Clinical trial NCT05588622: 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
Overall status: COMPLETED
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: Cancer Support Community, Headquarters
name: Eli Lilly and Company
First posted: 2022-10-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in PHQ-9 Scores
timeFrame: Baseline, Week 12, and 2 Month Follow-Up time points
measure: Change in GAD-7 Scores
timeFrame: Baseline, Week 12, and 2 Month Follow-Up time points
measure: Change in Eurohis-QOL-8 Scores
timeFrame: Baseline, Week 12, and 2 Month Follow-Up time points
measure: Change in CSS 15+ Scores
timeFrame: Baseline and Week 12 time points
Secondary outcomes:
measure: Change in Burnout Scores
timeFrame: Baseline, Week 12, and 2 Month Follow-Up
Other outcomes:
Locations:
city: Denver
country: United States
facility: Online Digital Mental Health Clinic
state: Colorado
Study officials:
References: