Enrichment With Meaning-generating ActivitiesNCT01732575
Enrichment of Day Centers in Community-based Psychiatry
A study testing Enrichment with meaning-generating activities in people with Enrichment With Meaning-generating Activities and Rehabilitation as Usual, run by Lund University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Enrichment With Meaning-generating Activities, Rehabilitation as Usual
- What is being tested?
- Enrichment with meaning-generating activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe mental illness > 2 years
- age 18-65 years
- visiting the day center > 4 hrs per week
Who cannot join
- comorbidity of dementia or developmental disorder
- acute psychosis
- primary diagnosis of substance use disorder
- insufficient knowledge of Swedish
About this study
Official title: 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.
Read more
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.
- Being tested
- Enrichment with meaning-generating activities
- Keywords
- everyday activities, rehabilitation, mental illness, occupational therapy
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enrichment with meaning-generating activitiesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Enrichment | Experimental | Enrichment with meaning-generating activities Receives: Behavioral: Enrichment with meaning-generating activities |
| Rehabilitation as usual | No intervention | The ongoing, normal day center program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on questionnaire regarding perceived meaning in day center occupations
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.
Measured: Up to 14 months
Secondary outcomes (1)
Score on satisfction with the rehabilitation
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.
Measured: Up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startOct 2008
- Primary completionFeb 2012
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enrichment With Meaning-generating ActivitiesStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Principal investigator, Mona Eklund, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732575
- Sponsor's protocol ID
- Enrich
- Status last verified
- Aug 2015
- First submitted
- 13 Nov 2012
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Eklund M, Sandlund M. Predictors of valued everyday occupations, empowerment and satisfaction in day centres: implications for services for persons with psychiatric disabilities. Scand J Caring Sci. 2014 Sep;28(3):582-90. doi: 10.1111/scs.12085. Epub 2013 Oct 8.
PubMed 25066326
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Intervention Tailored for Day Centers for People With Psychiatric Disabilities
- ClinicalTrials.gov ID
- NCT01732575
- Acronym / sponsor ID
- Enrich
- Keywords
- everyday activities, rehabilitation, mental illness, occupational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- Oct 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 26 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enrichment | Experimental | Behavioral: Enrichment with meaning-generating activitiesEnrichment with meaning-generating activities |
| Rehabilitation as usual | No intervention | –The ongoing, normal day center program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- severe mental illness > 2 years
- age 18-65 years
- visiting the day center > 4 hrs per week
Key exclusion criteria (4 listed)
- comorbidity of dementia or developmental disorder
- acute psychosis
- primary diagnosis of substance use disorder
- insufficient knowledge of Swedish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enrichment with meaning-generating activitiesGaps 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. | Behavioural | Enrichment |
Primary outcome
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.
1 secondary outcome
Score on satisfction with the rehabilitation
Time frame: Up to 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
- Derived from this study: PubMed 25066326Eklund M, Sandlund M. Predictors of valued everyday occupations, empowerment and satisfaction in day centres: implications for services for persons with psychiatric disabilities. Scand J Caring Sci. 2014 Sep;28(3):582-90. doi: 10.1111/scs.12085. Epub 2013 Oct 8.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Enrichment with meaning-generating activities in people with Enrichment With Meaning-generating Activities and Rehabilitation as Usual, run by Lund University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on questionnaire regarding perceived meaning in day center occupations (time frame: Up to 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01732575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2015.