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

Summary

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

Conditions

• Mental Illness

Interventions

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.

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

Sponsors & Collaborators

• The Royal Norwegian Ministry of Health

  collaborator OTHER

• Stiftelsen Helse og Rehabilitering

  collaborator OTHER

• Helse Sor-Ost

  collaborator OTHER_GOV

• Oslo University Hospital

  lead OTHER

Principal Investigators

• Erik Falkum, MD, PhD · Department of Research and Development, Oslo University Hospital, Norway

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2014-03-31

Completion

2014-03-31

Countries

• Norway

Study Locations