Multi-site Randomized Controlled Trial Comparing the Efficacy of Behavioral Approaches to Improve Mood and Sleep in Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 6
- 主要终点
- Depression Symptom Response
研究概览
简要总结
This is a multi-site randomized control trial involving people age 55+ years who have current depression symptoms plus another suicide risk indicator (either current suicidal ideation or a past history of attempt). Our goal is evaluate which of two different approaches works best to improve things like trouble sleeping, bad moods, and any suicidality.
Participants will complete diagnostic interviews, self-report scales, and wear an actigraphy device for the 8 weeks starting at the baseline visit.
详细描述
The main purpose of the study is to compare the effects of two approaches on sleep and mood including any symptoms of depression and suicidality. There will be 420 people invited to participate across three sites in the United States (University of Pittsburgh, UCLA, Augusta).
Participants will be randomized to receive one of two evidence-based programs that are designed to help improve outcomes. Each group will contain 210 participants. Researchers will enroll a total of 140 participants (70 in each group) at the University of Pittsburgh. Both groups will meet with a study therapist once a week to complete the assigned 8-week program. To determine which (if any) program has beneficial effect over time, researchers will ask participants to complete assessments of their sleep, mood, and health before and after the therapy. Certain information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.
There are three main study visits where participants will complete assessments about their sleep, mood, cognition and health. These would be:
- Before the therapy program begins
- Right after it ends
- Six months later
Around the time of each visit, researchers will ask participants to wear an actigraphy watch on their wrist 24/7 for a week while completing a sleep diary. The actigraphy watch is a wrist-watch like device that measures movement so that researchers can estimate the participant's activity and sleep levels.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 55 Years and older
- •Patient Health Questionnaire -9 score of 10 or higher
- •Past month Scale for Suicide Ideation score of 3 or higher OR any history of suicide attempt
- •PROMIS Sleep Disturbance or impairment scale t-scores of 55 or higher
- •Pharmacotherapy for depression meeting minimum adequate dose level as defined by FDA approval documents for at least 4 weeks.
排除标准
- •Active suicide planning with intent or clinical judgement that suicide risk is too high for outpatient treatment OR being currently treated at an inpatient unit.
- •Bipolar disorder
- •Psychotic disorder
- •Borderline personality disorder.
- •Active Cognitive/Behavioral Therapy (e.g., CBT-I), current or upcoming esketamine (ketamine) treatment, or active phase of ECT/TMS treatment course.
- •Illness with life expectancy of less than 1 year or plans to leave the study area
- •Incapacity to consent/dementia diagnosis
- •Active substance use disorder of at least moderate severity
- •Active night-shift work
- •Any physical, mental, or neurological condition that would make participation in the study, including either treatment arm, unsafe or infeasible.
研究组 & 干预措施
Concealed Control Intervention
Participants receive eight ~40 minute sessions (one per week) with a therapist/health coach. Specific information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.
干预措施: Active Comparator (Behavioral)
Active Condition
Participants receive eight ~40 minute sessions (one per week) with a therapist/health coach. Specific information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.
干预措施: Active Condition (Behavioral)
Concealed Control Intervention
Participants receive eight ~40 minute sessions (one per week) with a therapist/health coach. Specific information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.
干预措施: Treatment As Usual (Other)
Active Condition
Participants receive eight ~40 minute sessions (one per week) with a therapist/health coach. Specific information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.
干预措施: Treatment As Usual (Other)
结局指标
主要结局
Depression Symptom Response
时间窗: six months post-treatment
The outcome is the rate of clinically significant depression symptom responses six-months post treatment, defined as having ≥50% reduction in pre-treatment depression severity six-months posttreatment. Depression severity will be assessed as total scores from the 14 non-sleep items of the clinician rated GRID Hamilton Depression Rating Scale. Lower scores on the GRID Hamilton would indicate a reduction in depression symptoms.
次要结局
- Change in Suicide Ideation Severity(from Enrollment to the end of treatment at 6-months post-intervention)
- Suicide Behavior Outcomes(from Enrollment to the end of treatment at 6-months post-intervention)
研究者
Stephen Smagula
Associate Professor of Psychiatry
University of Pittsburgh