NCT00998569

Brief Summary

The purpose of this study is to examine the effects of neurocognitive enhancement on cognitive abilities and related social and adaptive behaviours in individuals diagnosed with major depressive disorder. Subjects in this study will be randomized to receive Neurocognitive Enhancement Therapy (NET) or to a wait list and then NET . Secondary aims include examining whether the cognitive benefits are potentiated by repeated exposure during in-home practice with complementary exercises. Additionally, the investigators will examine the durability of the effects and their generalization to functional capacity and everyday functional performance after completion of the groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

August 31, 2015

Status Verified

August 1, 2015

Enrollment Period

2.4 years

First QC Date

October 14, 2009

Last Update Submit

August 27, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Performance on paper and pencil assessments of neurocognition after treatment, compared to baseline assessment performance

    20 weeks

Study Arms (2)

Neurocognitive Enhancement

EXPERIMENTAL

neurocongnitive enhancement

Behavioral: Neurocognitive Enhancement

Wait List

OTHER

no intervention

Behavioral: Wait List

Interventions

Neurocognitive Enhancement Therapy (NET) uses behavioural treatment strategies that are designed to improve a range of cognitive skills. NET uses strategies such as coaching, repetition, practice, teaching, group discussion, and compensation for deficits by using cognitive strengths.

Neurocognitive Enhancement
Wait ListBEHAVIORAL

Participants will be wait listed for 10 weeks, following which time they will receive the intervention previously described.

Wait List

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female.
  • Subjects will be between the ages of 18 and 65, which is the age range with available normative comparison data.

You may not qualify if:

  • Presence of a medical diagnosis that is associated with known cognitive impairments, such as multiple sclerosis, cerebrovascular accident, dementia, or history of traumatic brain injury.
  • Subjects with a reading level below grade 6, as assessed with the Wide Range Achievement Test - Reading Recognition Subtest, will be excluded because of the likelihood of not understanding task instructions.
  • Subjects with uncorrectable vision or hearing impairment that would preclude valid assessments or intervention procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Christopher Bowie, PhD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

October 14, 2009

First Posted

October 20, 2009

Study Start

October 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

August 31, 2015

Record last verified: 2015-08

Locations