xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05997849</url>
    </required_header>
    <id_info>
      <org_study_id>FIC 40027682</org_study_id>
      <nct_id>NCT05997849</nct_id>
    </id_info>
    <brief_title>Development of a Multiplatform Mental Health Mobile Tool</brief_title>
    <official_title>Development of a Multiplatform Mobile Tool for the Prevention of Mental Health Pathologies in Chilean Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Talca</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Gobierno Regional del Maule</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Talca</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Mobile applications for mental health (MAMH) have shown great potential for delivering&#xD;
        digital interventions for the general population. However, most of these apps do not have&#xD;
        evidence on how they work. Thus, users may be exposed to products that do not offer any real&#xD;
        benefit, or that could harm them.&#xD;
  &#xD;
        Similarly, the most popular MAMHs use several techniques to deliver their mental health&#xD;
        content, but it is still necessary to identify how effective each component is, so that these&#xD;
        interventions can be optimized.&#xD;
  &#xD;
        The aim of this clinical trial is to evaluate how effective the components of evaluation,&#xD;
        psychoeducation, and emotional regulation strategies are in a multiplatform MAMH in Chile.&#xD;
        196 adults will have access to different components of the application after consenting to&#xD;
        participate in the study. They will be randomly assigned to one of four groups and will use&#xD;
        the mobile app for a fixed period. Researchers will compare depressive and anxiety symptoms&#xD;
        between the adults in these groups, will either receive:&#xD;
  &#xD;
          1. Psychoeducation.&#xD;
  &#xD;
          2. Psychoeducation and mindfulness strategies.&#xD;
  &#xD;
          3. Psychoeducation and behavioral activation strategies.&#xD;
  &#xD;
          4. Psychoeducation and cognitive strategies.&#xD;
  &#xD;
        All groups will be continuously assessed and monitored. The researchers hypothesize that the&#xD;
        psychoeducation combined with any set of self-regulatory strategies will prove more effective&#xD;
        than the psychoeducation component alone in decreasing symptomatology.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Anxiety and depressive symptoms are prevalent in Chilean adults. The considerable gaps in&#xD;
        health-related demand and medical-care supply hinders the access to psychological treatment,&#xD;
        which negatively impacts the population's overall well-being. In this scenario, it becomes&#xD;
        necessary to find alternatives that enable the access to mental health treatment. The use of&#xD;
        remote psychological treatments, particularly mobile applications for mental health (MAMH),&#xD;
        has been deemed as promising in this regard. Although in recent years the number of MAMH has&#xD;
        increased explosively, many of them do not have any theoretical support for their&#xD;
        effectiveness. The few MAHMs that have presented evidence of their effectiveness reducing&#xD;
        symptomathology use the elements of assessment, psychoeducation, and symptom-management&#xD;
        strategies as intervention pillars. The combination of these three elements seems to be&#xD;
        highly effective, but no studies have examined the effectiveness of said components in&#xD;
        detail. Thus, the aim of this exploratory study is to develop a multiplatform mobile&#xD;
        application for mental health care for adults, and test the effectiveness of its assessment,&#xD;
        psychoeducation, and emotional regulation strategy components, at post-intervention and&#xD;
        1-month follow-up. In the study, 4 experimental conditions are carried out to evaluate the&#xD;
        components both in their effectiveness, and their usability and applicability. The&#xD;
        researchers hypothesize that the combination of psychoeducation and any self-regulatory&#xD;
        strategies will prove more effective than the evaluation and psychoeducation component alone&#xD;
        in decreasing symptomatology.&#xD;
  &#xD;
        The expected sample comprises a total 196 participants equally divided in the 4 groups, that&#xD;
        will actively test the application. In Group 1: the participants will have access only to the&#xD;
        monitoring (or evaluation) and psychoeducation module for 30 days; Group 2: participants will&#xD;
        have access to the monitoring module, psychoeducation and mindfulness strategies for 30 days;&#xD;
        Group 3: participants will have access to the monitoring module, psychoeducation and&#xD;
        behavioral activation strategies for 30 days; Group 4: Participants will have access to the&#xD;
        monitoring, psychoeducation and cognitive strategies module for 30 days. Outcomes measured&#xD;
        will consider self-reported anxiety and depressive symptoms, among other psychological and&#xD;
        well-being variables. These outcomes will be measured at pre-intervention, post-intervention,&#xD;
        and 1-month follow-up. Participants will be randomly assigned to any group with a 1:1&#xD;
        allocation as per computer-generated randomization, using the PHP rand() function.&#xD;
        Additionally, a subsample of 32 random participants will also engage in focus-groups to&#xD;
        assess user experience with the application. Analyses of all outcomes at different timepoints&#xD;
        will be carried out through linear mixed model for repeated measures (MMRM) analyses, and&#xD;
        content analyses. This study is expected to last 14 months (September 2023 to October 2024).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <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.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>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.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Anxiety symptoms</measure>
      <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.</time_frame>
      <description>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 &amp; Löwe, 2009) has 4 items that assess depressive and anxiety symptoms in the last week.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Depressive symptoms</measure>
      <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.</time_frame>
      <description>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 =&quot;never&quot;, 1 = &quot;some days&quot;, 2 = &quot;more than half the days&quot; and 3 = &quot;almost every day&quot;. 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 &amp; Löwe, 2009) has 4 items that assess depressive and anxiety symptoms in the last week.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Wellbeing</measure>
      <time_frame>Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Resilience</measure>
      <time_frame>Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ruminative thoughts</measure>
      <time_frame>Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.</time_frame>
      <description>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 &amp; Nolen-Hoeksema, 2003).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emotion regulation</measure>
      <time_frame>Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.</time_frame>
      <description>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 &amp; John, 2003).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mindfulness skills</measure>
      <time_frame>Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.</time_frame>
      <description>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 &amp; Ryan, 2003)</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">196</enrollment>
    <condition>Depression</condition>
    <condition>Anxiety</condition>
    <arm_group>
      <arm_group_label>Monitoring and psychoeducation module</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Mindfulness strategies module</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Behavioral activation strategies module</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cognitive strategies module</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mobile application</intervention_name>
      <description>A mobile application for the management of anxiety and depressive symptoms through self-applied emotional regulation tools.</description>
      <arm_group_label>Behavioral activation strategies module</arm_group_label>
      <arm_group_label>Cognitive strategies module</arm_group_label>
      <arm_group_label>Mindfulness strategies module</arm_group_label>
      <arm_group_label>Monitoring and psychoeducation module</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult Chilean citizens, 18 years old or older.&#xD;
  &#xD;
            -  With access to a computer, tablet, or smartphone (Android or iOS) with Internet.&#xD;
  &#xD;
            -  No diagnosed mental health problems or&#xD;
  &#xD;
            -  With a diagnosed mental health problem undergoing treatment. The mental health&#xD;
               diagnosis and current treatment will be assessed solely by the participant's&#xD;
               self-report.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals with substance abuse problems, psychotic symptoms, organic brain disorders&#xD;
               (e.g., dementia), self-harm or harm to others, or serious health problems that prevent&#xD;
               the use of the application.&#xD;
  &#xD;
            -  Participants reporting scores greater than 1 on question 9 (suicidal ideation) on the&#xD;
               PHQ-9&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nadia A Ramos, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Talca</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nadia A Ramos, PhD</last_name>
      <phone>56-71-2201783</phone>
      <phone_ext>2853</phone_ext>
      <email>nramos@utalca.cl</email>
    </overall_contact>
    <location>
      <facility>
        <name>Universidad de Talca</name>
        <address>
          <city>Talca</city>
          <state>Maule</state>
          <zip>3460000</zip>
          <country>Chile</country>
        </address>
      </facility>
      <contact>
        <last_name>Nadia Ramos, PhD</last_name>
        <phone>56-71-2201783</phone>
        <email>nramos@utalca.cl</email>
      </contact>
    </location>
    <location_countries>
      <country>Chile</country>
    </location_countries>
    <reference>
      <citation>Torous, J., Levin, M. E., Ahern, D. K., &amp; 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>
    </reference>
    <reference>
      <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>
      <PMID>29875087</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>33835483</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Talca</investigator_affiliation>
      <investigator_full_name>Nadia Ramos Álvarado</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Mental health</keyword>
    <keyword>Mobile application</keyword>
    <keyword>Depression</keyword>
    <keyword>Anxiety</keyword>
    <keyword>RCT</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All collected IPD and any supporting information will be made available.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>IPD and any supporting information will be available starting 6 months after publication of study results.</ipd_time_frame>
      <ipd_access_criteria>Any researcher can contact the lead investigator (NR) and request access for all raw data.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05997849
  org study id: FIC 40027682
  nct id: NCT05997849
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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).
  allocation: Randomized
  intervention model: Parallel Assignment
  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
  masking: Double (Participant, Outcomes Assessor)
  masking description: 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.
  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.
  description: 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.
  measure: 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.
  description: 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.
  measure: Wellbeing
  time frame: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
  description: 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).
  measure: Resilience
  time frame: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
  description: 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).
  measure: Ruminative thoughts
  time frame: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
  description: 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).
  measure: Emotion regulation
  time frame: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
  description: 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).
  measure: Mindfulness skills
  time frame: Measured at baseline (pre-intervention), immediately after the intervention, and at 1-month follow-up for all groups.
  description: 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)
  arm group label: Monitoring and psychoeducation module
  arm group type: Active Comparator
  description: 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.
  arm group label: Mindfulness strategies module
  arm group type: Experimental
  description: 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.
  arm group label: Behavioral activation strategies module
  arm group type: Experimental
  description: 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.
  arm group label: Cognitive strategies module
  arm group type: Experimental
  description: 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.
  intervention type: Behavioral
  intervention name: Mobile application
  description: A mobile application for the management of anxiety and depressive symptoms through self-applied emotional regulation tools.
  arm group label: Behavioral activation strategies module
  arm group label: Cognitive strategies module
  arm group label: Mindfulness strategies module
  arm group label: Monitoring and psychoeducation module
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Nadia A Ramos, PhD
  role: Principal Investigator
  affiliation: University of Talca
  last name: Nadia A Ramos, PhD
  phone: 56-71-2201783
  phone ext: 2853
  email: nramos@utalca.cl
  facility: 
  contact: 
  country: Chile
  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.
  PMID: 29875087
  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.
  PMID: 33835483
  responsible party type: Principal Investigator
  investigator affiliation: University of Talca
  investigator full name: Nadia Ramos Álvarado
  investigator title: Assistant Professor
  mesh term: Depression
  sharing ipd: Yes
  ipd description: All collected IPD and any supporting information will be made available.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: IPD and any supporting information will be available starting 6 months after publication of study results.
  ipd access criteria: Any researcher can contact the lead investigator (NR) and request access for all raw data.