Depression in RemissionNCT02821975
Cognitive Computer Training in Patients With Depression
A study testing Cognitive computer training in people with Depression in Remission and Cognitive Computer Training, run by University of Southern Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 20 to 63 years
- Conditions the study is for
- Depression in Remission, Cognitive Computer Training, Returning to Work
- What is being tested?
- Cognitive computer training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 63 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- neurological disease of the central nervous system
- alcohol or substance abuse
- pregnancy
- receiving disability pension
- receiving electroconvulsive therapy within the last 6 weeks.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Research Unit of Psychiatry, Psychiatric Unit Odense - University function
Odense C, Region Syddanmark, 5000
Anja F Elliott, BACH.MED., +4560795724, anjaelliott@hotmail.com
About this study
Official title: Evaluating Cognitive Computer Training as a Tool for Returning Earlier to Work After Depression
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.
Read the 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.
- Being tested
- Cognitive computer training
- Keywords
- Depression, Cognitive function, Work
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive computer trainingOther
Also called Cognifit personalized 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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive computer training | Experimental | This is the intervention group receiving cognitive computer training three times a week for three months. Receives: Other: Cognitive computer training |
| cogntrol group | No intervention | The control group do not receive cognitive computer training for three months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Concentration is measured by The Digit Span Test
Measured: approximately nine months
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
Measured: approximately nine months
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
Measured: approximately nine months
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.
Measured: approximately nine months
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
Measured: approximately nine months
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).
Measured: approximately nine months
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
Measured: approximately nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startDec 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in RemissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kjeld Andersen, University of Southern Denmark
- Investigators
- Bent Nielsen, Prof.MD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821975
- Sponsor's protocol ID
- Cognex-depression
- Status last verified
- Jun 2016
- First submitted
- 6 Jun 2016
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Cognitive Computer Training as a Tool for Returning Earlier to Work After Depression
- ClinicalTrials.gov ID
- NCT02821975
- Acronym / sponsor ID
- Cognex-depression
- Keywords
- Depression, Cognitive function, Work
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 4 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive computer training | Experimental | Other: Cognitive computer trainingThis is the intervention group receiving cognitive computer training three times a week for three months. |
| cogntrol group | No intervention | –The control group do not receive cognitive computer training for three months |
Who may qualify
- Ages
- 20 to 63 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- neurological disease of the central nervous system
- alcohol or substance abuse
- pregnancy
- receiving disability pension
- receiving electroconvulsive therapy within the last 6 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive computer trainingAlso: Cognifit personalized trainingCOGNIFIT 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. | Other | Cognitive computer training |
Primary outcome
Employment status of the participants at nine months follow-up
Time frame: 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.
7 secondary outcomes
The difference in concentration from baseline to 3 months follow-up in the intervention group compared to the control group.
Time frame: approximately nine months
The difference in attention from baseline to 3 months follow-up in the intervention group compared to the control group
Time frame: approximately nine months
The difference in working memory from baseline to 3 months follow-up in the intervention group compared to the control group.
Time frame: approximately nine months
The difference in learning from baseline to 3 months follow-up in the intervention group compared to the control group.
Time frame: approximately nine months
The difference in executive function from baseline to 3 months follow-up in the intervention group compared to the control group.
Time frame: approximately nine months
The difference in psychomotor speed from baseline to 3 months follow-up in the intervention group compared to the control group.
Time frame: approximately nine months
The difference in executive function from baseline to 3 months follow-up in the intervention group compared to the control group.
Time frame: approximately nine months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bent Nielsen, Prof.MD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive computer training in people with Depression in Remission and Cognitive Computer Training, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anja F Elliott, BACH.MED. (+45 60 79 57 24, anjaelliott@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Employment status of the participants at nine months follow-up (time frame: When the study is completed, approximately 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2016.