Evaluation of an Intervention for Living With Mild Cognitive Impairment

NCT02083237 | Unknown

• 1 other identifier: REB0650
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change from baseline in memory strategy knowledge and application

  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.

  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

  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, Law et al., 1994) will help MCI participants self-identify memory problems, and, using 10 point Likert scales, rate their current performance and satisfaction level at managing the problems. This permits evaluation of the adaptive memory strategies acquired during the program. The scale has established psychometric properties. This approach has been shown to facilitate positive behaviour change in populations experiencing cognitive impairment (e.g., Dawson et al., 2009; Holliday et al., 2007; Handley et al., 2006). Family members will rate their MCI relative on the identified memory problem using the same scale.

  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).

Secondary Outcomes (2)

• Change from baseline in family member coping skills.

  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 in mood status from baseline

  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).

Other Outcomes (2)

• Positive change in healthy lifestyle practices in persons affected by Mild Cognitive Impairment

  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 instrumental activities of daily living - change from baseline

  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).

Study Arms (2)

Behavioural Intervention Program

ACTIVE COMPARATOR

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.

Behavioral: Behavioural Intervention Program

Waitlist Control

NO INTERVENTION

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 BEHAVIORAL

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.

Behavioural Intervention Program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• psychiatric illness
• dementia
• substance abuse

Sponsors & Collaborators

• Baycrest: lead
• University of Manitoba: collaborator

Study Sites (1)

Baycrest

Toronto, Ontario, M6A 2E1, Canada

RECRUITING

Related Publications (9)

• Petersen RC, Doody R, Kurz A, Mohs RC, Morris JC, Rabins PV, Ritchie K, Rossor M, Thal L, Winblad B. Current concepts in mild cognitive impairment. Arch Neurol. 2001 Dec;58(12):1985-92. doi: 10.1001/archneur.58.12.1985.

  PMID: 11735772 BACKGROUND

• Petersen RC. Mild cognitive impairment as a diagnostic entity. J Intern Med. 2004 Sep;256(3):183-94. doi: 10.1111/j.1365-2796.2004.01388.x.

  PMID: 15324362 BACKGROUND

• Troyer AK, Murphy KJ, Anderson ND, Moscovitch M, Craik FI. Changing everyday memory behaviour in amnestic mild cognitive impairment: a randomised controlled trial. Neuropsychol Rehabil. 2008 Jan;18(1):65-88. doi: 10.1080/09602010701409684.

  PMID: 17943615 BACKGROUND

• Cotelli M, Manenti R, Zanetti O, Miniussi C. Non-pharmacological intervention for memory decline. Front Hum Neurosci. 2012 Mar 9;6:46. doi: 10.3389/fnhum.2012.00046. eCollection 2012.

  PMID: 22408614 BACKGROUND

• Simon SS, Yokomizo JE, Bottino CM. Cognitive intervention in amnestic Mild Cognitive Impairment: a systematic review. Neurosci Biobehav Rev. 2012 Apr;36(4):1163-78. doi: 10.1016/j.neubiorev.2012.01.007. Epub 2012 Feb 1.

  PMID: 22322184 BACKGROUND

• Blieszner R, Roberto KA. Care partner responses to the onset of mild cognitive impairment. Gerontologist. 2010 Feb;50(1):11-22. doi: 10.1093/geront/gnp068. Epub 2009 Jun 2.

  PMID: 19491355 BACKGROUND

• Garand L, Dew MA, Eazor LR, DeKosky ST, Reynolds CF 3rd. Caregiving burden and psychiatric morbidity in spouses of persons with mild cognitive impairment. Int J Geriatr Psychiatry. 2005 Jun;20(6):512-22. doi: 10.1002/gps.1318.

  PMID: 15920711 BACKGROUND

• Savla J, Roberto KA, Blieszner R, Cox M, Gwazdauskas F. Effects of daily stressors on the psychological and biological well-being of spouses of persons with mild cognitive impairment. J Gerontol B Psychol Sci Soc Sci. 2011 Nov;66(6):653-64. doi: 10.1093/geronb/gbr041. Epub 2011 Jul 6.

  PMID: 21734229 BACKGROUND

• Tsolaki M, Kounti F, Agogiatou C, Poptsi E, Bakoglidou E, Zafeiropoulou M, Soumbourou A, Nikolaidou E, Batsila G, Siambani A, Nakou S, Mouzakidis C, Tsiakiri A, Zafeiropoulos S, Karagiozi K, Messini C, Diamantidou A, Vasiloglou M. Effectiveness of nonpharmacological approaches in patients with mild cognitive impairment. Neurodegener Dis. 2011;8(3):138-45. doi: 10.1159/000320575. Epub 2010 Dec 3.

  PMID: 21135531 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Kelly J. Murphy, PhD, CPsych

  Baycrest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rita Vitorino, H.B.Sc.

CONTACT

(416) 785-2500; rvitorino@baycrest.org

Kelly J. Murphy, PhD, CPsych

CONTACT

(416) 785-2500; kmurphy@baycrest.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Neuropsychologist

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: March 11, 2014
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: March 11, 2014

Record last verified: 2014-03

Locations

CA (1)