CBT vs. Supportive Texts for PTSD & Hazardous Drinking (Project Better Study 2)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

333 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-17

Study Completion Date

2026-10-31

Brief Summary

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The study aims to test the efficacy of a CBT-enhanced text message intervention and a supportive text message intervention to reduce symptom burden in individuals with post-traumatic stress disorder symptoms and co-occurring hazardous drinking.

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Detailed Description

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This study will test a previously piloted and refined text message intervention by comparing a CBT text message intervention to supportive messages condition for reducing hazardous drinking (HD) and PTSD symptoms. The intervention will be tested in a fully powered two-arm randomized controlled trial (RCT) comparing a text message intervention (3 texts/week based on CBT skills) to supportive texts. A sample of 333 participants with DSM-5 Criterion A trauma exposure, PTSD symptoms, and HD will be enrolled and randomized to condition. Baseline, post-, 1-, 3-, 6-, 9-, and 12-month assessments will capture change in primary outcomes (PTSD, hazardous drinking) long-term. Weekly assessments will be given to both conditions to understand shorter-term patterns of symptom change associated with the interventions.

Eligible participants will be individually randomized by the Study Research Coordinator to one of the two conditions. For those in the intervention condition, participants will receive three text messages presenting a CBT skill followed by framing and growth mindsets (sent on Tuesday, Wednesday, Friday). They will also be asked to complete weekly self-reports on PTSD and HD every Monday following their first week of text messages. The supportive messages only group will be sent three short supportive messages, timed to correspond with the CBT skill group, and will be asked to complete the weekly self-reports on PTSD and HD every Monday for four consecutive weeks.

Primary measures include measures assessing inclusion criteria and main outcomes. Primary measures are given at screening/baseline and all follow-ups unless otherwise noted.

Demographics including age, race/ethnicity, gender, income/work status, weight (for BAC calculation for safety monitoring), verification of cell phone ownership and willingness to receive messages, certification of English fluency, and current residential zipcode (to verify WA State residency) will be assessed at screening only.

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).

Secondary measures include those assessing secondary outcomes. Unless otherwise noted, secondary measures are given at baseline and 3-, 6-, 9-, and 12-month follow-ups. They include the Alcohol Use Disorders Identification Test (AUDIT), the Depression Anxiety Stress Scales (DASS-21), the Customary Drinking and Drug Use Record (CDDR), the Drug Abuse Screening Test (DAST-10) and the Treatment Services Received (TSR).

Analyses will compare conditions to test effect sizes between the two conditions (text message intervention vs supportive messages). The sample size was selected based on power calculations for detecting a small effect between conditions and also to allow for testing of a-priori chosen effect modifiers (race, gender, trauma type, CBT skill use).

Conditions

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Alcohol Use Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBT text messages

Participants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about a CBT skill, day 2 will be a remainder to use the skill that is framed toward preventing future losses from trauma exposure, and day 3 will have a reminder that aims to instill a growth mindset about using the skill. They will also be asked to complete weekly self-reports on PTSD and HD every Monday for four consecutive weeks.

Group Type ACTIVE_COMPARATOR

CBT Text Messages

Intervention Type BEHAVIORAL

CBT text messages will be sent 3 times per week for 4 weeks

Supportive Text Messages

Participants will be sent three short supportive messages each week that include messages of support, validation, and hope. They will also be asked to complete the weekly self-reports on PTSD and HD every Monday for four consecutive weeks.

Group Type ACTIVE_COMPARATOR

Supportive Messages

Intervention Type BEHAVIORAL

Supportive text messages will be sent 3 times per week for 4 weeks

Interventions

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CBT Text Messages

CBT text messages will be sent 3 times per week for 4 weeks

Intervention Type BEHAVIORAL

Supportive Messages

Supportive text messages will be sent 3 times per week for 4 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. 18+ years of age
2. Currently resides in WA State
3. Fluent in English
4. Reports at least one DSM-5 traumatic event that occurred 1+ months ago
5. Current PTSD severity of 33+ on the PCL-5
6. Current hazardous alcohol use (2+ heavy episodic drinking occasions \[4+ drinks on one occasion for women, 5+ drinks on one occasion for men\] in past month, 1+ negative consequences related to alcohol use)
7. Owns a functioning cellular phone
8. Is willing to receive weekly study text messages for 4 consecutive weeks
9. Is willing to provide contact information including phone number (for text messages and reminders), email (reminders), and mailing address (payment)

Exclusion Criteria

1. Previous participation in Project BETTER study 1 (NCT05372042)
2. Participation in Project COPE+ (IRB# STUDY00022875) (a small-scaled text-based message study that aims to increase positive mood and wellbeing for adults with posttraumatic stress symptoms and hazardous drinking)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No