Randomized Controlled Trial of Adjunctive Curcumin and the Meru Health Program for Adults With Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Depression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessors will not have information about each participant's study group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Meru Health Program plus adjunctive curcumin (MHP-CUR)
Meru Health Program (12 week program) with participants taking 2 turmeric supplements (1500mg/day) curcumin.
干预措施: Meru Health Program (Behavioral)
Meru Health Program (MHP-ONLY)
Meru Health Program (12 week program)
干预措施: Meru Health Program (Behavioral)
Meru Health Program plus adjunctive curcumin (MHP-CUR)
Meru Health Program (12 week program) with participants taking 2 turmeric supplements (1500mg/day) curcumin.
干预措施: Curcumin (Dietary Supplement)
结局指标
主要结局
Depression
时间窗: 12 weeks
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)
Patient-reported adverse events
时间窗: during the 12 week program
The proportion of patients reporting at least one adverse event during the 12-week intervention will be reported.
次要结局
- Burnout(12 weeks)
- Worker productivity and activity impairment(12 weeks)
- Interleukin-6(12 weeks)
- High Sensitivity C Reactive Protein(12 weeks)
- Anxiety(12 weeks)
- Therapist rating(12 weeks)