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Testing a PTSD m-Health Intervention to Improve Alcohol Treatment Outcomes

Primary Purpose

Posttraumatic Stress Disorder, Alcohol Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PTSD Coach App + Brief Support
Enhanced Usual Care (EUC)
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

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

Inclusion Criteria:

  • Currently in addictions treatment
  • Meet criteria for a current Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) AUD
  • A score of 33 or greater on the PTSD Checklist (PCL-5)
  • Own a smart phone or other type of Wi-Fi-enabled device with App capabilities

Exclusion Criteria:

  • Injection drug use in the past year
  • Patients who are unable to speak and/or understand English

Sites / Locations

  • Pine Rest Christian Mental Health ServicesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PTSD Coach App + Brief Support

Enhanced Usual Care (EUC)

Arm Description

PTSD Coach App + Brief Support will include brief instruction and support for the use of the PTSD Coach App developed by the study team. The PTSD Coach App incorporates evidence-based assessment, psychoeducation, and self-management strategies for PTSD symptoms that are customizable to the user.

EUC will include brief psychoeducation regarding PTSD and alcohol use disorder (AUD) and resources for PTSD-related mental health treatment.

Outcomes

Primary Outcome Measures

PTSD Checklist for DSM-5 (PCL-5) Change
The PCL-5 is a 20-item, self-reported measure that assesses the 20 DSM-5 symptoms of PTSD. Each symptom is measured on a 0-4 scale, with higher values indicating greater severity. Total scale scores range from 0 to 80.
Timeline Followback (TLFB) for Alcohol Change
The TLFB assessment method will be used to assess alcohol use in the past 30-days.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2022
Last Updated
September 26, 2023
Sponsor
Michigan State University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05564663
Brief Title
Testing a PTSD m-Health Intervention to Improve Alcohol Treatment Outcomes
Official Title
Testing a PTSD m-Health Intervention to Improve Alcohol Treatment Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2023 (Anticipated)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to learn whether a mobile health application (mHealth App) for posttraumatic stress disorder (PTSD) with brief support can help individuals who are in treatment for alcohol problems.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PTSD Coach App + Brief Support
Arm Type
Experimental
Arm Description
PTSD Coach App + Brief Support will include brief instruction and support for the use of the PTSD Coach App developed by the study team. The PTSD Coach App incorporates evidence-based assessment, psychoeducation, and self-management strategies for PTSD symptoms that are customizable to the user.
Arm Title
Enhanced Usual Care (EUC)
Arm Type
Active Comparator
Arm Description
EUC will include brief psychoeducation regarding PTSD and alcohol use disorder (AUD) and resources for PTSD-related mental health treatment.
Intervention Type
Behavioral
Intervention Name(s)
PTSD Coach App + Brief Support
Intervention Description
PTSD Coach App + Brief Support will include downloading the PTSD Coach App for personal use and four, brief (<20 minutes), weekly, individual support sessions. The sessions will focus on the instruction and encouragement of App use and activities (i.e., assessments, self-management strategies, and psychoeducational readings).
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care (EUC)
Intervention Description
EUC will consist of one brief session (with brochure) of PTSD and AUD psychoeducation and referral information for mental health clinics that provide PTSD services, with encouragement to schedule an appointment at one of the listed clinics to discuss PTSD-related symptoms.
Primary Outcome Measure Information:
Title
PTSD Checklist for DSM-5 (PCL-5) Change
Description
The PCL-5 is a 20-item, self-reported measure that assesses the 20 DSM-5 symptoms of PTSD. Each symptom is measured on a 0-4 scale, with higher values indicating greater severity. Total scale scores range from 0 to 80.
Time Frame
Baseline, 1-, 3-, 6-, and 12-months
Title
Timeline Followback (TLFB) for Alcohol Change
Description
The TLFB assessment method will be used to assess alcohol use in the past 30-days.
Time Frame
Baseline, 1-, 3-, 6-, and 12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Currently in addictions treatment Meet criteria for a current Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) AUD A score of 33 or greater on the PTSD Checklist (PCL-5) Own a smart phone or other type of Wi-Fi-enabled device with App capabilities Exclusion Criteria: Injection drug use in the past year Patients who are unable to speak and/or understand English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Adkins
Phone
(517) 353-8623
Ext
42098
Email
madkins@msu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kipling Bohnert
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pine Rest Christian Mental Health Services
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49548
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LeAnn Smart
First Name & Middle Initial & Last Name & Degree
Talal Khan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Testing a PTSD m-Health Intervention to Improve Alcohol Treatment Outcomes

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