InterventionNCT06695975
Occupational Self Analysis in People with a Serious Mental Illness.
A study testing Occupational self-analysis in people with Intervention and Control Condition, run by University of Malaga at 1 site in Spain.
Trial summary
In this study we test the efectiveness of an intervention called 'Occupational sefl-analysys' where particiapants are taught to analyze what activities they do and why do they choose those activities. Also they are encouage to reflect about those occupations that don't do but will like to. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intervention, Control Condition
- What is being tested?
- Occupational self-analysis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 8 Nov 2021to 28 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a serious mental illness
- Living in the Therapeutic Community or attend the device's day program.
Who cannot join
- Havin Acute psychopathology
- Diagnosis of cognitive impairment
- Dependence or abuse of toxic substances
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Occupational Self Analysis in People with a Serious Mental Illness on Occupational Balance, Participation in Meaningful Activities and Life Satisfaction
In this study we test the efectiveness of an intervention called 'Occupational sefl-analysys' where particiapants are taught to analyze what activities they do and why do they choose those activities. Also they are encouage to reflect about those occupations that don't do but will like to. In case they want to , they can make changes in their occupational routines. After he program we assessed the improvements in life satisfaction, participation in meaningful activities, perception of balance and occupational satisfaction,
Read the 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.
- Conditions
- Intervention, Control Condition
- Being tested
- Occupational self-analysis
- Keywords
- Occupational self-analysis, Occupational Balance, Occupational Satisfaction, Serious Mental Disorder, meaningful activities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational self-analysisBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Occupational self-analysis | Experimental | "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 Receives: Behavioral: Occupational self-analysis |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with Life Scale
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
Measured: From enrollment to the end of treatment at 16 weeks
Occupational Balance Questionnaire
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.
Measured: From enrollment to the end of treatment at 16 weeks
Engagement in Meaningful Activities Scale
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.
Measured: From enrollment to the end of treatment at 16 weeks
Satisfaction with Daily Occupation - Occupational Balance (SODEO)
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.
Measured: From enrollment to the end of treatment at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start8 Nov 2021
- Primary completion30 Apr 2022
- Study completion28 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InterventionStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group will participate in te 'Occupational self-analysis' program while the control group will have free time.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Burgos, Andaluz Health Service
- Responsible party
- Principal investigator, María Rodríguez Bailón, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695975
- Sponsor's protocol ID
- 1792-N-21
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31017354Fernandez-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.
PubMed 31730407
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Self Analysis in People with a Serious Mental Illness on Occupational Balance, Participation in Meaningful Activities and Life Satisfaction
- ClinicalTrials.gov ID
- NCT06695975
- Acronym / sponsor ID
- 1792-N-21
- Conditions
- Intervention, Control Condition
- Keywords
- Occupational self-analysis, Occupational Balance, Occupational Satisfaction, Serious Mental Disorder, meaningful activities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Collaborators
- Universidad de Burgos, Andaluz Health Service
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 28 May 2022 (actual)
- First posted
- 19 Nov 2024 (actual)
- 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.
In this study we test the efectiveness of an intervention called 'Occupational sefl-analysys' where particiapants are taught to analyze what activities they do and why do they choose those activities. Also they are encouage to reflect about those occupations that don't do but will like to. In case they want to , they can make changes in their occupational routines. After he program we assessed the improvements in life satisfaction, participation in meaningful activities, perception of balance and occupational satisfaction,
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The intervention group will participate in te 'Occupational self-analysis' program while the control group will have free time.
| Arm | Type | Receives |
|---|---|---|
| Occupational self-analysis | Experimental | Behavioral: 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 |
| Control group | No intervention | –The control group did not receive any specific intervention, and free time was simply included in their agenda within the Mental Helath Therapeutic Community. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having a serious mental illness
- Living in the Therapeutic Community or attend the device's day program.
Key exclusion criteria (3 listed)
- Havin Acute psychopathology
- Diagnosis of cognitive impairment
- Dependence or abuse of toxic substances
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 |
|---|---|---|
| Occupational self-analysisOccupational 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 | Behavioural | Occupational self-analysis |
Primary outcome
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
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.
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.
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.
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 19 Nov 2024.
- Background: PubMed 31017354Fernandez-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.
- Background: PubMed 31730407Fernandez-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.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational self-analysis in people with Intervention and Control Condition, run by University of Malaga at 1 site in Spain.
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 2 inclusion and 3 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 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Satisfaction with Life Scale (time frame: From enrollment to the end of treatment at 16 weeks). The study lists 4 primary outcomes in all. 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 NCT06695975, which also lists 2 linked publications.
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 19 Nov 2024.