search
Back to results

Mindfulness-Based Cognitive Therapy for Depression and Anxiety

Primary Purpose

Symptoms of Depression, Symptoms of Anxiety

Status
Completed
Phase
Phase 4
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 Symptoms of Depression focused on measuring late life, mindfulness meditation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients at least 60 years of age and above (clinical experience shows, that almost all patients with depressive and anxiety symptoms aged 60+ are able to participate in group MBCT)
  • Patients with depression and/or anxiety symptoms as indicated by scores of ≥10 on the Patient Health Questionnaire (PHQ-9) and/or General Anxiety Disorder-7 (GAD- 7)
  • Normal cognition or Mild Cognitive Impairment ("Normal" Result on the 3-minute Mini-Cog Test) [28]

Exclusion Criteria:

  • Mild, Moderate, or Severe Dementia ("Abnormal" Result on the 3-minute Mini-Cog Test)
  • Acute psychotic symptoms
  • Severe personality problems that will interfere with their ability to function in a group setting
  • Acute Suicidal ideation/intent
  • Change in psychotropic medication during the 8 weeks of the intervention
  • Hearing impairment not improved with hearing aids and/or sound amplification
  • Unable to engage with MBCT for physical or practical reasons
  • Ongoing Active Psychotherapy

Sites / Locations

  • CLSC Benny Farm
  • CLSC Benny Farm

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MBCT intervention

Control Group

Arm Description

Mindfulness Based Cognitive therapy (MBCT) will consist of group meditative practices, lasting 2 hours per week (or whatever the patient can tolerate). The interventions will be conducted at the "centre local de services communautaires" (CLSC) Benny Farm, once a week. Patients will be invited to try various techniques during sessions. The patients will be encouraged to practice the Mindfulness techniques, that includes formal mindfulness meditation and informal mindfulness practices (e.g. being in the present moment while not meditating), at home, between sessions, and will be provided with meditation compact discs to help them do so. MBCT interventions also include a cognitive therapy perspective. Specifically, the interventionists will offer education regarding depression and anxiety and will work on automatic mental processes that are believed to be at the root of the recurrence of depressive and anxious symptoms.

Patients randomized to the control group will be offered literature on mental health promotion and will receive treatment as usual in the primary care health center setting. After the end of the study, the control group will be offered MBCT.

Outcomes

Primary Outcome Measures

Significant decrease in the PHQ-9 (depression) score between baseline and 8-week follow-up
Symptoms of depression will be assessed with the PHQ-9 at baseline and at at 8 weeks follow-up. Significant changes in these scores will be assessed after treatment.

Secondary Outcome Measures

Decrease in the GAD-7 score (anxiety) between baseline and 8-week follow-up
Symptoms of anxiety will be assessed with the GAD-7 questionnaire at baseline and at at 8 weeks follow-up. Significant changes in these scores will be assessed after treatment.

Full Information

First Posted
April 26, 2016
Last Updated
September 8, 2020
Sponsor
Lady Davis Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT02777905
Brief Title
Mindfulness-Based Cognitive Therapy for Depression and Anxiety
Official Title
Group Mindfulness-Based Cognitive Therapy for the Treatment of Late-Life Depression and Anxiety Symptoms in Primary Care: A 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
January 2017 (Actual)
Study Completion Date
January 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
About 10-20% of older patients in primary care suffer from symptoms of depression and/or anxiety. Depression and anxiety are associated with higher rates of cognitive decline, lower quality of life, increased medical comorbidity, and higher mortality rates in these patients. Given the world's aging population and consequent rapid increase in older patients in primary care, many traditional therapeutic approaches for depression or anxiety in this patient population - e.g. assessment by a mental health practitioner, individual psychotherapy and/or appropriate psychotropic medication - have been inadequate, with many patients having undetected depression and anxiety. Additionally, geriatric depression and anxiety are very common, but difficult to treat with psychotropic medications: patients are more sensitive to adverse effects and respond relatively less well to medication. To help with this issue, the investigators are conducting a randomized controlled trial of mindfulness-based cognitive therapy (MBCT), a treatment that has been highly effective in treating depression and anxiety, but has not yet been assessed in older adults. There has been relatively little information about MBCT's effectiveness, particularly in the primary care setting and in the acute treatment of depression and anxiety(vs. maintenance treatment). This study will be conducted in 75-100 older adults in primary care with symptoms of anxiety and depression. The study will take place in the "centre local de services communautaires" CLSC Benny Farm, a primary health care centre in Montreal, Canada. Most patients aged 60+ with symptoms of depression (Patient Health Questionnaire 9 (PHQ-9) score ≥10) or anxiety (General Anxiety Disorder-7 (GAD- 7) score ≥10) will be eligible. Patients who are eligible for the study will be randomized: half the patients will get 8-week MBCT with a trained interventionist (occupational therapist, psychiatry resident, or psychiatrist). The other half (control group) will get patient treatment as usual with patient primary care physician/primary care team during the study, but then after the study, patients will be offered the treatment if patients would like.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptoms of Depression, Symptoms of Anxiety
Keywords
late life, mindfulness meditation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBCT intervention
Arm Type
Experimental
Arm Description
Mindfulness Based Cognitive therapy (MBCT) will consist of group meditative practices, lasting 2 hours per week (or whatever the patient can tolerate). The interventions will be conducted at the "centre local de services communautaires" (CLSC) Benny Farm, once a week. Patients will be invited to try various techniques during sessions. The patients will be encouraged to practice the Mindfulness techniques, that includes formal mindfulness meditation and informal mindfulness practices (e.g. being in the present moment while not meditating), at home, between sessions, and will be provided with meditation compact discs to help them do so. MBCT interventions also include a cognitive therapy perspective. Specifically, the interventionists will offer education regarding depression and anxiety and will work on automatic mental processes that are believed to be at the root of the recurrence of depressive and anxious symptoms.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients randomized to the control group will be offered literature on mental health promotion and will receive treatment as usual in the primary care health center setting. After the end of the study, the control group will be offered MBCT.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Cognitive Therapy
Primary Outcome Measure Information:
Title
Significant decrease in the PHQ-9 (depression) score between baseline and 8-week follow-up
Description
Symptoms of depression will be assessed with the PHQ-9 at baseline and at at 8 weeks follow-up. Significant changes in these scores will be assessed after treatment.
Time Frame
week 0 to 8 weeks
Secondary Outcome Measure Information:
Title
Decrease in the GAD-7 score (anxiety) between baseline and 8-week follow-up
Description
Symptoms of anxiety will be assessed with the GAD-7 questionnaire at baseline and at at 8 weeks follow-up. Significant changes in these scores will be assessed after treatment.
Time Frame
week 0 to 8 weeks
Other Pre-specified Outcome Measures:
Title
Decreases in stress markers between baseline (week 0) and 8-week follow-up
Description
Blood draws will be performed to assess the levels of hypothalamus-pituitary-adrenal (HPA) axis activation and stress such as cortisol, dehydroepiandrosterone, adrenaline, noradrenaline and aldosterone. The concentrations will be given in pg/ml.
Time Frame
week 0 to 8 weeks
Title
Decreases in inflammatory markers between baseline (week 0) and 8-week follow-up
Description
Blood draws will be performed to assess the levels of inflammatory markers such as C-reactive protein, cytokines, epidermal growth factor 1 (EGF-1) and indicators of the hypothalamus-pituitary-adrenal (HPA) axis activation and stress such as cortisol, dehydroepiandrosterone, adrenaline, noradrenaline and aldosterone. These measures will be taken at baseline and at 8-week follow-up. The concentrations will be given in pg/ml.
Time Frame
week 0 to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients at least 60 years of age and above (clinical experience shows, that almost all patients with depressive and anxiety symptoms aged 60+ are able to participate in group MBCT) Patients with depression and/or anxiety symptoms as indicated by scores of ≥10 on the Patient Health Questionnaire (PHQ-9) and/or General Anxiety Disorder-7 (GAD- 7) Normal cognition or Mild Cognitive Impairment ("Normal" Result on the 3-minute Mini-Cog Test) [28] Exclusion Criteria: Mild, Moderate, or Severe Dementia ("Abnormal" Result on the 3-minute Mini-Cog Test) Acute psychotic symptoms Severe personality problems that will interfere with their ability to function in a group setting Acute Suicidal ideation/intent Change in psychotropic medication during the 8 weeks of the intervention Hearing impairment not improved with hearing aids and/or sound amplification Unable to engage with MBCT for physical or practical reasons Ongoing Active Psychotherapy
Facility Information:
Facility Name
CLSC Benny Farm
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4B 1H3
Country
Canada
Facility Name
CLSC Benny Farm
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4B1H3
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Mindfulness-Based Cognitive Therapy for Depression and Anxiety

We'll reach out to this number within 24 hrs