposure- and Coping Skills-Based Treatments on Trauma-Related Guilt in Veterans With Co-Occurring Alcohol Use and Posttraumatic Stress Disorders. J Trauma Stress. 2020 Aug;33(4):603-609. doi: 10.1002/jts.22538. Epub 2020 Jun 10.
PMID: 32521096DERIVEDNorman SB, Trim R, Haller M, Davis BC, Myers US, Colvonen PJ, Blanes E, Lyons R, Siegel EY, Angkaw AC, Norman GJ, Mayes T. Efficacy of Integrated Exposure Therapy vs Integrated Coping Skills Therapy for Comorbid Posttraumatic Stress Disorder and Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Aug 1;76(8):791-799. doi: 10.1001/jamapsychiatry.2019.0638.
PMID: 31017639DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
\- Mostly male veteran sample
Results Point of Contact
- Title
- Sonya Norman, PhD
- Organization
- VA San Diego
Study Officials
- PRINCIPAL INVESTIGATOR
Sonya B. Norman, PhD
VA San Diego Healthcare System, San Diego, CA
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2012
First Posted
May 17, 2012
Study Start
January 21, 2013
Primary Completion
March 30, 2018
Study Completion
March 30, 2018
Last Updated
August 8, 2019
Results First Posted
August 8, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share
Not in our approval.