Treatment-resistant DepressionNCT06404320
Physical Activity Program for TRD
A study testing PA program - MoveU.HappyU in people with Treatment-resistant Depression and Major Depressive Disorder, run by Unity Health Toronto at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment-resistant Depression, Major Depressive Disorder
- What is being tested?
- PA program - MoveU.HappyU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 19 Sep 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Participants meeting diagnostic criteria for major depressive disorder without psychotic symptoms according to the Diagnostic and Statistical Manual of Mental Disorders - 5th Ed. and currently experiencing a major depressive episode (MDE) as confirmed by the Mini International Neuropsychiatric Interview (MINI).
- A Montgomery-Åsberg Depression Rating Scale total score of ≥ 7 at screening (mild-to-severe MDE).
- 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.
- Receiving treatments congruent with Canadian Network for Mood and Anxiety Treatments guidelines with no changes to treatments one month before screening (28 days).
Who cannot join
- Current symptoms of mania, hypomania, mixed episodes, or psychosis.
- 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.
- Pregnant females.
- Acute risk for a cardiovascular event (i.e., cardiovascular event in the past within the past 12 months).
- Have any medical contraindications to exercise according to the Physical Activity Readiness Questionnaire.
- Self-reported balance, gait, or locomotion difficulties that would preclude participation in a PA program.
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- 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.
- Have exercise-induced asthma.
- Taking medication that interferes with heart rate response to exercise, such as beta blockers.
- Do not own a smartphone.
- Do not have reliable access to the Internet.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital, Unity Health Toronto
Toronto, Ontario
Venkat Bhat
About this study
Official title: Remotely Delivered Physical Activity Program for Treatment-Resistant Depression: A Pilot Randomized Controlled Trial
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).
Read the 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.
- Being tested
- PA program - MoveU.HappyU
- Keywords
- Major Depressive Disorder, Physical Activity, Exercise
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA program - MoveU.HappyUBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PA program | Experimental | Participants in the PA group will receive a 4-week remotely delivered one-on-one individualized PA program adjunct to TAU. Receives: Behavioral: PA program - MoveU.HappyU |
| TAU | No intervention | Participants in the TAU group will be given a handout with the Canadian 24-hour movement guidelines and be told that they are encouraged to engage in PA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Recruitment rate, withdrawal rate, adherence rate, and data completion rate
Measured: 13 weeks
Acceptability
Responses to an exit survey
Measured: 13 weeks
Acceptability
Responses to semi-structured qualitative interviews
Measured: 13 weeks
Secondary outcomes (4)
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.
Measured: 13 weeks
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.
Measured: 13 weeks
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.
Measured: 13 weeks
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.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start19 Sep 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment-resistant DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404320
- Sponsor's protocol ID
- 23-069
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tassone VK, Quesnel DA, Parkington K, Rueda A, Martin J, Lee GH, Teixeira A, deJonge ML, Lou W, Wiljer D, Mulsant BH, Sabiston CM, Bhat V. Improving adherence to physical activity in treatment-resistant depression: Protocol for a pilot randomized controlled trial of a remotely delivered program. PLoS One. 2025 Sep 2;20(9):e0330848. doi: 10.1371/journal.pone.0330848. eCollection 2025.
PubMed 40892783
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely Delivered Physical Activity Program for Treatment-Resistant Depression: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06404320
- Acronym / sponsor ID
- 23-069
- Keywords
- Major Depressive Disorder, Physical Activity, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PA program | Experimental | Behavioral: PA program - MoveU.HappyUParticipants in the PA group will receive a 4-week remotely delivered one-on-one individualized PA program adjunct to TAU. |
| TAU | No intervention | –Participants in the TAU group will be given a handout with the Canadian 24-hour movement guidelines and be told that they are encouraged to engage in PA. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Participants meeting diagnostic criteria for major depressive disorder without psychotic symptoms according to the Diagnostic and Statistical Manual of Mental Disorders - 5th Ed. and currently experiencing a major depressive episode (MDE) as confirmed by the Mini International Neuropsychiatric Interview (MINI).
- A Montgomery-Åsberg Depression Rating Scale total score of ≥ 7 at screening (mild-to-severe MDE).
- 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.
- Receiving treatments congruent with Canadian Network for Mood and Anxiety Treatments guidelines with no changes to treatments one month before screening (28 days).
Key exclusion criteria (13 listed)
- Current symptoms of mania, hypomania, mixed episodes, or psychosis.
- 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.
- Pregnant females.
- Acute risk for a cardiovascular event (i.e., cardiovascular event in the past within the past 12 months).
- Have any medical contraindications to exercise according to the Physical Activity Readiness Questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PA program - MoveU.HappyUParticipants 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. | Behavioural | PA program |
Primary outcome
Feasibility
Time frame: 13 weeks
Recruitment rate, withdrawal rate, adherence rate, and data completion rate
Acceptability
Time frame: 13 weeks
Responses to an exit survey
Acceptability
Time frame: 13 weeks
Responses to semi-structured qualitative interviews
4 secondary outcomes
Hamilton Depression Rating Scale-17
Time frame: 13 weeks
Patient Health Questionnaire-9
Time frame: 13 weeks
General Anxiety Disorder-7
Time frame: 13 weeks
World Health Organization - Five Well-Being Index
Time frame: 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Derived from this study: PubMed 40892783Tassone VK, Quesnel DA, Parkington K, Rueda A, Martin J, Lee GH, Teixeira A, deJonge ML, Lou W, Wiljer D, Mulsant BH, Sabiston CM, Bhat V. Improving adherence to physical activity in treatment-resistant depression: Protocol for a pilot randomized controlled trial of a remotely delivered program. PLoS One. 2025 Sep 2;20(9):e0330848. doi: 10.1371/journal.pone.0330848. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PA program - MoveU.HappyU in people with Treatment-resistant Depression and Major Depressive Disorder, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Venkat Bhat (416-360-4000 ext. 76404, venkat.bhat@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 13 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06404320, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.