Major Depressive Disorder Clinical Trial
Official title:
Remotely Delivered Physical Activity Program for Treatment-Resistant Depression: A Pilot Randomized Controlled Trial
NCT number | NCT06404320 |
Other study ID # | 23-069 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2024 |
Est. completion date | August 2025 |
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).
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | August 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Sedentary adults (engage in less than 60 minutes of moderate-to-vigorous PA per week) between the ages of 18 and 65 years, inclusive, capable of giving informed consent. 2. Patients meeting diagnostic criteria for major depressive disorder without psychotic symptoms according to the Diagnostic and Statistical Manual of Mental Disorders - 5th Ed. (DSM-5) and currently experiencing a major depressive episode (MDE) as confirmed by the Mini International Neuropsychiatric Interview (MINI). 3. A Montgomery-Åsberg Depression Rating Scale total score of = 7 at screening (mild to severe MDE). 4. Failure of at least two trials of antidepressant therapy of adequate dose and duration during the current episode as established by the Antidepressant Treatment History Form and self-report. 5. Receiving treatments congruent with Canadian Network for Mood and Anxiety Treatments guidelines with no medication changes or no introduction of psychotherapy allowed one month before screening (28 days), during the randomized intervention phase (28 days), and during the follow-up phase (42 days). Exclusion Criteria: 1. Current symptoms of mania, hypomania, mixed episodes, or psychosis. 2. Have received a diagnosis of alcohol or a substance use disorder within the past 3 months or as confirmed by the MINI. Other secondary psychiatric comorbidities (e.g., anxiety disorders, trauma-related disorders, etc.) will not be excluded. 3. Pregnant females. 4. Have diabetes. 5. Acute risk for a cardiovascular event (i.e., cardiovascular event in the past within the past 12 months). 6. Have any medical contraindications to exercise according to the Physical Activity Readiness Questionnaire. 7. Self-reported balance, gait, or locomotion difficulties that would preclude participation in a PA program. 8. Have any other condition that, in the opinion of the investigator(s), would adversely affect the subject's ability to complete the study or its measures. 9. Have exercise-induced asthma. 10. Taking medication that interferes with heart rate response to exercise, such as beta blockers. 11. Do not own a smartphone. 12. Do not have reliable access to the Internet. 13. Have previously received intravenous ketamine treatment in the last 2 months. Non-English-speaking individuals are excluded because the ability to communicate study information, answer questions accurately and completely about the study, and obtain consent are necessary. |
Country | Name | City | State |
---|---|---|---|
Canada | St. Michael's Hospital, Unity Health Toronto | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Unity Health Toronto | University of Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Total duration of sleep; awake, light, rapid eye movement, and deep sleep durations | This outcome will be used to assess the effect of the PA program on digital physiological passive data relating to sleep, which will be collected through the use of a wearable device. | 13 weeks | |
Other | Metabolic equivalent minutes | This outcome will be used to assess the effect of the PA program on digital physiological passive data relating to activity, which will be collected through the use of a wearable device. | 13 weeks | |
Other | Readiness (interpreted from sleep, activity, resting heart rate, heart rate variability, recovery index, and body temperature scores) | This outcome will be used to assess the effect of the PA program on digital physiological passive data relating to readiness, which will be collected through the use of a wearable device. | 13 weeks | |
Primary | Feasibility | Recruitment rate, withdrawal rate, adherence rate, and data completion rate | 13 weeks | |
Primary | Acceptability | Responses to an exit survey | 13 weeks | |
Primary | Acceptability | Responses to semi-structured qualitative interviews | 13 weeks | |
Secondary | Hamilton Depression Rating Scale-17 | This is a semi-structured interview that has been well-validated in measuring the presence and severity of depression. This scale will be administered at baseline, at the end of the intervention phase, and at the last follow-up assessment. Scores range from 0 to 52. A decrease in total scores is defined as improvement in depressive symptoms. | 13 weeks | |
Secondary | Patient Health Questionnaire-9 | This scale is a self-rated measure of depressive symptom severity over the past two weeks. This scale will be administered at baseline, at the end of the intervention phase, and at the last follow-up assessment. Scores range from 0 to 27. A decrease in total scores is defined as improvement in depressive symptoms. | 13 weeks | |
Secondary | General Anxiety Disorder-7 | This scale is a self-rated measure of anxiety symptom severity over the past two weeks. This scale will be administered at baseline, at the end of the intervention phase, and at the last follow-up assessment. Scores range from 0 to 21. A decrease in total scores is defined as improvement in anxiety symptoms. | 13 weeks | |
Secondary | World Health Organization - Five Well-Being Index | This scale is a self-rated measure of well-being over the past two weeks. This scale will be modified for weekly administration. The sum of scores from the five items will be multiplied by 4, representing the participant's perceived quality of life as a percentage. Higher scores denote higher quality of life. | 13 weeks |
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