NCT04744545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

January 25, 2021

Last Update Submit

July 12, 2023

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

  • Depression

    Mean changes in the Patient Health Questionnaire, 9 item scale (PHQ-9) made during the program will be calculated. Scores range from 0 (no depression) to 27 (most severe depression)

    12 weeks

  • Patient-reported adverse events

    The proportion of patients reporting at least one adverse event during the 12-week intervention will be reported.

    during the 12 week program

Secondary Outcomes (6)

  • Anxiety

    12 weeks

  • Burnout

    12 weeks

  • Worker productivity and activity impairment

    12 weeks

  • Therapist rating

    12 weeks

  • Interleukin-6

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Meru Health Program plus adjunctive curcumin (MHP-CUR)

EXPERIMENTAL

Meru Health Program (12 week program) with participants taking 2 turmeric supplements (1500mg/day) curcumin.

Behavioral: Meru Health ProgramDietary Supplement: Curcumin

Meru Health Program (MHP-ONLY)

ACTIVE COMPARATOR

Meru Health Program (12 week program)

Behavioral: Meru Health Program

Interventions

Meru Health ProgramBEHAVIORAL

12 week evidence-based mental health intervention overseen by a licensed clinical therapist delivered via Smartphone app

Meru Health Program (MHP-ONLY)Meru Health Program plus adjunctive curcumin (MHP-CUR)
CurcuminDIETARY_SUPPLEMENT

1500mg/day curcumin plus black pepper to aid absorption

Meru Health Program plus adjunctive curcumin (MHP-CUR)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Online

Denver, Colorado, 80014, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessors will not have information about each participant's study group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial with two study groups.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2021

First Posted

February 9, 2021

Study Start

February 1, 2021

Primary Completion

September 30, 2021

Study Completion

December 30, 2021

Last Updated

July 13, 2023

Record last verified: 2023-07

Locations

US(1)