Depression Clinical Trial
Official title:
Efficacy of a Healthy Lifestyle Intervention to Reduce Depression in Older Spousally-bereaved Adults
Using an indicated prevention approach, investigators propose to enroll 150 spousally-bereaved adults aged 60 years and older in the first 6 months after spousal death who are at high risk for major depression disorder because of subthreshold symptoms of depression. A confirmatory efficacy trial will be conducted in which participants will be randomly assigned to (a) self-monitor sleep, meals, and physical activity for 12 weeks using digital monitoring plus motivational health coaching (WELL; n=75); or (b) enhanced usual care (EUC, usual care plus study assessments, n=75). Objective actigraphic measures of the 24-hour pattern of day and nighttime activity - known as the rest-activity rhythm - will be measured to evaluate circadian rhythms as a mediator of treatment outcomes. Participants will be assessed at baseline, months 1 & 2, post-intervention, and 3, 6,12, 18-months post-intervention. In addition, the investigators will include a subset of participants bereaved by COVID-19 (or suspected as bereaved by COVID-19). Participants in this subset will undergo the same research procedures as the main cohort. Participants in both the main cohort and subset determined to be fully eligible will be randomized into two groups with a total of: usual care (EUC;n=125) and WELL (WELL; n=125).
The primary aim of this R01 application is to test the efficacy of a new behavioral intervention that targets the timing and regularity of sleep, meals, and physical activity to stabilize circadian rhythms, for reducing symptoms of depression during the spousal bereavement period. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
| Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
| Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
| Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
| Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
| Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
| Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
| Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
| Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
| Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
| Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
| Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
| Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
| Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
| Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
| Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
| Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
| Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
| Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A |