Development of a Multiplatform Mental Health Mobile Tool

NCT05997849 | Completed

• 1 other identifier: FIC 40027682
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Mobile applications for mental health (MAMH) have shown great potential for delivering digital interventions for the general population. However, most of these apps do not have evidence on how they work. Thus, users may be exposed to products that do not offer any real benefit, or that could harm them. Similarly, the most popular MAMHs use several techniques to deliver their mental health content, but it is still necessary to identify how effective each component is, so that these interventions can be optimized. The aim of this clinical trial is to evaluate how effective the components of evaluation, psychoeducation, and emotional regulation strategies are in a multiplatform MAMH in Chile. 196 adults will have access to different components of the application after consenting to participate in the study. They will be randomly assigned to one of four groups and will use the mobile app for a fixed period. Researchers will compare depressive and anxiety symptoms between the adults in these groups, will either receive:

1. 1.Psychoeducation.
2. 2.Psychoeducation and mindfulness strategies.
3. 3.Psychoeducation and behavioral activation strategies.
4. 4.Psychoeducation and cognitive strategies.

Conditions

Depression; Anxiety

Keywords

Mental health; Mobile application; Depression; Anxiety; RCT

Outcome Measures

Primary Outcomes (2)

• Anxiety symptoms

  Current anxiety symptoms as measured by Generalized Anxiety Disorder Scale - 7 (Generalized Anxiety Disorder-7). It consists of 7 items that the person assesses on a scale of 0 to 3 according to the frequency with which each symptom has disturbed them during the last 2 weeks (Spitzer et al., 2006). (2) The PHQ-4 instrument (Kroenke, Spitzer, Williams \& Löwe, 2009) has 4 items that assess depressive and anxiety symptoms in the last week.

  Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups. Monitoring of anxiety symptoms is carried out with PHQ-4 on a weekly basis.

• Depressive symptoms

  Current depressive symptoms as measured by PHQ-9 depression scale (Patient Health Questionnaire) consists of 9 items that evaluate the presence of depressive symptoms present in the last 2 weeks; with a response scale of 0 ="never", 1 = "some days", 2 = "more than half the days" and 3 = "almost every day". It presents a Cronbach's alpha of 0.83 in the Chilean sample (Baader et al., 2012). (2) The PHQ-4 instrument (Kroenke, Spitzer, Williams \& Löwe, 2009) has 4 items that assess depressive and anxiety symptoms in the last week.

  Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups. Monitoring of depressive symptoms is carried out with PHQ-4 on a weekly basis.

Secondary Outcomes (5)

• Wellbeing

  Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.

• Resilience

  Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.

• Ruminative thoughts

  Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.

• Emotion regulation

  Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.

• Mindfulness skills

  Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.

Study Arms (4)

Monitoring and psychoeducation module

ACTIVE COMPARATOR

The participants in this group will have access only to the monitoring and psychoeducation module for 30 days. The monitoring module consists of a set of self-report measures, and the psychoeducation is delivered through videos.

Behavioral: Mobile application

Mindfulness strategies module

EXPERIMENTAL

Participants in this group will have access to the monitoring, psychoeducation and mindfulness strategies modules for 30 days. The mindfulness strategies module includes a set of mindfulness-based self-guided techniques for depression and anxiety symptoms. These techniques are delivered in three steps: Learning, Understanding and Practicing.

Behavioral: Mobile application

Behavioral activation strategies module

EXPERIMENTAL

Participants in this group will have access to the monitoring, psychoeducation and mindfulness strategies modules for 30 days. The behavioral activation strategies module includes a set of behavioral activation self-guided techniques for depression and anxiety symptoms. These techniques are delivered in three steps: Learning, Understanding and Practicing.

Behavioral: Mobile application

Cognitive strategies module

EXPERIMENTAL

Participants in this group will have access to the monitoring, psychoeducation and mindfulness strategies modules for 30 days. The mindfulness strategies module includes a set of cognitive-based self-guided techniques for depression and anxiety symptoms, derived from CBT guidelines. These techniques are delivered in three steps: Learning, Understanding and Practicing.

Behavioral: Mobile application

Interventions

Mobile application BEHAVIORAL

A mobile application for the management of anxiety and depressive symptoms through self-applied emotional regulation tools.

Behavioral activation strategies module; Cognitive strategies module; Mindfulness strategies module; Monitoring and psychoeducation module

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Chilean citizens, 18 years old or older.
• With access to a computer, tablet, or smartphone (Android or iOS) with Internet.
• No diagnosed mental health problems or
• With a diagnosed mental health problem undergoing treatment. The mental health diagnosis and current treatment will be assessed solely by the participant's self-report.

You may not qualify if:

• Individuals with substance abuse problems, psychotic symptoms, organic brain disorders (e.g., dementia), self-harm or harm to others, or serious health problems that prevent the use of the application.
• Participants reporting scores greater than 1 on question 9 (suicidal ideation) on the PHQ-9

Sponsors & Collaborators

• University of Talca: lead
• Gobierno Regional del Maule: collaborator

Study Sites (1)

Universidad de Talca

Talca, Maule Region, 3460000, Chile

Location

Related Publications (3)

• Torous, J., Levin, M. E., Ahern, D. K., & Oser, M. L. (2017). Cognitive Behavioral Mobile Applications: Clinical Studies, Marketplace Overview, and Research Agenda. Cognitive and Behavioral Practice, 24(2), 215-225. https://doi.org/10.1016/j.cbpra.2016.05.007

  BACKGROUND

• Stawarz K, Preist C, Tallon D, Wiles N, Coyle D. User Experience of Cognitive Behavioral Therapy Apps for Depression: An Analysis of App Functionality and User Reviews. J Med Internet Res. 2018 Jun 6;20(6):e10120. doi: 10.2196/10120.

  PMID: 29875087 BACKGROUND

• Lagan S, D'Mello R, Vaidyam A, Bilden R, Torous J. Assessing mental health apps marketplaces with objective metrics from 29,190 data points from 278 apps. Acta Psychiatr Scand. 2021 Aug;144(2):201-210. doi: 10.1111/acps.13306. Epub 2021 Apr 29.

  PMID: 33835483 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Study Officials

• Nadia A Ramos, PhD

  University of Talca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Masking of the participants will be achieved by assigning them to intervention groups without stating the content or purpose of said group beyond the general guidelines of knowing that the intervention is mental health related. Masking of the outcome assessors will be achieved by providing them an Anonymized participant database after the application period and recollection of data has ended.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study uses a parallel model for the delivery of the interventions, where the application-based interventions will be carried out simultaneously for all groups.

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 18, 2023
• Study Start: September 4, 2023
• Primary Completion: August 30, 2024
• Study Completion: January 24, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and any supporting information will be available starting 6 months after publication of study results.
• Access Criteria: Any researcher can contact the lead investigator (NR) and request access for all raw data.

Locations

CL (1)