DepressionNCT04595084
Remotely Delivered Programs Targeting COVID-19 Stress-Related Depression and Substance Use
A study testing Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell, Internet Cognitive Behavioral Therapy plus CHAMindWell and CHAMindWell in people with Depression and Anxiety, run by Cambridge Health Alliance at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Substance Use
- What is being tested?
- Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell, Internet Cognitive Behavioral Therapy plus CHAMindWell and CHAMindWell
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 6 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cambridge Health Alliance
Cambridge, Massachusetts, 02141
About this study
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).
Read the 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.
- Conditions
- Depression, Anxiety, Substance Use, Stress, Psychological, Stress, Emotional, Alcohol Use, Unspecified
- Being tested
- Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell, Internet Cognitive Behavioral Therapy plus CHAMindWell, CHAMindWell
- Medical subject headings
- Depression, Anxiety Disorders, Substance-Related Disorders, Stress, Psychological, Alcohol Drinking, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWellBehavioural
Also called MBCT-R + 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.
Internet Cognitive Behavioral Therapy plus CHAMindWellBehavioural
Also called iCBT + CHAMindWell, MoodGYM + 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.
CHAMindWellBehavioural
Also called CHA-MW
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.
| Study group | Role | What they receive |
|---|---|---|
| MBCT-R + CHA-MW | Experimental | 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. Receives: Behavioral: Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell; Behavioral: CHAMindWell |
| iCBT (MoodGym) + CHA-MW | Active comparator | 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. Receives: Behavioral: Internet Cognitive Behavioral Therapy plus CHAMindWell; Behavioral: CHAMindWell |
| CHA-MW | Active comparator | Participants randomized to the CHA-MW arm will only receive CHAMindWell mental wellness monitoring with CAT-MH and telephone coaching as needed. Receives: Behavioral: CHAMindWell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Severity (CAT-DI)
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.
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24
Secondary outcomes (3)
Drug Use Rates
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.
Measured: Week 24
Heavy Drinking Days
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.
Measured: Week 24
Televisits (AKA Mental Wellness Assessments)
Number of mental health clinician mental wellness assessments during 24 weeks
Measured: Randomization through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start15 Mar 2021
- Primary completion6 Mar 2023
- Study completion6 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Penn State University
- Responsible party
- Sponsor
- Investigators
- Zev Schuman-Olivier, MD, Principal investigator, Cambridge Health AllianceCarl Fulwiler, MD, Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595084
- Sponsor's protocol ID
- CHA-IRB-1141/05/20
- Other IDs
- 3R33AT010125-03S1
- Status last verified
- Apr 2024
- First submitted
- 19 Oct 2020
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37883149
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely Delivered Programs Targeting COVID-19 Stress-Related Depression and Substance Use
- ClinicalTrials.gov ID
- NCT04595084
- Acronym / sponsor ID
- CHA-IRB-1141/05/20
- Conditions
- Depression, Anxiety, Substance Use, Stress, Psychological, Stress, Emotional, Alcohol Use, Unspecified
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Penn State University
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| MBCT-R + CHA-MW | Experimental | Behavioral: Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell, Behavioral: CHAMindWellMindfulness-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 | Active comparator | Behavioral: Internet Cognitive Behavioral Therapy plus CHAMindWell, Behavioral: CHAMindWellMoodGym 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. |
| CHA-MW | Active comparator | Behavioral: CHAMindWellParticipants randomized to the CHA-MW arm will only receive CHAMindWell mental wellness monitoring with CAT-MH and telephone coaching as needed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWellAlso: MBCT-R + CHAMindWellMBCT-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. | Behavioural | MBCT-R + CHA-MW |
| Internet Cognitive Behavioral Therapy plus CHAMindWellAlso: iCBT + CHAMindWell, MoodGYM + CHAMindWellMoodGYM 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. | Behavioural | iCBT (MoodGym) + CHA-MW |
| CHAMindWellAlso: CHA-MWParticipants 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. | Behavioural | CHA-MW, MBCT-R + CHA-MW, iCBT (MoodGym) + CHA-MW |
Primary outcome
Depression Severity (CAT-DI)
Time frame: 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.
3 secondary outcomes
Drug Use Rates
Time frame: Week 24
Heavy Drinking Days
Time frame: Week 24
Televisits (AKA Mental Wellness Assessments)
Time frame: Randomization through Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Results publication: PubMed 37883149Rosansky 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zev Schuman-Olivier, MD principal investigator
Cambridge Health Alliance
Carl Fulwiler, MD principal investigator
Cambridge Health Alliance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell, Internet Cognitive Behavioral Therapy plus CHAMindWell and CHAMindWell in people with Depression and Anxiety, run by Cambridge Health Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Severity (CAT-DI) (time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04595084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.