Back to resultsNeurocognitive Enhancement in Major Depressive Disorder (MDDNET)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Neurocognitive Enhancement
Wait List
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- Male or Female.
- Subjects will be between the ages of 18 and 65, which is the age range with available normative comparison data.
Exclusion Criteria:
- 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.
Sites / Locations
- Queen's University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Neurocognitive Enhancement
Wait List
Arm Description
neurocongnitive enhancement
no intervention
Outcomes
Primary Outcome Measures
Performance on paper and pencil assessments of neurocognition after treatment, compared to baseline assessment performance
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00998569
Brief Title
Neurocognitive Enhancement in Major Depressive Disorder
Acronym
MDDNET
Official Title
Neurocognitive Enhancement in Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neurocognitive Enhancement
Arm Type
Experimental
Arm Description
neurocongnitive enhancement
Arm Title
Wait List
Arm Type
Other
Arm Description
no intervention
Intervention Type
Behavioral
Intervention Name(s)
Neurocognitive Enhancement
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wait List
Intervention Description
Participants will be wait listed for 10 weeks, following which time they will receive the intervention previously described.
Primary Outcome Measure Information:
Title
Performance on paper and pencil assessments of neurocognition after treatment, compared to baseline assessment performance
Time Frame
20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or Female.
Subjects will be between the ages of 18 and 65, which is the age range with available normative comparison data.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Bowie, PhD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
12. IPD Sharing Statement
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Neurocognitive Enhancement in Major Depressive Disorder
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