Mindfulness-Based Cognitive Therapy for Depression and Anxiety

NCT ID: NCT02777905

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-01-31

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.

Conditions

Symptoms of Depression; Symptoms of Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MBCT intervention

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.

Group Type: EXPERIMENTAL

Mindfulness Based Cognitive Therapy

Intervention Type: BEHAVIORAL

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness Based Cognitive Therapy

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lady Davis Institute

OTHER

Sponsor Role: lead

Responsible Party

Dr. Karl Looper

Psychiatrist-in-Chief, Department of Psychiatry, Jewish General Hospital Co-Director, Mental Health Program, CIUSSS West-Central Montreal Health Associate Professor, Department of Psychiatry, McGill University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CLSC Benny Farm

Montreal, Quebec, Canada

CLSC Benny Farm

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2016-008

Identifier Type: -

Identifier Source: org_study_id