Clinical trial NCT05615662: Meru Health Program to Treat Depression in Primary Care
Official title: Hybrid Type-1 Effectiveness-implementation Trial for Primary Care Depression Screening and Referral to a Remote Digital Mental Health Clinic
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression
Anxiety
Keywords: Mental Health
Digital Mental Health
Depression
Anxiety
Meru Health
Lead sponsor: Meru Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
name: Curebase Inc.
First posted: 2022-11-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 scores
timeFrame: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
Secondary outcomes:
measure: Change in Generalized Anxiety Disorder-7 scores
timeFrame: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
measure: Change in EUROHIS- Quality of Life-8 scores
timeFrame: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
measure: Change in PROMIS: Self-Efficacy for Managing Chronic Conditions and Emotions scores
timeFrame: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
measure: Change in PROMIS: Sleep Disturbance scores
timeFrame: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
measure: Change in PROMIS: Sleep-Related Impairment scores
timeFrame: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
measure: Change in Brief Resilience Scale scores
timeFrame: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
measure: Change in Worker Productivity and Activity Impairment responses
timeFrame: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
measure: Change in Single Item Burnout responses
timeFrame: Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up
measure: System Usability Scale
timeFrame: Week 12
Other outcomes:
Locations:
city: Denver
country: United States
facility: Online Digital Mental Health Clinic
state: Colorado
Study officials:
affiliation: Meru Health: Director of Research
name: Nicholas C Peiper, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: