CBT Texts for PTSD & Hazardous Drinking (Project Better)

Sponsor

University of Washington (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05372042

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

500

Enrollment

Arms

14.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder Alcohol Use	Behavioral: CBT Text Messages	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 30, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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.
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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18+ 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)

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Washington
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator: Kristen Lindgren, PhD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kristen Lindgren, Professor, School of Medicine, University of Washington

ClinicalTrials.gov Identifier:

NCT05372042

Other Study ID Numbers:

STUDY00013533
1R01AA028776-01A1

First Posted:

May 12, 2022

Last Update Posted:

Jun 30, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kristen Lindgren, Professor, School of Medicine, University of Washington

hazardous drinking

posttraumatic stress disorder

Additional relevant MeSH terms:

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Jun 30, 2022