DepressionNCT01748032
Short-term Cognitive Training in Late-life Depression
A study testing Cognitive training in people with Depression, run by Rotman Research Institute at Baycrest at 1 site in Canada.
Trial 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. post-training cognitive performance will be superior to pre-training cognitive performance 2. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2012to Sep 2014
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Short-term Cognitive Training on Cognition and Mood Symptoms in Late-life Depression: A Pilot Study
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:
- post-training cognitive performance will be superior to pre-training cognitive performance
- post-training depressive symptomatology will be less severe as compared with pre-training clinical severity and
- AUT group will show better post-training cognitive performance and improved mood symptoms when compared with the WAT group.
- Conditions
- Depression
- Being tested
- Cognitive training
- Keywords
- depression, intervention studies
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
Also called cognitive intervention
20 minutes/day for 5 sequential working days
| Study group | Role | What they receive |
|---|---|---|
| Alternative Uses Training | Other | In this task, subjects are asked to produce atypical and alternative uses for common daily objects. Receives: 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. Receives: Behavioral: Cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
- Montgomery Asberg Depression Rating Scale (MADRS)
- Apathy Evaluation Scale (AES)
- Hamilton Anxiety Rating Scale (Ham-A)
- Beck Depression Inventory (BDI)
Measured: Within 3 days before the first cognitive training day and within 3 days after the last cognitive training day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2014
- Study completionSep 2014
Why it stopped: Low Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rotman Research Institute at Baycrest
- Sponsor type
- University, hospital or other
- Collaborators
- Baycrest
- Responsible party
- Principal investigator, Linda Mah, MD, Rotman Research Institute at Baycrest
- Investigators
- Linda Mah, MD, M.H.Sc., Principal investigator, Rotman Research Institute at Baycrest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748032
- Sponsor's protocol ID
- 12-28
- Status last verified
- Apr 2016
- First submitted
- 10 Dec 2012
- Last updated
- 7 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Short-term Cognitive Training on Cognition and Mood Symptoms in Late-life Depression: A Pilot Study
- ClinicalTrials.gov ID
- NCT01748032
- Acronym / sponsor ID
- 12-28
- Conditions
- Depression
- Keywords
- depression, intervention studies
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Rotman Research Institute at BaycrestUniversity, hospital or other
- Collaborators
- Baycrest
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Dec 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.
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:
- post-training cognitive performance will be superior to pre-training cognitive performance
- post-training depressive symptomatology will be less severe as compared with pre-training clinical severity and
- AUT group will show better post-training cognitive performance and improved mood symptoms when compared with the WAT group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternative Uses Training | Other | Behavioral: Cognitive trainingIn this task, subjects are asked to produce atypical and alternative uses for common daily objects. |
| Word Association Training | Other | Behavioral: Cognitive trainingIn this task, subjects are asked to generate the first word that comes to their mind, and thus, encourages more general and spontaneous divergent thinking. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Cognitive trainingAlso: cognitive intervention20 minutes/day for 5 sequential working days | Behavioural | Alternative Uses Training, Word Association Training |
Primary outcome
Changes in cognitive functions including fluid intelligence, executive function, language, memory and motor speed
Time frame: Within 3 days before the first cognitive training day and within 3 days after the last cognitive training day
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)
1 secondary outcome
Changes in mood including depression, anxiety and apathy
Time frame: Within 3 days before the first cognitive training day and within 3 days after the last cognitive training day
Results and safety
The study was stopped early (reason given: Low Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
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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.
Linda Mah, MD, M.H.Sc. principal investigator
Rotman Research Institute at Baycrest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training in people with Depression, run by Rotman Research Institute at Baycrest 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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 7 Apr 2016. 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?
The study was stopped early (reason given: Low Recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cognitive functions including fluid intelligence, executive function, language, memory and motor speed (time frame: Within 3 days before the first cognitive training day and within 3 days after the last cognitive training day). 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 7 Apr 2016.