Enrichment of Day Centers in Community-based Psychiatry

August 24, 2015 updated by: Mona Eklund, Lund University

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enrichment
Enrichment with meaning-generating activities
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.
No Intervention: Rehabilitation as usual
The ongoing, normal day center program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

Up to 14 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

Up to 14 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

Up to 14 monts

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

November 13, 2012

First Submitted That Met QC Criteria

November 19, 2012

First Posted (Estimate)

November 26, 2012

Study Record Updates

Last Update Posted (Estimate)

August 25, 2015

Last Update Submitted That Met QC Criteria

August 24, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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