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

NCT06648395 | Active Not Recruiting DMC

• 2 other identifiers: STUDY00020173R01AA028776-01A1
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use; Posttraumatic Stress Disorder

Keywords

Alcohol Use; Posttraumatic Stress Disorder; text messages

Outcome Measures

Primary Outcomes (4)

• Posttraumatic Stress Disorder Checklist, Civilian Version DSM-5 (PCL-5)

  The Posttraumatic Stress Disorder Checklist for the 5th Edition of Diagnostic and Statistical Manual of Mental Disorders (PCL-5) assesses the severity of symptoms of posttraumatic stress disorder (PTSD) as defined by the 5th Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and is administered at screening through 12 month follow up. The range of the scale is 0-80. Higher scores represent more severe PTSD symptoms.

  screening through 12 month follow-up

• Heavy Episodic Drinking (HED)

  Heavy Episodic Drinking (HED) assesses the quantity of heavy drinking episodes (i.e., \>4/5 drinks per occasion for women/men, based on the National Institute of Alcohol Abuse and Alcoholism's definition) over the last month. It is administered at screening through 12 month follow up. The range of the scale is 0-10 (count of the number of heavy drinking episodes in the last month); 10 is described as 10 or more heavy drinking episodes. Higher scores represent a greater number of heavy drinking episodes.

  screening through 12 month follow up

• Daily Drinking Questionnaire (DDQ)

  The Daily Drinking Questionnaire (DDQ) assesses the number of standard drinks consumed each day of a typical week over the last month and is administered at screening through 12 month follow up. The range for the scale to report drinks consumed each day is 0-25. Each day's score for the week is summed to created a total number of drinks consumed per week; the count of drinks consumed per week ranges from 0 to 175. Higher scores representing greater number of drinks consumed during a typical week.

  screening through 12 month follow-up

• Short Index of Problems (SIP)

  The Short Index of Problems (SIP) assesses the negative consequences from alcohol consumption over the last month and is administered at screening through 12 month follow up. The range for the scale is 0-15. Higher scores represent a greater number of alcohol-related consequences.

  screening through 12 month follow-up

Secondary Outcomes (5)

• Alcohol Use Disorders Identification Test (AUDIT)

  screening, 12 month follow-up

• Depression Anxiety Stress Scales (DASS-21)

  baseline through 12 month follow-up

• Customary Drinking and Drug Use Record (CDDR)

  baseline, 12 month follow-up

• Drug Abuse Screening Test (DAST-10)

  baseline, 12 month follow-up

• Treatment Services Received (TSR)

  baseline and 12 month follow-up

Study Arms (2)

CBT text messages

ACTIVE COMPARATOR

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.

Behavioral: CBT Text Messages

Supportive Text Messages

ACTIVE COMPARATOR

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.

Behavioral: Supportive Messages

Interventions

CBT Text Messages BEHAVIORAL

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

CBT text messages

Supportive Messages BEHAVIORAL

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

Supportive Text Messages

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years of age
• Currently resides in WA State
• Fluent in English
• Reports at least one DSM-5 traumatic event that occurred 1+ months ago
• Current PTSD severity of 33+ on the PCL-5
• 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)
• Owns a functioning cellular phone
• Is willing to receive weekly study text messages for 4 consecutive weeks
• Is willing to provide contact information including phone number (for text messages and reminders), email (reminders), and mailing address (payment)

You may not qualify if:

• Previous participation in Project BETTER study 1 (NCT05372042)
• 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)

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• 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.

  PMID: 38532251 BACKGROUND

• 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.

  PMID: 35988440 BACKGROUND

MeSH Terms

Conditions

Alcohol Drinking; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Kristen Lindgren, PhD, ABPP

  University of Washington

  PRINCIPAL INVESTIGATOR

• Michele Bedard-Gilligan, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 18, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)