Clinical trial NCT05997849: Development of a Multiplatform Mental Health Mobile Tool
Official title: Development of a Multiplatform Mobile Tool for the Prevention of Mental Health Pathologies in Chilean Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: Mental health
Mobile application
Depression
Anxiety
RCT
Lead sponsor: University of Talca
Sponsor class: OTHER
Collaborators: name: Gobierno Regional del Maule
First posted: 2023-08-18
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

All groups will be continuously assessed and monitored. The researchers hypothesize that the psychoeducation combined with any set of self-regulatory strategies will prove more effective than the psychoeducation component alone in decreasing symptomatology.

Detailed description: Anxiety and depressive symptoms are prevalent in Chilean adults. The considerable gaps in health-related demand and medical-care supply hinders the access to psychological treatment, which negatively impacts the population's overall well-being. In this scenario, it becomes necessary to find alternatives that enable the access to mental health treatment. The use of remote psychological treatments, particularly mobile applications for mental health (MAMH), has been deemed as promising in this regard. Although in recent years the number of MAMH has increased explosively, many of them do not have any theoretical support for their effectiveness. The few MAHMs that have presented evidence of their effectiveness reducing symptomathology use the elements of assessment, psychoeducation, and symptom-management strategies as intervention pillars. The combination of these three elements seems to be highly effective, but no studies have examined the effectiveness of said components in detail. Thus, the aim of this exploratory study is to develop a multiplatform mobile application for mental health care for adults, and test the effectiveness of its assessment, psychoeducation, and emotional regulation strategy components, at post-intervention and 1-month follow-up. In the study, 4 experimental conditions are carried out to evaluate the components both in their effectiveness, and their usability and applicability. The researchers hypothesize that the combination of psychoeducation and any self-regulatory strategies will prove more effective than the evaluation and psychoeducation component alone in decreasing symptomatology.

The expected sample comprises a total 196 participants equally divided in the 4 groups, that will actively test the application. In Group 1: the participants will have access only to the monitoring (or evaluation) and psychoeducation module for 30 days; Group 2: participants will have access to the monitoring module, psychoeducation and mindfulness strategies for 30 days; Group 3: participants will have access to the monitoring module, psychoeducation and behavioral activation strategies for 30 days; Group 4: Participants will have access to the monitoring, psychoeducation and cognitive strategies module for 30 days. Outcomes measured will consider self-reported anxiety and depressive symptoms, among other psychological and well-being variables. These outcomes will be measured at pre-intervention, post-intervention, and 1-month follow-up. Participants will be randomly assigned to any group with a 1:1 allocation as per computer-generated randomization, using the PHP rand() function. Additionally, a subsample of 32 random participants will also engage in focus-groups to assess user experience with the application. Analyses of all outcomes at different timepoints will be carried out through linear mixed model for repeated measures (MMRM) analyses, and content analyses. This study is expected to last 14 months (September 2023 to October 2024).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Anxiety symptoms
timeFrame: 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.
measure: Depressive symptoms
timeFrame: 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:
measure: Wellbeing
timeFrame: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
measure: Resilience
timeFrame: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
measure: Ruminative thoughts
timeFrame: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
measure: Emotion regulation
timeFrame: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
measure: Mindfulness skills
timeFrame: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
Other outcomes:
Locations:
city: Talca
country: Chile
facility: Universidad de Talca
state: Maule
Study officials:
affiliation: University of Talca
name: Nadia A Ramos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: 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.