Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT06404320
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 MoveU.HappyU 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 (MoveU.HappyU) 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 2:1 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:
NCT06404320
Study Brief:
Protocol Section:
NCT06404320