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Remotely Delivered Programs Targeting COVID-19 Stress-Related Depression and Substance Use

CompletedNA

Sponsor: Cambridge Health Alliance

Conditions: Depression, Anxiety, Substance Use, Stress, Psychological, Stress, Emotional

Interventions: Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell, Internet Cognitive Behavioral Therapy plus CHAMindWell, CHAMindWell

Countries: United States

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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
* Inability to complete screening, baseline assessments and 5 daily diaries at baseline.

Locations (1)

Cambridge, Massachusetts, United States