NCT01532739

Brief 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).

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2012

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2025

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

14 years

First QC Date

February 10, 2012

Last Update Submit

August 19, 2024

Conditions

Keywords

Mild Cognitive ImpairmentAgingMemoryExecutive FunctionCognitive InterventionMemory TrainingMental Health

Outcome Measures

Primary Outcomes (1)

  • Change in everyday memory functioning

    Rivermead Behavioural Memory Test (3rd Edition)

    Measured at baseline and months 3, 5, 8

Secondary Outcomes (8)

  • Change on traditional memory testing

    Measured at baseline and months 3, 5, 8

  • Change in memory perception

    Measured at baseline and months 3, 5, 8

  • Change in mood (i.e., self-report symptoms of depression)

    Measured at baseline and months 3, 5, 8

  • Change in mood (i.e., self-report symptoms of anxiety)

    Measured at baseline and months 3, 5, 8

  • Change in other psychiatric symptoms (informant-report)

    Measured at baseline and months 3, 5, 8

  • +3 more secondary outcomes

Study Arms (2)

Cognitive training

EXPERIMENTAL
Behavioral: Cognitive training

No cognitive training

NO INTERVENTION

Interventions

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.

Cognitive training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Mild Cognitive Impairment

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuropsychology Service, Nova Scotia Hospital

Dartmouth, Nova Scotia, B2Y 3Z9, Canada

Location

MeSH Terms

Conditions

Cognitive DysfunctionPsychological Well-Being

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Karen A Chipman, PhD

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2012

First Posted

February 14, 2012

Study Start

December 5, 2011

Primary Completion

December 5, 2025

Study Completion

December 5, 2025

Last Updated

August 21, 2024

Record last verified: 2024-08

Locations