- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06695975
Occupational Self Analysis in People with a Serious Mental Illness.
Occupational Self Analysis in People with a Serious Mental Illness on Occupational Balance, Participation in Meaningful Activities and Life Satisfaction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The appearance of a mental disorder forces the person to modify their occupational choices and participation, due, among other aspects, to the continuous presence of symptoms and relapses. 'Occupational self-analysis' programs are based on increasing occupational awareness to promote changes in meaningful occupational participation. The objective of this study was to test the effectiveness of the 'Occupational self-analysis' program in people with Serious Mental Disorder specially on life satisfaction, participation in meaningful activities, perception of balance and occupational satisfaction, compared to the standard intervention received in a Therapeutic Community of Mental Health.
The program was implemented for 4 months, twice a week, while the control group received the standard treatment.
Ten people participated in the 'Occupational self-analysis' program. Results show that participants improved their perception of occupational balance and occupational satisfaction, as well as increasing their participation in meaningful activities.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sevilla
-
Dos Hermanas, Sevilla, Spain
- Comunidad Terapeutica de salud mental Valme
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having a serious mental illness
- Living in the Therapeutic Community or attend the device's day program.
Exclusion Criteria:
- Havin Acute psychopathology
- Diagnosis of cognitive impairment
- Dependence or abuse of toxic substances
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Occupational self-analysis
"Occupational Self-Analysis" program had the focus on increasing "occupational awareness", making it easier for the participants to analyze their occupations, reflect on whether the activities in which they were involved were meaningful to them and learn about their supports and barriers for occupational participation which allowed modifications to their occupational routines
|
Occupational self analysis program is delivered in group sessions, each session lasting 45 minutes, twice a week. Also Individual sessions are held throughout the program with each participant, with the intention of clarifying certain concepts and resolving specific difficulties that were occurring.The thematic modules worked are 5; occupation-health and difficulty, occupational balance, adaptation strategies to difficulties, social relationships and knowing other realities. The methodological strategies used to structure the program were the Model of Human Occupation (MOHO) and the See-Judge-Act methodology |
|
No Intervention: Control group
The control group did not receive any specific intervention, and free time was simply included in their agenda within the Mental Helath Therapeutic Community.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction with Life Scale
Time Frame: From enrollment to the end of treatment at 16 weeks
|
It is a self-administered questionnaire that consists of 5 items.
It measures the subjective criterion of life satisfaction, with multiple response alternatives ranging between 5 (strongly agree) and 1 (strongly disagree).
The score ranges between 5 and 25.
The reliability index calculated for the Cronbach's alpha scale indicates that the scale had acceptable internal consistency
|
From enrollment to the end of treatment at 16 weeks
|
|
Occupational Balance Questionnaire
Time Frame: From enrollment to the end of treatment at 16 weeks
|
It consists of a brief self-report questionnaire with 13 items that measure occupational balance.
The person has to rate the degree of agreement with each of the statements presented.
A 6-point ordinal scale is used ranging from 0 (strongly disagree) to 5 (strongly agree).
Thus, the maximum score that can be obtained is 65 points by adding the points for each item which means the greater the occupational balance.
The scale, in its Spanish version, has adequate psychometric properties.
|
From enrollment to the end of treatment at 16 weeks
|
|
Engagement in Meaningful Activities Scale
Time Frame: From enrollment to the end of treatment at 16 weeks
|
Is the adaptation to the Spanish context of the "Engagement in Meaningful Activities Survey" (EMAS) (Goldberg et al., 2002) , it is a self-report, it consists of 12 items, developed specifically for people with SMI.
Measures the degree of participation in meaningful activities.
Items are answered using a 4-point Likert scale ranging from 1 (never) to 4 (always).
The score is obtained by the sum of the responses to the 12 items, which ranges from 12-48.
|
From enrollment to the end of treatment at 16 weeks
|
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Satisfaction with Daily Occupation - Occupational Balance (SODEO)
Time Frame: From enrollment to the end of treatment at 16 weeks
|
It is an instrument based on an interview that consists of 13 items organized under 4 areas: Productivity, Leisure or free time, Housework and Self-care.
Evaluates: The number of activities in which the person participates daily, the score can range between 0 and 13.
The occupational satisfaction derived from participating in this activity, the participant rates each item ranging from 1 (extremely dissatisfied) to 7 (extremely dissatisfied).
satisfied).
The satisfaction score can range between 13 and 91.
And the perceived occupational balance within each area in terms of doing very little (-2), little (-1), neither much nor little (0), a lot (1) or too much (2).
The score range is between -8 and 8.
|
From enrollment to the end of treatment at 16 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Fernandez-Solano AJ, Del Bano-Aledo ME, Rodriguez-Bailon M. From thinking to acting: occupational self-analysis tools for use with people with intellectual disability. A pilot study. J Intellect Disabil Res. 2019 Sep;63(9):1086-1096. doi: 10.1111/jir.12621. Epub 2019 Apr 24.
- Fernandez-Solano AJ, Del Bano-Aledo ME, Rodriguez-Bailon M. Results of an occupational self-analysis program in people with acquired brain injury. A pilot study. Brain Inj. 2020;34(2):253-261. doi: 10.1080/02699052.2019.1689576. Epub 2019 Nov 15.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1792-N-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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