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Clinical trial on effectiveness of mindfulness meditation on improving cognitive functions in people over 60 years of age -

SLCTR Registration Number

SLCTR/2017/020


Date of Registration

06 Jul 2017

The date of last modification

Jul 06, 2017



Application Summary


Scientific Title of Trial

Clinical trial on effectiveness of mindfulness meditation on improving cognitive functions in people over 60 years of age


Public Title of Trial

The Effects of Mindfulness Meditation on Cognitive Functions among People over 60 years of age


Disease of Health Condition(s) Studied

Mild cognitive impairment in the elderly


Scientific Acronym

None


Public Acronym

None


Brief title

Effects of Mindfulness on Cognitive functions


Universal Trail Number

U1111-1197-8890


Any other number(s) assigned to the trial and issuing authority

P/127/05/2017 (ERC: Kelaniya)


Trial Details


What is the research question being addressed?

What is the effect of mindfulness meditation on cognitive functions in people over 60 years?


Type of study

Interventional


Study design

Allocation

Single arm study


Masking

Masking not used


Control

Uncontrolled


Assignment

Single


Purpose

Supportive care


Intervention(s) planned

The study will be carried out at the Professorial Medicine Unit, North Colombo Teaching Hospital (NCTH) Ragama.

Random cluster sampling method will be used to select study participants. All consecutive consenting participants meeting inclusion/exclusion criteria will be recruited until target sample size is achieved.

Mindfulness meditation will be modeled on basic Buddhist Anapanasathi (meditation on breathing) methods. Meditation training will be conducted by a facilitator with experience in teaching meditation. The intervention will be provided in small groups (3-5 participants). Trainer guided meditation programme will be provided only on the first day and the programme will take about 30 minutes.

As a manipulation check, each subject will be asked after meditation session, ‘‘Did you feel that you were truly meditating?”

Participants will be provided with an audio aid (CD) to practice the meditation programme by their own at home. They will be advised to follow the meditation programme which will run for 20 minutes (at a specified time) every day for 6 weeks.


Inclusion criteria

  1. Patients attending professorial medicine clinics at NCTH for long term medical problems
  2. Male and female patients aged over 60 years
  3. Ability to use the audio aid provided for the meditation programme.
  4. Ability to understand the Sinhala language.

Exclusion criteria

  1. Parkinson’s disease
  2. Stroke
  3. Psychiatric illnesses
  4. Moderate to severe dementia.
  5. Hearing impairment.


Primary outcome(s)

Improvement of 1. Mini Mental Score Examination (MMSE) 2. Montreal Cognitive Assessment (MoCA)


Primary outcome(s) - Time of assessment(s)

At baseline, 6 weeks after the commencement of the intervention and 2 months after the conclusion of the intervention


Secondary outcome

Improvement of Extended cognitive assessments:
• Paired associate learning • Clock drawing • Verbal fluency - letters and categories • Backward digit span • Proverbs • Cognitive estimates • Go-no-go tasks • Luria 3-step test


Secondary outcome(s) - Time of assessment(s)

Improvement of Extended cognitive assessments:
• Paired associate learning • Clock drawing • Verbal fluency - letters and categories • Backward digit span • Proverbs • Cognitive estimates • Go-no-go tasks • Luria 3-step test



Target number/sample size

60


Countries of recruitment

Sri Lanka


Anticipated start date

2017-07-15


Anticipated end date

2017-10-16


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee, Faculty of Medicine, University of Kelaniya on 9.5.2017 (Ref: – P/127/05/2017)


Funding source

None (Investigator funded)



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Asiri Rodrigo
Lecturer and Consultant Psychiatrist
Department of Psychiatry, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka
Tel: 0112961000
Mob: 0777865791

asirir2000@yahoo.com

Contact Person for Public Queries

Dr. Asiri Rodrigo
Lecturer and Consultant Psychiatrist
Department of Psychiatry, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka
Tel: 0112961000
Mob: 0777865791

asirir2000@yahoo.com


Primary study sponsor/organization

Department of Psychiatry, Faculty of Medicine, University of Kelaniya

Ragama, Sri Lanka
Tel: +94-11-2958039
Fax: +94-11-2958337

http://medicine.kln.ac.lk/depts/phychiatry/

Secondary study sponsor (If any)

None