Cognitive Computer Training in Patients With Depression

NCT ID: NCT02821975

Last Updated: 2016-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-10-31

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.

Conditions

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Depression in Remission Cognitive Computer Training Returning to Work

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive computer training

This is the intervention group receiving cognitive computer training three times a week for three months.

Group Type EXPERIMENTAL

Cognitive computer training

Intervention Type OTHER

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.

cogntrol group

The control group do not receive cognitive computer training for three months

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive computer training

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.

Intervention Type OTHER

Other Intervention Names

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Cognifit personalized training

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

63 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Kjeld Andersen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bent Nielsen, Prof.MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Locations

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Research Unit of Psychiatry, Psychiatric Unit Odense - University function

Odense C, Region Syddanmark, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Anja F Elliott, BACH.MED.

Role: CONTACT

+45 60 79 57 24

Morten D Hell, cand.psych.

Role: CONTACT

+45 28 86 49 19

Facility Contacts

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Anja F Elliott, BACH.MED.

Role: primary

+4560795724

Other Identifiers

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Cognex-depression

Identifier Type: -

Identifier Source: org_study_id

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