Clinical Trials Directory

Trials / Completed

CompletedNCT05372042

CBT Texts for PTSD & Hazardous Drinking (Project Better)

Testing the Efficacy of a CBT-enhanced Text Message Intervention to Reduce Symptom Burden in Individuals With Post-traumatic Stress Disorder Symptoms and Co-occurring Hazardous Drinking

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
505 (actual)
Sponsor
University of Washington · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The research study seeks to refine and test a brief, self-directed, intervention for individuals from the general public with PTSD and co-occurring HD that can be delivered via text-messaging. This application seeks to refine the intervention further by testing whether theoretically-driven, evidence-based strategies from basic cognitive psychology (message framing) and social psychology (facilitating growth mindsets) result in better outcomes for PTSD symptoms and HD by addressing pilot participant feedback related to avoidance and motivation.

Detailed description

This study will refine a previously piloted text message intervention by integrating and testing the efficacy of behavioral nudge and psychologically-wise intervention techniques when added to CBT text messages for reducing hazardous drinking (HD) and PTSD symptoms.The enhancements will be tested in a fully crossed 3 (message framing: avoid losses vs. maximize gains vs. no framing) x 2 (mindsets: facilitate growth mindset reminder vs. simple reminder to use skills) factorial design to identify the most effective combination of text messages. A sample of 500 participants with DSM-5 Criterion A trauma exposure, PTSD symptoms, and HD will be enrolled and randomized to condition. Baseline, immediate post-, 1-, and 3-month assessments will capture change in primary outcomes (PTSD, hazardous drinking). Trauma exposure and PTSD symptoms will be assessed using the Posttraumatic Stress Disorder Checklist, Civilian Version DSM-5 with the Life Events Checklist (PCL-5 and LEC). HD will be assessed via a set of measures that provide a detailed picture of drinking patterns. First, two questions will ask about heavy episodic drinking (HED: 4/5 or more drinks per single occasion for men/women) episodes, assessing both frequency over the lifetime and frequency over the last month. Typical weekly alcohol consumption will also be assessed using the Daily Drinking Questionnaire (DDQ). Negative alcohol-related consequences will be assessed via the Short Index of Problems (SIP).

Conditions

Interventions

TypeNameDescription
BEHAVIORALCBT Text MessagesCBT skills based text messages delivered 3x per week for four weeks

Timeline

Start date
2022-10-31
Primary completion
2024-04-25
Completion
2024-04-25
First posted
2022-05-12
Last updated
2025-06-26
Results posted
2025-06-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05372042. Inclusion in this directory is not an endorsement.