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Sequence of Symptom Change During AUD or PTSD Treatment for Comorbid PTSD/AUD

Primary Purpose

PTSD, Alcohol Abuse, Alcohol Dependence

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Processing Therapy (CPT)
Relapse Prevention (RP)
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring Posttraumatic Stress Disorder, PTSD, Alcohol Abuse, Alcohol Dependance, Alcoholism, Comorbid, Relapse Prevention (RP), Cognitive Processing Therapy (CPT)

Eligibility Criteria

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

Inclusion Criteria:

  • Men and women age ≥ 18 years with a current DSM-V diagnosis of alcohol abuse/dependence
  • Recent alcohol consumption for at least 2 weeks in the past 30 day period OR at least 2 days of heavy drinking in the past 30 day period
  • Desire to abstain from alcohol
  • Current DSM-V (Diagnostic and Statistical Manual of Mental Disorders) diagnosis of PTSD
  • Capacity to provide informed consent
  • English fluency

Exclusion Criteria:

  • Men and women with an unstable psychiatric medication regimen
  • Current trauma-focused mental health treatment (MH) or behaviorally focused alcohol dependence (AD) AD/MH treatment in the past 30 days
  • Suicide attempt or suicidal ideation with intent or plan, or self-harm in the past month
  • Presence of a psychotic disorder or uncontrolled Bipolar Disorder
  • Signs or symptoms of alcohol withdrawal at the time of initial consent

Sites / Locations

  • Harborview Center for Sexual Assault and Traumatic Stress
  • VA Puget Sound Health Care (Seattle Campus)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Cognitive Processing Therapy (CPT)

Relapse Prevention Therapy (RP)

Assessment Only (AO)

Arm Description

AO functions as a benchmark comparison condition. Consists of baseline assessment, daily interactive voice response (IVR) monitoring, and immediate post-test assessment. Not an active treatment

Outcomes

Primary Outcome Measures

Reduction in PTSD Symptom Severity from baseline to immediately post treatment, baseline to 3 months, baseline to 6 months, baseline to 9 months, and baseline to 12 months; Clinician-Administered PTSD Scale (CAPS)
Reduction in alcohol consumption from baseline to immediately post treatment, baseline to 3 months, baseline to 6 months, baseline to 9 months, and baseline to 12 months; Form-90 (Alcohol Consumption)

Secondary Outcome Measures

Anxiety (GAD-7 & OASIS)
Penn Alcohol Craving Scale (PACS)
Patient Health Questionnaire Depression Scale (PHQ-9)

Full Information

First Posted
August 2, 2012
Last Updated
July 16, 2018
Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT01663337
Brief Title
Sequence of Symptom Change During AUD or PTSD Treatment for Comorbid PTSD/AUD
Official Title
Sequence of Symptom Change During AUD (Alcohol Use or Dependence) or PTSD (Posttraumatic Stress Disorder) Treatment for Comorbid PTSD/AUD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The broad, long-term objective of the current research is to improve treatment outcomes for individuals with comorbid posttraumatic stress disorder (PTSD) and alcohol abuse and dependence (AUD). The purpose of which is to evaluate changes in both PTSD symptoms and alcohol use and cravings associated with Cognitive Processing Therapy (CPT) or Relapse Prevention (RP) treatment in individuals with PTSD/AUD, along with mediators and moderators of outcomes. The study will randomize 235 PTSD/AUD participants recruited from the VA and from the community to CPT, RP, or Interactive Voice Response (IVR) assessment only (AO). Those in the AO condition will be re-randomized after the treatment phase to either RP or CPT. Individuals will be assessed pretreatment, immediately post-treatment, 3-, 6-, 9-, and 12-months post-treatment and will monitor symptoms daily throughout treatment.
Detailed Description
Prior research has established that PTSD and AUD are frequently comorbid. Although combined treatments have been developed, they are complex and lengthy with mixed results as to their efficacy. Excellent treatments exist for PTSD or AUD alone, however, it has not been adequately addressed to what extent these treatments are effective in treating comorbid symptom presentations. To address this research gap, the investigators will evaluate two widely accepted treatments for each respective disorder; Cognitive Processing Therapy (CPT) an effective PTSD treatment and Relapse Prevention (RP), a widely used effective AUD treatment. The investigators will build on our prior work using a daily telephone Interactive Voice Response (IVR) system to test models of self-medication and the sequence of symptom change for both primary and secondary symptom targets associated with each therapy. Creating a more comprehensive model of symptom change in PTSD and alcohol use with widely used selective treatments is critical in testing theories of PTSD/AUD, evaluating these treatments for use with PTSD/AUD, and implementing these therapies with PTSD/AUD patients in standard clinical practice

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Alcohol Abuse, Alcohol Dependence
Keywords
Posttraumatic Stress Disorder, PTSD, Alcohol Abuse, Alcohol Dependance, Alcoholism, Comorbid, Relapse Prevention (RP), Cognitive Processing Therapy (CPT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
235 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Processing Therapy (CPT)
Arm Type
Active Comparator
Arm Title
Relapse Prevention Therapy (RP)
Arm Type
Active Comparator
Arm Title
Assessment Only (AO)
Arm Type
No Intervention
Arm Description
AO functions as a benchmark comparison condition. Consists of baseline assessment, daily interactive voice response (IVR) monitoring, and immediate post-test assessment. Not an active treatment
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy (CPT)
Intervention Description
CPT is a highly structured course of therapy that focuses primarily on the cognitive restructuring of trauma related beliefs.
Intervention Type
Behavioral
Intervention Name(s)
Relapse Prevention (RP)
Intervention Description
RP utilizes high-risk situation assessment/avoidance, drink refusal skills, assertiveness training,cognitive restructuring as well as other approaches to address issues of alcohol use/dependance.
Primary Outcome Measure Information:
Title
Reduction in PTSD Symptom Severity from baseline to immediately post treatment, baseline to 3 months, baseline to 6 months, baseline to 9 months, and baseline to 12 months; Clinician-Administered PTSD Scale (CAPS)
Time Frame
12 Months
Title
Reduction in alcohol consumption from baseline to immediately post treatment, baseline to 3 months, baseline to 6 months, baseline to 9 months, and baseline to 12 months; Form-90 (Alcohol Consumption)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Anxiety (GAD-7 & OASIS)
Time Frame
Baseline, Immediately post-treatment, 3-, 6-, 9-, 12-months post-treatment
Title
Penn Alcohol Craving Scale (PACS)
Time Frame
Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment
Title
Patient Health Questionnaire Depression Scale (PHQ-9)
Time Frame
Baseline, Immediately post treatment, 3-, 6-, 9-, and 12-months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women age ≥ 18 years with a current DSM-V diagnosis of alcohol abuse/dependence Recent alcohol consumption for at least 2 weeks in the past 30 day period OR at least 2 days of heavy drinking in the past 30 day period Desire to abstain from alcohol Current DSM-V (Diagnostic and Statistical Manual of Mental Disorders) diagnosis of PTSD Capacity to provide informed consent English fluency Exclusion Criteria: Men and women with an unstable psychiatric medication regimen Current trauma-focused mental health treatment (MH) or behaviorally focused alcohol dependence (AD) AD/MH treatment in the past 30 days Suicide attempt or suicidal ideation with intent or plan, or self-harm in the past month Presence of a psychotic disorder or uncontrolled Bipolar Disorder Signs or symptoms of alcohol withdrawal at the time of initial consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra Kaysen
Organizational Affiliation
Univeristy of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tracy Simpson
Organizational Affiliation
VA Puget Sound Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Center for Sexual Assault and Traumatic Stress
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
VA Puget Sound Health Care (Seattle Campus)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

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Sequence of Symptom Change During AUD or PTSD Treatment for Comorbid PTSD/AUD

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