Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01139502 |
| Other study ID # |
CogTherCogTrainWork |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
June 2, 2010 |
| Last updated |
October 15, 2015 |
| Start date |
January 2010 |
| Est. completion date |
March 2014 |
Study information
| Verified date |
June 2013 |
| Source |
Oslo University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Norway:National Committee for Medical and Health Research Ethics |
| Study type |
Interventional
|
Clinical Trial 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
Description:
Cognitive behaviour therapy and cognitive training in work rehabilitation for persons with
severe mental illness.
A randomised controlled trial
Introduction 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 in the detailed description
below. The counties will be randomised to the two different intervention groups: 1. a group
receiving CBT inspired work rehabilitation, and 2. a group receiving work rehabilitation
integrated with 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 in a District Psychiatric Centre (DPS), and by a local
psychiatrist/psychologist. 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.
Background Vulnerability and stress in schizophrenia Schizophrenia is a mental disorder
characterised by psychotic symptoms, apathy, social isolation and cognitive problems, which
often reduce the functional capacity in central life arenas. Patients have problems in
school and at work, with being a parent or friend, and in severe cases with being able to
live on their own and cope with the challenges of daily life (Mueser & McGurk 2004).
Schizophrenia is one of the ten most important causes of severe chronic disability (Velligan
& Gonzales 2007). The course of the disease is perhaps best described and understood by the
so-called stress/diathesis model. According to this model the person has a psychobiological
vulnerability basically determined by genetic and perinatal environmental factors. The debut
and course of the disease is determined by a dynamic interplay between biological and
psychosocial factors. Medication and use of legal and illegal drugs are the most important
biological factors. Antipsychotic medication can reduce symptom intensity and the
probability of relapse, whereas drug abuse often has the opposite effects. The most
important psychosocial factors are perceived stress, social support, and the patient's
coping profile. High levels of stress can increase the biological vulnerability, symptom
intensity, and relapse probability, whereas social support and the development of social
abilities and problem solving skills tend to protect the individual.
Cognitive behaviour therapy Cognitive behaviour therapy (CBT) in schizophrenia was
originally developed to help the patient cope with delusions and hallucinations that did not
respond to medical treatment. CBT assumes that delusions and hallucinations are influenced
by the person's problems sorting and interpreting information, and that cognitive
interventions can increase coping(Velligan & Gonzales 2007). Therapist and patient examine
the contents of the symptoms in detail, and explore whether the symptoms can be understood
in new and more functional ways. Controlled studies clearly support the efficacy of CBT in
schizophrenia (Tarrier & Wykes 2004, Turkington et al 2004).
The explanatory model of CBT, including core concepts as schema, automatic thoughts,
socratic questioning, and alternative thoughts, now colour most of the rehabilitation
programmes in schizophrenia.
Cognitive training It was previously assumed that the reason why persons with psychotic
diseases have problems in daily life is their reduced sense of reality, delusions and
hallucinations. Today there is consensus that the problem is far more complex. Research
shows that neurocognitive dysfunction is prevalent in persons with schizophrenia, and that
this rather stable dysfunction is an important prognostic factor (Velligan et al 1997). The
patients have problems with memory, attention, problem solving capacity, and reduced
psychomotor speed. It has been demonstrated that neurocognitive dysfunction impacts more
strongly on activities of daily life than do positive symptoms of psychosis, and that it
predicts coping about as strongly as negative symptoms (Green et al 2000). Neurocognitive
dysfunction impairs the person's ability to learn new skills, social relations, academic
capacity and work capacity. It is particularly manifested as attention and concentration
problems, when complex work tasks must be solved under time pressure. Consequently, many of
these patients have problems handling jobs and academic courses that demand speed and mental
flexibility. They have serious problems qualifying for a job, and if employed they tend to
loose their job more often than other workers, with adverse social, economic and mental
consequences. These patients also strive to cope with rehabilitation projects involving many
people (Bell & Bryson 2001). Today several researchers maintain that neurocognitive
dysfunction is the key problem in schizophrenia.
These findings have produced new rehabilitation programmes aiming at developing or restoring
neurocognitive function (McGurk et al 2007). Cognitive rehabilitation focuses on improving
function through a) reinforcement or reestablishment of previously learned behaviour, b)
establishment of new cognitive abilities or compensatory mechanisms for impaired
neurological systems (Harley et al 1992). These methods have for many years been used
successively in treatment of patients with brain damages. Great progress has been made in
this field during the last two decades, and training programmes are now also available for
persons with mental disorders. The effects of cognitive rehabilitation have been examined in
controlled studies showing that neurocognitive function can be improved by structured
training (Ueland & Rund 2005), and as a consequence psychosocial adaptation may be improved.
Work rehabilitation in schizophrenia The National Norwegian Development Plan for Mental
Health (Opptrappingsplanen for psykisk helse) states that work and meaningful activities are
important sources of social identity and self esteem.
Work rehabilitation for patients with schizophrenia and other psychotic disorders
traditionally has been a great challenge both in Norway and other countries. Even though
about half of the patients want a job, only a minority of these are employed (McGurk &
Mueser 2004). Chronic social dysfunction makes it difficult to compete effectively on the
ordinary job market. Optimal treatment of symptoms combined with cognitive training that
increase competence may somewhat improve their chances, but recent studies indicate that for
many patients adjustments of job demands are necessary in addition to continuing support to
cope with the job (Drake et al 1999). More than 50% of the participants cope in supported
employment programmes in the US, compared to only 20% in control groups. Programmes
combining cognitive training with supported employment seem to be particularly promising
(Wexler & Bell 2005, McGurk & Mueser 2004). These programmes reduce stress through personal
support and tailoring of job demands, and increase competence through cognitive training.
Prejudice and lack of openness and understanding are still prevalent at the work place, and
tend to prevent successful work rehabilitation of patients with psychotic disorders. Like
family members leaders and colleagues may easily perceive symptoms as incomprehensible and
frightening or as expressions of laziness or hostility, and react negatively and correcting,
with the same adverse consequences. In a pilot project we investigated whether the
psycho-educative method could be adapted and used in work rehabilitation of patients with
severe mental disorder. The goal of this project was to examine whether the psycho-educative
method used in work rehabilitation can increase the chances that persons with severe mental
disorders will cope with a job, and, secondly, to develop good models of collaboration
between the welfare institutions to improve work rehabilitation for persons with severe
mental disorders. Two external evaluations of the pilot project concluded that both the
psycho-educative method and the other cognitive methods can be adapted to the work
rehabilitation context, and that the organised collaboration between clinicians and job
consultants has a great potential. The participants were generally very stable and evaluated
the experience positively. The engagement in the pilot project grew over time both in the
work and welfare system and in the psychiatric health care system (DPS), and so it was
decided to spread the project to nine different counties.
Research questions
The present project will compare the effects of cognitive behaviour therapy and 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.
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
Material and Method
Material Persons with DSM-IV schizophrenia spectrum disorders about to start work
rehabilitation will be recruited in nine different counties in Norway. From each county
around 27-30 patients can be recruited during a two-year period, giving a total of a little
less than 250 patients.
Method
Instruments
The following instruments will be used:
Diagnosis: The MINI interview (Sheehan et al 1997). Intensity of positive and negative
symptoms: The Health of the Nation Scale (HoNOS, Wing et al 1996), The Apathy Evaluation
Scale (self rating version) (Marin et al 1991), and the PANSS (Key et al 1987).
Global functioning: The Global Assessment of Functioning Scale (GAF) (APA 1987).
Complicating drug abuse: The Alcohol Use Disorders Identification Test (AUDIT) (Saunders et
al 1993) and Drug Use Disorders Identification Test (DUDIT) (Bermann et al 2005).
Cognitive functioning: The Measurement and Treatment Research to Improve Cognition in
Schizophrenia (MATRIX)-battery (Marder et al 2004).
Relations to leaders and colleagues: The Felt Expressed Emotion Rating Scale (FEERS, Bentsen
1999).
Work performance: The Work Behavior Inventory (Bell et al 2004)
Intervention CBT in work rehabilitation: The contents of the psychoeducative classes in the
pilot study has been adjusted and standardised. Classes will be offered to all employees in
the participating companies. Central themes are symptoms, course, methods of treatment,
rehabilitation, relapse prevention and prognosis in schizophrenia and other psychoses. The
core elements and the basic ways of reasoning in CBT (schema, automatic and alternative
thoughts) will be particularly emphasised. The DPS supervisor in each county will meet the
job consultants weekly through the whole project period and be easily available for
consultations on telephone. The central supervision focus will be current communicative and
behavioural problems at the work site. Attempts to solve such problems will continuously
include the participants. Each participant will be offered 10 months in the project.
Cognitive training: The cognitive training will be computer based and use a programme
package developed by dr. psychol. Torill Ueland. The programmes include training of
attention, memory, executive functioning, and psychomotor speed. Computer based training
allows for multi-sensoric feedback and positive reinforcement. Moreover, computer based
training can be used individually in that the degree of difficulty can be varied . This is
important since neurocognitive profile and functioning vary among patients. Group training
is economically attractive since one person can administrate the programme to six persons
simultaneously. The programme package has been adapted to the Norwegian context, but the
selection of tasks is based on international research. It combines tasks originally
developed for patients with brain injuries (Cog Rehab) and tasks developed for psychiatric
patients (Cogpack). Tasks from both sources have been used in several previous studies (Bell
et al 2001, McGurk et al 2005).
Design Six counties have been randomised to one (n=80) of the two intervention groups. A
matched control group (treatment as usual, n=80) will be established in three other
counties. With a total N=160 for comparison of two groups, a significance level of 0.05 and
a power level of 0.80, a standardised group difference of 0.44 can be detected. The
standardised difference between supported employment and treatment as usual in comparable
American studies have been as high as 0.80 (Velligan & Gonzales 2007), meaning that N should
be acceptable in the present project.
