Clinical trial NCT06648395: CBT Vs. Supportive Texts for PTSD & Hazardous Drinking (Project Better Study 2)
Official title: Study 2: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use
Posttraumatic Stress Disorder
Keywords: Alcohol Use
Posttraumatic Stress Disorder
text messages
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-10-18
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Posttraumatic Stress Disorder Checklist, Civilian Version DSM-5 (PCL-5)
timeFrame: screening through 12 month follow-up
measure: Heavy Episodic Drinking (HED)
timeFrame: screening through 12 month follow up
measure: Daily Drinking Questionnaire (DDQ)
timeFrame: screening through 12 month follow-up
measure: Short Index of Problems (SIP)
timeFrame: screening through 12 month follow-up
Secondary outcomes:
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: baseline, 12 month follow-up
measure: Depression Anxiety Stress Scales (DASS-21)
timeFrame: baseline through 12 month follow-up
measure: Customary Drinking and Drug Use Record (CDDR)
timeFrame: baseline, 12 month follow-up
measure: Drug Abuse Screening Test (DAST-10)
timeFrame: baseline, 12 month follow-up
measure: Treatment Services Received (TSR)
timeFrame: baseline and 12 month follow-up
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Kristen Lindgren, PhD, ABPP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Michele Bedard-Gilligan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bedard-Gilligan M, Lindgren K, Dworkin E, Tristao T, Kaysen D, Rhew I. A randomized controlled trial testing theory-driven enhancements to increase the efficacy of and engagement in a brief cognitive-behavioural therapy text-message intervention for co-occurring posttraumatic stress disorder symptoms and alcohol misuse. Br J Clin Psychol. 2025 Mar;64(1):110-124. doi: 10.1111/bjc.12463. Epub 2024 Mar 26.
citation: Bedard-Gilligan MA, Dworkin ER, Kaysen D, Ojalehto HJ, Stappenbeck CA, Lindgren KP. A pilot study on the feasibility, acceptability, and preliminary efficacy of a brief text message intervention for co-occurring alcohol misuse and PTSD symptoms in a community sample. J Anxiety Disord. 2022 Oct;91:102615. doi: 10.1016/j.janxdis.2022.102615. Epub 2022 Aug 6.