Remotely Delivered Programs Targeting COVID-19 Stress-Related Depression and Substance Use (NCT04595084) | Clinical Trial Compass
CompletedNot Applicable
Remotely Delivered Programs Targeting COVID-19 Stress-Related Depression and Substance Use
United States113 participantsStarted 2021-03-15
Plain-language summary
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).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.