<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01732575</url>
  </required_header>
  <id_info>
    <org_study_id>Enrich</org_study_id>
    <nct_id>NCT01732575</nct_id>
  </id_info>
  <brief_title>Enrichment of Day Centers in Community-based Psychiatry</brief_title>
  <official_title>Effectiveness of an Intervention Tailored for Day Centers for People With Psychiatric Disabilities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Swedish Research Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lund University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This RCT study addresses the topic of improving the possibilities for people with severe&#xD;
      mental illness (SMI) to be engaged in meaningful daily occupations at community-based&#xD;
      activity (CBA) centers. Meaningful occupation, which includes not only work-related&#xD;
      activities, but also leisure, household and social activities, is assumed to generate health&#xD;
      and wellbeing. It is well established that there is a relationship between satisfaction with&#xD;
      daily occupations and well-being.&#xD;
&#xD;
      A Swedish mental health care reform stated that the social services should provide meaningful&#xD;
      daily occupations to people with SMI. However, evaluations of the effects of the reform&#xD;
      conclude that the target group's needs for meaningful daily occupation have not been met.&#xD;
&#xD;
      Thus, on the basis of governmental reports and evaluations, there is an urgent need for&#xD;
      improving the quality of the activities and support offered at CBA centers. Therefore, the&#xD;
      overarching aim of this project is to develop and implement an intervention method for&#xD;
      improving the activities offered and support given at CBA centers, and evaluate the outcomes&#xD;
      of that intervention.&#xD;
&#xD;
      Specific aims&#xD;
&#xD;
        -  Developing and implementing an intervention that means reorganization of CBA centers in&#xD;
           such a way that they become enriched with characteristics that have been identified as&#xD;
           rewarding and meaningful in previous research.&#xD;
&#xD;
        -  Evaluating the outcome of that intervention on:&#xD;
&#xD;
             -  the unit level, i.e., in terms of changes in the characteristics of the CBA&#xD;
                centers,&#xD;
&#xD;
             -  the individual level, in terms of changes among the consumers regarding&#xD;
                satisfaction with the activities at the CBA center, perceived control, social&#xD;
                interaction, quality of life, etc.&#xD;
&#xD;
      Cluster randomization is used. Day centers are randomized to either giving the new&#xD;
      intervention (&quot;enrichment&quot;) or continuing with &quot;care as usual&quot; during the study period, which&#xD;
      is 14 months. This means that all participants in a day center get the type care their&#xD;
      specific day center offers during the study period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2008</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">February 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Score on questionnaire regarding perceived meaning in day center occupations</measure>
    <time_frame>Up to 14 months</time_frame>
    <description>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.&#xD;
Nilsson, I., Argentzell, E., Sandlund, M., Leufstadius, C., &amp; Eklund, M. (2011). Measuring perceived meaningfulness in day centres for persons with mental illness. Scand J Occup Ther, 18(4), 312-320.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Score on satisfction with the rehabilitation</measure>
    <time_frame>Up to 14 months</time_frame>
    <description>The instrument is widely used an well-tested. It is a self-report measure that targets satisfaction with the care/rehabilitation received.&#xD;
Larsen, D. L., Attkisson, C. C., Hargreaves, W. A., &amp; Nguyen, T. D. (1979). Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann, 2(3), 197-207.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of life score</measure>
    <time_frame>Up to 14 monts</time_frame>
    <description>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.&#xD;
Priebe, S., Huxley, P., Knight, S., &amp; Evans, S. (1999). Application and results of the Manchester Short Assessment of Quality of Life (MANSA). Int J Soc Psychiatry, 45(1), 7-12.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">107</enrollment>
  <condition>Enrichment With Meaning-generating Activities</condition>
  <condition>Rehabilitation as Usual</condition>
  <arm_group>
    <arm_group_label>Enrichment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrichment with meaning-generating activities</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rehabilitation as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The ongoing, normal day center program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enrichment with meaning-generating activities</intervention_name>
    <description>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.</description>
    <arm_group_label>Enrichment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  severe mental illness &gt; 2 years&#xD;
&#xD;
          -  age 18-65 years&#xD;
&#xD;
          -  visiting the day center &gt; 4 hrs per week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  comorbidity of dementia or developmental disorder&#xD;
&#xD;
          -  acute psychosis&#xD;
&#xD;
          -  primary diagnosis of substance use disorder&#xD;
&#xD;
          -  insufficient knowledge of Swedish&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>August 24, 2015</last_update_submitted>
  <last_update_submitted_qc>August 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 25, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lund University</investigator_affiliation>
    <investigator_full_name>Mona Eklund</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>everyday activities</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>mental illness</keyword>
  <keyword>occupational therapy</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01732575
org study id: Enrich
nct id: NCT01732575
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Score on questionnaire regarding perceived meaning in day center occupations
time frame: Up to 14 months
description: 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.
measure: Score on satisfction with the rehabilitation
time frame: Up to 14 months
description: 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.
measure: Quality of life score
time frame: Up to 14 monts
description: 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.
arm group label: Enrichment
arm group type: Experimental
description: Enrichment with meaning-generating activities
arm group label: Rehabilitation as usual
arm group type: No Intervention
description: The ongoing, normal day center program.
intervention type: Behavioral
intervention name: Enrichment with meaning-generating activities
description: 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.
arm group label: Enrichment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Lund University
investigator full name: Mona Eklund
investigator title: Professor