Meru Health Program for Cancer Patients With Depression and Anxiety
Primary Purpose
Depression, Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meru Health Program
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Mental Health, Digital Mental Health, Depression, Anxiety, Meru Health
Eligibility Criteria
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
Sites / Locations
- Online Digital Mental Health Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
This single-arm study will enroll all 20 participants in the Meru Health Program.
Outcomes
Primary Outcome Measures
Change in PHQ-9 Scores
9-item questionnaire to measure depression symptoms
Change in GAD-7 Scores
7-item questionnaire to measure anxiety symptoms
Change in Eurohis-QOL-8 Scores
8-item Quality of Life questionnaire.
Change in CSS 15+ Scores
15-item questionnaire to measure psychological distress experiencing and receiving treatment for cancer.
Secondary Outcome Measures
Change in Burnout Scores
A single-item questionnaire to address worker stress and burnout.
Full Information
NCT ID
NCT05588622
First Posted
October 13, 2022
Last Updated
July 12, 2023
Sponsor
Meru Health, Inc.
Collaborators
Cancer Support Community, Headquarters, Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT05588622
Brief Title
Meru Health Program for Cancer Patients With Depression and Anxiety
Official Title
Feasibility of a Therapist-Supported Digital Mental Health Intervention in Addressing Mental Health Symptoms Among People With Cancer: A Mixed Methods Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
June 9, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meru Health, Inc.
Collaborators
Cancer Support Community, Headquarters, Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
Mental Health, Digital Mental Health, Depression, Anxiety, Meru Health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
This single-arm study will enroll all 20 participants in the Meru Health Program.
Intervention Type
Behavioral
Intervention Name(s)
Meru Health Program
Intervention Description
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 Outcome Measure Information:
Title
Change in PHQ-9 Scores
Description
9-item questionnaire to measure depression symptoms
Time Frame
Baseline, Week 12, and 2 Month Follow-Up time points
Title
Change in GAD-7 Scores
Description
7-item questionnaire to measure anxiety symptoms
Time Frame
Baseline, Week 12, and 2 Month Follow-Up time points
Title
Change in Eurohis-QOL-8 Scores
Description
8-item Quality of Life questionnaire.
Time Frame
Baseline, Week 12, and 2 Month Follow-Up time points
Title
Change in CSS 15+ Scores
Description
15-item questionnaire to measure psychological distress experiencing and receiving treatment for cancer.
Time Frame
Baseline and Week 12 time points
Secondary Outcome Measure Information:
Title
Change in Burnout Scores
Description
A single-item questionnaire to address worker stress and burnout.
Time Frame
Baseline, Week 12, and 2 Month Follow-Up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Online Digital Mental Health Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Meru Health Program for Cancer Patients With Depression and Anxiety
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