DepressionNCT05588622
Meru Health Program for Cancer Patients With Depression and Anxiety
A study testing Meru Health Program in people with Depression and Anxiety, run by Meru Health, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Meru Health Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Online Digital Mental Health Clinic
Denver, Colorado, 80014
About this study
Official title: Feasibility of a Therapist-Supported Digital Mental Health Intervention in Addressing Mental Health Symptoms Among People With Cancer: A Mixed Methods Study
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.
Read the 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.
- Conditions
- Depression, Anxiety
- Being tested
- Meru Health Program
- Keywords
- Mental Health, Digital Mental Health, Depression, Anxiety, Meru Health
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meru Health ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | This single-arm study will enroll all 20 participants in the Meru Health Program. Receives: Behavioral: Meru Health Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PHQ-9 Scores
9-item questionnaire to measure depression symptoms
Measured: Baseline, Week 12, and 2 Month Follow-Up time points
Change in GAD-7 Scores
7-item questionnaire to measure anxiety symptoms
Measured: Baseline, Week 12, and 2 Month Follow-Up time points
Change in Eurohis-QOL-8 Scores
8-item Quality of Life questionnaire.
Measured: 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.
Measured: Baseline and Week 12 time points
Secondary outcomes (1)
Change in Burnout Scores
A single-item questionnaire to address worker stress and burnout.
Measured: Baseline, Week 12, and 2 Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start6 Sep 2022
- Primary completion9 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meru Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cancer Support Community, Headquarters, Eli Lilly and Company
- Responsible party
- Principal investigator, Nicholas Peiper, PhD, MPH, Meru Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588622
- Sponsor's protocol ID
- 22-MERU-117
- Status last verified
- Jul 2023
- First submitted
- 13 Oct 2022
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Therapist-Supported Digital Mental Health Intervention in Addressing Mental Health Symptoms Among People With Cancer: A Mixed Methods Study
- ClinicalTrials.gov ID
- NCT05588622
- Acronym / sponsor ID
- 22-MERU-117
- Conditions
- Depression, Anxiety
- Keywords
- Mental Health, Digital Mental Health, Depression, Anxiety, Meru Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Meru Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cancer Support Community, Headquarters, Eli Lilly and Company
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Meru Health ProgramThis single-arm study will enroll all 20 participants in the Meru Health Program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- Active suicide intent with plan to act
- Substance use disorder in the past 3 months
- Lifetime bipolar disorder
- Lifetime psychotic disorder
- Currently pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meru Health ProgramThe 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. | Behavioural | Treatment Group |
Primary outcome
Change in PHQ-9 Scores
Time frame: Baseline, Week 12, and 2 Month Follow-Up time points
9-item questionnaire to measure depression symptoms
Change in GAD-7 Scores
Time frame: Baseline, Week 12, and 2 Month Follow-Up time points
7-item questionnaire to measure anxiety symptoms
Change in Eurohis-QOL-8 Scores
Time frame: Baseline, Week 12, and 2 Month Follow-Up time points
8-item Quality of Life questionnaire.
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.
1 secondary outcome
Change in Burnout Scores
Time frame: Baseline, Week 12, and 2 Month Follow-Up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meru Health Program in people with Depression and Anxiety, run by Meru Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PHQ-9 Scores (time frame: Baseline, Week 12, and 2 Month Follow-Up time points). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.