Clinical trial NCT02821975: Cognitive Computer Training in Patients With Depression
Official title: Evaluating Cognitive Computer Training as a Tool for Returning Earlier to Work After Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression in Remission
Cognitive Computer Training
Returning to Work
Keywords: Depression
Cognitive function
Work
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Employment status of the participants at nine months follow-up
timeFrame: When the study is completed, approximately 15 months
Secondary outcomes:
measure: The difference in concentration from baseline to 3 months follow-up in the intervention group compared to the control group.
timeFrame: approximately nine months
measure: The difference in attention from baseline to 3 months follow-up in the intervention group compared to the control group
timeFrame: approximately nine months
measure: The difference in working memory from baseline to 3 months follow-up in the intervention group compared to the control group.
timeFrame: approximately nine months
measure: The difference in learning from baseline to 3 months follow-up in the intervention group compared to the control group.
timeFrame: approximately nine months
measure: The difference in executive function from baseline to 3 months follow-up in the intervention group compared to the control group.
timeFrame: approximately nine months
measure: The difference in psychomotor speed from baseline to 3 months follow-up in the intervention group compared to the control group.
timeFrame: approximately nine months
measure: The difference in executive function from baseline to 3 months follow-up in the intervention group compared to the control group.
timeFrame: approximately nine months
Other outcomes:
measure: Compliance of cognitive computer training
timeFrame: approximately nine months
measure: The difference in health status from baseline to 9 months follow-up in the intervention group compared to the control group.
timeFrame: approximately 15 months
measure: The difference in depression severity from baseline to 3 months follow-up in the intervention group compared to the control group.
timeFrame: approximately nine months
Locations:
city: Odense C
country: Denmark
facility: Research Unit of Psychiatry, Psychiatric Unit Odense - University function
state: Region of southern Denmark
Study officials:
affiliation: University of Southern Denmark
name: Bent Nielsen, Prof.MD
role: PRINCIPAL_INVESTIGATOR
References: