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

NCT01139502 | Completed DMC

• 1 other identifier: CogTherCogTrainWork
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Keywords

schizophrenia spectrum disorders; work rehabilitation; cognitive therapy; cognitive training; Adaptation to work; Work as a treatment factor

Outcome Measures

Primary Outcomes (1)

• The Work Behavior Inventory

  The instrument assesses various dimensions of the participant's work performance

  Ten months

Secondary Outcomes (6)

• The Global Assessment of Function

  Ten months

• The Positive and Negative Symptom Scale (PANSS)

  Ten months

• The Apathy Evaluation Scale

  Ten months

• The Alcohol Use Disorder Identification Test

  Ten months

• The Drug Use Disorder Identification Test

  Ten months

Study Arms (2)

Work rehab with cognitive therapy

ACTIVE COMPARATOR

Work rehabilitation based on the cognitive therapeutical model

Behavioral: Work rehabilitation based on the cognitive therapeutical model

Work rehab with cognitive training

ACTIVE COMPARATOR

Work rehabilitation with the addition of weekly training of concentration, memory, and executive function

Behavioral: Work rehabilitation with the addition of cognitive training

Interventions

Work rehabilitation based on the cognitive therapeutical model BEHAVIORAL

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 rehab with cognitive therapy

Work rehabilitation with the addition of cognitive training BEHAVIORAL

Work rehabilitation with the addition of two hours weekly training of concentration, memory, and executive function

Work rehab with cognitive training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons with schizophrenia spectrum disorders

You may not qualify if:

• IQ \<70
• neurological disease diagnosis
• Active suicidality
• Severe drug abuse

Sponsors & Collaborators

• Oslo University Hospital: lead
• The Royal Norwegian Ministry of Health: collaborator
• Stiftelsen Helse og Rehabilitering: collaborator
• Helse Sor-Ost: collaborator

Study Sites (1)

Department of Research and Development, clinic for Mental Health, Oslo University Hospital

Oslo, Norway

Location

Related Publications (3)

• Klungsoyr O, Lystad JU, Bull H, Evensen S, Ueland T, Falkum E. G-estimation of causal pathways in vocational rehabilitation for adults with psychotic disorders - a secondary analysis of a randomized trial. BMC Psychiatry. 2021 Jul 23;21(1):370. doi: 10.1186/s12888-021-03349-1.

  PMID: 34301224 DERIVED

• Evensen S, Wisloff T, Lystad JU, Bull H, Martinsen EW, Ueland T, Falkum E. Exploring the potential cost-effectiveness of a vocational rehabilitation program for individuals with schizophrenia in a high-income welfare society. BMC Psychiatry. 2019 May 7;19(1):140. doi: 10.1186/s12888-019-2130-7.

  PMID: 31064371 DERIVED

• Falkum E, Klungsoyr O, Lystad JU, Bull HC, Evensen S, Martinsen EW, Friis S, Ueland T. Vocational rehabilitation for adults with psychotic disorders in a Scandinavian welfare society. BMC Psychiatry. 2017 Jan 17;17(1):24. doi: 10.1186/s12888-016-1183-0.

  PMID: 28095813 DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Erik Falkum, MD, PhD

  Department of Research and Development, Oslo University Hospital, Norway

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 8, 2010
• Study Start: January 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 16, 2015

Record last verified: 2013-06

Locations

NO (1)