DepressionNCT05997849
Development of a Multiplatform Mental Health Mobile Tool
A study testing Mobile application in people with Depression and Anxiety, run by University of Talca at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Mobile application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChile
- Study dates
- 4 Sep 2023to 24 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Multiplatform Mobile Tool for the Prevention of Mental Health Pathologies in Chilean Adults
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.
Read more
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:
- Psychoeducation.
- Psychoeducation and mindfulness strategies.
- Psychoeducation and behavioral activation strategies.
- 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.
Read the 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).
- Conditions
- Depression, Anxiety
- Being tested
- Mobile application
- Keywords
- Mental health, Mobile application, Depression, Anxiety, RCT
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile applicationBehavioural
A mobile application for the management of anxiety and depressive symptoms through self-applied emotional regulation tools.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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
Perceived psychological and overall wellbeing is measured by PHI Scale (Pemberton Happiness Index): 21-item instrument, evaluates in 2 subscales, psychological well-being (experienced, 5 positive experiences and 5 negative experiences) and subjective well-being (remembered). The scale is Likert-type, with scores per item from 0 to 10 (Paiva et al., 2016).
Measured: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
Resilience
Perceived resilience as measured by the BRS (Brief Resilience Scale), a 6-item instrument, Likert score from 1 to 5. It has three inverted items and the rating results from the average of the scores obtained (Smith et al., 2008).
Measured: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
Ruminative thoughts
Rumination and ruminative thoughts are assessed by the Ruminative Response Scale (RRS Short version), consisting of 10 items that measure ruminant thoughts in two dimensions: reflection and restlessness. It has a high level of internal consistency (Cronbach's a = .85). Each item is scored on a 4-point Likert scale from 1 (almost never) to 4 (almost always) (Treynor, Gonzalez \& Nolen-Hoeksema, 2003).
Measured: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
Emotion regulation
Emotion regulation is assessed by the Emotional Regulation Questionnaire (ERQ), a 10-item questionnaire designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal (1,3,5,7,8,10) and (2) Expressive suppression (2, 4, 6, 9) (Gross \& John, 2003).
Measured: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
Mindfulness skills
Assessed with MAAS (Mindfulness attention awareness scale), an instrument composed of 14 items, Likert score from 1 to 6. The scores obtained are added and the higher the score, the greater the ability to pay attention fully and consciously. The average scores of the non-clinical participants tend to be around 65 points out of a total of 84. (Brown \& Ryan, 2003)
Measured: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start4 Sep 2023
- Primary completion30 Aug 2024
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Talca
- Sponsor type
- University, hospital or other
- Collaborators
- Gobierno Regional del Maule
- Responsible party
- Principal investigator, Nadia Ramos Álvarado, University of Talca
- Investigators
- Nadia A Ramos, PhD, Principal investigator, University of Talca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997849
- Sponsor's protocol ID
- FIC 40027682
- Status last verified
- Mar 2025
- First submitted
- 4 Aug 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD and any supporting information will be made available.
Publications
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
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.
PubMed 29875087Lagan 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.
PubMed 33835483
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Multiplatform Mobile Tool for the Prevention of Mental Health Pathologies in Chilean Adults
- ClinicalTrials.gov ID
- NCT05997849
- Acronym / sponsor ID
- FIC 40027682
- Conditions
- Depression, Anxiety
- Keywords
- Mental health, Mobile application, Depression, Anxiety, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of TalcaUniversity, hospital or other
- Collaborators
- Gobierno Regional del Maule
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Psychoeducation.
- Psychoeducation and mindfulness strategies.
- Psychoeducation and behavioral activation strategies.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Monitoring and psychoeducation module | Active comparator | Behavioral: Mobile applicationThe 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. |
| Mindfulness strategies module | Experimental | Behavioral: Mobile applicationParticipants 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 activation strategies module | Experimental | Behavioral: Mobile applicationParticipants 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. |
| Cognitive strategies module | Experimental | Behavioral: Mobile applicationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile applicationA mobile application for the management of anxiety and depressive symptoms through self-applied emotional regulation tools. | Behavioural | Behavioral activation strategies module, Cognitive strategies module, Mindfulness strategies module, Monitoring and psychoeducation module |
Primary outcome
Anxiety symptoms
Time frame: 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.
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.
Depressive symptoms
Time frame: 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.
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.
5 secondary outcomes
Wellbeing
Time frame: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
Resilience
Time frame: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
Ruminative thoughts
Time frame: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
Emotion regulation
Time frame: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
Mindfulness skills
Time frame: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- BackgroundTorous, 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: PubMed 29875087Stawarz 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.
- Background: PubMed 33835483Lagan 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.
- Individual participant dataSharing planned: Yes. All collected IPD and any supporting information will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia A Ramos, PhD principal investigator
University of Talca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application in people with Depression and Anxiety, run by University of Talca at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety symptoms (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05997849, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025; AzTrials last refreshed its copy on 2 Nov 2026.