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

Not Applicable

Recruiting

• Conditions: Alcohol Use; Posttraumatic Stress Disorder

• Registration Number: NCT06648395
• Lead Sponsor: University of Washington

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-16
• Study Start: 2024-10-17
• Study First Posted: 2024-10-18
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 333

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Daily Drinking Questionnaire (DDQ)	screening through 12 month follow-up	The DDQ will assess frequency and quantity of use over the last week or last month. Regarding the frequency of use, participants can select values ranging from 0 to 25 drinks. If participants select a value greater than 0 drinks, they will be asked to choose the number of hours spent drinking, with values ranging from less than an hour to 24 hours.
Short Index of Problems (SIP)	screening through 12 month follow-up	The SIP will assess negative consequences from alcohol use over the last week or last month.
Posttraumatic Stress Disorder Checklist, Civilian Version DSM-5 (PCL-5)	screening through 12 month follow-up	PTSD symptom severity will be measured using the PCL-5.
Heavy Episodic Drinking (HED)	screening through 12 month follow up	Alcohol use will be measured using items assessing heavy episodic drinking (\>4/5 drinks per occasion for women/men) over the last week or last month.

Secondary Outcome Measures

Name	Time	Method
Drug Abuse Screening Test (DAST-10)	baseline, 12 month follow-up	The DAST-10 will be included to assess problems related to other substance use and likely drug use disorder diagnosis over the last 12 months.
Treatment Services Received (TSR)	baseline and 12 month follow-up	The TSR will be included to assess treatment seeking.
Alcohol Use Disorders Identification Test (AUDIT)	baseline, 12 month follow-up	The AUDIT will be used to assess problem drinking and likely diagnosis of an alcohol use disorder over the last 12 months.
Depression Anxiety Stress Scales (DASS-21)	baseline through 12 month follow-up	The DASS-21 will be used to assess general psychopathology symptoms over the last month.
Customary Drinking and Drug Use Record (CDDR)	baseline, 12 month follow-up	The CDDR will be used to assess comprehensive substance use, other than alcohol, over the last 3 months.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States