CBT Texts for PTSD & Hazardous Drinking (Project Better)

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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Use; Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: CBT Text Messages

Detailed Description

This study will refine a previously piloted text message intervention by integrating and testing the efficacy of behavioral nudge and psychologically-wise intervention techniques when added to CBT text messages for reducing hazardous drinking (HD) and PTSD symptoms.The enhancements will be tested in a fully crossed 3 (message framing: avoid losses vs. maximize gains vs. no framing) x 2 (mindsets: facilitate growth mindset reminder vs. simple reminder to use skills) factorial design to identify the most effective combination of text messages. A sample of 500 participants with DSM-5 Criterion A trauma exposure, PTSD symptoms, and HD will be enrolled and randomized to condition. Baseline, immediate post-, 1-, and 3-month assessments will capture change in primary outcomes (PTSD, hazardous drinking).

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).

• Study Type: Interventional
• Enrollment (Actual): 505
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Loss Framing + Growth Mindset; 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; CBT skills based text messages delivered 3x per week for four weeks
Experimental: Loss Framing + Simple Reminder; 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; CBT skills based text messages delivered 3x per week for four weeks
Experimental: Gain Framing + Growth Mindset; 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; CBT skills based text messages delivered 3x per week for four weeks
Experimental: Gain Framing + Simple Reminder; 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; CBT skills based text messages delivered 3x per week for four weeks
Experimental: No Framing + Growth Mindset; 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; CBT skills based text messages delivered 3x per week for four weeks
Active Comparator: No Framing + Simple Reminder; 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; CBT skills based text messages delivered 3x per week for four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of Alcohol Use Disorder (AUD)	The Alcohol Use Disorders Identification Test (AUDIT) assesses problem drinking and likely diagnosis of an alcohol use disorder over the last 12 months and is administered at pre-intervention (baseline) and 3 month follow up (week 16). The total range of scores is 0-40 and higher scores represent greater risks of having an alcohol use disorder.	Baseline,16 weeks
Depression, Anxiety, and Stress Scale	The Depression Anxiety Stress Scale (DASS-21) assesses the general psychopathology symptoms over the last month and is administered at pre-intervention (baseline), 1 month follow up (week 8), and 3 month follow up (week 16). It has 3 subscales; two of which (anxiety and depression subscales) are outcomes for this study. The total range of scores of the anxiety subscale of the DASS-21 is 0-21 and higher scores indicate more severe symptoms. The total range of scores of the depression subscale of the DASS-21 is 0-21 and higher scores indicate more severe symptoms.	Baseline, 8 weeks, 16 weeks
Treatment Seeking	The Treatment Services Received (TSR) assesses the types of mental health and addictions treatments that individuals (e.g., inpatient, outpatient, 12-step, etc) received since enrolling in the study and is administered at 3 month follow up (week 16). Twelve types of treatment are listed and counted to calculate the number of types of treatment that individuals received over the 16-week study period. The minimum possible score is 0 (no services received) and the maximum is 12 types of treatment. Higher numbers indicate receiving more types of treatment.	16 weeks
Drug Use	The Customary Drinking and Drug Use Record (CDDR) assesses comprehensive substance use, other than alcohol, over the last 3 months and is administered at pre-intervention (baseline) and 3 month follow up (week 16). The total range of scores is 0-12 and higher scores indicate more drug use.	Baseline,16 weeks
Drug Use Problems	The Drug Abuse Screening Test (DAST-10) assesses the problems related to other substance use and likely drug use disorder diagnosis over the last 12 months and is administered at pre-intervention (baseline) and 3 month follow up (week 16). The total range of scores is 0-10 and higher scores indicate more substance use-related problems and likely drug use disorder diagnosis.	Baseline, 16 weeks

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Kristen Lindgren, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2022
• Primary Completion (Actual): April 25, 2024
• Study Completion (Actual): April 25, 2024

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: hazardous drinking; posttraumatic stress disorder
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: STUDY00013533; 1R01AA028776-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No