Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404320
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-04-29
Brief Title:
Physical Activity Program for TRD
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
Remotely Delivered Physical Activity Program for Treatment-Resistant Depression a Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
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 pilot study examining the delivery of a remotely delivered one-on-one individualized physical activity PA program in adult participants with treatment-resistant depression TRD
Detailed Description:
More than one-third of patients with major depressive disorder will not respond to at least two antidepressant medication trials meeting the criteria for TRD As a result alternative therapeutic modalities such as PA are garnering interest Numerous studies have reported an association between PA and improvements in mood and mental health The MoveUHappyU PA program is an initiative that considers individuals PA preferences and priorities and works collaboratively to develop individualized PA programs The program has been found to improve depressive symptoms in a non-clinical sample of university students
This is a single-site pilot randomized controlled clinical trial The trial will evaluate the feasibility of randomizing adult participants with TRD to a remotely delivered one-on-one individualized PA program MoveUHappyU in addition to treatment as usual TAU or TAU The trial will also assess the acceptability of the PA program and collect data to monitor the efficacy of the PA program for depressive and anxiety symptoms as well as quality of life This trial includes the use of a digital platform to evaluate the effect of the PA program on passive physiological data that are collected through the use of a wearable device
Thirty participants will be randomized in a 21 allocation to one of two treatment arms 1 TAU with a 4-week remotely delivered one-on-one individualized PA program add-on 2 TAU without the PA program add-on Participants in both arms will complete the same clinician-administered scales self-reported mental health questionnaires and use a wearable device After the 4-week interventional period participants will enter a 6-week observational follow-up period
This is a single-site pilot randomized controlled clinical trial The trial will evaluate the feasibility of randomizing adult participants with TRD to a remotely delivered one-on-one individualized PA program MoveUHappyU in addition to treatment as usual TAU or TAU The trial will also assess the acceptability of the PA program and collect data to monitor the efficacy of the PA program for depressive and anxiety symptoms as well as quality of life This trial includes the use of a digital platform to evaluate the effect of the PA program on passive physiological data that are collected through the use of a wearable device
Thirty participants will be randomized in a 21 allocation to one of two treatment arms 1 TAU with a 4-week remotely delivered one-on-one individualized PA program add-on 2 TAU without the PA program add-on Participants in both arms will complete the same clinician-administered scales self-reported mental health questionnaires and use a wearable device After the 4-week interventional period participants will enter a 6-week observational follow-up period
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