search
Back to results

Mindfulness Based Cognitive Therapy for Depression and Cognitive Inhibition in Suicide

Primary Purpose

Depression, Anxiety

Status
Completed
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness Based Cognitive Therapy
Sponsored by
Lady Davis Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Anxiety

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Douglas Mental Health University Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Mindfulness Group

Arm Description

Patients randomized to the control group will be offered literature on mental health promotion and Treatment as usual

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.

Outcomes

Primary Outcome Measures

Fulfillment of initial recruitment goals (first 20 patients)

Secondary Outcome Measures

Decreases in HAM-D Scale
Improvement in the Stroop task performances

Full Information

First Posted
September 20, 2016
Last Updated
September 8, 2020
Sponsor
Lady Davis Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT02954250
Brief Title
Mindfulness Based Cognitive Therapy for Depression and Cognitive Inhibition in Suicide
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 Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lady Davis Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients randomized to the control group will be offered literature on mental health promotion and Treatment as usual
Arm Title
Mindfulness Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Cognitive Therapy
Intervention Description
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 Measure Information:
Title
Fulfillment of initial recruitment goals (first 20 patients)
Time Frame
within 12 months
Secondary Outcome Measure Information:
Title
Decreases in HAM-D Scale
Time Frame
over 8-weeks period
Title
Improvement in the Stroop task performances
Time Frame
over 8-weeks period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Douglas Mental Health University Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4H1R3
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Mindfulness Based Cognitive Therapy for Depression and Cognitive Inhibition in Suicide

We'll reach out to this number within 24 hrs