Cognitive Computer Training in Patients With Depression

NCT02821975 | Unknown DMC

• 1 other identifier: Cognex-depression
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression in Remission; Cognitive Computer Training; Returning to Work

Keywords

Depression; Cognitive function; Work

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The difference in concentration from baseline to 3 months follow-up in the intervention group compared to the control group.

  approximately nine months

• The difference in attention from baseline to 3 months follow-up in the intervention group compared to the control group

  approximately nine months

• The difference in working memory from baseline to 3 months follow-up in the intervention group compared to the control group.

  approximately nine months

• The difference in learning from baseline to 3 months follow-up in the intervention group compared to the control group.

  approximately nine months

• The difference in executive function from baseline to 3 months follow-up in the intervention group compared to the control group.

  approximately nine months

Other Outcomes (3)

• Compliance of cognitive computer training

  approximately nine months

• The difference in health status from baseline to 9 months follow-up in the intervention group compared to the control group.

  approximately 15 months

• The difference in depression severity from baseline to 3 months follow-up in the intervention group compared to the control group.

  approximately nine months

Study Arms (2)

Cognitive computer training

EXPERIMENTAL

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

Other: Cognitive computer training

cogntrol group

NO INTERVENTION

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

Interventions

Cognitive computer training 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.

Also known as: Cognifit personalized training

Cognitive computer training

Eligibility Criteria

• Age: 20 Years - 63 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• neurological disease of the central nervous system
• alcohol or substance abuse
• pregnancy
• receiving disability pension
• receiving electroconvulsive therapy within the last 6 weeks.

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Research Unit of Psychiatry, Psychiatric Unit Odense - University function

Odense C, Region Syddanmark, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Bent Nielsen, Prof.MD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anja F Elliott, BACH.MED.

CONTACT

+45 60 79 57 24; anjaelliott@hotmail.com

Morten D Hell, cand.psych.

CONTACT

+45 28 86 49 19; Old.Morten.Dvoracek.Hell@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: July 4, 2016
• Study Start: December 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: July 4, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)