NCT01748032

Brief Summary

The purpose of this study is to examine the effects of the alternative uses training (AUT) and word association training (WAT) on cognitive functions and mood symptoms in late-life depression (LLD). The hypotheses are:

  1. 1.post-training cognitive performance will be superior to pre-training cognitive performance
  2. 2.post-training depressive symptomatology will be less severe as compared with pre-training clinical severity and
  3. 3.AUT group will show better post-training cognitive performance and improved mood symptoms when compared with the WAT group.

Trial Health

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Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

1.8 years

First QC Date

December 10, 2012

Last Update Submit

April 6, 2016

Conditions

Keywords

depressionintervention studies

Outcome Measures

Primary Outcomes (1)

  • Changes in cognitive functions including fluid intelligence, executive function, language, memory and motor speed

    Computerized Executive Tasks: * Number-Letter Task * Letter-Memory Task * Stroop Task Non-Computerized Measures: * Cattell Culture Fair Intelligence Test * Mattis Dementia Rating Scale-2 (DRS-2)

    Within 3 days before the first cognitive training day and within 3 days after the last cognitive training day

Secondary Outcomes (1)

  • Changes in mood including depression, anxiety and apathy

    Within 3 days before the first cognitive training day and within 3 days after the last cognitive training day

Study Arms (2)

Alternative Uses Training

OTHER

In this task, subjects are asked to produce atypical and alternative uses for common daily objects.

Behavioral: Cognitive training

Word Association Training

OTHER

In this task, subjects are asked to generate the first word that comes to their mind, and thus, encourages more general and spontaneous divergent thinking.

Behavioral: Cognitive training

Interventions

20 minutes/day for 5 sequential working days

Also known as: cognitive intervention
Alternative Uses TrainingWord Association Training

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • Age \>=55
  • Proficiency in English
  • Current depressive episode and meet criteria for DSM-IV major depressive disorder
  • Hamilton Depression Rating Scale score \>=15
  • Able to give informed consent
  • Stable medication dosages during the training period

You may not qualify if:

  • Other DSM-IV Axis I psychiatric disorders, except for anxiety disorders due to high comorbidity with mood disorders
  • Mini-Mental State Examination score of \<26
  • Diagnosis of dementia
  • Neurological and medical conditions known to affect cognition (e.g., stroke, head injury, previous chemotherapy for cancer)
  • Unstable medical illnesses requiring active treatment
  • Vision or hearing impairment affecting ability to participate in training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rotman Research Institute at Baycrest

Toronto, Ontario, M6A 2E1, Canada

Location

MeSH Terms

Conditions

Depression

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Linda Mah, MD, M.H.Sc.

    Rotman Research Institute at Baycrest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician Scientist

Study Record Dates

First Submitted

December 10, 2012

First Posted

December 12, 2012

Study Start

August 1, 2012

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

April 7, 2016

Record last verified: 2016-04

Locations