Making Memory Better for Seniors With Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

Neuropsychological Intervention for a Seniors Mental Health Population With Mild Cognitive Impairment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01532739
• Other study ID #: CDHA-RS/2012-227
• Status: Active, not recruiting
• Phase: N/A
• First received: February 10, 2012
• Last updated: August 8, 2016
• Start date: April 2012
• Est. completion date: April 2017

Study information

• Verified date: August 2016
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the feasibility and effectiveness of a cognitive training group in individuals with Mild Cognitive Impairment, using a new paradigm that will optimize ecological validity by (1) focusing on everyday memory problems, (2) supplementing traditional memory training with the teaching of an empirically-supported problem-solving approach, and (3) employing a clinically representative sample of individuals with MCI (e.g., not excluding those with mild affective symptoms).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Mild Cognitive Impairment

Exclusion Criteria:

• Clinical diagnosis of dementia

• History of neurological conditions known to impair cognition

• History of alcohol or drug abuse

• History of chronic psychiatric illness

• Current symptoms of moderate to severe depression (Geriatric Depression Scale >19) or anxiety (Beck Anxiety Inventory >15)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Behavioral:
• Cognitive training
The cognitive training consists of 10 weekly 2-hour sessions. It is run with groups of MCI participants and their study partners (who help with reinforcing the strategies in everyday activities). The program provides information about memory and lifestyle factors in the first two weeks, followed by training and practice over the next eight weeks on empirically-supported cognitive strategies known to be effective at supporting day-to-day remembering in MCI. Participants learn to apply a core set of strategies (spaced retrieval, memory book logging) across a variety of common memory problems (e.g., remembering names, appointments, etc). To enhance the likelihood that these strategies will transfer to other settings beyond training, participants are also taught a memory problem solving approach that will cue them to recognize situations in which they need to: (1) stop and remember something, (2) select and apply an appropriate memory strategy, and (3) monitor that it is working.

Locations

Country	Name	City	State
Canada	Neuropsychology Service, Nova Scotia Hospital	Dartmouth	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Karen Chipman	Nova Scotia Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in everyday memory functioning	Rivermead Behavioural Memory Test (3rd Edition)	Measured at baseline and months 3, 5, 8	No
Secondary	Change on traditional memory testing	California Verbal Learning Test (2nd Edition)	Measured at baseline and months 3, 5, 8	No
Secondary	Change in memory perception	Multifactorial Metamemory Questionnaire	Measured at baseline and months 3, 5, 8	No
Secondary	Change in mood (i.e., self-report symptoms of depression)	Geriatric Depression Scale	Measured at baseline and months 3, 5, 8	No
Secondary	Change in mood (i.e., self-report symptoms of anxiety)	Beck Anxiety Inventory	Measured at baseline and months 3, 5, 8	No
Secondary	Change in other psychiatric symptoms (informant-report)	Neuropsychiatric Inventory	Measured at baseline and months 3, 5, 8	No
Secondary	Change in quality of life	Zarit Burden Interview	Measured at baseline and months 3, 5, 8	No
Secondary	Change in caregiver burden	Zarit Burden Interview	Measured at baseline and months 3, 5, 8	No
Secondary	Feasibility	Recruitment, retention, and compliance rates	Measured at end of study	No