Cognitive Computer Training in Patients With Depression

Study Overview
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Brief Summary
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Cognitive impairment plays an important role in functional recovery and leads to long-term sickness absence. Therefore there is a need of a treatment specifically improving cognitive functions. In this pilot study the investigators aim to evaluate the feasibility of using cognitive computer training in patients with unipolar depression to enhance cognitive performance. Further the investigators investigate whether this intervention shortens sick leave.

Detailed Description
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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.

Official Title
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Evaluating Cognitive Computer Training as a Tool for Returning Earlier to Work After Depression

Conditions
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Depression in Remission, Cognitive Computer Training, Returning to Work

Intervention / Treatment
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* Other: Cognitive computer training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 63 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive computer training<br>This is the intervention group receiving cognitive computer training three times a week for three months. | Other: Cognitive computer training<br>* 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.<br>* Other names: Cognifit personalized training;|
| No Intervention: cogntrol group<br>The control group do not receive cognitive computer training for three months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Employment status of the participants at nine months follow-up | 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. | When the study is completed, approximately 15 months | 

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. | Concentration is measured by The Digit Span Test | approximately nine months | 
| The difference in attention from baseline to 3 months follow-up in the intervention group compared to the control group | Attention is measured by The Letter Cancellation Test | approximately nine months | 
| The difference in working memory from baseline to 3 months follow-up in the intervention group compared to the control group. | Working memory is measured by The Letter Number Sequencing | approximately nine months | 
| The difference in learning from baseline to 3 months follow-up in the intervention group compared to the control group. | Learning is measured by the Rey Auditory Verbal Learning Test. | approximately nine months | 
| The difference in executive function from baseline to 3 months follow-up in the intervention group compared to the control group. | Executive function is measured by The Verbal Fluency | approximately nine months | 
| The difference in psychomotor speed from baseline to 3 months follow-up in the intervention group compared to the control group. | Psychomotor speed is measured by The Trial Making Test (TMT). | approximately nine months | 
| The difference in executive function from baseline to 3 months follow-up in the intervention group compared to the control group. | Executive function is measured by The Tower of London | approximately nine months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Cognitive function, Work