Subjective Memory Complaints, Objective Memory Performance and Cognitive Training

January 24, 2017 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • NKSS Nasjonal kompetansetjeneste for sammensatte symptomlidelser

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective memory complaints (SMC)
Time Frame: 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.
7 weeks
Transfer to inhibition
Time Frame: 7 weeks
Transfer to inhibition is demonstrated by significantly reduced Stop Signal Reaction Time on The Stop Signal Task
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Investigators

  • Study Director: Nils I Landrø, Prof, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

June 3, 2014

First Submitted That Met QC Criteria

June 4, 2014

First Posted (Estimate)

June 5, 2014

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100878

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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