OcupApp: Occupational Self-analysis Intervention Through an Mobile Application

Depressive Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05867823
• Other study ID #: B1-2020_25
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2023
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 134
• Est. completion date: July 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Depressive Disorder
• Disease
• Mobile App
• Occupational Therapy

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Malaga	Universitat Autonoma de Barcelona, University of Vic - Central University of Catalonia

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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