Late Life DepressionNCT01908673
Automatic Self Transcending Meditation (ASTM) Versus Heart Rate Variability (HRV) Biofeedback in Patients With Late Life Depression (LLD): a Longitudinal Pilot Feasibility Study
A study testing HRV biofeedback and ASTM in people with Late Life Depression, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 66 to 80 years
- Conditions the study is for
- Late Life Depression
- What is being tested?
- HRV biofeedback and ASTM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 66 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Of either gender, age 66-80 years.
- 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).
- HAMD-24 score of >20.
- Low risk of suicide as elicited by clinical interview.
- Being able to sit for 30-45 minutes, without physical pain
- Of general good physical health with no severe cardiovascular disease in the past 12 months (myocardial infarction, stroke or TIA).
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- No past history of neurological disease or seizures.
- Sufficient hearing to comprehend verbal instructions without the need to lip read.
- Able to attend regular outpatient follow-up appointments.
Who cannot join
- Incapable of giving informed consent to study participation.
- Participating in other similar studies.
- Other significant Axis I diagnosis (including PTSD, OCD, Panic Disorder, Bipolar Affective Disorder, Substance dependence, Dementia)
- Psychotic episodes within the past 12 months.
- Recent (within the past 6 months) head trauma that required emergency care
- 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.
- Currently practicing any type of formal meditation, mindfulness or breathing techniques.
- Mini Mental Score Exam (MMSE) ≤18
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Late Life Depression
- Being tested
- HRV biofeedback, ASTM
- Keywords
- heart rate variability biofeedback, automatic self transcedental meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRV biofeedbackBehavioural
ASTMBehavioural
Also called Automatic Self Transcedental Meditation
| Study group | Role | What they receive |
|---|---|---|
| HRV biofeedback | Active comparator | heart rate variability biofeedback Receives: Behavioral: HRV biofeedback |
| ASTM | Active comparator | Automatic Self Transcedental Meditation Receives: Behavioral: ASTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate Variability (HRV)
HRV will be assessed at baseline and at end of study period (week 12)
Measured: Week 0 and week 12
Secondary outcomes (1)
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)
Measured: week 0 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Life DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akshya Vasudev, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Akshya Vasudev, MBBS MD MRCPSych, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908673
- Sponsor's protocol ID
- HSREB 103966
- Status last verified
- Feb 2014
- First submitted
- 18 Jul 2013
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01908673
- Acronym / sponsor ID
- HSREB 103966
- Conditions
- Late Life Depression
- Keywords
- heart rate variability biofeedback, automatic self transcedental meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRV biofeedback | Active comparator | Behavioral: HRV biofeedbackheart rate variability biofeedback |
| ASTM | Active comparator | Behavioral: ASTMAutomatic Self Transcedental Meditation |
Who may qualify
- Ages
- 66 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Of either gender, age 66-80 years.
- 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).
- HAMD-24 score of >20.
- Low risk of suicide as elicited by clinical interview.
- Being able to sit for 30-45 minutes, without physical pain
Key exclusion criteria (8 listed)
- Incapable of giving informed consent to study participation.
- Participating in other similar studies.
- Other significant Axis I diagnosis (including PTSD, OCD, Panic Disorder, Bipolar Affective Disorder, Substance dependence, Dementia)
- Psychotic episodes within the past 12 months.
- Recent (within the past 6 months) head trauma that required emergency care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRV biofeedback | Behavioural | HRV biofeedback |
| ASTMAlso: Automatic Self Transcedental Meditation | Behavioural | ASTM |
Primary outcome
Change in Heart Rate Variability (HRV)
Time frame: Week 0 and week 12
HRV will be assessed at baseline and at end of study period (week 12)
1 secondary outcome
Change in depression severity
Time frame: week 0 and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
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Late Life Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akshya Vasudev, MBBS MD MRCPSych principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HRV biofeedback and ASTM in people with Late Life Depression, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart Rate Variability (HRV) (time frame: Week 0 and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2014; AzTrials last refreshed its copy on 31 Oct 2026.