OcupApp: Occupational Self-analysis Intervention Through an Mobile Application

NCT05867823 | Unknown DMC

• 1 other identifier: B1-2020_25
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety Disorder; Depressive Disorder; Occupational Therapy; Mobile App

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The General Health Questionnaire (GHQ).

  10 minutes

Other Outcomes (2)

• The Engagement in Meaningful Activities Survey (EMAS).

  5 minutes

• Occupational Balance Questionnaire (OBQ).

  15 minutes

Study Arms (2)

OcuApp Users

EXPERIMENTAL

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

Behavioral: OcuApp

Three-part work users

ACTIVE COMPARATOR

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

Interventions

OcuApp BEHAVIORAL

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.

OcuApp Users

Three-part work BEHAVIORAL

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.

Three-part work users

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: "OcupApp": Development and effectiveness of a mobile application for the involvement in meaningful activities in the elderly population.

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 22, 2023
• Study Start: September 15, 2023
• Primary Completion: December 1, 2023
• Study Completion: July 1, 2024
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The protocol will be accessible when published in a journal and the data once collected.
• Access Criteria: Public