Fatigue Syndrome, ChronicNCT02156128
Subjective Memory Complaints, Objective Memory Performance and Cognitive Training
A study testing Cogmed working memory training in people with Fatigue Syndrome, Chronic and Chronic Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The aim of this study is to examine if repetitive computerized cognitive training improves working memory in patients who are on sick leave due to complex symptom disorders (chronic pain, chronic fatigue, anxiety, depression and or sleep disorders), and whether effects of cognitive control training transfer to other… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Fatigue Syndrome, Chronic, Chronic Pain, Anxiety Disorders
- What is being tested?
- Cogmed working memory training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2013to Apr 2015
- 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- on sick leave due to complex symptom disorders: chronic pain, chronic fatigue, anxiety, depression and/or sleep disorders
- on sick leave for at least eight weeks.
Who cannot join
- severe mental disorder
- acute psychosis
- ongoing manic episode
- suicidal ideation
- ongoing abuse of alcohol or any other substance.
- not able to communicate in Norwegian
Trial locations and contacts
1 site in 1 country.
Norway1 site
NKSS Nasjonal kompetansetjeneste for sammensatte symptomlidelser
Trondheim
About this study
Official title: Study of Subjective Memory Complaints, Objective Memory Performance and Cognitive Training in Patients With Complex Symptom Disorders
The aim of this study is to examine if repetitive computerized cognitive training improves working memory in patients who are on sick leave due to complex symptom disorders (chronic pain, chronic fatigue, anxiety, depression and or sleep disorders), and whether effects of cognitive control training transfer to other tasks.
- Conditions
- Fatigue Syndrome, Chronic, Chronic Pain, Anxiety Disorders, Depressive Disorder, Sleep Disorders
- Being tested
- Cogmed working memory training, Control group
- Keywords
- Cognitive therapy
- Medical subject headings
- Fatigue Syndrome, Chronic, Chronic Pain, Anxiety Disorders, Depressive Disorder, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cogmed working memory trainingBehavioural
Control groupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Cogmed | Experimental | Participants in a 3,5 week vocational rehabilitation program (containing cognitive therapy and physical exercise) are instructed to use a computer-based working memory training program (named CogMed) each weekday (5 days a week) for 5 weeks. Each training session consists of 8 different tasks and lasts 40-50 minutes. Receives: Behavioral: Cogmed working memory training |
| Control group | Active comparator | These subjects will participate in the vocational rehabilitation program for 3,5 weeks. The program includes cognitive therapy (ACT) and physical activity, but no working memory training. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working memory capacity
Objective memory performance as assessed by a sample of neuropsychological tests from Cambridge Cognition - Cantab tests (Spatial Working Memory (SWM), One Touch Stockings of Cambridge (OTS), Stop Signal Task (SST)) Including Paced Auditory Serial Addition Test (PASAT).
Measured: 7 weeks
Secondary outcomes (2)
Subjective memory complaints (SMC)
Subjective memory complaints (SMC) are measured by a self-report questionnaire "The Everyday Memory Questionnaire" We estimate prevalence of subjective memory complaints and examine the correspondence between SMC and symptoms of depression, anxiety, sleep disturbances, chronic fatigue and chronic pain.
Measured: 7 weeks
Transfer to inhibition
Transfer to inhibition is demonstrated by significantly reduced Stop Signal Reaction Time on The Stop Signal Task
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startOct 2013
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fatigue Syndrome, ChronicStudies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nils I Landrø, Prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156128
- Sponsor's protocol ID
- 100878
- Status last verified
- Jan 2017
- First submitted
- 3 Jun 2014
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Aasvik JK, Woodhouse A, Stiles TC, Jacobsen HB, Landmark T, Glette M, Borchgrevink PC, Landro NI. Effectiveness of Working Memory Training among Subjects Currently on Sick Leave Due to Complex Symptoms. Front Psychol. 2017 Jan 6;7:2003. doi: 10.3389/fpsyg.2016.02003. eCollection 2016.
PubMed 28111555
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Subjective Memory Complaints, Objective Memory Performance and Cognitive Training in Patients With Complex Symptom Disorders
- ClinicalTrials.gov ID
- NCT02156128
- Acronym / sponsor ID
- 100878
- Conditions
- Fatigue Syndrome, Chronic, Chronic Pain, Anxiety Disorders, Depressive Disorder, Sleep Disorders
- Keywords
- Cognitive therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 5 Jun 2014 (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.
The aim of this study is to examine if repetitive computerized cognitive training improves working memory in patients who are on sick leave due to complex symptom disorders (chronic pain, chronic fatigue, anxiety, depression and or sleep disorders), and whether effects of cognitive control training transfer to other tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cogmed | Experimental | Behavioral: Cogmed working memory trainingParticipants in a 3,5 week vocational rehabilitation program (containing cognitive therapy and physical exercise) are instructed to use a computer-based working memory training program (named CogMed) each weekday (5 days a week) for 5 weeks. Each training session consists of 8 different tasks and lasts 40-50 minutes. |
| Control group | Active comparator | Behavioral: Control groupThese subjects will participate in the vocational rehabilitation program for 3,5 weeks. The program includes cognitive therapy (ACT) and physical activity, but no working memory training. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- on sick leave due to complex symptom disorders: chronic pain, chronic fatigue, anxiety, depression and/or sleep disorders
- on sick leave for at least eight weeks.
Key exclusion criteria (6 listed)
- severe mental disorder
- acute psychosis
- ongoing manic episode
- suicidal ideation
- ongoing abuse of alcohol or any other substance.
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 |
|---|---|---|
| Cogmed working memory training | Behavioural | Cogmed |
| Control group | Behavioural | Control group |
Primary outcome
Working memory capacity
Time frame: 7 weeks
Objective memory performance as assessed by a sample of neuropsychological tests from Cambridge Cognition - Cantab tests (Spatial Working Memory (SWM), One Touch Stockings of Cambridge (OTS), Stop Signal Task (SST)) Including Paced Auditory Serial Addition Test (PASAT).
2 secondary outcomes
Subjective memory complaints (SMC)
Time frame: 7 weeks
Transfer to inhibition
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Results publication: PubMed 28111555Aasvik JK, Woodhouse A, Stiles TC, Jacobsen HB, Landmark T, Glette M, Borchgrevink PC, Landro NI. Effectiveness of Working Memory Training among Subjects Currently on Sick Leave Due to Complex Symptoms. Front Psychol. 2017 Jan 6;7:2003. doi: 10.3389/fpsyg.2016.02003. eCollection 2016.
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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.
Nils I Landrø, Prof study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cogmed working memory training in people with Fatigue Syndrome, Chronic and Chronic Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 25 Jan 2017. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Working memory capacity (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02156128, which also lists 1 linked publication.
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 25 Jan 2017; AzTrials last refreshed its copy on 27 Oct 2026.