Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04744545
Status:
COMPLETED
Last Update Posted:
2023-07-13
First Post:
2021-01-25
Brief Title:
RCT of Adjunctive Curcumin and the Meru Health Program
Sponsor:
Meru Health Inc
Organization:
Meru Health Inc
Study Overview
Official Title:
Randomized Controlled Trial of Adjunctive Curcumin and the Meru Health Program for Adults With Depression
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 telephoneZoom 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 users Smartphone made available via email The lab orders will be sent to each patients Ultalabs center of choice or if preferred done in the patients 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
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 telephoneZoom 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 users Smartphone made available via email The lab orders will be sent to each patients Ultalabs center of choice or if preferred done in the patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None