The Impact of CBT for Insomnia on Alcohol Treatment Outcomes Among Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Insomnia Severity
研究概览
简要总结
Project SAVE aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I supplement to alcohol treatment of Veterans.
详细描述
Alcohol use disorders (AUDs) are prevalent among Veterans and result in significant physical and psychological burden. Among those who receive treatment for AUDs, 1 in 3 relapses to problematic drinking within one year of treatment. Thus, additional strategies are needed to enhance alcohol treatment outcomes. One promising approach involves providing concurrent treatment for a common complaint - difficulty falling or staying asleep. Up to 74% of Veterans seeking treatment for AUD report co-occurring symptoms of insomnia. Given the negative impact of insomnia on attention and emotion regulation, insomnia symptoms may decrease patients' abilities to attend to alcohol treatment and manage negative emotions that lead to craving and relapse. Moreover, approximately 50% of individuals with AUDs report using alcohol to help them sleep, making relapse more likely for those with no other tools or skills to help them sleep. Indeed, sleep disturbance has been identified as a risk factor for relapse among individuals in alcohol treatment. Thus, effective treatment of sleep problems may enhance alcohol treatment. Cognitive Behavioral Therapy for Insomnia (CBT-I) has been effective in reducing insomnia severity in individuals with AUDs; however, no investigations have examined the efficacy of CBT-I delivered concurrently with AUD treatment to determine its impact on treatment outcomes. This R21 aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I supplement to ongoing alcohol treatment. A randomized pilot trial with 80 Veterans who meet diagnostic criteria for AUD and Insomnia Disorder will be conducted. Participants will be randomly assigned to receive Cognitive Behavioral Therapy for Insomnia (CBT-I) or minimal treatment (educational handout only; EDU) in addition to alcohol treatment as usual. Outcomes will be assessed at the end of the active intervention period (6 weeks) and 6 weeks post-intervention. Preliminary process outcomes include recruitment/retention rates and treatment satisfaction (feasibility and acceptability, respectively). Primary outcomes are insomnia severity, percentage of heavy drinking days, and alcohol-related problems; and we plan to examine post-treatment changes in insomnia severity as a mediator of treatment effects on alcohol use outcomes. We will also assess treatment effects on a variety of secondary clinical and mechanistic outcomes (e.g., PTSD symptoms, attention, working memory, treatment-related learning). Multiple imputation will be used for missing data, and analyses will be intent-to-treat.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The project manager will inform study therapists of participant assignment to conditions. PI Miller and study therapists will be blinded to assessment outcomes, and the assessment RA will be blinded to participant condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participation in alcohol treatment at the Truman VA (Columbia, MO)
- •DSM-5 criteria for moderate to severe Alcohol Use Disorder
- •Substance use in the past 2 months
- •DSM-5 episodic criterion (duration at least 1 month) for Insomnia Disorder
排除标准
- •unable to provide informed consent
- •cognitive impairment
- •continuous sobriety for 2+ months at baseline
- •manic episode or seizure in the past year (contraindications for CBT-I)
- •severe psychiatric disorder that requires immediate clinical attention
- •initiation of a sleep medication in the past six (6) weeks
研究组 & 干预措施
CBT-I + AUD-TAU
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)
CBT-I + AUD-TAU
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
干预措施: Alcohol Use Disorder Treatment as Usual (Behavioral)
Sleep Hygiene + AUD-TAU
Sleep hygiene education delivered once to all participants
干预措施: Sleep Hygiene (Behavioral)
Sleep Hygiene + AUD-TAU
Sleep hygiene education delivered once to all participants
干预措施: Alcohol Use Disorder Treatment as Usual (Behavioral)
结局指标
主要结局
Insomnia Severity
时间窗: Baseline to post-treatment (week 6) to follow up (week 12)
Assessed using the Insomnia Severity Index (ISI); ISI will be used as a 7-item measure of insomnia severity in the past two weeks. Items assess difficulty falling or staying asleep, satisfaction with current sleep pattern, interference with daily functioning, the extent to which others notice their sleep problems, and worry/distress related to sleep problems. Response options for each item range from 0 (not at all worried) to 4 (very much worried). Individual item scores are summed to a total score - the highest possible score being 28. Higher scores indicate more severe insomnia. Participants scoring 10 or higher will be classified as screening positive for insomnia.
Percent of Heavy-drinking Days
时间窗: Baseline to post-treatment (week 6) to follow-up (week 12)
Assessed using the Timeline Followback (TLFB) for alcohol; TLFB allows participants to trace their alcohol use back 30 days.
Alcohol Problems
时间窗: Baseline to post-treatment (week 6) to follow-up (week 12)
Assessed using the Short Inventory of Problems (SIP). SIP measures adverse consequences of substance use. Scores range 0 to 45, where higher scores indicate more frequent problems.
次要结局
- Sleep Efficiency(Baseline to post-treatment (week 6) to follow up (week 12))
- Post-Traumatic Stress Disorder Symptoms(Baseline to post-treatment (week 6) to follow up (week 12))
- Symptoms of Depression(Baseline to post-treatment (week 6) to follow up (week 12))
- Symptoms of Anxiety(Baseline to post-treatment (week 6) to follow up (week 12))
- Treatment-Related Learning(Change from baseline to post-treatment (week 6))
- Percentage of Days Where Alcohol Was Used to Help With Sleep(Baseline to post-treatment (week 6) to follow up (week 12))
- Alcohol Craving(Baseline to post-treatment (week 6) to follow up (week 12))
- Negative Affect(Baseline to post-treatment (week 6) to follow up (week 12))
- Emotion Regulation(Baseline to post-treatment (week 6) to follow up (week 12))
- Delay Discounting(Baseline to post-treatment (week 6) to follow up (week 12))
研究者
Mary E Miller
Professor, Psychiatry
University of Missouri-Columbia