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Integrated Alcohol Disorder and PTSD Treatment

Primary Purpose

PTSD, Alcoholism

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Integrated Prolonged Exposure Therapy
Seeking Safety
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring posttraumatic stress disorder, psychotherapy, alcoholism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: Integrated Prolonged Exposure Therapy

Arm 2: Seeking Safety

Arm Description

Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder)

Seeking Safety

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 28, 2012
Last Updated
August 5, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01601067
Brief Title
Integrated Alcohol Disorder and PTSD Treatment
Official Title
Integrated Alcohol Disorder and PTSD Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 21, 2013 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Alcoholism
Keywords
posttraumatic stress disorder, psychotherapy, alcoholism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Integrated Prolonged Exposure Therapy
Arm Type
Experimental
Arm Description
Integrated Prolonged exposure Psychotherapy (I-PE; PE integrated with elements of Integrated Cognitive Behavioral Therapy for alcohol use disorder)
Arm Title
Arm 2: Seeking Safety
Arm Type
Active Comparator
Arm Description
Seeking Safety
Intervention Type
Behavioral
Intervention Name(s)
Integrated Prolonged Exposure Therapy
Other Intervention Name(s)
I-PE
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Seeking Safety
Other Intervention Name(s)
SS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS)
Description
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
Secondary Outcome Measure Information:
Title
Timeline Follow-Back Procedure (TLFB) for Alcohol Use
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonya B. Norman, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not in our approval.
Citations:
PubMed Identifier
34941354
Citation
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.
Results Reference
derived
PubMed Identifier
32673006
Citation
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.
Results Reference
derived
PubMed Identifier
32557843
Citation
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.
Results Reference
derived
PubMed Identifier
32521096
Citation
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.
Results Reference
derived
PubMed Identifier
31017639
Citation
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.
Results Reference
derived

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Integrated Alcohol Disorder and PTSD Treatment

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