Mindfulness-Based Cognitive Therapy for Depression and Anxiety

NCT02777905 | Completed Phase 4

• 1 other identifier: 2016-008
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Keywords

late life; mindfulness meditation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  week 0 to 8 weeks

Other Outcomes (2)

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

  week 0 to 8 weeks

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

  week 0 to 8 weeks

Study Arms (2)

MBCT intervention

EXPERIMENTAL

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.

Behavioral: Mindfulness Based Cognitive Therapy

Control Group

NO INTERVENTION

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.

Interventions

Mindfulness Based Cognitive Therapy BEHAVIORAL

MBCT intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) \[28\]

You may not qualify if:

• 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

Sponsors & Collaborators

• Lady Davis Institute: lead

Study Sites (2)

CLSC Benny Farm

Montreal, Quebec, H4B 1H3, Canada

Location

CLSC Benny Farm

Montreal, Quebec, H4B1H3, Canada

Location

MeSH Terms

Conditions

Depression

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: May 19, 2016
• Study Start: September 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

CA (2)