Condition category
Mental and Behavioural Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
18/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.kenniscentrumrehabilitatie.nl

Contact information

Type

Scientific

Primary contact

Dr W. Swildens

ORCID ID

Contact details

Altrecht Institute for Mental Health Care
Lange Nieuwstraat 119
Utrecht
3512 PG
Netherlands
+31 (0)30 2308820
w.swildens@altrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness of the psychiatric rehabilitation approach in the Netherlands

Acronym

Study hypothesis

The central research question is: what is the effectiveness of psychiatric rehabilitation (PR) in attaining patients personal rehabilitation goals, in improving patients functioning, empowerment and quality of life compared to 'rehabilitation as usual'?

PR is a systematic rehabilitation process consisting of three phases:
1. Diagnosis: helping patients gain insight into their future goals in the rehabilitation areas (housing, work/daily activities, learning and social contacts), and insight into which skills and resources are needed to attain these goals
2. Planning: describing the interventions necessary to attain the clients' rehabilitation goals
3. Intervention: conducting resource development and/or skill development

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Psychiatric mental disorders/illness

Intervention

The study is designed as a randomised controlled trial (RCT) in four mental health organisations, comparing:
1. PR by fully trained rehabilitation workers (EXP)
3. ‘Rehabilitation as usual’ by case managers/psychiatric–MHC nurses with no PR training (CC)

A total of 160 patients were planned to be included in the RCT: 80 EXP and 80 CC. Fidelity criteria for the performance of PR in the experimental condition were developed at the start of the study. The patients can receive either the PR intervention or ‘rehabilitation as usual’ during the whole research period of two years following randomisation.

In both conditions there is a minimum of at least once per three weeks an individual contact between the patient and the rehabilitation worker.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome criterion is goal attainment. Patients are interviewed three times, at the start (T0) after one year (T1) and after two years (T2). At the same time rehabilitation workers and psychiatrists are asked to fill out questionnaires.

Secondary outcome measures

Other outcome criteria are (changes in):
1. Functioning
2. Empowerment
3. Quality of life
4. Met and unmet needs for care

Overall trial start date

01/05/2003

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults with severe mental illness who receive Mental Health Care (MHC) in clinical settings or in out-patients settings
2. Must have a wish for change in at least one of the main rehabilitation areas (housing, work/daily activities, learning and social contacts)
3. Patients must have new goals: he/she is not already trying to obtain the goals mentioned with a rehabilitation worker
4. Patients must accept the rehabilitation offer and participate in the research
5. Patients should be willing to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

157

Participant exclusion criteria

There are no other exclusion criteria patients with severe mental illness with different ages, and different psychiatric diagnosis can participate

Recruitment start date

01/05/2003

Recruitment end date

01/01/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Altrecht Institute for Mental Health Care
Utrecht
3512 PG
Netherlands

Sponsor information

Organisation

Altrecht Institute for Mental Health Care (The Netherlands)

Sponsor details

Nieuwstraat 119
Utrecht
3512 PG
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Funder name

Groningen Mental Health Care (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bavo RNO Group (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Eindhoven Mental Health Care (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Altrecht Mental Health Care (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 24-month outcome results in http://www.ncbi.nlm.nih.gov/pubmed/22152644
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26979849

Publication citations

  1. Swildens W, van Busschbach JT, Michon H, Kroon H, Koeter MW, Wiersma D, van Os J, Effectively working on rehabilitation goals: 24-month outcome of a randomized controlled trial of the Boston psychiatric rehabilitation approach., Can J Psychiatry, 2011, 56, 12, 751-760.

  2. Results

    van Busschbach JT, Swildens W, Michon H, Kroon H, Koeter M, Wiersma D, van Os J, Working effectively towards rehabilitation goals: long-term outcome of a randomised controlled trial of the Boston psychiatric rehabilitation approach, Tijdschr Psychiatr, 2016, 58, 3, 179-89.

Additional files

Editorial Notes

18/03/2016: Publication reference added.