Clinical trial NCT04595084: Remotely Delivered Programs Targeting COVID-19 Stress-Related Depression and Substance Use
Official title: Remotely Delivered Programs Targeting COVID-19 Stress-Related Depression and Substance Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Substance Use
Stress, Psychological
Stress, Emotional
Alcohol Use, Unspecified
Drug Use
Covid19
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Penn State University
First posted: 2020-10-20
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Depression Severity (CAT-DI)
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24
Secondary outcomes:
measure: Drug Use Rates
timeFrame: Week 24
measure: Heavy Drinking Days
timeFrame: Week 24
measure: Televisits (AKA Mental Wellness Assessments)
timeFrame: Randomization through Week 24
Other outcomes:
measure: Positive and Negative Affect Reactivity Scales
timeFrame: Weeks -4, -3, -2, -1, 0, 9, 10, 11
measure: Daily Inventory of Stressful Events
timeFrame: Weeks -4, -3, -2, -1, 9, 10, 11, 12
measure: Inflammatory Cytokines (IL-6, IL-1b, IL-8, TNF-a)
timeFrame: Weeks -4, -3, -2, -1, 9, 10, 11, 12
measure: Brief Experiential Avoidance Questionnaire (BEAQ)
timeFrame: Baseline, Weeks 4, 8, 12
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline, Weeks 4, 8, 12
measure: Perceived Stress Scale (PSS-14)
timeFrame: Baseline, Weeks 4, 8, 12, 24
measure: Self-Compassion Scale Short Form (SCS-SF)
timeFrame: Baseline, Weeks 4, 8, 12
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
timeFrame: Baseline, Weeks 4, 8, 12
measure: Responses to Stress Questionnaire - COVID -19 (RSQ-COVID-19) Stress coping style (disengagement, involuntary engagement)
timeFrame: Baseline, Weeks 12, 24
measure: Experiences Questionnaire (EQ) (Rumination and Decentering)
timeFrame: Baseline, Weeks 4, 8, 12
measure: Computerized Adaptive Testing for Mental Health (CAT-MH) Interviews
timeFrame: Screening, Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24
measure: Beck Depression Inventory (BDI-II)
timeFrame: Baseline
measure: Credibility and Expectancy
timeFrame: Week 2
measure: COVID-19 Fear
timeFrame: Baseline, Week 12
measure: COVID-19 status (self-report)
timeFrame: Week 0, 4, 8, 12, 16, 20, 24
measure: COVID-19 status (salivary IgG)
timeFrame: Week 12
measure: UCI Oral Health Questionnaire
timeFrame: Screening and at Week 12
measure: Home Skills Use Diary
timeFrame: Weeks 1, 2, 3, 4, 5, 6, 7, 8
measure: Adverse Event Patient Participant Self-Report Form
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24
Locations:
city: Cambridge
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
affiliation: Cambridge Health Alliance
name: Zev Schuman-Olivier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cambridge Health Alliance
name: Carl Fulwiler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosansky JA, Okst K, Tepper MC, Baumgart Schreck A, Fulwiler C, Wang PS, Schuman-Olivier Z. Participants' Engagement With and Results From a Web-Based Integrative Population Mental Wellness Program (CHAMindWell) During the COVID-19 Pandemic: Program Evaluation Study. JMIR Ment Health. 2023 Oct 26;10:e48112. doi: 10.2196/48112.