Clinical Trial: Evaluation of an Intervention for Living With Mild Cognitive Impairment

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Evaluation of a Behavioural Intervention for People Living With Mild Cognitive Impairment

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.

Detailed Summary:

The following outcomes from our multicomponent behavioural intervention are expected.

MCI participants will show:

1) Improved functional memory 2) Increased engagement in leisure activities 2) Improved instrumental activities of daily living 4) A reduction in neuropsychiatric symptoms (e.g., depressed mood, irritability)

Family members of MCI relatives will show:

  1. Improvement in ability to adapt to and effectively manage challenges posed from living with a relative experiencing cognitive decline
  2. Improvement in mood
  3. Improvement in one or more health related behaviours

These expected outcomes are based on previously presented pilot showing improved abilities dealing with problems faced from cognitive decline due to MCI, previous research by one of us demonstrating that self-perceptions of better problem solving skills are associated with positive intervention outcomes, previous research showing improvement in mood and well-being in dementia caregivers following psychosocial intervention, and our previous findings of improved memory knowledge and strategy use in people with MCI after experiencing a similar intervention.

In researching these expected outcomes we will additionally investigate the following hypotheses:

  1. The degree of cognitive, functional, and neuropsychiatric impairments exhibited by the MCI clients at baseline will influence the degree of benefit experienced by both the MCI clients
    Sponsor: Baycrest

    Current Primary Outcome:

    • 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). ]
      Improved memory strategy knowledge and application will be established with the following measures: A) The Strategy subscale of the Multifactorial Metamemory Questionnaire (Troyer and Rich, 2002) which measures self-reported use of 19 memory aids and strategies (e.g., writing on a calendar, repeating information). Respondents indicate, on a 5-point scale, the frequency with which they used each strategy over the past two weeks; and B) Memory Situations (Troyer, 2001) assesses memory strategy knowledge. Respondents generate memory strategies to solve typical everyday memory situations (e.g., learning a new name). Responses are scored based on how effective, specific, and self-reliant they are for a maximum score of 12 points.
    • 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). ]
      1] Memory Assessment Clinics Rating Scale (Crook & Larrabee, 1990) measures self and other perceptions of the MCI participant's memory ability and frequency of memory mistakes in everyday memory situations. The scale has reliable psychometric properties (Crook & Larrabee, 1992). 2] A modified version of the Canadian Occupational Performance Measure (COPM,

      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      • Change from baseline in family member coping 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). ]
        The Mastery Scale (Pearlin & Schooler, 1978) uses 7 items, rated on a 4-point scale, to assess the extent to which individuals feel personal control and mastery over important life outcomes. This reliable and valid scale is often used as a proxy measure of coping. The scale has solid psychometric properties (Majer et al., 2004; Marshall & Lang, 1990).
      • Change in mood status from baseline [ 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). ]
        1] Depression Anxiety Stress Scales (DASS-21, Lovibond & Lovibond, 1995) assesses self-reported symptoms of anxiety, depression, and general stress and has solid psychometric properties for younger and older adults (Antony et al., 1998). 2] The Neuropsychiatric Inventory (NPI- Cummings et al., 1994). Developed for measuring neuropsychiatric symptoms in dementia, this is one of the most commonly used measures for such symptoms in MCI (14). It consists of 10 questions examining the presence and severity of a broad range of psychopathology (e.g., anxiety, irritability, apathy, euphoria) and is based on family report. It has been demonstrated to have excellent validity and reliability.


      Original Secondary Outcome: Same as current

      Information By: Baycrest

      Dates:
      Date Received: January 31, 2013
      Date Started: January 2013
      Date Completion: April 2015
      Last Updated: March 7, 2014
      Last Verified: March 2014