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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2023-03-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing Cognitive-Behavioral Therapy Versus Mindfulness-Based Therapy for Autistic Adults

NCT06060860

Autism Spectrum Disorder Depression Anxiety

RECRUITING NA

Brief Video Interventions for Depression

NCT04643964

Depressive Symptoms

COMPLETED NA

Mental Health Among Patients, Providers, and Staff During the COVID-19 Era

NCT04700137

Covid19 Mental Health

COMPLETED NA

The Effects and Mechanisms of Mindfulness Based Cognitive Therapy (MBCT) on Depressive Symptoms and Depression Relapse

NCT01145872

Major Depressive Disorder Recurrent

COMPLETED PHASE3

Effectiveness and Implementation of a Mindfulness Intervention for Depressive Symptoms Among Adults in a FQHC

NCT03620721

Depressive Symptoms Stress, Psychological Stress, Physiological

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Anxiety Substance Use Stress, Psychological Stress, Emotional Alcohol Use, Unspecified Drug Use Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell

Intervention Type BEHAVIORAL

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.

CHAMindWell

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Internet Cognitive Behavioral Therapy plus CHAMindWell

Intervention Type BEHAVIORAL

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.

CHAMindWell

Intervention Type BEHAVIORAL

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.

CHA-MW

Participants randomized to the CHA-MW arm will only receive CHAMindWell mental wellness monitoring with CAT-MH and telephone coaching as needed.

Group Type ACTIVE_COMPARATOR

CHAMindWell

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mindfulness 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.

Intervention Type BEHAVIORAL

Internet 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.

Intervention Type BEHAVIORAL

CHAMindWell

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MBCT-R + CHAMindWell iCBT + CHAMindWell MoodGYM + CHAMindWell CHA-MW

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes