Back to resultsSubjective Memory Complaints, Objective Memory Performance and Cognitive Training
Primary Purpose
Fatigue Syndrome, Chronic, Chronic Pain, Anxiety Disorders
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cogmed working memory training
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Fatigue Syndrome, Chronic focused on measuring Cognitive therapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- severe mental disorder
- acute psychosis
- ongoing manic episode
- suicidal ideation
- ongoing abuse of alcohol or any other substance.
- not able to communicate in Norwegian
Sites / Locations
- NKSS Nasjonal kompetansetjeneste for sammensatte symptomlidelser
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cogmed
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Transfer to inhibition
Transfer to inhibition is demonstrated by significantly reduced Stop Signal Reaction Time on The Stop Signal Task
Full Information
NCT ID
NCT02156128
First Posted
June 3, 2014
Last Updated
January 24, 2017
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT02156128
Brief Title
Subjective Memory Complaints, Objective Memory Performance and Cognitive Training
Official Title
Study of Subjective Memory Complaints, Objective Memory Performance and Cognitive Training in Patients With Complex Symptom Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 tasks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue Syndrome, Chronic, Chronic Pain, Anxiety Disorders, Depressive Disorder, Sleep Disorders
Keywords
Cognitive therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cogmed
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cogmed working memory training
Intervention Type
Behavioral
Intervention Name(s)
Control group
Primary Outcome Measure Information:
Title
Working memory capacity
Description
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).
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Subjective memory complaints (SMC)
Description
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.
Time Frame
7 weeks
Title
Transfer to inhibition
Description
Transfer to inhibition is demonstrated by significantly reduced Stop Signal Reaction Time on The Stop Signal Task
Time Frame
7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
severe mental disorder
acute psychosis
ongoing manic episode
suicidal ideation
ongoing abuse of alcohol or any other substance.
not able to communicate in Norwegian
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nils I Landrø, Prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
NKSS Nasjonal kompetansetjeneste for sammensatte symptomlidelser
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
28111555
Citation
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.
Results Reference
result
Learn more about this trial
Subjective Memory Complaints, Objective Memory Performance and Cognitive Training
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