CBT Texts for PTSD & Hazardous Drinking (Project Better)

Posttraumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372042
• Other study ID #: STUDY00013533
• Secondary ID: 1R01AA028776-01A
• Status: Completed
• Phase: N/A
• Start date: October 31, 2022
• Est. completion date: April 25, 2024

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: April 25, 2024
• Est. primary completion date: April 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Alcohol Use
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• CBT Text Messages
CBT skills based text messages delivered 3x per week for four weeks

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heavy Episodic Drinking	Alcohol use will be measured using items assessing heavy episodic drinking (>4/5 drinks per occasion for women/men) over the last month.	month
Primary	Posttraumatic Stress Disorder (PTSD)	PTSD symptom severity will be measured using the PCL-5. PCL-5 will assess last month's symptoms.	month
Primary	Typical weekly alcohol consumption	The DDQ will assess frequency and quantity of use over the last month.	month
Primary	Alcohol Use Consequences	The SIP will assess negative consequences from alcohol use over the last month/	month
Secondary	Risk of AUD	The AUDIT will be used to assess problem drinking and likely diagnosis of an alcohol use disorder over the last 12 months.	12 months
Secondary	Depression, Anxiety, Stress	The DASS will be used to assess general psychopathology symptoms over the last month.	month
Secondary	Treatment Seeking	The TSR will be included to assess treatment seeking	Lifetime and during study period
Secondary	Drug Use	The CDDR will be used to assess comprehensive substance use, other than alcohol, over the last 3 months.	3 months
Secondary	Drug Use Problems	The DAST will be included to assess problems related to other substance use and likely drug use disorder diagnosis over the last 12 months.	12 months