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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2022
  • participants needed
    240
  • sponsor
    Cambridge Health Alliance
Updated on 12 August 2021
anxiety
substance use
behavior therapy
behavioral therapy
depressive symptoms
depressed mood
cognitive therapy

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).

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.

Details
Condition Depression (Treatment-Resistant), Depression (Major/Severe), Generalized Anxiety Disorder (GAD), Substance Abuse, Depressed, depressive disorders, Depression, Alcohol Use, Unspecified, Depression (Adolescent), Depression (Pediatric), Drug abuse, depressed mood, Anxiety Disorders, Psychological stress, Depression (Adult and Geriatric), ANXIETY NEUROSIS, Generalized Anxiety Disorder (GAD - Pediatric), Substance Use, Endogenous depression, Anxiety Disorders (Pediatric), emotional stress, Anxiety Symptoms, miserable, Anxiety, anxious, COVID19, anxiety disorder, depressive disorder, Drug use
Treatment Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell, Internet Cognitive Behavioral Therapy plus CHAMindWell, CHAMindWell
Clinical Study IdentifierNCT04595084
SponsorCambridge Health Alliance
Last Modified on12 August 2021

Eligibility

Yes No Not Sure

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, which is CAT-DI PHQ-9 equivalency score 10-20

Exclusion Criteria

Active psychosis or severe level of psychosis on PSY-S-CAT > 30
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 (>75)
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 14 daily diaries at baseline
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