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NCT Number: NCT02777905

Mindfulness-Based Cognitive Therapy for Depression and Anxiety

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CLSC Benny Farm, Montreal, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Based Cognitive Therapy

Behavioral

Primary outcomes

  1. Significant decrease in the PHQ-9 (depression) score between baseline and 8-week follow-up

    Time frame: week 0 to 8 weeks

    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 outcomes

  1. Decrease in the GAD-7 score (anxiety) between baseline and 8-week follow-up

    Time frame: week 0 to 8 weeks

    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.

Other outcomes

  1. Decreases in stress markers between baseline (week 0) and 8-week follow-up

    Time frame: week 0 to 8 weeks

    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.

  2. Decreases in inflammatory markers between baseline (week 0) and 8-week follow-up

    Time frame: week 0 to 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Lady Davis Institute

Other

Registry information

Official study title

Group Mindfulness-Based Cognitive Therapy for the Treatment of Late-Life Depression and Anxiety Symptoms in Primary Care: A Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 19, 2016
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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