Clinical trial NCT04744545: RCT of Adjunctive Curcumin and the Meru Health Program
Official title: Randomized Controlled Trial of Adjunctive Curcumin and the Meru Health Program for Adults With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Meru Health, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with two study groups.
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial (RCT) to compare the Meru Health Program plus adjunctive curcumin (MHP-CUR) versus Meru Health Program only (MHP-ONLY) for adults with depression. Meru Health is a 12-week integrative treatment program based on several evidence-based practices and overseen by licensed clinical therapists that is delivered via a Smartphone app. The primary objective of the study is to determine the feasibility, initial efficacy (depressive symptoms), and potential harms of taking adjunctive curcumin supplementation during the 12-week MHP among adults with depression. Secondary objectives include comparing changes in inflammation biomarkers, anxiety, worker productivity, and burnout that occur during the program between those in MHP-CUR and MHP-ONLY.

Detailed description: This is a randomized controlled trial (RCT) to compare the Meru Health Program plus adjunctive curcumin (MHP-CUR) versus Meru Health Program only (MHP-ONLY) for adults with depression. Meru Health is a 12-week integrative treatment program based on several evidence-based practices and overseen by licensed clinical therapists that is delivered via a Smartphone app. The primary objective of the study is to determine the feasibility, initial efficacy (depressive symptoms), and potential harms of taking adjunctive curcumin supplementation during the 12-week MHP among adults with depression. Secondary objectives include comparing changes in inflammation biomarkers, anxiety, worker productivity, and burnout that occur during the program between those in MHP-CUR and MHP-ONLY.

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.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* 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:

* Lifetime bipolar disorder or a psychotic disorder
* 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

Primary outcomes:
measure: Depression
timeFrame: 12 weeks
measure: Patient-reported adverse events
timeFrame: during the 12 week program
Secondary outcomes:
measure: Anxiety
timeFrame: 12 weeks
measure: Burnout
timeFrame: 12 weeks
measure: Worker productivity and activity impairment
timeFrame: 12 weeks
measure: Therapist rating
timeFrame: 12 weeks
measure: Interleukin-6
timeFrame: 12 weeks
measure: High Sensitivity C Reactive Protein
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: Online
state: Colorado
Study officials:
References: