NCT02156128

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

June 3, 2014

Last Update Submit

January 24, 2017

Conditions

Keywords

Cognitive therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Subjective memory complaints (SMC)

    7 weeks

  • Transfer to inhibition

    7 weeks

Study Arms (2)

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.

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.

Behavioral: Control group

Interventions

Control groupBEHAVIORAL
Control group

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • severe mental disorder
  • acute psychosis
  • ongoing manic episode
  • suicidal ideation
  • ongoing abuse of alcohol or any other substance.
  • not able to communicate in Norwegian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NKSS Nasjonal kompetansetjeneste for sammensatte symptomlidelser

Trondheim, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Fatigue Syndrome, ChronicChronic PainAnxiety DisordersDepressive DisorderSleep Wake Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsMental DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Nils I Landrø, Prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2014

First Posted

June 5, 2014

Study Start

October 1, 2013

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

January 25, 2017

Record last verified: 2017-01

Locations