- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02821975
Cognitive Computer Training in Patients With Depression
Evaluating Cognitive Computer Training as a Tool for Returning Earlier to Work After Depression
Study Overview
Status
Intervention / Treatment
Detailed Description
This study will evaluate cognitive computer training on patients in remission from depression by measuring the compliance and effect, investigating whether patients returned earlier to work and examine patients' physical and psychological health. This is done by comparing an intervention group and a control group.
Outpatients from psychiatric department Odense in Denmark will be recruited from December 2015 to July 2017.
At enrolment the participants wil be randomized 1:1 to either the intervention group or the control group. After the participants will complete a clinical interview and answer the The Short Form (36) Health Survey (SF-36) questionnaire. The participants' cognitive function and depression severity will be measured at baseline and three months follow-up. At nine months follow-up the participants will receive an email with the SF-36 questionnaire and questions about their education and work status, which they were required to answer.
The intervention is a cognitive computer program, consisting of different computer games. The intervention will start at enrolment and finish at the three months follow-up. The participants in the intervention group will do trainings session lasting 10-20 minutes three times a week. Each participant ends up with a total of 36 training sessions.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Region of southern Denmark
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Odense C, Region of southern Denmark, Denmark, 5000
- Recruiting
- Research Unit of Psychiatry, Psychiatric Unit Odense - University function
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Contact:
- Anja F Elliott, BACH.MED.
- Phone Number: +4560795724
- Email: anjaelliott@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- a diagnosis of a moderate to severe unipolar depression according to the International Classification of Diseases -10 criteria
- receiving antidepressant medicine
- completed their treatment for depression
- not be in any risk of suicide
- study or work on reduced hours, be unemployed or on long-term sickness leave at enrolment.
Exclusion Criteria:
- neurological disease of the central nervous system
- alcohol or substance abuse
- pregnancy
- receiving disability pension
- receiving electroconvulsive therapy within the last 6 weeks.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive computer training
This is the intervention group receiving cognitive computer training three times a week for three months.
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COGNIFIT is cognitive computer training.
Its purpose is to improve cognitive function and is designed to accommodate each individual's cognitive strengths and weaknesses.
The cognitive computer training last three months and must be done three times a week, in session lasting 10-20 minutes.
Other Names:
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No Intervention: cogntrol group
The control group do not receive cognitive computer training for three months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Employment status of the participants at nine months follow-up
Time Frame: When the study is completed, approximately 15 months
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Questionnaire about employment status and will be send to the participants via email at nine months follow-up.
The questionnaire include questions according to: current working situation; why they are not working; when they started working; do they work at the same workplace; do they have the same work assignments as before they got ill; do whey work the same number of hour as before the got ill.
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When the study is completed, approximately 15 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference in concentration from baseline to 3 months follow-up in the intervention group compared to the control group.
Time Frame: approximately nine months
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Concentration is measured by The Digit Span Test
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approximately nine months
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The difference in attention from baseline to 3 months follow-up in the intervention group compared to the control group
Time Frame: approximately nine months
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Attention is measured by The Letter Cancellation Test
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approximately nine months
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The difference in working memory from baseline to 3 months follow-up in the intervention group compared to the control group.
Time Frame: approximately nine months
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Working memory is measured by The Letter Number Sequencing
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approximately nine months
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The difference in learning from baseline to 3 months follow-up in the intervention group compared to the control group.
Time Frame: approximately nine months
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Learning is measured by the Rey Auditory Verbal Learning Test.
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approximately nine months
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The difference in executive function from baseline to 3 months follow-up in the intervention group compared to the control group.
Time Frame: approximately nine months
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Executive function is measured by The Verbal Fluency
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approximately nine months
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The difference in psychomotor speed from baseline to 3 months follow-up in the intervention group compared to the control group.
Time Frame: approximately nine months
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Psychomotor speed is measured by The Trial Making Test (TMT).
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approximately nine months
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The difference in executive function from baseline to 3 months follow-up in the intervention group compared to the control group.
Time Frame: approximately nine months
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Executive function is measured by The Tower of London
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approximately nine months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compliance of cognitive computer training
Time Frame: approximately nine months
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The participants were supposed to do 36 sessions of cognitive computer training during three months.
The actual completed trainings sessions are available on the website of the cognitive computer training, called COGNIFIT.
The compliance is defined as the percentage of actual completed training sessions of the 36 sessions of training.
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approximately nine months
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The difference in health status from baseline to 9 months follow-up in the intervention group compared to the control group.
Time Frame: approximately 15 months
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The health status is measured by a patient-reported survey called the The Short Form (36) Health Survey (SF-36) questionnaire
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approximately 15 months
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The difference in depression severity from baseline to 3 months follow-up in the intervention group compared to the control group.
Time Frame: approximately nine months
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The depression severity is measured by Hamilton Rating Scale for Depression (17-items)
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approximately nine months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bent Nielsen, Prof.MD, University of Southern Denmark
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cognex-depression
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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