Meru Health Program for Cancer Patients With Depression and Anxiety

NCT05588622 | Completed

• 1 other identifier: 22-MERU-117
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Anxiety

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change in PHQ-9 Scores

  9-item questionnaire to measure depression symptoms

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

• Change in GAD-7 Scores

  7-item questionnaire to measure anxiety symptoms

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

• Change in Eurohis-QOL-8 Scores

  8-item Quality of Life questionnaire.

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

• Change in CSS 15+ Scores

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

  Baseline and Week 12 time points

Secondary Outcomes (1)

• Change in Burnout Scores

  Baseline, Week 12, and 2 Month Follow-Up

Study Arms (1)

Treatment Group

EXPERIMENTAL

This single-arm study will enroll all 20 participants in the Meru Health Program.

Behavioral: Meru Health Program

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.

Treatment Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meru Health, Inc.: lead
• Cancer Support Community, Headquarters: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

Online Digital Mental Health Clinic

Denver, Colorado, 80014, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 20, 2022
• Study Start: September 6, 2022
• Primary Completion: June 9, 2023
• Study Completion: July 1, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)