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

Not Applicable

Completed

• Conditions: Stress, Emotional; Alcohol Use, Unspecified; Drug Use; Depression; Stress, Psychological; Covid19; Substance Use; Anxiety
• Interventions: Behavioral: Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell; Behavioral: Internet Cognitive Behavioral Therapy plus CHAMindWell; Behavioral: CHAMindWell

• Registration Number: NCT04595084
• Lead Sponsor: Cambridge Health Alliance

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.

Study Timeline

• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-20
• Study Start: 2021-03-15
• Primary Completion: 2023-03-06
• Study Completion: 2023-03-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MBCT-R + CHA-MW	Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell	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.
iCBT (MoodGym) + CHA-MW	Internet Cognitive Behavioral Therapy plus CHAMindWell	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.
iCBT (MoodGym) + CHA-MW	CHAMindWell	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.
MBCT-R + CHA-MW	CHAMindWell	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.
CHA-MW	CHAMindWell	Participants randomized to the CHA-MW arm will only receive CHAMindWell mental wellness monitoring with CAT-MH and telephone coaching as needed.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Cambridge Health Alliance; 🇺🇸 Cambridge, Massachusetts, United States