CBT Texts for PTSD & Hazardous Drinking (Project Better)

Not Applicable

Completed

• Conditions: Alcohol Use; Posttraumatic Stress Disorder
• Interventions: Behavioral: CBT Text Messages

• Registration Number: NCT05372042
• Lead Sponsor: University of Washington

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.

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 Timeline

• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-05-09
• Study First Posted: 2022-05-12
• Study Start: 2022-10-31
• Primary Completion: 2024-04-25
• Study Completion: 2024-04-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 505

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)

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
No Framing + Simple Reminder	CBT Text Messages	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.
Loss Framing + Growth Mindset	CBT Text Messages	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.
Gain Framing + Simple Reminder	CBT Text Messages	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.
Loss Framing + Simple Reminder	CBT Text Messages	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.
Gain Framing + Growth Mindset	CBT Text Messages	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.
No Framing + Growth Mindset	CBT Text Messages	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.

Primary Outcome Measures

Name	Time	Method
Heavy Episodic Drinking	month	Alcohol use will be measured using items assessing heavy episodic drinking (\>4/5 drinks per occasion for women/men) over the last month.
Posttraumatic Stress Disorder (PTSD)	month	PTSD symptom severity will be measured using the PCL-5. PCL-5 will assess last month's symptoms.
Typical weekly alcohol consumption	month	The DDQ will assess frequency and quantity of use over the last month.
Alcohol Use Consequences	month	The SIP will assess negative consequences from alcohol use over the last month/

Secondary Outcome Measures

Name	Time	Method
Depression, Anxiety, Stress	month	The DASS will be used to assess general psychopathology symptoms over the last month.
Treatment Seeking	Lifetime and during study period	The TSR will be included to assess treatment seeking
Risk of AUD	12 months	The AUDIT will be used to assess problem drinking and likely diagnosis of an alcohol use disorder over the last 12 months.
Drug Use	3 months	The CDDR will be used to assess comprehensive substance use, other than alcohol, over the last 3 months.
Drug Use Problems	12 months	The DAST will be included to assess problems related to other substance use and likely drug use disorder diagnosis over the last 12 months.

Trial Locations

Locations (1)

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