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Cognitive Computer Training in Patients With Depression

Primary Purpose

Depression in Remission, Cognitive Computer Training, Returning to Work

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cognitive computer training
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression in Remission focused on measuring Depression, Cognitive function, Work

Eligibility Criteria

20 Years - 63 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Unit of Psychiatry, Psychiatric Unit Odense - University functionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive computer training

cogntrol group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
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.
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
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).
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

Full Information

First Posted
June 6, 2016
Last Updated
June 29, 2016
Sponsor
University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02821975
Brief Title
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

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression in Remission, Cognitive Computer Training, Returning to Work
Keywords
Depression, Cognitive function, Work

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive computer training
Arm Type
Experimental
Arm Description
This is the intervention group receiving cognitive computer training three times a week for three months.
Arm Title
cogntrol group
Arm Type
No Intervention
Arm Description
The control group do not receive cognitive computer training for three months
Intervention Type
Other
Intervention Name(s)
Cognitive computer training
Other Intervention Name(s)
Cognifit personalized training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Employment status of the participants at nine months follow-up
Description
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.
Time Frame
When the study is completed, approximately 15 months
Secondary Outcome Measure Information:
Title
The difference in concentration from baseline to 3 months follow-up in the intervention group compared to the control group.
Description
Concentration is measured by The Digit Span Test
Time Frame
approximately nine months
Title
The difference in attention from baseline to 3 months follow-up in the intervention group compared to the control group
Description
Attention is measured by The Letter Cancellation Test
Time Frame
approximately nine months
Title
The difference in working memory from baseline to 3 months follow-up in the intervention group compared to the control group.
Description
Working memory is measured by The Letter Number Sequencing
Time Frame
approximately nine months
Title
The difference in learning from baseline to 3 months follow-up in the intervention group compared to the control group.
Description
Learning is measured by the Rey Auditory Verbal Learning Test.
Time Frame
approximately nine months
Title
The difference in executive function from baseline to 3 months follow-up in the intervention group compared to the control group.
Description
Executive function is measured by The Verbal Fluency
Time Frame
approximately nine months
Title
The difference in psychomotor speed from baseline to 3 months follow-up in the intervention group compared to the control group.
Description
Psychomotor speed is measured by The Trial Making Test (TMT).
Time Frame
approximately nine months
Title
The difference in executive function from baseline to 3 months follow-up in the intervention group compared to the control group.
Description
Executive function is measured by The Tower of London
Time Frame
approximately nine months
Other Pre-specified Outcome Measures:
Title
Compliance of cognitive computer training
Description
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.
Time Frame
approximately nine months
Title
The difference in health status from baseline to 9 months follow-up in the intervention group compared to the control group.
Description
The health status is measured by a patient-reported survey called the The Short Form (36) Health Survey (SF-36) questionnaire
Time Frame
approximately 15 months
Title
The difference in depression severity from baseline to 3 months follow-up in the intervention group compared to the control group.
Description
The depression severity is measured by Hamilton Rating Scale for Depression (17-items)
Time Frame
approximately nine months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anja F Elliott, BACH.MED.
Phone
+45 60 79 57 24
Email
anjaelliott@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Morten D Hell, cand.psych.
Phone
+45 28 86 49 19
Email
Old.Morten.Dvoracek.Hell@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bent Nielsen, Prof.MD
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Unit of Psychiatry, Psychiatric Unit Odense - University function
City
Odense C
State/Province
Region of southern Denmark
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anja F Elliott, BACH.MED.
Phone
+4560795724
Email
anjaelliott@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Cognitive Computer Training in Patients With Depression

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