Clinical trial NCT05366088: RCT of MBCT vs HEP for Late-Life Depression
Official title: Mindfulness-Based Cognitive Therapy (MBCT) vs. Health Enhancement Program (HEP) Active Control for Late-Life Depression: An RCT
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression in Old Age
Quality of Life
Keywords: Late-life depression
Quality of Life
Mindfulness-Based Cognitive Therapy
Behavioural Activation
Executive Functioning
Processing Speed
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study Design \& Recruitment: Phase III randomized controlled trial (RCT) with 100-110 patients. Participants \>60 years old, with symptoms of late-life depression (LLD; MADRS score\>=10), excluding dementia and other psychiatric comorbidities, will be recruited in Montreal and via social media, across Canada.

Interventions: Mindfulness-based Cognitive Therapy (MBCT) or Health Enhancement Program (HEP) for 8-weeks, in addition to treat as usual (TAU). MBCT and HEP will have the same group sizes, meeting frequency, and amount of home practice. HEP is a recognized active control where participants learn about diet and exercise, but not meditation.

Detailed description: Late life depression (LLD) affects 5 million American seniors yearly with $1.81 billion in direct health-care costs. Biomarkers of LLD have consistently been linked to elevated dementia risk. Mindfulness-based cognitive therapy (MBCT) holds promise for treating symptoms of depression, ameliorating cognitive deficits and preventing decline in older adults by targeting brain circuits implicated in memory and attention. While preliminary findings are promising, the effects of mindfulness delivered through virtual videoconferencing platforms have not been assessed in older adults with depression. This proposed research aims are:

Primary Objective: Using an 8-week RCT, assess whether MBCT improves scores of LLD and quality of life compared to an active control (Health Enhancement Program (HEP)). Hypothesis 1(A): The MBCT group will have a lower score in the Montgomery Asberg Depression Scale (MADRS) at 8-weeks, compared to HEP controls. Hypothesis 1(B): The MBCT group will have higher scores of quality of life (EQ-5D) scores at 8-weeks.

Secondary Objective: To investigate the effects of MBCT on cognitive function in LLD. Hypothesis 2: MBCT will lead to higher scores in executive functioning and processing speed at 8 weeks.

Exploratory Objective: To investigate effects of MBCT on scores of anxiety (GAD-7) and mindfulness presence (Five-Factor Mindfulness Questionnaire (FFMQ) Hypothesis 3(A): The MBCT group will have reduced scores in the Generalized Anxiety Disorder 7 (GAD-7) at 8-weeks, compared to HEP controls. Hypothesis 3(B): The MBCT group will have a higher score in mindfulness presence (FFMQ), compared to HEP controls.

One-hundred (n =100) patients with LLD will be recruited at various centres in Montreal and throughout Canada via social media. Participants will undergo stratified randomization to either MBCT or Health Enhancement Program (HEP) intervention groups. The investigators will assess changes in (1) depression symptoms and quality of life, (2) processing speed and executive functioning, (3) anxiety and mindfulness presence, at baseline (0 weeks), post intervention (8 weeks), after baseline. Raters and clinicians will be blinded to group allocation while participants will be blinded to the study hypotheses.

The proposed study will assess the clinical potential of MBCT to improve symptoms of depression, as well as examine its impact on quality of life and cognition. If virtual delivery of MBCT is found to be effective in treating LLD and improving quality of life, the potential exists to implement this intervention at the study sites, across Canada, and internationally.

Eligibility criteria: Inclusion Criteria:

1. MADRS score ≥ 10 (experiencing symptoms of moderate/severe depression) at baseline
2. Ability to provide informed consent (shown as to be able to explain back to the research assistant the purpose of the study as well as voluntary participation, rights, time commitments, etc.)
3. participants who have access to internet and basic digital skills to use their computer/tablet
4. willing and able to attend ≥75% of MBCT or HEP sessions
5. adequate understanding of English or French
6. ability to sit for 90 minutes without discomfort
7. willing to inform if any change is made to their psychotropic medications and dosage for the first 8 weeks of the study

Exclusion Criteria:

1. cognitive deficits at baseline, as defined by MoCA score \<19
2. diagnosis of post-traumatic stress disorder, bipolar I or II disorder, primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder), and/or severe personality disorder interfering with ability to function in a group setting intervention on a regular basis
3. substance abuse within the past 6 months
4. high suicide risk (e.g., active suicidal ideation and/or recent intent or plan)
5. significant visual or hearing impairment
6. significant impairments in fine motor skills
7. any medical illnesses that could prevent the participant from engaging in the intervention
8. history of psychiatric hospitalization in the last 3 months

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale (MADRS) score
timeFrame: 8 weeks
Secondary outcomes:
measure: Quality of Life 5 dimensions
timeFrame: 8 weeks
Other outcomes:
measure: executive functioning and processing speed
timeFrame: 8 weeks
measure: anxiety, Mindfulness Presence and global cognition
timeFrame: 8 weeks
Locations:
city: Montreal
country: Canada
facility: Lady Davis Institute
state: Quebec
Study officials:
References:
citation: Bein M, Lesage M, Dikaios E, Chakravarty M, Segal Z, Royal I, Speechley M, Schiavetto A, Blumberger D, Sacchet MD, Therriault J, Gruber J, Tourjman V, Richard-Devantoy S, Nair V, Bruneau MA, Rej S, Lifshitz M, Sekhon H. Mindfulness-based cognitive therapy vs. a health enhancement program for the treatment of late-life depression: Study protocol for a multi-site randomized controlled trial. Front Aging Neurosci. 2022 Sep 1;14:976636. doi: 10.3389/fnagi.2022.976636. eCollection 2022.