Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-27 @ 10:33 PM
Study NCT ID:
NCT06648395
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-08
First Post:
2024-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CBT vs. Supportive Texts for PTSD & Hazardous Drinking (Project Better Study 2)
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
Study 2: 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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to test the efficacy of a CBT-enhanced text message intervention and a supportive text message intervention to reduce symptom burden in individuals with post-traumatic stress disorder symptoms and co-occurring hazardous drinking.
Detailed Description:
This study will test a previously piloted and refined text message intervention by comparing a CBT text message intervention to supportive messages condition for reducing hazardous drinking (HD) and PTSD symptoms. The intervention will be tested in a fully powered two-arm randomized controlled trial (RCT) comparing a text message intervention (3 texts/week based on CBT skills) to supportive texts. A sample of 333 participants with DSM-5 Criterion A trauma exposure, PTSD symptoms, and HD will be enrolled and randomized to condition. Baseline, post-, 1-, 3-, 6-, 9-, and 12-month assessments will capture change in primary outcomes (PTSD, hazardous drinking) long-term. Weekly assessments will be given to both conditions to understand shorter-term patterns of symptom change associated with the interventions.
Eligible participants will be individually randomized by the Study Research Coordinator to one of the two conditions. For those in the intervention condition, participants will receive three text messages presenting a CBT skill followed by framing and growth mindsets (sent on Tuesday, Wednesday, Friday). They will also be asked to complete weekly self-reports on PTSD and HD every Monday following their first week of text messages. The supportive messages only group will be sent three short supportive messages, timed to correspond with the CBT skill group, and will be asked to complete the weekly self-reports on PTSD and HD every Monday for four consecutive weeks.
Primary measures include measures assessing inclusion criteria and main outcomes. Primary measures are given at screening/baseline and all follow-ups unless otherwise noted.
Demographics including age, race/ethnicity, gender, income/work status, weight (for BAC calculation for safety monitoring), verification of cell phone ownership and willingness to receive messages, certification of English fluency, and current residential zipcode (to verify WA State residency) will be assessed at screening only.
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).
Secondary measures include those assessing secondary outcomes. Unless otherwise noted, secondary measures are given at baseline and 3-, 6-, 9-, and 12-month follow-ups. They include the Alcohol Use Disorders Identification Test (AUDIT), the Depression Anxiety Stress Scales (DASS-21), the Customary Drinking and Drug Use Record (CDDR), the Drug Abuse Screening Test (DAST-10) and the Treatment Services Received (TSR).
Analyses will compare conditions to test effect sizes between the two conditions (text message intervention vs supportive messages). The sample size was selected based on power calculations for detecting a small effect between conditions and also to allow for testing of a-priori chosen effect modifiers (race, gender, trauma type, CBT skill use).
Eligible participants will be individually randomized by the Study Research Coordinator to one of the two conditions. For those in the intervention condition, participants will receive three text messages presenting a CBT skill followed by framing and growth mindsets (sent on Tuesday, Wednesday, Friday). They will also be asked to complete weekly self-reports on PTSD and HD every Monday following their first week of text messages. The supportive messages only group will be sent three short supportive messages, timed to correspond with the CBT skill group, and will be asked to complete the weekly self-reports on PTSD and HD every Monday for four consecutive weeks.
Primary measures include measures assessing inclusion criteria and main outcomes. Primary measures are given at screening/baseline and all follow-ups unless otherwise noted.
Demographics including age, race/ethnicity, gender, income/work status, weight (for BAC calculation for safety monitoring), verification of cell phone ownership and willingness to receive messages, certification of English fluency, and current residential zipcode (to verify WA State residency) will be assessed at screening only.
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).
Secondary measures include those assessing secondary outcomes. Unless otherwise noted, secondary measures are given at baseline and 3-, 6-, 9-, and 12-month follow-ups. They include the Alcohol Use Disorders Identification Test (AUDIT), the Depression Anxiety Stress Scales (DASS-21), the Customary Drinking and Drug Use Record (CDDR), the Drug Abuse Screening Test (DAST-10) and the Treatment Services Received (TSR).
Analyses will compare conditions to test effect sizes between the two conditions (text message intervention vs supportive messages). The sample size was selected based on power calculations for detecting a small effect between conditions and also to allow for testing of a-priori chosen effect modifiers (race, gender, trauma type, CBT skill use).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01AA028776-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |