CBT Texts for PTSD & Hazardous Drinking (Project Better)

NCT05372042 | Completed Results DMC

• 2 other identifiers: STUDY000135331R01AA028776-01A1
• Study Type: interventional
• Target: 505
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorder; Alcohol Use

Keywords

hazardous drinking; posttraumatic stress disorder

Outcome Measures

Primary Outcomes (4)

• Heavy Episodic Drinking

  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 pre-intervention (baseline), post-intervention (week 4), 1 month follow up (week 8), and 3 month follow up (week 16). 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.

  Baseline, 4 weeks, 8 weeks, 16 weeks

• Posttraumatic Stress Disorder (PTSD)

  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 pre-intervention (baseline), post-intervention (week 4), 1 month follow up (week 8), and 3 month follow up (week 16) to assess change in PTSD symptoms. The range of the scale is 0-80. Higher scores represent more severe PTSD symptoms.

  Baseline, 4 weeks, 8 weeks, and 16 weeks

• Typical Weekly Alcohol Consumption

  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 pre-intervention (baseline), post-intervention (week 4), 1 month follow up (week 8), and 3 month follow up (week 16). 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.

  Baseline, 4 weeks, 8 weeks, 16 weeks

• Alcohol Use Consequences

  The Short Index of Problems (SIP) assesses the negative consequences from alcohol consumption over the last month and is administered at pre-intervention (baseline), post-intervention (week 4), 1 month follow up (week 8), and 3 month follow up (week 16). The range for the scale is 0-15 and higher scores represent a greater number of alcohol-related consequences.

  Baseline, 4 weeks, 8 weeks, 16 weeks

Secondary Outcomes (5)

• Risk of Alcohol Use Disorder (AUD)

  Baseline,16 weeks

• Depression, Anxiety, and Stress Scale

  Baseline, 8 weeks, 16 weeks

• Treatment Seeking

  16 weeks

• Drug Use

  Baseline,16 weeks

• Drug Use Problems

  Baseline, 16 weeks

Study Arms (6)

Loss Framing + Growth Mindset

EXPERIMENTAL

Participants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about CBT skill, day 2 will be a remainder to use the skill that is framed with 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.

Behavioral: CBT Text Messages

Loss Framing + Simple Reminder

EXPERIMENTAL

Participants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about CBT skill, day 2 will be a remainder to use the skill that is framed with toward prevent future losses from trauma exposure, and day 3 will have a simple reminder to use the skill.

Behavioral: CBT Text Messages

Gain Framing + Growth Mindset

EXPERIMENTAL

Participants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about CBT skill, day 2 will be a remainder to use the skill that is framed with toward future benefits from doing so, and day 3 will have a reminder that aims to instill a growth mindset about using the skill.

Behavioral: CBT Text Messages

Gain Framing + Simple Reminder

EXPERIMENTAL

Participants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about CBT skill, day 2 will be a remainder to use the skill that is framed with toward future benefits from doing so, and day 3 will have a simple reminder to use the skill.

Behavioral: CBT Text Messages

No Framing + Growth Mindset

EXPERIMENTAL

Participants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about CBT skill, day 2 will be a remainder to use the skill that has no framing, and day 3 will have a reminder that aims to instill a growth mindset about using the skill.

Behavioral: CBT Text Messages

No Framing + Simple Reminder

ACTIVE COMPARATOR

Participants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about CBT skill, day 2 will be a remainder to use the skill that has no framing, and day 3 will have a simple reminder to use the skill.

Behavioral: CBT Text Messages

Interventions

CBT Text Messages BEHAVIORAL

CBT skills based text messages delivered 3x per week for four weeks

Gain Framing + Growth Mindset; Gain Framing + Simple Reminder; Loss Framing + Growth Mindset; Loss Framing + Simple Reminder; No Framing + Growth Mindset; No Framing + Simple Reminder

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)

Sponsors & Collaborators

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

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Alcohol Drinking

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Kristen Lindgren
• Organization: University of Washington

kpl9716@uw.edu

206-658-8083

Study Officials

• Kristen Lindgren, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: Participants will receive text messages 3 days a week for a 4 week period. To keep text messages within the length of standard SMS limits (160 characters), each day's message will be sent in the form of two brief texts (each will be 160 characters or less). The content of the text messages will vary as a function of condition. Participants will be assigned to CBT text messages plus one of six combinations of framing (3: loss vs. gain vs. no framing) and mindsets (2: growth vs reminder) texts. The combination that consists of no framing and simple reminder is an active comparator as it is the version of CBT text messages closest to what has been tested previously.

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 12, 2022
• Study Start: October 31, 2022
• Primary Completion: April 25, 2024
• Study Completion: April 25, 2024
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2025-06

Locations

US (1)