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Completed

NCT Number: NCT01732575

Enrichment of Day Centers in Community-based Psychiatry

This RCT study addresses the topic of improving the possibilities for people with severe mental illness (SMI) to be engaged in meaningful daily occupations at community-based activity (CBA) centers. Meaningful occupation, which includes not only work-related activities, but also leisure, household and social activities, is assumed to generate health and wellbeing. It is well established that there is a relationship between satisfaction with daily occupations and well-being.

A Swedish mental health care reform stated that the social services should provide meaningful daily occupations to people with SMI. However, evaluations of the effects of the reform conclude that the target group's needs for meaningful daily occupation have not been met.

Thus, on the basis of governmental reports and evaluations, there is an urgent need for improving the quality of the activities and support offered at CBA centers. Therefore, the overarching aim of this project is to develop and implement an intervention method for improving the activities offered and support given at CBA centers, and evaluate the outcomes of that intervention.

Specific aims

* Developing and implementing an intervention that means reorganization of CBA centers in such a way that they become enriched with characteristics that have been identified as rewarding and meaningful in previous research. * Evaluating the outcome of that intervention on:

* the unit level, i.e., in terms of changes in the characteristics of the CBA centers, * the individual level, in terms of changes among the consumers regarding satisfaction with the activities at the CBA center, perceived control, social interaction, quality of life, etc.

Cluster randomization is used. Day centers are randomized to either giving the new intervention ("enrichment") or continuing with "care as usual" during the study period, which is 14 months. This means that all participants in a day center get the type care their specific day center offers during the study period.

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Key information

Conditions

Enrichment With Meaning-generating Activities Mental Disorders Rehabilitation as Usual

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • severe mental illness > 2 years
  • age 18-65 years
  • visiting the day center > 4 hrs per week

Exclusion criteria

  • comorbidity of dementia or developmental disorder
  • acute psychosis
  • primary diagnosis of substance use disorder
  • insufficient knowledge of Swedish

Treatment and study plan

Enrichment with meaning-generating activities

Behavioral

Gaps in the rehabilitation are identified by staff and researchers in dialogue. Staff gets relevant education. An intervention is tailored by staff and researchers to bridge the gaps. Consumers have a say and the intervention is revised accordingly. The intervention is implemented and continues for 14 months.

Primary outcomes

  1. Score on questionnaire regarding perceived meaning in day center occupations

    Time frame: Up to 14 months

    A self-report measure, Estimation of Perceived Meaning in Day Centers (EPM-DC,) has been developed in previous research. It is a psychometrically sound instrument for assessing meaningfulness in the day center context.

    Nilsson, I., Argentzell, E., Sandlund, M., Leufstadius, C., & Eklund, M. (2011). Measuring perceived meaningfulness in day centres for persons with mental illness. Scand J Occup Ther, 18(4), 312-320.

Secondary outcomes

  1. Score on satisfction with the rehabilitation

    Time frame: Up to 14 months

    The instrument is widely used an well-tested. It is a self-report measure that targets satisfaction with the care/rehabilitation received.

    Larsen, D. L., Attkisson, C. C., Hargreaves, W. A., & Nguyen, T. D. (1979). Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann, 2(3), 197-207.

Other outcomes

  1. Quality of life score

    Time frame: Up to 14 monts

    The individual assesses his/her quality of life according to the MANSA scale, which is a self-report measure asking for satisfaction in 11 life domains.

    Priebe, S., Huxley, P., Knight, S., & Evans, S. (1999). Application and results of the Manchester Short Assessment of Quality of Life (MANSA). Int J Soc Psychiatry, 45(1), 7-12.

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • The Swedish Research Council

Registry information

Official study title

Effectiveness of an Intervention Tailored for Day Centers for People With Psychiatric Disabilities

Important dates

Study start
2008
Primary completion
2012
Study completion
2015
First posted
Nov 26, 2012
Registry last updated
Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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