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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00998569
Other study ID # PSYC-092-09
Secondary ID
Status Completed
Phase N/A
First received October 14, 2009
Last updated August 27, 2015
Start date October 2009
Est. completion date March 2012

Study information

Verified date August 2015
Source Queen's University
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

1. Male or Female.

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

Exclusion Criteria:

1. 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.

2. 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.

3. Subjects with uncorrectable vision or hearing impairment that would preclude valid assessments or intervention procedures.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Neurocognitive Enhancement
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.
Wait List
Participants will be wait listed for 10 weeks, following which time they will receive the intervention previously described.

Locations

Country Name City State
Canada Queen's University Kingston Ontario

Sponsors (1)

Lead Sponsor Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Performance on paper and pencil assessments of neurocognition after treatment, compared to baseline assessment performance 20 weeks No
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