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Completed

NCT Number: NCT05588622

Meru Health Program for Cancer Patients With Depression and Anxiety

The primary objective of this study is to evaluate clinical outcomes among people with cancer who participate in a 12-week therapist-supported digital mental health intervention (DMHI) called the Meru Health Program (MHP). Study participants (N=20) will be referred to the MHP through the Cancer Support Community (CSC) Helpline and network of Gilda's Club locations. The main outcomes will be depression symptoms, anxiety symptoms, health-related quality of life (HRQoL), intervention adherence, and intervention satisfaction. The secondary objective will be to determine the acceptability of the screening and referral process from the CSC networks into the MHP. Data pertaining to implementability will be collected from study participants, MHP clinicians, and CSC staff.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Online Digital Mental Health Clinic

Denver, Colorado, 80014, United States

About this study

The goal of this single-arm intervention study is to test the feasibility of the Meru Health Program (MHP) in reducing symptoms of depression and anxiety among 20 people with cancer referred from the Cancer Support Community (CSC). The MHP is a 12-week digital mental health intervention delivered via a smartphone app. The intervention focuses on cognitive behavioral techniques and mindfulness skills with the aim of improving mental health symptoms. The platform provides informational videos, skills practices, group discussion, and messaging with a licensed clinician employed by Meru Health. The licensed clinician supports patients as needed and reviews engagement logs within the app. As part of the intervention, depression and anxiety symptoms are measured on a biweekly basis over 12 weeks. For this study, self-reported surveys will be administered at baseline, week 12, and 2-months post-treatment to measure health-related quality of life and intervention satisfaction. In-depth interviews will be conducted with patients. Two focus groups will be conducted with MHP clinicians and CSC navigators to understand barriers and facilitators to the screening processes and intervention delivery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Positive screen (score >= 3 out of 8) on the anxiety or depression subscale of the CSS 15+ Questionnaire
  • PHQ-9 and/or GAD-7 score >= 5 at clinical intake
  • 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 1 of the 3 past versions of an Apple or Android mobile phone operating system
  • Currently in active cancer treatment at the time of enrollment

Exclusion criteria

  • Active suicide intent with plan to act
  • Substance use disorder in the past 3 months
  • Lifetime bipolar disorder
  • Lifetime psychotic disorder
  • Currently pregnant
  • Less than 3 months postpartum

Treatment and study plan

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.

Primary outcomes

  1. Change in PHQ-9 Scores

    Time frame: Baseline, Week 12, and 2 Month Follow-Up time points

    9-item questionnaire to measure depression symptoms

  2. Change in GAD-7 Scores

    Time frame: Baseline, Week 12, and 2 Month Follow-Up time points

    7-item questionnaire to measure anxiety symptoms

  3. Change in Eurohis-QOL-8 Scores

    Time frame: Baseline, Week 12, and 2 Month Follow-Up time points

    8-item Quality of Life questionnaire.

  4. Change in CSS 15+ Scores

    Time frame: Baseline and Week 12 time points

    15-item questionnaire to measure psychological distress experiencing and receiving treatment for cancer.

Secondary outcomes

  1. Change in Burnout Scores

    Time frame: Baseline, Week 12, and 2 Month Follow-Up

    A single-item questionnaire to address worker stress and burnout.

Sponsors and collaborators

Lead sponsor

Meru Health, Inc.

Industry

Collaborators

  • Cancer Support Community, Headquarters
  • Eli Lilly and Company

Registry information

Official study title

Feasibility of a Therapist-Supported Digital Mental Health Intervention in Addressing Mental Health Symptoms Among People With Cancer: A Mixed Methods Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 20, 2022
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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