SSM vs HEP in Late-Life Depression (NCT03564041) | Clinical Trial Compass
TerminatedNot Applicable
SSM vs HEP in Late-Life Depression
Stopped: COVID-19
Canada95 participantsStarted 2018-08-20
Plain-language summary
The investigators will conduct a randomized controlled trial (RCT), comparing SSM (n=96) versus HEP (n=96) in 192 LLD participants stratified by site and presence of treatment resistant late life depression (TR-LLD). Participants will be blinded to the treatment hypothesis while investigators, raters and treating clinicians will be additionally blinded to the intervention. Both SSM and HEP will be taught over 4 consecutive days in similar sized groups (4-10 participants) followed by weekly reinforcement sessions for subsequent 11 weeks. Trained raters will collect data on depression symptoms (HAM-D 17 scale) and cognition at baseline, 12-week and 26-week follow-up as the primary and secondary outcome measures respectively.
Who can participate
Age range
60 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients will be 60-85 years of age presenting with major depressive disorder, single or recurrent, as diagnosed by a Mini Neuropsychiatric Interview (MINI) \[41\].
. A 17-item Hamilton Depression Rating Scale score of 10-22\[42\].
. Participants will be willing and able to attend all 4 training sessions of SSM/HEP, as well as 75% of follow-up sessions.
. Have sufficient hearing to follow verbal instructions;
. Have adequate understanding of English in London and English and/or French in Montreal.
. Able to sit for 45 minutes without discomfort.
. Willing to remain on the same antidepressants including dosage for the first 12 weeks of the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in depressive symptoms: Hamilton Depression Scale (HAM-D17)
Timeframe: Change from week 0 to week 12 and change from week 0 to week 26.
Trial details
NCT IDNCT03564041
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
. Inability to independently provide informed consent.
. Clinical evidence of dementia as defined by Mini-Cog \< 3.a lifetime diagnosis of other mental disorders, including bipolar I or II disorder, primary psychotic disorder (schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder).
. Substance abuse or dependence within the past 3 months; high risk of suicide (e.g., active suicidal ideation and/or current/recent intent or plan) as assessed by the MINI.
. Severe personality disorder, that will interfere with their ability to function in a group setting.
. Substance use disorder as assessed by the MINI.
. Clinically significant sensory impairment.
. IQ estimated to be below 70 on the Test of Premorbid Functioning
. Acutely unstable medical illnesses, including delirium or acute cerebrovascular or cardiovascular events within the last 6 months; having a terminal medical diagnosis with prognosis of less than 12 months.