Automatic Self Transcending Meditation (ASTM) Versus Heart Rate Variability (HRV) Biofeedback in Patients With Late Life Depression (LLD): a Longitudinal Pilot Feasibility Study

Late Life Depression Clinical Trial

Official title:

Automatic Self Transcending Meditation (ASTM) Versus Heart Rate Variability (HRV) Biofeedback in Patients With Late Life Depression (LLD): a Randomized Controlled Longitudinal Pilot Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908673
• Other study ID #: HSREB 103966
• Status: Completed
• Phase: N/A
• First received: July 18, 2013
• Last updated: February 25, 2014
• Start date: August 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Public Health Agency of Canada
• Study type: Interventional

Clinical Trial Summary

Background: Depression in the elderly, also known as late life depression (LLD) is common and its prevalence ranges from 2 to 6% in the community. Heart Rate Variability (HRV), a physiological autonomic variable is reduced in LLD and this might have implications for cardiovascular events including death. Methods to improve HRV in LLD have not been adequately assessed. Automatic Self-Transcending Meditation (ASTM) is a simple yet powerful technique that allows the mind to become calm and peaceful. HRV biofeedback is a method of teaching individuals to voluntarily improve HRV and other physiological functions to a prescribed range.This pilot study attempts to investigate feasibility of these interventions and provide preliminary data regarding the effectiveness of these techniques.

Hypothesis: ASTM and HRV biofeedback are feasible and their effectiveness for improving HRV in patients with LLD can be assessed.

Methods: Participants with LLD between the ages of 66 and 80 will be randomized to either ASTM or HRV biofeedback after optimizing them on antidepressant therapy. Participants will receive training and continue practice in either of these techniques over a period of twelve weeks. HRV and secondary measures will be assessed pre and post at the end of study period.

Expected Results and Significance: The investigators expect to find both techniques to be feasible treatments for those with LLD. Results from this pilot study will help to assess the potential for successful implementation of a future larger study which will evaluate the efficacy of these treatments for improving HRV.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 66 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Of either gender, age 66-80 years.

2. Have an Axis 1 diagnosis of major depressive disorder (DSM IV code 296.2x or 296.3x) (comorbid anxiety and dysthymic disorder will be acceptable).

3. HAMD-24 score of >20.

4. Low risk of suicide as elicited by clinical interview.

5. Being able to sit for 30-45 minutes, without physical pain

6. Of general good physical health with no severe cardiovascular disease in the past 12 months (myocardial infarction, stroke or TIA).

7. No past history of neurological disease or seizures.

8. Sufficient hearing to comprehend verbal instructions without the need to lip read.

9. Able to attend regular outpatient follow-up appointments.

Exclusion Criteria:

1. Incapable of giving informed consent to study participation.

2. Participating in other similar studies.

3. Other significant Axis I diagnosis (including PTSD, OCD, Panic Disorder, Bipolar Affective Disorder, Substance dependence, Dementia)

4. Psychotic episodes within the past 12 months.

5. Recent (within the past 6 months) head trauma that required emergency care

6. Currently on an antidepressant from the classes of Tricyclic antidepressants, Monoamine oxidase (MAO) inhibitors, or Serotonin Noradrenaline Reuptake inhibitors (SNRI) such as venlafaxine, desvenlafaxine or duloxetine.

7. Currently practicing any type of formal meditation, mindfulness or breathing techniques.

8. Mini Mental Score Exam (MMSE) =18

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Late Life Depression

Intervention

Behavioral:
• HRV biofeedback

• ASTM

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Heart Rate Variability (HRV)	HRV will be assessed at baseline and at end of study period (week 12)	Week 0 and week 12	No
Secondary	Change in depression severity	Depression symptoms will be assessed on the Hamilton depression rating scale (HAM-D, 24 items), Clinical Global Impression (CGI), and self-rated Geriatric Depression Scale (GDS)	week 0 and week 12	No