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Cognitive Behaviour Therapy and Cognitive Training in Work Rehabilitation for Persons With Severe Mental Illness

This study is currently recruiting participants.
Verified August 2011 by Oslo University Hospital
Sponsor:
Collaborators:
Directorate of Health, Norway
Stiftelsen Helse og Rehabilitering
Helse Sor-Ost
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01139502
First received: June 2, 2010
Last updated: August 8, 2011
Last verified: August 2011
History of Changes
  Purpose

This study will compare the effects of cognitive behaviour therapy (CBT) and cognitive training in work rehabilitation of patients with severe mental illness (psychoses).

These interventions will be compared with a matched control group ('treatment as usual'). The patients will be recruited in nine different counties in Norway. During a two-year period around 27-30 patients can be recruited from each county, meaning that each intervention arm will contain approximately 80 patients. The evaluation of the patients will include several validated diagnostic instruments as described below. The counties has been randomised to the two different intervention groups by a neutral institution: 1.group receiving work rehabilitation based on cognitive behaviour therapy, and 2.group receiving cognitive training. The control group will be matched according to gender and age. With Ntotal=160 for the comparison of two groups (80 patients x 2), a 0.05 level of significance and a power of 0.80, a standardised group difference of 0.44 can be detected. The standardised difference detected between supported employment and treatment as usual has been as high as 0.80 in comparable American studies, indicating that N is large enough in the present study.

The participants in each county will be evaluated and followed by a local project coordinator and by a local psychiatrist/psychologist in a District Psychiatric Centre. Written evaluation protocols will be sent anonymously to the research centre for registration. Data will be stored according to current laws of person protection and data security. Pre-post differences in each group, differences between the control group and the intervention groups, and differences between the intervention groups will be tested using a mixed linear model programme.

Research questions The project will compare the effects of CBT oriented work rehabilitation and work rehabilitation with cognitive training with regard to the ability of persons with severe mental disorders to cope with and keep a job. The two intervention arms will be compared with each other and with a matched treatment as usual control group.

Main hypotheses

  1. By the end of the project (T2) and by follow up examination (T3) the global psychosocial function of patients will be higher in the CBT work rehabilitation group than in the control group
  2. The global psychosocial function of patients at T2 and T3 will be higher in the cognitive training group than in the control group

Condition Intervention
Mental Illness
 Behavioral: Work rehabilitation based on the cognitive therapeutical model
Behavioral: Work rehabilitation with the addition of cognitive training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Therapy and Cognitive Training in Work Rehabilitation for Persons With Severe Mental Illness. A Randomised Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • The Work Behavior Inventory [ Time Frame: Ten months ] [ Designated as safety issue: No ]
    The instrument assesses various dimensions of the participant's work performance


Secondary Outcome Measures:
  • The Global Assessment of Function [ Time Frame: Ten months ] [ Designated as safety issue: No ]
    Assesses adaptation and general function of the participant

  • The Positive and Negative Symptom Scale (PANSS) [ Time Frame: Ten months ] [ Designated as safety issue: No ]
    Assesses the number and intensity of symptoms

  • The Apathy Evaluation Scale [ Time Frame: Ten months ] [ Designated as safety issue: No ]
    Assesses the intensity of apathy in the participant

  • The Alcohol Use Disorder Identification Test [ Time Frame: Ten months ] [ Designated as safety issue: No ]
    Assesses health problems caused by use of alcohol

  • The Drug Use Disorder Identification Test [ Time Frame: Ten months ] [ Designated as safety issue: No ]
    Assesses health problems caused by drug use

  • The Measurement and Treatment Research to Improve Cognitive Function in Schizophrenia [ Time Frame: Ten months ] [ Designated as safety issue: No ]
    Assesses concentration, memory, and executive function


Estimated Enrollment: 240
Study Start Date: January 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Work rehab with cognitive therapy
Work rehabilitation based on the cognitive therapeutical model
 Behavioral: Work rehabilitation based on the cognitive therapeutical model
Work rehabilitation including two weekly meetings in which participant and work consultant discuss problems interfering with work and social interaction. Home work related to these problems is assigned between the meetings.
Active Comparator: Work rehab with cognitive training
Work rehabilitation with the addition of weekly training of concentration, memory, and executive function
 Behavioral: Work rehabilitation with the addition of cognitive training
Work rehabilitation with the addition of two hours weekly training of concentration, memory, and executive function

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persons with schizophrenia spectrum disorders

Exclusion Criteria:

  • IQ <70
  • neurological disease diagnosis
  • Active suicidality
  • Severe drug abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139502

Contacts
Contact: Erik Falkum, MD, PhD +47 22 92 34 59 erik.falkum@medisin.uio.no
Contact: Torill Ueland, PhD +47 91 72 53 39 torill.ueland@medisin.uio.no

Locations
Norway
Department of Research and Development, clinic for Mental Health, Oslo University Hospital Recruiting
Oslo, Norway
Contact: Erik Falkum, MD, PhD     +47 22 92 34 59     erik.falkum@medisin.uio.no    
Contact: Torill Ueland, PhD     +47 91 72 53 39     torill.ueland@medisin.uio.no    
Principal Investigator: Erik Falkum, MD, PhD            
Sponsors and Collaborators
Oslo University Hospital
Directorate of Health, Norway
Stiftelsen Helse og Rehabilitering
Helse Sor-Ost
Investigators
Study Director: Erik Falkum, MD, PhD Department of Research and Development, Oslo University Hospital, Norway
  More Information

No publications provided

Responsible Party: Erik Falkum, professor of psychiatry, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01139502     History of Changes
Other Study ID Numbers: CogTherCogTrainWork
Study First Received: June 2, 2010
Last Updated: August 8, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
schizophrenia spectrum disorders
work rehabilitation
cognitive therapy
 cognitive training
Adaptation to work in persons with psychotic illness
Work as a treatment and rehabilitation factor in severe mental illness

Additional relevant MeSH terms:
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013