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Trial record 5 of 5 for:    karl looper

Mindfulness Based Cognitive Therapy for Depression and Cognitive Inhibition in Suicide

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ClinicalTrials.gov Identifier: NCT02954250
Recruitment Status : Unknown
Verified November 2016 by Dr. Karl Looper, Lady Davis Institute.
Recruitment status was:  Recruiting
First Posted : November 3, 2016
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Karl Looper, Lady Davis Institute

Brief Summary:

Background: According to the World Health Organization, one million people die by suicide each year worldwide and the rate of attempted suicide is ten times greater. A less known fact is that suicide is 3 times more frequent in elderly adults compared to younger counterpart. Unfortunately, predicting and preventing suicidal behaviours (SB) in general, and in elderly in particular, remain difficult. Clinical, biological and genetic data suggests that SB may be best understood according to a stress-vulnerability model where, more vulnerable individuals are at increased risk of committing a suicidal act when experiencing (mostly social) stress. Vulnerability to SB has also been associated with specific (i.e. distinct from comorbid psychiatric disorders like depression) neurocognitive alterations. However, the neurocognitive basis of suicidal behavior in elderly has been more rarely investigated.

Aim: Mindfulness based cognitive therapy (MBCT) has been successfully used to treat many psychiatric symptoms in many different populations, given that this therapy reduces cognitive creativity. Thus, this pilot study aims at addressing the SB in older adults with a Modified Mindfulness Based Cognitive Therapy (MMBCT).

Hypotheses: We hypothesise that MMBCT is not only a feasible intervention in older people with SB, but also, effective to treat depressive symptoms and suicidal ideation. Additionally, we will explore the changes in cognitive testing.

Methods: This is a pilot randomized controlled trial of a MMBCT tailored to older adults with depression and suicidal behaviors at the Douglas Mental Health University Institute. Patients with depression Hamilton Depression Rating Scale (HAM-D) >10 and suicidal ideation (Scale for Suicide Ideation [SSI] score ≥1) will be randomized to MMBCT or usual care. The meditation intervention will involve doing seated 90minute/week meditation exercises for 8 weeks. The primary outcomes will examine feasibility and acceptability of the treatment. The secondary outcome measures will scores in HAM-D and we will control for any important covariates differing between groups, (e.g. age, sex, # medical illnesses).

Perspectives: Implementation of these interventions could potentially prevent many consultations to psychiatry/mental health professionals. Increase quality of life, decrease medical comorbidity, illness and mortality. [2] Taken together, in our rapidly aging population, this could translate to substantial savings in health costs.


Condition or disease Intervention/treatment Phase
Depression, Anxiety Behavioral: Mindfulness Based Cognitive Therapy Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modified Mindfulness Based Cognitive Therapy for the Treatment of Depressive Symptoms and Cognitive Inhibition in Patients at Risk for Suicide: A Pilot Randomized Controlled Trial
Study Start Date : September 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Suicide

Arm Intervention/treatment
No Intervention: Control
Patients randomized to the control group will be offered literature on mental health promotion and Treatment as usual
Experimental: Mindfulness Group
The intervention will consist of group, lasting 90 minutes in one session per week for 8 weeks. The exercises will be 5 minutes long alternating between 4 or 5 each session.
Behavioral: Mindfulness Based Cognitive Therapy
The 8-week MMBCT protocol combines the practice of specific meditation techniques with cognitive therapy principles applicable to anxiety and depression. Each session will cover a meditation practice, as well as a relevant topic for discussion. The initial sessions will introduce general concepts of mindfulness (non-judgemental awareness, being in the moment, fostering curiosity, etc.), which will be expanded to more elaborate notions that are particularly relevant to anxiety, depression and suicidal ideations (recognizing thoughts are not facts, cultivating loving kindness for oneself, improving communication with others, etc.) Participants will be encouraged to practice the mindfulness techniques between sessions, a process that will be reviewed during groups in an ongoing fashion.




Primary Outcome Measures :
  1. Fulfillment of initial recruitment goals (first 20 patients) [ Time Frame: within 12 months ]

Secondary Outcome Measures :
  1. Decreases in HAM-D Scale [ Time Frame: over 8-weeks period ]
  2. Improvement in the Stroop task performances [ Time Frame: over 8-weeks period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current major depressive episode, major depressive disorder (DSM-V) as per the HAM-D-21 ≥ 10;
  • With no recent psychotropic modifications;
  • History of suicidal ideation and/or personal history of suicide attempt;
  • Normal cognition or Mild Cognitive Impairment ("Normal" Result on the 3-minute Mini-Cog Test).

Exclusion Criteria:

  • Mild, Moderate, or Severe Dementia ("Abnormal" Result on the 3-minute Mini-Cog Test)[48]
  • Acute psychotic symptoms
  • Acute Suicidal intent (within 48-72 hours)
  • Hearing impairment not improved with hearing aids and/or sound amplification
  • Unable to engage in a group meditation for physical or practical reasons
  • Ongoing Active Psychotherapy (e.g. a course of CBT psychotherapy)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954250


Contacts
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Contact: Stephane Richard-Devantoy, MD richarddevantoy@orange.fr
Contact: S. Gabriela Torres-Platas, Ph.D. 514-340-8222 ext 5205 gabriela.torresplatas@mail.mcgill.ca

Locations
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Canada, Quebec
Douglas Mental Health University Institute Recruiting
Montreal, Quebec, Canada, H4H1R3
Contact: Stephane Richard Devantoy, M.D.       richarddevantoy@orange.fr   
Sponsors and Collaborators
Lady Davis Institute

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Responsible Party: Dr. Karl Looper, Psychiatrist-in-Chief, Jewish General Hospital; Associate Professor, Dept. of Psychiatry, McGill University; Co-Lead, Geri-PARTy Research Group, Lady Davis Institute
ClinicalTrials.gov Identifier: NCT02954250     History of Changes
Other Study ID Numbers: IUSMD-16-17
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Suicide
Behavioral Symptoms
Mood Disorders
Mental Disorders
Self-Injurious Behavior