Memory ImpairmentNCT01708200
A Comparison of the Effectiveness of Two Types of Memory Training Programs in People With a Diagnosis of Mental Illness.
A study testing Memory Intervention in people with Memory Impairment, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Memory Impairment
- What is being tested?
- Memory Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Memory impairment equivalent to 1.5 std. dev. below average for age
- Speak and read English fluently
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Michele Bridge contact
Canada1 site
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 3K7
Bruno J Losier, Ph.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Memory Impairment
- Being tested
- Memory Intervention
- Keywords
- Memory, Intervention, Computerized, Psychoeducational, Mental Illness
- Medical subject headings
- Memory Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Memory Intervention | Experimental | Two types of memory protocols (psychoeducational vs computerized) will be compared in a population of individuals with mental illness. Receives: Other: Memory Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Declarative Memory Measure - Hopkins Verbal Learning Test
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.
Measured: 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 outcomes (1)
Mood Measure - Depression Anxiety Stress Scale (Lovibond & Lovibond, 1993)
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Losier, St. Joseph's Healthcare Hamilton
- Investigators
- Bruno J Losier, Ph.D., Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708200
- Sponsor's protocol ID
- R.P. #12-3749
- Other IDs
- SJHH
- Status last verified
- Oct 2012
- First submitted
- 10 Oct 2012
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effectiveness of Two Types of Cognitive Training Interventions Administered to Individuals With a Diagnosis of a Mental Health Condition.
- ClinicalTrials.gov ID
- NCT01708200
- Acronym / sponsor ID
- R.P. #12-3749
- Conditions
- Memory Impairment
- Keywords
- Memory, Intervention, Computerized, Psychoeducational, Mental Illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Memory Intervention | Experimental | Other: Memory InterventionTwo types of memory protocols (psychoeducational vs computerized) will be compared in a population of individuals with mental illness. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Memory impairment equivalent to 1.5 std. dev. below average for age
- Speak and read English fluently
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memory InterventionA 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. | Other | Memory Intervention |
Primary outcome
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.
1 secondary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Bridge contact
Bruno J Losier, Ph.D. principal investigator
St. Joseph's Healthcare Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memory Intervention in people with Memory Impairment, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno J Losier, Ph.D. ((905) 522-1155 ext. 35592, losierb@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2012.