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 range60 Years ā 85 Years
SexALL
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Inclusion criteria
ā. Patients will be 60-85 years of age presenting with major depressive disorder, single or recurrent, as diagnosed by a Mini Neuropsychiatric Interview (MINI) \[41\].
ā. A 17-item Hamilton Depression Rating Scale score of 10-22\[42\].
ā. Participants will be willing and able to attend all 4 training sessions of SSM/HEP, as well as 75% of follow-up sessions.
ā. Have sufficient hearing to follow verbal instructions;
ā. Have adequate understanding of English in London and English and/or French in Montreal.
ā. Able to sit for 45 minutes without discomfort.
ā. Willing to remain on the same antidepressants including dosage for the first 12 weeks of the study.
Exclusion criteria
ā. Inability to independently provide informed consent.
ā. 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).
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
ā. 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.
ā. Severe personality disorder, that will interfere with their ability to function in a group setting.
ā. Substance use disorder as assessed by the MINI.
ā. Clinically significant sensory impairment.
ā. IQ estimated to be below 70 on the Test of Premorbid Functioning
ā. 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.