Recruiting

Observational Study

Sponsor:

Baycrest

Code:

NCT02083237

Conditions

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Behavioural Intervention Program

Study Details

Brief summary:

Mild cognitive impairment (MCI) is a significant risk factor for dementia. Persons with MCI experience cognitive changes, most typically affecting memory; that are greater than those experienced in "normal" aging. However, these cognitive changes in MCI, unlike in dementia, are not significant enough to markedly interfere with functional independence. In addition to cognitive change, some people with MCI also experience elevated symptoms of depression and anxiety, which adds to their risk of developing dementia. Close family are also impacted by their relative's MCI and show mild physical (e.g., increased incidence of systemic health problems such as high blood pressure) and mental health declines (e.g., elevated symptoms associated with depression and anxiety) that are similar, though not as severe, to those experienced by caregivers of a relative with dementia. Programs aimed at behavioural intervention have real potential to reduce and/or prevent negative health outcomes associated with MCI and future dementia by promoting positive behaviour changes. We wish to scientifically establish the utility of a behavioural intervention aimed at addressing the needs of both the person with MCI and their close family member, with the ultimate goal of lowering current and future susceptibility to mental health declines and chronic disease in people living with MCI. We have an 8 session (16 hour) program, where participants with MCI and their close relative are together for the first half of each session, which is devoted primarily to enabling positive lifestyle choice. In the second hour the group splits up, with MCI clients engaging in memory training while their close family member participates in a psychosocial intervention.

Conditions

Mild Cognitive Impairment

Study ID

NCT02083237

Start date

Jan, 2013

Status verified date

Mar, 2014

Completion date

Apr, 2015

Anticipated

Primary completion date

Dec, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • diagnosis of mild cognitive impairment
  • a supportive family or friend of the person with mild cognitive impairment

Exclusion Criteria:

  • psychiatric illness
  • dementia
  • substance abuse

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Behavioural Intervention Program

People with MCI and their close family member (80% spouses) participate jointly in the first hour, which provides education about MCI, lifestyle influences on cognitive health, and community resources. During the second hour, family members participate in a separate psychosocial group intervention, while the individuals with MCI participate in memory training. The first 6 of the 8 sessions occur weekly, the 7th occurs as a 1-month follow-up session and the 8th as a 3-month follow-up session. These follow-up sessions provide support to sustain positive outcomes and provide further assistance with resolving continued challenges.

no intervention: Waitlist Control

Due to the heavy demand for this clinical program, there is a naturally-occurring waitlist of approximately 3 months. Control participants are assessed during this period.

Interventions

Behavioural Intervention Program

People with MCI and their close family member (80% spouses) participate jointly in the first hour, which provides education about MCI, lifestyle influences on cognitive health, and community resources. During the second hour, family members participate in a separate psychosocial group intervention, while the individuals with MCI participate in memory training. The first 6 of the 8 sessions occur weekly, the 7th occurs as a 1-month follow-up session and the 8th as a 3-month follow-up session. These follow-up sessions provide support to sustain positive outcomes and provide further assistance with resolving continued challenges.

Primary outcome measure

  • Change from baseline in memory strategy knowledge and application [ Time Frame: Baseline pre-test; repeat testing at 10 weeks (post-test measure for control group and repeat-pre-test for treatment group); repeat testing at 20 weeks (post-test measures of treatment group at 1 month follow-up and repeat post-test for control group). ]
  • Change from baseline in functional memory skills [ Time Frame: Baseline pre-test; repeat testing at 10 weeks (post-test measure for control group and repeat-pre-test for treatment group); repeat testing at 20 weeks (post-test measures of treatment group at 1 month follow-up and repeat post-test for control group). ]

Central Contacts and Locations

Central contacts

Kelly J. Murphy, PhD, CPsych

(416) 785-2500kmurphy@baycrest.org

Locations

Baycrest

Recruiting

Toronto, Ontario, Canada, M6A 2E1

Contacts

Kelly J Murphy, PhD, CPsych

(416) 785-2500kmurphy@baycrest.org

Principal Investigator:

Kelly J. Murphy, PhD, CPsych

More Information

Sponsor

Baycrest

Last update posted

Mar 11, 2014

Last verified

Mar, 2014

Keywords

  • mild cognitive impairment
  • memory training
  • healthy lifestyle
  • psychosocial support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baycrest on 2014-03-11.