DepressionNCT05615662
Meru Health Program to Treat Depression in Primary Care
A study testing Meru Health Program and Treatment as Usual in people with Depression and Anxiety, run by Meru Health, Inc. at 1 site in United States.
Trial summary
Meru Health Inc. seeks to further validate the Meru Health Program (MHP) as a single solution to screening, referral, and treatment in primary care as compared to treatment as usual using a Randomized Controlled Trial (RCT) study design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Meru Health Program and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 18 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PHQ-9 score of 10 or more at the time of screening
- Willing to commit to the Meru Health Program if selected
- Proficient in the English language
- At least 18 years of age at the time of enrollment
- Has a valid mailing address
- Owns an Apple or Android smartphone with 1 of the 3 most recent versions of the operating system software.
Who cannot join
- Active suicide intent with plan to act
- Substance use disorder in the past 3 months
- Ever been diagnosed with bipolar disorder
- Ever been diagnosed with a psychotic disorder
- Currently pregnant
- Less than 3 months postpartum
Trial locations and contacts
1 site in 1 country.
United States1 site
Online Digital Mental Health Clinic
Denver, Colorado, 80014
About this study
Official title: Hybrid Type-1 Effectiveness-implementation Trial for Primary Care Depression Screening and Referral to a Remote Digital Mental Health Clinic
Meru Health Inc. seeks to further validate the Meru Health Program (MHP) as a single solution to screening, referral, and treatment in primary care as compared to treatment as usual using a Randomized Controlled Trial (RCT) study design. The goal of this study is to determine the feasibility, effectiveness, and implementability of this digital mental health (DMH) solution.
If proven effective and implementable, more widely integrating the MHP into primary care has the potential to improve the systems of screening, referral, and treatment for depression nationwide. This, in turn, will serve as a solution to improve access to effective care for the millions of Americans currently suffering from depression, ultimately reducing its public health burden.
Read the detailed description
The goal of this study is to test the MHP as a 'package solution' of screening and treatment in a primary care setting through a 2-step clinical trial process: (1) A smaller proof-of-concept (POC) trial to provide guidance and establish the settings and assessments for (2) A larger confirmatory type 1 hybrid effectiveness Randomized Controlled Trial (RCT) followed by the collection of potential facilitators and barriers to the treatment's wide scale implementation.
The POC study is aimed to develop all of the study materials for the RCT, and test the screening, referral, and study enrollment procedures. 30 participants will be recruited from 1 primary care clinic. The first 15 eligible participants will be referred to TAU, while the second 15 eligible participants will be referred to the MHP. Study assessments will be performed at the baseline (prior to treatment), 6-week, and 12- week (EOT) time points. In addition, at the end of the 12- week study period, we will interview the participants and providers about their experiences with the study to inform the eventual trial. Feedback will be incorporated into improved study methods.
The 300 participant RCT will be used to demonstrate long lasting and significant improvements of the MHP on participants, measured by a set of assessments completed 6 times for each enrolled participant. Study assessments will be performed at the baseline (prior to treatment), 6-, and 12 weeks (EOT) after baseline, as well as 1-, 3-, 6- and 12-month follow-up time points. Using a stepped-wedge randomization study design, 150 participants will be assigned to MHP and 150 to TAU. Participants with a screening PHQ-9 of 10+ will be randomly assigned to MHP or TAU. For TAU participants, primary care providers will not be directed on how to manage the case, while participants in the MHP group will be scheduled into groups of 10-15 individuals who will work through the program together. Participants will receive the Heart Rate Variability Biofeedback (HRV-B) device and be directed to download and follow the MHP app which prompts daily practices and chat communication. Study assessments for both groups will be administered online with response as the primary outcome.
Lastly will be a multistakeholder process evaluation of the delivery of the MHP intervention. Data collected from the 300 RCT participants, as well as administrators and providers from the 8 primary care clinics, will be evaluated for completion rates, engagement metrics, and satisfaction using multiple factors. We will then evaluate the program through surveys and interviews and examine patterns of mental health treatment utilization during the 12-week period, intervention fidelity and competence, attitudes, competencies, and barriers and facilitators of implementation of the MHP.
- Conditions
- Depression, Anxiety
- Being tested
- Meru Health Program, Treatment as Usual
- Keywords
- Mental Health, Digital Mental Health, Depression, Anxiety, Meru Health
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meru Health ProgramBehavioural
The Meru Health Program is a 12-week, evidence-based, smartphone-delivered, therapist-supported digital mental health intervention with as-needed psychiatrist oversight. Enrolled participants work through the program with a cohort of peers similarly affected by depression, with whom they can engage in confidential, anonymous, voluntary group chats overseen by a licensed clinical therapist. The MHP incorporates a continuous care model including daily interaction with a dedicated clinician, several evidence-based treatment components such as cognitive behavioral therapy (CBT), behavioral activation therapy, and mindfulness meditation (MM), as well as promising newer types of depression treatments such as HRVB, nutritional psychiatry, and sleep training. Practices are introduced to weekly topics via video lessons that are reinforced via CBT practices, meditations, and biofeedback sessions and therapist messaging.
Treatment as UsualBehavioural
Treatment as Usual in this study will include all of the regular standards of care for mental health needs. These standards of care may include, but are not limited to psychotherapy, pharmacotherapy, or complementary therapy.
| Study group | Role | What they receive |
|---|---|---|
| Meru Health Program | Experimental | This group of participants will receive the app-based 12-Week Meru Health Program as their study intervention. Receives: Behavioral: Meru Health Program |
| Treatment as Usual | Active comparator | This group of participants will receive "Treatment as Usual" mental health services under the direction and referral of their Primary Care Physician. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire-9 scores
This 9-item Questionnaire is to measure levels of depression and is scored from 0-27. Higher scores indicate more severe symptoms.
Measured: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
Secondary outcomes (9)
Change in Generalized Anxiety Disorder-7 scores
This 7-item Questionnaire is to measure levels of anxiety and is scored from 0-21. Higher scores indicate more severe symptoms.
Measured: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
Change in EUROHIS- Quality of Life-8 scores
This 8-item Quality of Life measurement tool is scored from 5-40. Higher scores indicate a higher satisfaction with life.
Measured: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
Change in PROMIS: Self-Efficacy for Managing Chronic Conditions and Emotions scores
This 4-item Questionnaire is used to measure management of stress and emotions. It is scored from 0-20 with higher scores indicating more severe symptoms.
Measured: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
Change in PROMIS: Sleep Disturbance scores
This 4-item Questionnaire is used to address sleep quality. It is scored from 0-20 with higher scores indicating more severe symptoms.
Measured: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
Change in PROMIS: Sleep-Related Impairment scores
This 4-item Questionnaire is used to address how sleepy a person is during the day and how it affects productivity. It is scored from 0-20 with higher scores indicating more severe symptoms.
Measured: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
Change in Brief Resilience Scale scores
This 6-item Questionnaire is used to measure resilience. It is scored from 1-5 with higher scores indicating greater levels of resilience.
Measured: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
Change in Worker Productivity and Activity Impairment responses
This qualitative questionnaire is used to assess presenteeism, absenteeism, overall worker productivity, and activity impairment. Responses will be analyzed over time to study the employment status, time missed or spent at work, and the impact of health-related issues.
Measured: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
Change in Single Item Burnout responses
This 1-item Questionnaire is used to measure levels of work-related burnout. The responses to this single item will be analyzed over time to study changes in the severity of worker burnout.
Measured: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
System Usability Scale
This 10-item scale that has been validated as a measure of acceptability and satisfaction with digital interventions. It is scored from 0-100, with higher scores indicating higher user satisfaction.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Dec 2022
- Primary completion8 May 2023
- Study completion18 May 2023
Why it stopped: Loss of grant funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meru Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), Curebase Inc.
- Responsible party
- Sponsor
- Investigators
- Nicholas C Peiper, PhD, MPH, Principal investigator, Meru Health: Director of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615662
- Sponsor's protocol ID
- 22-MERU-116
- Other IDs
- R44MH126836
- Status last verified
- Jul 2023
- First submitted
- 7 Nov 2022
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Type-1 Effectiveness-implementation Trial for Primary Care Depression Screening and Referral to a Remote Digital Mental Health Clinic
- ClinicalTrials.gov ID
- NCT05615662
- Acronym / sponsor ID
- 22-MERU-116
- Conditions
- Depression, Anxiety
- Keywords
- Mental Health, Digital Mental Health, Depression, Anxiety, Meru Health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Loss of grant funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Meru Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH), Curebase Inc.
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 14 Nov 2022 (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.
Meru Health Inc. seeks to further validate the Meru Health Program (MHP) as a single solution to screening, referral, and treatment in primary care as compared to treatment as usual using a Randomized Controlled Trial (RCT) study design. The goal of this study is to determine the feasibility, effectiveness, and implementability of this digital mental health (DMH) solution.
If proven effective and implementable, more widely integrating the MHP into primary care has the potential to improve the systems of screening, referral, and treatment for depression nationwide. This, in turn, will serve as a solution to improve access to effective care for the millions of Americans currently suffering from depression, ultimately reducing its public health burden.
Detailed description
The goal of this study is to test the MHP as a 'package solution' of screening and treatment in a primary care setting through a 2-step clinical trial process: (1) A smaller proof-of-concept (POC) trial to provide guidance and establish the settings and assessments for (2) A larger confirmatory type 1 hybrid effectiveness Randomized Controlled Trial (RCT) followed by the collection of potential facilitators and barriers to the treatment's wide scale implementation.
The POC study is aimed to develop all of the study materials for the RCT, and test the screening, referral, and study enrollment procedures. 30 participants will be recruited from 1 primary care clinic. The first 15 eligible participants will be referred to TAU, while the second 15 eligible participants will be referred to the MHP. Study assessments will be performed at the baseline (prior to treatment), 6-week, and 12- week (EOT) time points. In addition, at the end of the 12- week study period, we will interview the participants and providers about their experiences with the study to inform the eventual trial. Feedback will be incorporated into improved study methods.
The 300 participant RCT will be used to demonstrate long lasting and significant improvements of the MHP on participants, measured by a set of assessments completed 6 times for each enrolled participant. Study assessments will be performed at the baseline (prior to treatment), 6-, and 12 weeks (EOT) after baseline, as well as 1-, 3-, 6- and 12-month follow-up time points. Using a stepped-wedge randomization study design, 150 participants will be assigned to MHP and 150 to TAU. Participants with a screening PHQ-9 of 10+ will be randomly assigned to MHP or TAU. For TAU participants, primary care providers will not be directed on how to manage the case, while participants in the MHP group will be scheduled into groups of 10-15 individuals who will work through the program together. Participants will receive the Heart Rate Variability Biofeedback (HRV-B) device and be directed to download and follow the MHP app which prompts daily practices and chat communication. Study assessments for both groups will be administered online with response as the primary outcome.
Lastly will be a multistakeholder process evaluation of the delivery of the MHP intervention. Data collected from the 300 RCT participants, as well as administrators and providers from the 8 primary care clinics, will be evaluated for completion rates, engagement metrics, and satisfaction using multiple factors. We will then evaluate the program through surveys and interviews and examine patterns of mental health treatment utilization during the 12-week period, intervention fidelity and competence, attitudes, competencies, and barriers and facilitators of implementation of the MHP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meru Health Program | Experimental | Behavioral: Meru Health ProgramThis group of participants will receive the app-based 12-Week Meru Health Program as their study intervention. |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualThis group of participants will receive "Treatment as Usual" mental health services under the direction and referral of their Primary Care Physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- PHQ-9 score of 10 or more at the time of screening
- Willing to commit to the Meru Health Program if selected
- Proficient in the English language
- At least 18 years of age at the time of enrollment
- Has a valid mailing address
Key exclusion criteria (6 listed)
- Active suicide intent with plan to act
- Substance use disorder in the past 3 months
- Ever been diagnosed with bipolar disorder
- Ever been diagnosed with a psychotic disorder
- Currently pregnant
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 |
|---|---|---|
| Meru Health ProgramThe Meru Health Program is a 12-week, evidence-based, smartphone-delivered, therapist-supported digital mental health intervention with as-needed psychiatrist oversight. Enrolled participants work through the program with a cohort of peers similarly affected by depression, with whom they can engage in confidential, anonymous, voluntary group chats overseen by a licensed clinical therapist. The MHP incorporates a continuous care model including daily interaction with a dedicated clinician, several evidence-based treatment components such as cognitive behavioral therapy (CBT), behavioral activation therapy, and mindfulness meditation (MM), as well as promising newer types of depression treatments such as HRVB, nutritional psychiatry, and sleep training. Practices are introduced to weekly topics via video lessons that are reinforced via CBT practices, meditations, and biofeedback sessions and therapist messaging. | Behavioural | Meru Health Program |
| Treatment as UsualTreatment as Usual in this study will include all of the regular standards of care for mental health needs. These standards of care may include, but are not limited to psychotherapy, pharmacotherapy, or complementary therapy. | Behavioural | Treatment as Usual |
Primary outcome
Change in Patient Health Questionnaire-9 scores
Time frame: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
This 9-item Questionnaire is to measure levels of depression and is scored from 0-27. Higher scores indicate more severe symptoms.
9 secondary outcomes
Change in Generalized Anxiety Disorder-7 scores
Time frame: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
Change in EUROHIS- Quality of Life-8 scores
Time frame: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
Change in PROMIS: Self-Efficacy for Managing Chronic Conditions and Emotions scores
Time frame: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
Change in PROMIS: Sleep Disturbance scores
Time frame: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
Change in PROMIS: Sleep-Related Impairment scores
Time frame: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
Change in Brief Resilience Scale scores
Time frame: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
Change in Worker Productivity and Activity Impairment responses
Time frame: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
Change in Single Item Burnout responses
Time frame: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
System Usability Scale
Time frame: Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
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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.
Nicholas C Peiper, PhD, MPH principal investigator
Meru Health: Director of Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meru Health Program and Treatment as Usual in people with Depression and Anxiety, run by Meru Health, Inc. 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 6 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: withdrawn, as of the sponsor's last update on 13 Jul 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Patient Health Questionnaire-9 scores (time frame: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2023.