Overview

This trial is active, not recruiting.

Condition mild cognitive impairment
Treatment cognitive training
Sponsor Karen Chipman
Collaborator Nova Scotia Health Research Foundation
Start date April 2012
End date April 2017
Trial size 40 participants
Trial identifier NCT01532739, CDHA-RS/2012-227

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
(No Intervention)

Primary Outcomes

Measure
Change in everyday memory functioning
time frame: Measured at baseline and months 3, 5, 8

Secondary Outcomes

Measure
Change on traditional memory testing
time frame: Measured at baseline and months 3, 5, 8
Change in memory perception
time frame: Measured at baseline and months 3, 5, 8
Change in mood (i.e., self-report symptoms of depression)
time frame: Measured at baseline and months 3, 5, 8
Change in mood (i.e., self-report symptoms of anxiety)
time frame: Measured at baseline and months 3, 5, 8
Change in other psychiatric symptoms (informant-report)
time frame: Measured at baseline and months 3, 5, 8
Change in quality of life
time frame: Measured at baseline and months 3, 5, 8
Change in caregiver burden
time frame: Measured at baseline and months 3, 5, 8
Feasibility
time frame: Measured at end of study

Eligibility Criteria

Male or female participants of any age.

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)

Additional Information

Official title Neuropsychological Intervention for a Seniors Mental Health Population With Mild Cognitive Impairment
Principal investigator Karen A Chipman, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Nova Scotia Health Authority.