Cognitive Computer Training in Patients With Depression

Depression in Remission Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02821975
• Other study ID #: Cognex-depression
• Status: Recruiting
• Phase: N/A
• First received: June 6, 2016
• Last updated: June 29, 2016
• Start date: December 2015
• Est. completion date: October 2017

Study information

• Verified date: June 2016
• Source: University of Southern Denmark
• Contact: Anja F Elliott, BACH.MED.
• Phone: +45 60 79 57 24
• Email: anjaelliott[@]hotmail.com
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics CommitteeDemark: OPEN - Odense Patient data Explorative Network
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 63 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognitive Computer Training
• Depression
• Depression in Remission
• Depressive Disorder
• Returning to Work

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Denmark	Research Unit of Psychiatry, Psychiatric Unit Odense - University function	Odense C	Region of southern Denmark

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance of cognitive computer training	The participants were supposed to do 36 sessions of cognitive computer training during three months. The actual completed trainings sessions are available on the website of the cognitive computer training, called COGNIFIT. The compliance is defined as the percentage of actual completed training sessions of the 36 sessions of training.	approximately nine months	No
Other	The difference in health status from baseline to 9 months follow-up in the intervention group compared to the control group.	The health status is measured by a patient-reported survey called the The Short Form (36) Health Survey (SF-36) questionnaire	approximately 15 months	No
Other	The difference in depression severity from baseline to 3 months follow-up in the intervention group compared to the control group.	The depression severity is measured by Hamilton Rating Scale for Depression (17-items)	approximately nine months	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No