Depression
Conditions
Keywords
depression, anxiety, digital health intervention
Brief summary
This is a randomized controlled trial (RCT) of the Meru Health Program (MHP) versus a waitlist (WL) control group, which will be offered access to the MHP after the waitlist period (12 weeks) is over, for adults with depression. The Meru Health Program (MHP) is a 12-week mobile mental health intervention delivered via Smartphone app that includes components of several evidence-based treatments (Cognitive Behavioral Therapy, Behavioral Activation Therapy, Mindfulness Meditation) and also several promising therapies (heart rate variability-biofeedback \[HRVB\], nutritional psychiatry, sleep training) that is overseen by a licensed clinical therapist.
Detailed description
Title: Randomized Controlled Trial of the Meru Health Program versus Waitlist Control for Adults with Depression Study Description: This is a randomized controlled trial (RCT) of the Meru Health Program (MHP) versus a waitlist (WL) control group, which will be offered access to the MHP after the waitlist period (12 weeks) is over, for adults with depression. Objectives\*: Primary Objective: To compare changes in depressive symptoms and reduction in clinically significant depression at the end of the program and compare between those in the MHP group versus WL group Secondary Objectives: To compare changes in anxiety, worker productivity, burnout symptoms, resilience, insomnia, quality of life, days spent engaging with the program per week and hours spent in various program activities per week between those in the MHP group versus WL group Endpoints\*: Primary Endpoint: Depressive symptoms and adverse events at 12 weeks Secondary Endpoints: Anxiety, worker productivity, burnout, resilience, insomnia, and quality of life at 12 weeks; days spent engaging with program per week and hours spent in various program activities per week, program satisfaction, therapist rating, system usability scale.. Study Population: Patients aged 18 or older presenting to the Meru Health Program with depression (defined as having a PHQ-9 score of 10 or higher at baseline) Description of Sites/Facilities Enrolling Participants: MHP online clinic Description of Study Intervention/Experimental Manipulation: The Meru Health Program (MHP) is a 12-week mobile health app delivered via Smartphone that includes components of several evidence-based treatments (Cognitive Behavioral Therapy, Behavioral Activation Therapy, Mindfulness Meditation) and also several promising therapies (heart rate variability-biofeedback \[HRVB\], nutritional psychiatry, sleep training) that is overseen by a licensed clinical therapist. This study will test the MHP versus a WL control group, of which patients enrolled will be offered access to the MHP after 12 weeks in the WL control group, to compare groups on depressive symptom outcomes and, secondarily, on other mood and behavioral outcomes, engagement, and patient satisfaction outcomes. Study Duration\*: 1 year Participant Duration: 12 weeks
Interventions
BEHAVIORALMeru Health Program
Each week of the 12 week program follows a different theme. Patients and therapists interact asynchronously after their initial Zoom-based intake call. Psychiatrists and medical doctors are available for consults if needed.
Sponsors
Meru Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Data analyst will be blind to study group
Intervention model description
Patients randomized to one of two groups, the Meru Health Program which is a 12 week program or a 12-week waitlist control group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years or older * Own a Smartphone * PHQ-9\>9 * Lives in Colorado
Exclusion criteria
* Screen positive for a psychotic disorder, bipolar disorder, alcohol or drug use disorder, or suicidal plans
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | 12 weeks | Mean change in Patient Health Questionnaire-9 item depression scale during the program. Scores range from 0 to 27, with higher scores indicative of more depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Worker Productivity and Activity Impairment | 12 weeks | The 6-item WPAI will be used to quantify changes in baseline to 12-week (post-program) scores on 4 subscales of worker productivity and activity impairment: absenteeism, presenteeism, overall worker productivity impairment, and impairment in activities of daily living, which each range from 0 (no impairment) to 100% (fully impaired) |
| Insomnia | 12 weeks | The Insomnia Severity Scale will be used to assess mean changes made during the program. The ISS has a minimum of 0 (no insomnia) to 28 (very severe insomnia) |
| Quality of life as measured by the EQ-5D | 12 weeks | The EQ-5D will be used to evaluate mean changes in quality of life for each of the 5 subscales of the EQ-5D, which range from (no difficulties) to 3 (a lot of difficulty) |
| Patient-reported adverse events | during the 12-week intervention | The proportion of patients reporting at least one adverse event during the study period will be calculated. |
| Anxiety | 12 weeks | Mean change in Generalized Anxiety Disorder-7 item anxiety scale during the program. Scores range from 0 to 21, with higher scores indicative of more anxiety. |
| Burnout | 12 weeks | Percent of participants with change in burnout during program. A validated, single item burnout score measure will be used. Burnout is assessed through an item with 5-level responses and categorized as yes (\>=3) or no (\<3) on a 5 point scale ranging from 1 (no symptoms of burnout) to 5 (completely burned out). |
| Resilience | 12 weeks | Mean change in scores on the Resilience Scale score, which has a minimum of 25 (lowest resilience) and 175 (highest resilience). |
Other
| Measure | Time frame | Description |
|---|---|---|
| System usability | 12 weeks | The mean rating of system usability will be calculated from a single-item question with responses that range from 1 (lowest usability) to 5 (maximum usability) |
| Patient-reported program satisfaction | 12 weeks | The mean patient satisfaction on a single item question asking about overall satisfaction with the program will be used to calculate mean satisfaction (minimum 1, maxium 5) |
| Therapist rating | 12 weeks | The mean therapist rating assessed via a single item question asking about overall satisfaction with the program will be used to calculate mean satisfaction (minimum 1, maxium 5) |
Countries
United States
Outcome results
None listed