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SSM vs HEP in Late-Life Depression

NCT03564041 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2022-04-20

No results posted yet for this study

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.

Conditions

  • Late-life Depression
  • Treatment-resistant Depression

Interventions

BEHAVIORAL

Sahaj Samadhi Meditation (SSM)

This is the experimental arm of the study, where participants will be trained in a form of meditation that may improve depressive symptoms.

BEHAVIORAL

Health Enhancement Program (HEP)

This is the active control group of the study, where participants will be educated on health promotion, healthy diet, music, and exercise, but do not learn breathing techniques, or meditation.

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-20
Primary Completion
2022-04-09
Completion
2022-04-09

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03564041 on ClinicalTrials.gov