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OcupApp: Occupational Self-analysis Intervention Through an Mobile Application (OcupApp)

Primary Purpose

Anxiety Disorder, Depressive Disorder, Occupational Therapy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OcuApp
Three-part work
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorder

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    OcuApp Users

    Three-part work users

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    The World Health Organization Quality of Life (WHOQOL-BREF)
    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

    The General Health Questionnaire (GHQ).
    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.

    Full Information

    First Posted
    May 8, 2023
    Last Updated
    May 18, 2023
    Sponsor
    University of Malaga
    Collaborators
    University of Vic - Central University of Catalonia, Universitat Autonoma de Barcelona
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05867823
    Brief Title
    OcupApp: Occupational Self-analysis Intervention Through an Mobile Application
    Acronym
    OcupApp
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    July 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Malaga
    Collaborators
    University of Vic - Central University of Catalonia, Universitat Autonoma de Barcelona

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety Disorder, Depressive Disorder, Occupational Therapy, Mobile App

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes 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.
    Allocation
    Randomized
    Enrollment
    134 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    OcuApp Users
    Arm Type
    Experimental
    Arm Description
    the experimental group will use a movile aplication (OcuApp), to generate a personal self-analisys about meaningful activities.
    Arm Title
    Three-part work users
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    OcuApp
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Three-part work
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The World Health Organization Quality of Life (WHOQOL-BREF)
    Description
    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).
    Time Frame
    15 minutes
    Secondary Outcome Measure Information:
    Title
    The General Health Questionnaire (GHQ).
    Description
    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.
    Time Frame
    10 minutes
    Other Pre-specified Outcome Measures:
    Title
    The Engagement in Meaningful Activities Survey (EMAS).
    Description
    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.
    Time Frame
    5 minutes
    Title
    Occupational Balance Questionnaire (OBQ).
    Description
    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.
    Time Frame
    15 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The study protocol will be published in an indexed journal. Once collected, participants' data will be uploaded to a public repository.
    IPD Sharing Time Frame
    The protocol will be accessible when published in a journal and the data once collected.
    IPD Sharing Access Criteria
    Public

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