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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Integrated Prolonged Exposure Therapy | Experimental | Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder) |
|
| Arm 2: Seeking Safety | Active Comparator | Seeking Safety |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated Prolonged Exposure Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sonya B. Norman, PhD | VA San Diego Healthcare System, San Diego, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37384482 | Derived | 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. | |
| 34941354 | Derived | Marx 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. |
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Not in our approval.
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Enrolled participants were excluded from the study for the following reasons: 27 did not meet inclusion criteria; 15 did not complete intake or did not return for intake following informed consent;5 refused research after consent; 2 had travel or logistical constrains.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) 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. |
| FG001 | Arm 2: Seeking Safety | Seeking Safety 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline through 6 month follow-up |
|
Four years and seven months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization for alcohol intoxication and mood stabilization | Psychiatric disorders | Systematic Assessment |
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- Mostly male veteran sample
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sonya Norman, PhD | VA San Diego | 858-552-8585 | sonya.norman@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 14, 2016 | Jun 5, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 3, 2011 | Jun 5, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D019973 | Alcohol-Related Disorders |
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|
| Seeking Safety | Behavioral | 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. |
|
|
| baseline to 6-month follow-up |
| 32673006 | Derived | Tripp 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. |
| 32557843 | Derived | Tripp 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. |
| 32521096 | Derived | Capone 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. |
| 31017639 | Derived | Norman 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. |
| BG001 | Arm 2: Seeking Safety | Seeking Safety 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Arm 2: Seeking Safety | Seeking Safety 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. |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | percentage of days | baseline to 6-month follow-up |
|
|
|
|
| 0 |
| 63 |
| 2 |
| 63 |
| 0 |
| 63 |
| EG001 | Arm 2: Seeking Safety | Seeking Safety 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. | 0 | 56 | 0 | 56 | 0 | 56 |
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| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| % Days heavy drinking - 3 month follow up |
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| % Days heavy drinking - 6-month follow-up |
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| % Days abstinent - baseline |
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| % Days abstinent - After treatment |
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| % Days abstinent - 3-month follow up |
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| % Days abstinent - 6-month follow-up |
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