Cognitive Computer Training in Patients With Depression

Not Applicable

• Conditions: Cognitive Computer Training; Depression in Remission; Returning to Work
• Interventions: Other: Cognitive computer training

• Registration Number: NCT02821975
• Lead Sponsor: University of Southern Denmark

Brief Summary

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

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 Timeline

• Study Start: 2015-12
• Status Verified: 2016-06
• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-06-29
• Last Update Submitted: 2016-06-29
• Study First Posted: 2016-07-04
• Last Update Posted: 2016-07-04
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Employment status of the participants at nine months follow-up	When the study is completed, approximately 15 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Unit of Psychiatry, Psychiatric Unit Odense - University function; 🇩🇰 Odense C, Region of southern Denmark, Denmark