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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depressive Disorder; Anxiety Disorder; Occupational Therapy; Mobile App
• Intervention / Treatment: Behavioral: OcuApp; Behavioral: Three-part work

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 Type: Interventional
• Enrollment (Anticipated): 134
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Engagement in Meaningful Activities Survey (EMAS).	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.	5 minutes
Occupational Balance Questionnaire (OBQ).	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.	15 minutes

Collaborators and Investigators

• Sponsor: University of Malaga
• Collaborators: Universitat Autonoma de Barcelona; University of Vic - Central University of Catalonia

Study record dates

Study Major Dates

• Study Start (Anticipated): September 15, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Depressive Disorder; Disease; Anxiety Disorders
• Other Study ID Numbers: B1-2020_25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No