Physical Activity Program for TRD

Major Depressive Disorder Clinical Trial

Official title:

Remotely Delivered Physical Activity Program for Treatment-Resistant Depression: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06404320
• Other study ID #: 23-069
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: Unity Health Toronto
• Contact: Venkat Bhat
• Phone: 416-360-4000
• Email: venkat.bhat[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depressive Disorder
• Treatment-resistant Depression

Intervention

Behavioral:
• PA program - MoveU.HappyU
Participants will meet with their program trainer once a week virtually for 4 weeks to engage in 30 minutes of behavioral change coaching and 30 minutes of a structured PA program that is tailored to their needs and goals. The intensity of the PA sessions will be self-selected. PA sessions will involve a warmup, a conditioning component consisting of individualized aerobic or resistance exercises, and a cool down/stretch. Participants will also be instructed to independently engage in PA (outside of their session with the trainer) for 120 minutes at 50-65% of their maximum work capacity. This can be done by engaging in PA between 3-5 times per week.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital, Unity Health Toronto	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Unity Health Toronto	University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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