SSM vs HEP in Late-Life Depression

NCT03564041 | Terminated DMC

• 1 other identifier: 4961
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

depression; late-life; executive functioning; sahaj samadhi; meditation; treatment-resistant

Outcome Measures

Primary Outcomes (1)

• Change in depressive symptoms: Hamilton Depression Scale (HAM-D17)

  The HAM-D17 is a measure of depressive symptoms. Higher scores on this scale indicate greater depression severity; whereas lower scores indicate minimal/no presence of depression. Change in participant scores on this scale throughout the study will be assessed.

  Change from week 0 to week 12 and change from week 0 to week 26.

Secondary Outcomes (3)

• Delis-Kaplan Executive Function System (D-KEFS): Verbal Fluency Test

  0 weeks (baseline); 12 weeks; and 26 weeks

• California Verbal Learning Test-II (CVLT-II), Short Form

  0 weeks (baseline); 12 weeks; and 26 weeks

• Rey-Osterrieth Complex Figure-Copy Trial

  0 weeks (baseline); 12 weeks; and 26 weeks

Other Outcomes (32)

• Generalized Anxiety Disorder 7-item (GAD-7) scale

  0 weeks (at screening or at baseline); 12 weeks; and 26 weeks

• Clinical Global Impression (CGI) scale

  0 weeks (baseline); 12 weeks; and 26 weeks

• Athens Insomnia Scale

  0 weeks (baseline); 12 weeks; and 26 weeks

Study Arms (2)

Sahaj Samadhi Meditation (SSM)

EXPERIMENTAL

SSM will be taught to participants over 4 consecutive days, for 2 hours each day. Participants will initially learn about the nature of meditation and will be taken through a guided meditation. Afterwards, participants will undergo training which includes understanding the nature of the mind and the thoughts arising from it, guided meditation by the instructor, and a discussion of what is correct and incorrect meditation. Follow-ups will be conducted once every week for the following 11 weeks, each including guided meditation. Participants will be encouraged to practice the meditation at home for 20 minutes per session and will be given weekly practice logs to complete.

Behavioral: Sahaj Samadhi Meditation (SSM)

Health Enhancement Program (HEP)

OTHER

Arm type: Active control group HEP controls for several non-specific factors found in a meditation group such as Sahaj Samadhi, including: group support and morale, behavioral activation, reduction of stigma, facilitator attention, treatment duration, and time spent on at-home practice. HEP has been tailored to be structurally equivalent to a SSM intervention, with similar-sized groups, meeting for 4 days for 2 hours, and then a one-hour follow up session weekly for the subsequent 11 weeks, and completing the same amount of home practice (20 minutes twice daily, every day), and will be asked to complete weekly practice logs.

Behavioral: Health Enhancement Program (HEP)

Interventions

Sahaj Samadhi Meditation (SSM) BEHAVIORAL

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

Sahaj Samadhi Meditation (SSM)

Health Enhancement Program (HEP) BEHAVIORAL

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.

Health Enhancement Program (HEP)

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Currently practicing any form of body-mind intervention on a regular basis.

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (1)

• Peckham SB, Ionson E, Nassim M, Ojha K, Palaniyappan L, Gati J, Theberge J, Lazosky A, Speechley M, Baruss I, Rej S, Vasudev A. Sahaj Samadhi meditation vs a Health Enhancement Program in improving late-life depression severity and executive function: study protocol for a two-site, randomized controlled trial. Trials. 2019 Oct 24;20(1):605. doi: 10.1186/s13063-019-3682-z.

  PMID: 31651355 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant enrolment will be masked from care provider, investigator, and the outcomes assessors through the use of third party randomization. This ensures that only participants, and those necessary in coordinating their participation in the study, are aware of whether or not they are part of the experimental or control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be a blinded (rater, investigator, and clinician), 12-week randomized controlled trial (RCT) conducted at Western University, London, ON, Canada, and McGill University, Montreal, QC, Canada.

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: June 20, 2018
• Study Start: August 20, 2018
• Primary Completion: April 9, 2022
• Study Completion: April 9, 2022
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)