NCT06695975

Brief 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. 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,

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2022

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 15, 2024

Last Update Submit

November 15, 2024

Conditions

Keywords

Occupational self-analysisOccupational BalanceOccupational SatisfactionSerious Mental Disordermeaningful activities

Outcome Measures

Primary Outcomes (4)

  • 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

    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.

    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.

    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.

    From enrollment to the end of treatment at 16 weeks

Study Arms (2)

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

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.

Interventions

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

Occupational self-analysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having a serious mental illness
  • Living in the Therapeutic Community or attend the device's day program.

You may not qualify if:

  • Havin Acute psychopathology
  • Diagnosis of cognitive impairment
  • Dependence or abuse of toxic substances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comunidad Terapeutica de salud mental Valme

Dos Hermanas, Sevilla, Spain

Location

Related Publications (2)

  • 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.

    PMID: 31017354BACKGROUND
  • 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.

    PMID: 31730407BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The intervention group will participate in te 'Occupational self-analysis' program while the control group will have free time.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

November 15, 2024

First Posted

November 19, 2024

Study Start

November 8, 2021

Primary Completion

April 30, 2022

Study Completion

May 28, 2022

Last Updated

November 19, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations