Alcohol Use, Unspecified, Anxiety, Covid19, Depression, Drug Use, Stress, Emotional, Stress, Psychological, Substance Use
Conditions
Brief 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).
Detailed description
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.
Interventions
BEHAVIORALMindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell
MBCT-R is designed to foster resilience and prevent new-onset anxiety and depression disorders or exacerbation of existing conditions. MBCT-R follows the MBCT structure of eight classes and one half-day retreat, with home practice and specific daily meditation, but is live-online and focuses on specific stressors (COVID-19, its economic and social consequences). Classes of 40-50 participants are led by 2 co-leaders. Participants have CHA MindWell Monitoring and telephone support during weeks 1-8 and then every 4 weeks afterwards for 24 weeks. Participants with severe symptoms or worsening moderate symptoms will be asked if they would like a mental wellness assessment with a clinician. If monitoring with CAT-MH interviews suggests symptomatic worsening, then a CHA MindWell technician will contact the participant and check-in and offer support, including setting up a televisit with a member of a clinical member of the outpatient mental health team if needed.
BEHAVIORALInternet Cognitive Behavioral Therapy plus CHAMindWell
MoodGYM is based on CBT and interpersonal therapy targeting depression, anxiety, stress, and general psychological distress. MoodGYM has 6 sessions with five curriculum modules and a review session that can be completed within an 8-week period. iCBT participants will also be enrolled in CHA MindWell Monitoring and Support (CHA-MW). Participants across arms will have CHA MindWell Monitoring and Technician telephone support during weeks 1-8 and then every 4 weeks afterwards for 24 weeks. Participants with severe symptoms or worsening moderate symptoms will be asked if they would like a mental wellness assessment with a clinician. If there are difficulties with accessing iCBT technology or if monitoring with CAT-MH or CAT-DI/ANX-CAT interviews suggests symptomatic worsening, then a CHA MindWell technician will contact the participant and check-in and offer support, including setting up a televisit with a member of a clinical member of the outpatient mental health team if needed.
BEHAVIORALCHAMindWell
Participants across arms will have CHA MindWell Monitoring and Technician support during weeks 1-8 and then every 4 weeks afterwards for 24 weeks. Participants across arms will have CHA MindWell Monitoring and Technician telephone support during weeks 1-8 and then every 4 weeks afterwards for 24 weeks. Participants with severe symptoms or worsening moderate symptoms will be asked if they would like a mental wellness assessment with a clinician. If monitoring with CAT-MH or CAT-DI/ANX-CAT interviews suggests symptomatic worsening, then a CHA MindWell technician will contact the participant and check-in and offer support, including setting up a televisit with a member of a clinical member of the outpatient mental health team if needed.
Sponsors
Cambridge Health Alliance
National Center for Complementary and Integrative Health (NCCIH)
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Three arms, one intervention (8-wk MBCT-R + CHA-MW) and two comparator arms (8-wk iCBT + CHA-MW or CHA-MW alone) which are randomly assigned at the same time and are implemented in parallel.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Severity (CAT-DI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug Use Rates | Week 24 | Rates of positive toxicology screens for illicit drugs or unprescribed controlled substances at 24 weeks. Rates of positive toxicology for illicit drug use or controlled substances (non prescribed) at week 24 is the secondary outcome. |
| Heavy Drinking Days | Week 24 | We will conduct an Alcohol Use History at Week 24. We will conduct 30-day alcohol and substance use history using the TimeLine Follow Back (TLFB) Method at Week 24 visit by telephone or video conference. Heavy Drinking Days in past 30 days is the secondary outcome. |
| Televisits (AKA Mental Wellness Assessments) | Randomization through Week 24 | Number of mental health clinician mental wellness assessments during 24 weeks |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORZev Schuman-Olivier, MD
Cambridge Health Alliance
PRINCIPAL_INVESTIGATORCarl Fulwiler, MD
Cambridge Health Alliance
Outcome results
None listed