OcupApp: Occupational Self-analysis Intervention Through an Mobile Application

Sponsor
University of Malaga (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05867823
Collaborator
University of Vic - Central University of Catalonia (Other), Universitat Autonoma de Barcelona (Other)
134
2
9.5

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to test the effectiveness of the use of mobile application ("OcupApp") to generate a personal self-analysis about meaningful activities in which adults between the ages of 50 and 70 with anxiety and subclinical depression participant.

A randomized study will be carried out comparing the effects of the use of the application "OcupApp" with a control intervention on the quality of life related to health, mental health, frequency of participation on meaningful activities, and perceived occupational balance.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: OcuApp
  • Behavioral: Three-part work
N/A

Detailed Description

OcupApp is a mobile application developed within the research team, which aims to promote occupational self-analysis in adults with depression and/or anxiety. The mobile application allows to offer feedback to participants about the meaning of the activities they carry out daily and their perception of occupational balance, which generates a subjective self-reflection that can lead to the implementation of some personal changes in their weekly routine. For this, the person must register the activities they carry out throughout a week and mark each one of them with a punctuation related to the meaning of the following dimensions: identity, pleasure, competence, importance and value of the activity by other people. The punctuation give will be on a Likert-type scale from 1 to 5. The application also allows to collect other information such as where the activity takes place, its duration, and the people with whom it is carried out. Also, at the end of the week, the application will ask users about their perceived occupational balance. All the information registered in the mobile application will be returned to the person in a dynamic and understandable way. Based on this, the person can establish two goals to accomplish. In this sense, OcupApp will offer personalized recommendations based on the objectives to be achieved related to the dimensions of meaning.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
134 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Masking will be single blind since the researchers will know the assigned arm. Participants will know the group they belong, but not the hypotheses of the study or the superiority that is sought of one intervention over the other. However, data evaluators will remain blind to the allocation of patients to group.
Primary Purpose:
Treatment
Official Title:
Effectivity of an Occupational-self-analysis Intervention Through a Mobile Application (OcupApp) in People With Anxiety or Depression: A Randomised Controlled Trial Protocol
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: OcuApp Users

the experimental group will use a movile aplication (OcuApp), to generate a personal self-analisys about meaningful activities.

Behavioral: OcuApp
The participants will have instaled a mobile aplication (OcuApp) by a member of the researchs team who will teach them how to use it. The person must register the activities they carry out throughout a week and mark each one of them with a punctuation (from 1 to 5) related to the meaning of the following dimensions: identity, pleasure, competence, importance and value of the activity by other people.The application also allows to collect other information such as where the activity takes place, its duration, and the people with whom it is carried out. Also, at the end of the week, the application will ask users about their perceived occupational balance. All the information registered in the mobile application will be returned to the person in a dynamic and understandable way. Based on this, the person can establish two goals to accomplish. In this sense, OcupApp will offer personalized recommendations based on the objectives to be achieved related to the dimensions of meaning.

Active Comparator: Three-part work users

The intervention on the control group will focus on offering to the participants an informative three-part work on the positive effects of performing activities.

Behavioral: Three-part work
The intervention on the control group will focus on offering to the participants an informative three-part work on the positive effects of performing activities to control anxiety and depression. After providing this information, any doubts in this regard will be answered.

Outcome Measures

Primary Outcome Measures

  1. The World Health Organization Quality of Life (WHOQOL-BREF) [15 minutes]

    The WHOQOL is a generic, multidimensional profile for assessing quality of life with 26 questions; 2 related to their general quality of life and their satisfaction with their health status and 24 item-version assessing 4 domains of quality of life (physical health, psychological health, social relations and environment).

Secondary Outcome Measures

  1. The General Health Questionnaire (GHQ). [10 minutes]

    The mental health of the participants was assessed using the 12-item version of the General Health Questionnaire (GHQ), which is a valid and reliable instrument to assess psychological well-being and distinct aspects of distress.The total sum of scores can range from 0 to 36, with higher total scores reflecting higher levels of psychological distress.

Other Outcome Measures

  1. The Engagement in Meaningful Activities Survey (EMAS). [5 minutes]

    The 12 items comprising the EMAS measure engagement in meaningful activities by assessing through a 5-point Likert-scale varied aspects of meaning such as creativity, pleasure, and satisfaction, feelings of competence and control, and a sense of belonging and a capacity for helping others.

  2. Occupational Balance Questionnaire (OBQ). [15 minutes]

    The Occupational Balance Questionnaire (OBQ) is a questionnaire in which the person evaluates their occupational balance in relation to their current situation and their daily life. a final score can be obtained summing scores from 0 to 65, where a higher score indicates a higher Occupational balance.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Have a smarthphone and know how to use mobile apps to exchange information.

  • Have a low or moderate depression (DEP 5 <= 4) or low or moderate anxiety (ANX5 <= 3) or DEP5 or ANX5 =3).

Exclusion Criteria:
  • Have a serious mental illness or psychosis.

  • Have a diagnosis of dementia

  • Have language problems or cognitive alterations that doesn't allow comprehension of assessment tools.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Malaga
  • University of Vic - Central University of Catalonia
  • Universitat Autonoma de Barcelona

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
María Rodríguez Bailón, "OcupApp": Development and effectiveness of a mobile application for the involvement in meaningful activities in the elderly population., University of Malaga
ClinicalTrials.gov Identifier:
NCT05867823
Other Study ID Numbers:
  • B1-2020_25
First Posted:
May 22, 2023
Last Update Posted:
May 22, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 22, 2023