OcupApp: Occupational Self-analysis Intervention Through an Mobile Application

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectivity of an Occupational-self-analysis Intervention Through a Mobile Application (OcupApp) in People With Anxiety or Depression: A Randomised Controlled Trial Protocol

Conditions
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Anxiety Disorder, Depressive Disorder, Occupational Therapy, Mobile App

Intervention / Treatment
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* Behavioral: OcuApp
* Behavioral: Three-part work


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OcuApp Users<br>the experimental group will use a movile aplication (OcuApp), to generate a personal self-analisys about meaningful activities. | Behavioral: OcuApp<br>* 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.<br>|
| Active Comparator: Three-part work users<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 minutes |