Subjective Memory Complaints, Objective Memory Performance and Cognitive Training

Sponsor

Norwegian University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT02156128

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fatigue Syndrome, Chronic Chronic Pain Anxiety Disorders Depressive Disorder Sleep Disorders	Behavioral: Cogmed working memory training Behavioral: Control group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cogmed 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
Active Comparator: Control group 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

Arm

Intervention/Treatment

Experimental: Cogmed

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

Active Comparator: Control group

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

Outcome Measures

Primary Outcome Measures

Working memory capacity [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).

Secondary Outcome Measures

Subjective memory complaints (SMC) [7 weeks]
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 [7 weeks]
Transfer to inhibition is demonstrated by significantly reduced Stop Signal Reaction Time on The Stop Signal Task

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.