Cognitive Behaviour Therapy and Cognitive Training in Work Rehabilitation for Persons With Severe Mental Illness
Condition: Mental Illness
MeSH terms: Mental Disorders
Study type: Interventional

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
    

Detailed 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.
    

Intervention name(s): Work rehabilitation based on the cognitive therapeutical model; Work rehabilitation with the addition of cognitive training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; Work rehabilitation with the addition of two hours weekly training of concentration, memory, and executive function
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia spectrum disorders; work rehabilitation; cognitive therapy; cognitive training; Adaptation to work; Work as a treatment factor