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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05564663
Enrollment
300
Registered
2022-10-03
Start date
2023-10-06
Completion date
2027-05-31
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder, Posttraumatic Stress Disorder

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.

Interventions

BEHAVIORALPTSD Coach App + Brief Support

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).

BEHAVIORALEnhanced Usual Care (EUC)

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.

Sponsors

Michigan State University
Lead SponsorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Aged ≥ 18 years old * Currently in addictions treatment * Meet criteria for a current Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) AUD diagnosis * 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 * Patients who are currently engaged in specific therapy for PTSD (Prolonged Exposure Therapy, Cognitive Reprocessing Therapy, EMDR)

Design outcomes

Primary

MeasureTime frameDescription
PTSD Checklist for DSM-5 (PCL-5) ChangeBaseline, 1-, 3-, 6-, and 12-monthsThe 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 ChangeBaseline, 1-, 3-, 6-, and 12-monthsThe TLFB assessment method will be used to assess alcohol use in the past 30-days.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKipling Bohnert

Michigan State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026