Remotely Delivered Programs Targeting COVID-19 Stress-Related Depression and Substance Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Depression Severity (CAT-DI)
研究概览
简要总结
This 3-arm study compares the effectiveness of an (1) 8-week mindfulness-based intervention, MBCT-R (Mindfulness-Based Cognitive Therapy for Resilience During COVID-19)+CHA MindWell vs. (2) iCBT (internet based Cognitive Behavioral Therapy)+ CHA MindWell vs. (3) CHA MindWell remote monitoring and telephone coaching alone on depressive symptoms as measured over the course of 24-weeks by the computerized adaptive mental health (CAT-MH) interview for depression (CAT-DI). Secondary outcomes include rates and levels of alcohol and drug use, as well as the number of required mental health clinician visits (televisits and in-person visits). Exploratory outcomes include stress-related affect reactivity and salivary inflammatory markers (e.g., interleukin-6).
详细描述
We will conduct a comparative effectiveness RCT comparing two online programs for people enrolled in the CHA MindWell mental wellness monitoring and telephone coaching program with a low-impact control condition of CHA MindWell alone. Mindfulness-Based Cognitive Therapy for Resilience (MBCT-R), and iCBT, are online versions of evidence-based treatments for depression. MBCT-R integrates training in mindfulness with elements of CBT with a focus on the psychosocial stressors associated with COVID-19 that increase risk for depression. It is based on the 8-week MBCT program which has well-established efficacy for symptoms of depression, anxiety and stress, and for preventing relapse in recurrent depression. The iCBT arm will use MoodGym, which is a 6-week web-based asynchronous cognitive-behavioral therapy educational curriculum for depression and anxiety. The two programs will be compared with CHA MindWell alone, which is weekly monitoring with CAT-MH plus telephone support and referral to treatment as needed. Primary outcomes are levels of depressive symptoms. Secondary outcomes include alcohol and drug use, healthcare utilization. Online oral fluid toxicology testing, daily diaries for stress-related affect reactivity, salivary inflammatory markers, salivary testing for COVID-19, and completion of computerized adaptive mental health interviews (CAT-MH) represent several innovative data collection modalities in this study.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current patient of CHA primary care or behavioral health provider
- •Active enrollment in CHA MindWell
- •Sufficient English fluency to understand procedures and questionnaires
- •Ability to provide informed consent
- •Access to the internet and an electronic device to attend study groups and complete questionnaires.
- •CAT-DI 50-75
排除标准
- •Active psychosis or severe level of psychosis on PSY-S-CAT ≥60
- •Bipolar I disorder history or severe level of mania on CAT-M/H50 (>70)
- •Acute suicidality or self-injurious behavior or severe level of suicidality on CAT-SS(≥71)
- •Severe depression, indicated by CAT-DI PHQ-9 equivalency score >20
- •Severe level of PTSD on CAT-PTSD (>70)
- •Current treatment with antipsychotic medication, mood stabilizer or benzodiazepine equivalent of 3mg/day of lorazepam
- •Cognitive inability as demonstrated by the inability to complete an online informed consent assessment
- •Current participation in another experimental research study
- •Previous participation in an 8-week intensive Mindfulness-Based Intervention in past 1 year
- •Expected medical hospitalization in next 6 months
- •Expected incarceration in next 6 months
- •Severe substance use disorder or high risk on CAT-MH SUD. In addition, use of or positive toxicology for cocaine, unprescribed opioids, stimulants, or benzodiazepines in the past 3 months.
- •Inability to participate in group intervention without disrupting group in opinion of principal investigator
- •Inability to complete screening, baseline assessments and 5 daily diaries at baseline.
研究组 & 干预措施
MBCT-R + CHA-MW
Mindfulness-Based Cognitive Therapy (MBCT) is an effective group intervention for depression and anxiety that combines mindfulness training with elements of cognitive therapy. This will be delivered with CHAMindWell mental wellness monitoring with CAT-MH and telephone coaching as needed.
干预措施: Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell (Behavioral)
MBCT-R + CHA-MW
Mindfulness-Based Cognitive Therapy (MBCT) is an effective group intervention for depression and anxiety that combines mindfulness training with elements of cognitive therapy. This will be delivered with CHAMindWell mental wellness monitoring with CAT-MH and telephone coaching as needed.
干预措施: CHAMindWell (Behavioral)
iCBT (MoodGym) + CHA-MW
MoodGym is a form of iCBT, which an evidence-based online program for depression, anxiety, stress and general psychological well-being. This will be delivered with CHAMindWell mental wellness monitoring with CAT-MH and telephone coaching as needed.
干预措施: Internet Cognitive Behavioral Therapy plus CHAMindWell (Behavioral)
iCBT (MoodGym) + CHA-MW
MoodGym is a form of iCBT, which an evidence-based online program for depression, anxiety, stress and general psychological well-being. This will be delivered with CHAMindWell mental wellness monitoring with CAT-MH and telephone coaching as needed.
干预措施: CHAMindWell (Behavioral)
CHA-MW
Participants randomized to the CHA-MW arm will only receive CHAMindWell mental wellness monitoring with CAT-MH and telephone coaching as needed.
干预措施: CHAMindWell (Behavioral)
结局指标
主要结局
Depression Severity (CAT-DI)
时间窗: Baseline, Weeks 4, 8, 12, 16, 20, 24
Change in depression symptom severity as measured by CAT-MH Depression Inventory (DI) scores completed at baseline and every 4 weeks during the 24 weeks after randomization. Difference between MBCT-R arm and CHA-MW monitoring alone arm is primary outcome. Difference between iCBT arm and CHA-MW monitoring alone arm is secondary outcome. Difference between iCBT arm and MBCT-R is an exploratory outcome.
次要结局
- Heavy Drinking Days(Week 24)
- Televisits (AKA Mental Wellness Assessments)(Randomization through Week 24)
- Drug Use Rates(Week 24)