- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01708200
A Comparison of the Effectiveness of Two Types of Memory Training Programs in People With a Diagnosis of Mental Illness.
October 15, 2012 updated by: Bruno Losier, St. Joseph's Healthcare Hamilton
A Comparison of the Effectiveness of Two Types of Cognitive Training Interventions Administered to Individuals With a Diagnosis of a Mental Health Condition.
This study will compare the effectiveness of a psychoeducational memory program versus a computerized memory program in individuals with mental illness.
Although improvements are expected with both form of interventions, we do not know which will provide maximal benefit in this population.
Study Overview
Detailed Description
The aim of the current study is to compare two memory strategies, a top-down (i.e., educational and interventional)protocol vs. a bottom-up (computerized)protocol, in a population of individuals diagnosed with mental illness.
Performance on ecologically validated memory tasks will be measured before and after each intervention protocol.
Improvements are expected following each protocol.
However, there is no evidence available to support added benefits from one protocol over another.
As such, the current study will endeavour to contrast the two intervention types (top-down vs. bottom-up) to determine which, if any, provides maximal benefit.
Study Type
Interventional
Enrollment (Anticipated)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
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Hamilton, Ontario, Canada, L8N 3K7
- St. Joseph's Healthcare Hamilton
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Memory impairment equivalent to 1.5 std. dev. below average for age
- Speak and read English fluently
Exclusion Criteria:
- Older than 65 years of age
- Significant visual impairment (e.g., cataracts, macular degeneration)
- Motor impairment (e.g., hemiplegia on dominant side)
- Diagnosis of Dementia
- Alcohol and/or substance abuse (in past 3 months)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Memory Intervention
Two types of memory protocols (psychoeducational vs computerized) will be compared in a population of individuals with mental illness.
|
A comparison of two type of memory intervention protocols; a psychoeducational/intervention protocol versus a computerized memory protocol in a population of individuals with mental illness.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Declarative Memory Measure - Hopkins Verbal Learning Test
Time Frame: Participants will be asked to complete this measure prior to the start of the intervention and again at the completion of the intervention (i.e., interval of 5 weeks between pre and post measurements).
|
Individuals participating in either protocol (i.e., top-down or bottom-up) will complete the memory measure before the commencement of the treatment and again at the end of treatment.
|
Participants will be asked to complete this measure prior to the start of the intervention and again at the completion of the intervention (i.e., interval of 5 weeks between pre and post measurements).
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mood Measure - Depression Anxiety Stress Scale (Lovibond & Lovibond, 1993)
Time Frame: Participants will be asked to complete this measure prior to the start of the intervention and again at the completion of the intervention (i.e., interval of 5 weeks between pre and post measurements).
|
Participants will be asked to complete this measure prior to the start of the intervention and again at the completion of the intervention (i.e., interval of 5 weeks between pre and post measurements).
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Functional - Multifactorial Metamemory Questionnaire (Troyer & Rich, 2011)
Time Frame: Participants will be asked to complete this measure prior to the start of the intervention and again at the completion of the intervention (i.e., interval of 5 weeks between pre and post measurements).
|
Participants will be asked to complete this measure prior to the start of the intervention and again at the completion of the intervention (i.e., interval of 5 weeks between pre and post measurements).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bruno J Losier, Ph.D., St. Joseph's Healthcare Hamilton
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Anticipated)
October 1, 2015
Study Completion (Anticipated)
October 1, 2015
Study Registration Dates
First Submitted
October 10, 2012
First Submitted That Met QC Criteria
October 15, 2012
First Posted (Estimate)
October 16, 2012
Study Record Updates
Last Update Posted (Estimate)
October 16, 2012
Last Update Submitted That Met QC Criteria
October 15, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R.P. #12-3749
- SJHH (Other Identifier: St. Joseph Healthcare Hamilton)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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