Cognitive Behaviour Therapy and Cognitive Training in Work Rehabilitation for Persons With Severe Mental Illness
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|ClinicalTrials.gov Identifier: NCT01139502|
Recruitment Status : Completed
First Posted : June 8, 2010
Last Update Posted : October 16, 2015
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.
- 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
- The global psychosocial function of patients at T2 and T3 will be higher in the cognitive training group than in the control group
|Condition or disease||Intervention/treatment||Phase|
|Mental Illness||Behavioral: Work rehabilitation based on the cognitive therapeutical model Behavioral: Work rehabilitation with the addition of cognitive training||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cognitive Therapy and Cognitive Training in Work Rehabilitation for Persons With Severe Mental Illness. A Randomised Controlled Trial|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
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
- The Work Behavior Inventory [ Time Frame: Ten months ]The instrument assesses various dimensions of the participant's work performance
- The Global Assessment of Function [ Time Frame: Ten months ]Assesses adaptation and general function of the participant
- The Positive and Negative Symptom Scale (PANSS) [ Time Frame: Ten months ]Assesses the number and intensity of symptoms
- The Apathy Evaluation Scale [ Time Frame: Ten months ]Assesses the intensity of apathy in the participant
- The Alcohol Use Disorder Identification Test [ Time Frame: Ten months ]Assesses health problems caused by use of alcohol
- The Drug Use Disorder Identification Test [ Time Frame: Ten months ]Assesses health problems caused by drug use
- The Measurement and Treatment Research to Improve Cognitive Function in Schizophrenia [ Time Frame: Ten months ]Assesses concentration, memory, and executive function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139502
|Department of Research and Development, clinic for Mental Health, Oslo University Hospital|
|Study Director:||Erik Falkum, MD, PhD||Department of Research and Development, Oslo University Hospital, Norway|