Mindfulness-Based Cognitive Therapy for Depression and Anxiety

Symptoms of Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777905
• Other study ID #: 2016-008
• Status: Completed
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: January 2017

Study information

• Verified date: September 2020
• Source: Lady Davis Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Symptoms of Anxiety
• Symptoms of Depression

Intervention

Behavioral:
• Mindfulness Based Cognitive Therapy

Locations

Country	Name	City	State
Canada	CLSC Benny Farm	Montreal	Quebec
Canada	CLSC Benny Farm	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Lady Davis Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Decreases in stress markers between baseline (week 0) and 8-week follow-up	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.	week 0 to 8 weeks
Other	Decreases in inflammatory markers between baseline (week 0) and 8-week follow-up	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.	week 0 to 8 weeks
Primary	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.	week 0 to 8 weeks
Secondary	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.	week 0 to 8 weeks