Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2021-02-01
2021-12-30
Brief Summary
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Detailed Description
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This feasibility study will use a randomized controlled trial of up to 60 adult patients with depression. Patients will be recruited through Facebook ads, complete online and telephone/Zoom screening and, if eligible, invited to participate in the 12-week Meru Health program. One group will be randomized to being in the MHP plus receiving curcumin supplementation (MHP-CUR) and the other will be randomized to being in the MHP only (MHP-only). The MHP overseen by a licensed therapist who is available to the participant as needed via text messaging and, when requested, telephone. The program is delivered via an app downloaded to the user's Smartphone made available via email. The lab orders will be sent to each patient's Ultalabs center of choice or, if preferred, done in the patient's home. All study participants (in both groups) will be asked to get their blood drawn before starting the program, 6 weeks into the program, and just after the 12-week program. Two vials of blood will be taken at each visit, one to test for high sensitivity-CRP (hs-CRP) levels and the other to test for interleukin (IL-6) levels. 2ml of serum is needed for each vial. Patients in both groups will receive a wearable HRVB device via US mail; patients in the MHP-CUR group will also receive curcumin supplements via US mail. All non-laboratory study assessments will be made via the app and online via email.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Meru Health Program plus adjunctive curcumin (MHP-CUR)
Meru Health Program (12 week program) with participants taking 2 turmeric supplements (1500mg/day) curcumin.
Meru Health Program
12 week evidence-based mental health intervention overseen by a licensed clinical therapist delivered via Smartphone app
Curcumin
1500mg/day curcumin plus black pepper to aid absorption
Meru Health Program (MHP-ONLY)
Meru Health Program (12 week program)
Meru Health Program
12 week evidence-based mental health intervention overseen by a licensed clinical therapist delivered via Smartphone app
Interventions
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Meru Health Program
12 week evidence-based mental health intervention overseen by a licensed clinical therapist delivered via Smartphone app
Curcumin
1500mg/day curcumin plus black pepper to aid absorption
Eligibility Criteria
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Inclusion Criteria
* Patient presenting to the Meru Health online clinic
* Able to read and understand English
* Own a Smartphone
* Willing to commit to doing program practices for 10 minutes a day, 6 days a week for 12 weeks
* PHQ-9 of 10 or higher
Exclusion Criteria
* Possible cognitive impairment
* Substance use disorder in the past 3 months
* Active suicidal ideation with at least some intent to act
* Pregnant, breastfeeding, or desiring to become pregnant in the next 6 months
* Self-reported current suffering from a major medical illness including neurodegenerative/neuroinflammatory disorders, anemia, Alzheimer's disease, stroke, Parkinson's disease, or multiple sclerosis, autoimmune disorders, diabetes, inflammatory bowel disease, chronic obstructive pulmonary disease, asthma, coagulation disorder, cardiovascular disease, hypertension, chronic fatigue syndrome, fibromyalgia
* Self-reported current use of glucocorticoids, antibiotics, anticoagulant medications, antioxidant supplements (including curcumin), herbal supplements, or ω3 polyunsaturated fatty acids
* Self-reported past suffering from an infection or illness over the past month
18 Years
ALL
Yes
Sponsors
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Meru Health, Inc.
INDUSTRY
Responsible Party
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Locations
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Online
Denver, Colorado, United States
Countries
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Other Identifiers
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#20-MERU-106
Identifier Type: -
Identifier Source: org_study_id
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