Meru Health Program to Treat Depression in Primary Care

NCT05615662 | Withdrawn

• 2 other identifiers: 22-MERU-116R44MH126836
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety

Keywords

Mental Health; Digital Mental Health; Depression; Anxiety; Meru Health

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  Baseline, Week 6, Week 12, 1 Month Follow-up, 3 Month Follow-up, 6 Month Follow-up, 1 Year Follow-up

Study Arms (2)

Meru Health Program

EXPERIMENTAL

This group of participants will receive the app-based 12-Week Meru Health Program as their study intervention.

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.

Behavioral: Treatment as Usual

Interventions

Meru Health Program BEHAVIORAL

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.

Meru Health Program

Treatment as Usual BEHAVIORAL

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.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Meru Health, Inc.: lead
• National Institute of Mental Health (NIMH): collaborator
• Curebase Inc.: collaborator

Study Sites (1)

Online Digital Mental Health Clinic

Denver, Colorado, 80014, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Study Officials

• Nicholas C Peiper, PhD, MPH

  Meru Health: Director of Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: December 1, 2022
• Primary Completion: May 8, 2023
• Study Completion: May 18, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Locations

US (1)