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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 333
- 试验地点
- 1
- 主要终点
- Posttraumatic Stress Disorder Checklist, Civilian Version DSM-5 (PCL-5)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Previous participation in Project BETTER study 1 (NCT05372042)
- •Participation in Project COPE+ (IRB# STUDY00022875) (a small-scaled text-based message study that aims to increase positive mood and wellbeing for adults with posttraumatic stress symptoms and hazardous drinking)
研究组 & 干预措施
CBT text messages
Participants in this condition will receive 3 days of text messages for 4 weeks. Day 1 will consist of psychoeducation about a CBT skill, day 2 will be a remainder to use the skill that is framed 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. They will also be asked to complete weekly self-reports on PTSD and HD every Monday for four consecutive weeks.
干预措施: CBT Text Messages (Behavioral)
Supportive Text Messages
Participants will be sent three short supportive messages each week that include messages of support, validation, and hope. They will also be asked to complete the weekly self-reports on PTSD and HD every Monday for four consecutive weeks.
干预措施: Supportive Messages (Behavioral)
结局指标
主要结局
Posttraumatic Stress Disorder Checklist, Civilian Version DSM-5 (PCL-5)
时间窗: screening through 12 month follow-up
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 screening through 12 month follow up. The range of the scale is 0-80. Higher scores represent more severe PTSD symptoms.
Heavy Episodic Drinking (HED)
时间窗: screening through 12 month follow up
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 screening through 12 month follow up. 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.
Daily Drinking Questionnaire (DDQ)
时间窗: screening through 12 month follow-up
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 screening through 12 month follow up. 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.
Short Index of Problems (SIP)
时间窗: screening through 12 month follow-up
The Short Index of Problems (SIP) assesses the negative consequences from alcohol consumption over the last month and is administered at screening through 12 month follow up. The range for the scale is 0-15. Higher scores represent a greater number of alcohol-related consequences.
次要结局
- Alcohol Use Disorders Identification Test (AUDIT)(screening, 12 month follow-up)
- Depression Anxiety Stress Scales (DASS-21)(baseline through 12 month follow-up)
- Customary Drinking and Drug Use Record (CDDR)(baseline, 12 month follow-up)
- Drug Abuse Screening Test (DAST-10)(baseline, 12 month follow-up)
- Treatment Services Received (TSR)(baseline and 12 month follow-up)
研究者
Michele Bedard-Gilligan
Professor, School of Medicine
University of Washington