Enrichment of Day Centers in Community-based Psychiatry

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Swedish Research Council
Information provided by (Responsible Party):
Mona Eklund, Lund University
ClinicalTrials.gov Identifier:
NCT01732575
First received: November 13, 2012
Last updated: November 19, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Enrichment With Meaning-generating Activities
Rehabilitation as Usual
Behavioral: Enrichment with meaning-generating activities

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of an Intervention Tailored for Day Centers for People With Psychiatric Disabilities

Resource links provided by NLM:


Further study details as provided by Lund University:

Primary Outcome Measures:
  • Score on questionnaire regarding perceived meaning in day center occupations [ Time Frame: Up to 14 months ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Score on satisfction with the rehabilitation [ Time Frame: Up to 14 months ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Quality of life score [ Time Frame: Up to 14 monts ] [ Designated as safety issue: No ]

    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.



Enrollment: 107
Study Start Date: October 2008
Estimated Study Completion Date: February 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enrichment
Enrichment with meaning-generating activities
Behavioral: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Lund University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mona Eklund, Professor, Lund University
ClinicalTrials.gov Identifier: NCT01732575     History of Changes
Other Study ID Numbers: Enrich
Study First Received: November 13, 2012
Last Updated: November 19, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Lund University:
everyday activities
rehabilitation
mental illness
occupational therapy

ClinicalTrials.gov processed this record on October 30, 2014