Subjective Memory Complaints, Objective Memory Performance and Cognitive Training

Study Overview
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Brief Summary
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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.

Official Title
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Study of Subjective Memory Complaints, Objective Memory Performance and Cognitive Training in Patients With Complex Symptom Disorders

Conditions
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Fatigue Syndrome, Chronic, Chronic Pain, Anxiety Disorders, Depressive Disorder, Sleep Disorders

Intervention / Treatment
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* Behavioral: Cogmed working memory training
* Behavioral: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cogmed<br>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. | Behavioral: Cogmed working memory training<br> <br> |
| Active Comparator: Control group<br>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. | Behavioral: Control group<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 weeks | 
| Transfer to inhibition | Transfer to inhibition is demonstrated by significantly reduced Stop Signal Reaction Time on The Stop Signal Task | 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive therapy