Anxiety SymptomsTOUCHmindsNCT07366580
TOUCHminds: Help-seeking in Adolescents With Anxiety
A study testing TOUCHminds - Web-Based Intervention in people with Anxiety Symptoms and Anxiety Disorders, run by Aveiro University at 1 site in Portugal.
Trial summary
Adolescents frequently experience clinical and subclinical anxiety symptoms, yet many avoid seeking professional help. While universal interventions exist to promote help-seeking, targeted programs for adolescents with elevated anxiety symptoms remain scarce. Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Symptoms, Anxiety Disorders
- What is being tested?
- TOUCHminds - Web-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePortugal
- Study dates
- 8 May 2026to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For all experimental and control groups, the inclusion criteria are:
- Aged between 15 and 19 years old at the time of screening;
- Fluent in Portuguese;
- Have access to a smartphone, tablet, or computer;
- Have reliable internet access.
- Clinical Groups Specific:
Show all 9Show fewer
- Must meet criteria for a primary diagnosis of at least one anxiety disorder, as assessed by the MINI-KID (Rijo et al., 2016).
- Subclinical Groups Specific:
- Must not meet diagnostic criteria for any mental health disorder, as assessed by the MINI-KID (Rijo et al., 2016).
Who cannot join
- Exclusion criteria for all experimental and all control groups are:
- Psychotic symptoms or suicidal risk as assessed via the Mini-Kid (Rijo et al., 2016);
- Being part of the special needs teaching system.
- Currently receiving psychological counselling.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
William James Center for Research, Department of Education and Psychology, University of Aveiro.
Aveiro
Catarina Monteiro, M.Sc., 969232691 ext. 00351, catarinaamonteiro@ua.pt
Catarina Monteiro, M.Sc.
About this study
Official title: TOUCHMinds: An RCT on Help-seeking for Adolescent Anxiety
Adolescents frequently experience clinical and subclinical anxiety symptoms, yet many avoid seeking professional help. While universal interventions exist to promote help-seeking, targeted programs for adolescents with elevated anxiety symptoms remain scarce. Therefore, accessible and tailored strategies are needed to effectively promote help-seeking among this group.
TOUCHminds is a web-based intervention designed to enhance help-seeking among adolescents with clinical or subclinical anxiety. The program consists of six self-guided modules featuring interactive activities (e.g., images, videos, simulation activities, and audio recordings), combined with three synchronous sessions led by a psychologist via videoconference. The intervention explicitly targets precursors of help-seeking, including mental health literacy, mental health stigma, self-compassion and readiness to change.
Read more
This research project comprises two studies. Study I, a feasibility study involving 10 adolescents aged 15 to 19, will assess recruitment procedures, dropout rates, usage patterns, therapist fidelity, acceptability, usability, satisfaction, and preliminary effects. Study II, a randomized controlled trial (RCT), intends to include 96 adolescents randomly assigned to four groups: clinical intervention, clinical control, subclinical intervention, and subclinical control. Clinical participants are those who meet diagnostic criteria for one or more anxiety disorders, whereas subclinical participants present high self-reported anxiety but no mental disorder diagnosis. Intervention effects will based on self-report assessments conducted at pre-intervention, post-intervention (9 weeks later), and at 3-month follow-up.
This research will provide evidence regarding the suitability and effectiveness of TOUCHminds in promoting help-seeking among adolescents experiencing different levels of anxiety symptoms. Findings will contribute to the field of empirically validated web-based interventions tailored specifically for adolescents.
Read the detailed description
Nearly 14% of adolescents experience mental health disorders, many of which remain unrecognized and untreated. Anxiety disorders, affecting approximately 5.5% of adolescents aged 15-19, commonly emerge during childhood or adolescence and are linked to anxiety persisting into adulthood, increased risk of other disorders such as substance abuse and major depressive disorder, and significant impairments across life domains, including reduced quality of life and lower educational attainment. Despite these risks, adolescents often show reluctance to seek help, particularly when symptoms are more severe. Barriers to help-seeking include lack of mental health literacy, which prevents from recognizing the severity of one's condition or from identifying it as a mental health issue, and mental health stigma, leading adolescents to conceal their struggles. Interventions often overlook additional barriers such as shame and low self-confidence. Promising facilitators for overcoming these barriers include fostering self-compassion, involving kindness and understanding towards oneself in difficult situations, and promoting well-being across emotional, psychological, and social dimensions. Additionally, enhancing readiness to change and utilizing motivational interviewing techniques, based on the transtheoretical model stages of change, may further facilitate adolescents' engagement in help-seeking behaviors by increasing motivation and managing ambivalence.
Interventions aimed at promoting adolescent help-seeking have typically been universal, potentially limiting their effectiveness for adolescents with clinical or subclinical symptoms who require more targeted support to recognize their need for professional help. Selective and indicated interventions, specifically tailored to these adolescents, have shown greater long-term efficacy but remain underexplored. Most existing programs primarily address barriers such as stigma and mental health literacy. Web-based interventions, particularly those that are multicomponent (e.g., psychoeducation, quizzes, vignettes) and involve minimal professional contact, have been suggested as effective in overcoming barriers such as stigma and low mental health literacy. However, key facilitators such as self-compassion, readiness for change and motivational interviewing techniques are largely absent from existing interventions, even though web-based interventions targeting self-compassion or integrating motivational interviewing appear to enhance their well-being and adolescents' engagement with mental health care.
TOUCHminds targets these gaps through a multicomponent web-based intervention, combined with synchronous psychologist-led sessions, addressing both help-seeking intentions and behaviors. The investigators will also assess changes in post-intervention and during follow-up, as the stability of change has been rarely explored in previous works targeting help-seeking. Additionally, the investigators aim to include adolescents with subclinical symptoms, often overlooked in existing programs. Finally, mechanisms of change remain unclear, particularly whether reduced stigma or improved mental health literacy drive help-seeking. Study I (feasibility) will assess recruitment procedures, dropout rates, usage patterns, therapist fidelity, acceptability, usability, satisfaction, and preliminary effects on help-seeking, in the precursors (mental health literacy, stigma, self-compassion, readiness for change) of help-seeking and in well-being. Study II (RCT) will compare intervention groups (clinical, subclinical) with control groups across three moments. Expected results include increases in help-seeking intentions (both intervention groups), behaviors (intervention group clinical), precursors, and well-being, and changes in those precursors will explain shifts in intentions/behaviors over time.
All procedures were approved by the Directorate-General for Education and the Ethics Committee for Clinical Research of the University of Aveiro; all aplicable General Data Protection Regulation procedures were also througougly considered and implemented. Adolescents will be recruited in portuguese schools; adolescents and their guardians will receive full study information, confidentiality assurances, and will provide parental consent and adolescent assent, with no incentives. Screening comprises the State-Trait Anxiety Inventory for Children (STAIC) and a sociodemographic form; participants scoring above the mean will be invited to a Mini-KID diagnostic interview via videoconference to confirm inclusion/exclusion (i.e., include primary anxiety disorder and no diagnosis; exclude psychotic symptoms and suicidal risk). After completing the Mini-KID interview, the psychologist will complete the Clinical Global Impression - Severity scale (CGI-S) to provide a baseline assessment of psychopathology severity. Eligible participants will then be emailed to register to the platform, while adolescents outside criteria (e.g., psychotic symptoms, suicidal risk, other primary disorders) will be referred to school psychology services.
- Conditions
- Anxiety Symptoms, Anxiety Disorders
- Being tested
- TOUCHminds - Web-Based Intervention
- Keywords
- Anxiety, Adolescents, Help-seeking, Web-based intervention
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOUCHminds - Web-Based InterventionBehavioural
A web-based intervention designed to promote help-seeking in adolescents with clinical or subclinical anxiety symptoms. The program combines six self-guided online modules with three individual videoconference sessions with a trained psychologist. It integrates core components from Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), Compassion-Focused Therapy (CFT), Motivational Interviewing, and the Transtheoretical Model of Change. The intervention is tailored to the developmental stage of adolescents and is delivered remotely to participants meeting the inclusion criteria.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Clinical Group (study I and study II) | Experimental | Adolescents meeting diagnostic criteria for one or more anxiety disorders (study I n= 5; study II n = 24). Participants receive the TOUCHminds intervention. Assessments are conducted at pre-intervention (study I and II), post-intervention (9 weeks later; study I and II), and at 3-month follow-up (study II). Receives: Behavioral: TOUCHminds - Web-Based Intervention |
| Control: Clinical Group (study II) | No intervention | Adolescents meeting diagnostic criteria for one or more anxiety disorders (study II n = 24). Participants do not receive the intervention during the main study period but are assessed at the same time points as the intervention group: pre-intervention, post-intervention (9 weeks later), and 3-month follow-up. After completing the final assessment, they are granted access to the TOUCHminds intervention. |
| Experimental: Subclinical Group (study I and study II) | Experimental | Adolescents presenting subclinical anxiety symptoms (i.e., high self-reported anxiety but no mental disorder diagnosis; study I n= 5; study II n = 24). Participants receive the TOUCHminds intervention. Assessments are conducted at pre-intervention (study I and II), post-intervention (9 weeks later; study I and II), and at 3-month follow-up (study II). Receives: Behavioral: TOUCHminds - Web-Based Intervention |
| Control: Subclinical Group (study II) | No intervention | Adolescents presenting subclinical anxiety symptoms (i.e., high self-reported anxiety but no mental disorder diagnosis; study II n = 24). Participants do not receive the intervention during the main study period but are assessed at the same time points as the intervention group: baseline (pre-intervention), post-intervention (9 weeks later), and 3-month follow-up. After completing the final assessment, they are granted access to the TOUCHminds intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Help-Seeking Questionnaire (GHSQ).
The GHSQ is a 12-item self-report scale that assesses adolescents' intentions to seek help for personal-emotional problems from various sources. Responses are rated on a 7-point Likert scale (1 = 'extremely unlikely' to 7 = 'extremely likely'). Its items refer to formal help (e.g., mental health professionals), semi-formal help (e.g., priests), informal help (e.g., partner), and self-help (e.g., the internet). sources. Higher scores indicate stronger intentions to seek help. The GHSQ has been adapted for use in Portugal and, despite the lack of formal psychometric studies, has been widely applied in research. For this study, the scale is further adapted to better reflect adolescents' social context. The adapted version includes formal help (e.g., psychologist), semi-formal help (e.g., teacher), informal help (e.g., friend), and self-help (e.g., online websites) sources. In addition, the original response option "I would not seek help from anyone" will be retaine.
Measured: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).
Adolescent Help-Seeking Behavior Scale (AHSBS).
The AHSBS is a 17-item self-report scale developed for this study to assess how often adolescents seek help for emotional or psychological difficulties. Using the same items as the adapted GHSQ, but with new instructions, participants are asked to indicate how frequently they have turned to various sources of help in recent weeks. Responses are given on a 5-point Likert scale (1 = 'never' to 5 = 'always'). Help sources are categorized into formal, semi-formal, informal, and self-help. The total score reflects overall help-seeking frequency, with sub-scores available for each category. The AHSBS is currently under study for its psychometric properties and is expected to show good internal consistency, a structure consistent with help-seeking categories (formal, informal, semi-formal, and self-help), and construct validity in relation help-seeking intentions, stigma, and well-being.
Measured: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).
Secondary outcomes (5)
Mental Health Literacy Scale for Adolescents (MHLS-A)
The MLHS-A is a 14-item self-report scale assessing mental health literacy in adolescents, including symptom recognition, help-seeking, and attitudes toward mental health. Items (e.g., "If someone, over a period of time, avoids or misses school parties or oral presentations because they are afraid of being judged, to what extent do you consider it likely that they are experiencing symptoms of social anxiety?") are rated on a 4-point Likert-type scale ranging from 1 ("Very unlikely" or "Very useless") to 4 ("Very likely" or "Very useful"). It was adapted from the Mental Health Literacy Scale (MHLS) and developed with input from adolescents through think-aloud sessions to ensure developmental and cultural relevance. The measure is currently undergoing validation in a Portuguese adolescent sample to assess its internal consistency, construct validity, and factorial structure.
Measured: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).
Peer Mental Health Stigmatization Scale (PMHSS).
The PMHSS is a 24-item self-report scale that assesses peer attitudes toward adolescents with mental health problems. Of these, 16 negative items measure two components: Stigma Agreement (personal endorsement of stigmatizing beliefs) and Stigma Awareness (perceptions of societal stigma). In this study, only these 16 items were used. Items (e.g., "Most people believe that young people with emotional or behavioral problems are dangerous") are rated on a 5-point Likert scale ranging from 'strongly disagree' to 'strongly agree'. Previous psychometric information indicates good internal consistency for the negative items and acceptable values for Stigma Agreement and Stigma Awareness. The Portuguese version is currently undergoing validation in an adolescent sample to assess its internal consistency, construct validity, and factorial structure.
Measured: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).
Self-Compassion Scale for Adolescents (SCS-A).
The SCS-A is a 26-item self-report measure that assesses adolescents' self-compassion, defined as the ability to respond to personal difficulties with understanding and non-judgment. Items (e.g., "How I typically act toward myself in difficult times") are rated on a 5-point Likert scale (1 = 'almost never' to 5 = 'almost always'). The scale includes six subscales reflecting both compassionate (Self-Kindness, Common Humanity, Mindfulness) and uncompassionate (Self-Judgment, Isolation, Over-Identification) self-responding. Previous psychometric information on its Portuguese version indicates good internal consistency for the total scale and acceptable reliability for the subscales. Construct validity has been supported by positive associations with positive emotional memories and negative associations with symptoms of depression, anxiety, and stress.
Measured: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).
University of Rhode Island Change Assessment (URICA).
The URICA is a 32-item self-report scale designed to evaluate motivation for behavior change across four stages: pre-contemplation, contemplation, action, and maintenance. Items (e.g., "I have been thinking that I could change something about myself") are rated on a 5-point Likert scale (1 = 'strongly disagree' to 5 = 'strongly agree'). Each stage is scored from 8 to 32, allowing identification of the individual's predominant stage. A readiness to change score is derived by summing the scores of contemplation, action, and maintenance, and subtracting the pre-contemplation score. Previous psychometric information indicates acceptable internal consistency for the total score in late adolescents and young adults, although subscale reliability was more variable. No analyses of item quality or factorial structure were previously performed. This measure is currently being further adapted and validated for use with Portuguese adolescents.
Measured: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).
Mental Health Continuum - Short Form - for youth (MHC-SF).
The MHC-SF is a 14-item self-report scale for the assessment of adolescents' flourishing based on levels of subjective well-being: emotional, social, and psychological well-being. In response to the instruction ("Please answer the following questions about how you have been feeling during the past month"), participants rate each item (e.g., "How often do you felt happy?") using a 6-point Likert scale ranging from 0 = 'Never' to 5 = 'Every day'. Previous psychometric information indicates good internal consistency values and construct validity in relation to measures of quality of life, life satisfaction, anxiety, depression and internalizing and externalizing problems.
Measured: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start8 May 2026
- Primary completion15 Jun 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Anxiety SymptomsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This investigation comprises two sequential studies. Study I (feasibility) is a single-arm, pre-post study design with two intervention groups (clinical, n=5; subclinical, n=5), both receiving the TOUCHminds. Study I will assess recruitment procedures, dropout rates, usage patterns, therapist fidelity, acceptability, usability, satisfaction, and preliminary effects. Study II (RCT) is a randomized, controlled, parallel-group trial evaluating the effectiveness of the TOUCHminds in adolescents with clinical and subclinical anxiety symptoms. Participants will be randomly assigned to one of four conditions: Clinical Intervention (n = 24), Clinical Control (n = 24), Subclinical Intervention (n = 24), or Subclinical Control (n = 24).
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Science and Technology
- Responsible party
- Principal investigator, Paula Vagos, Aveiro University
- Investigators
- Catarina Monteiro, M.Sc., Principal investigator, William James Center for Research, Department of Education and Psychology, University of Aveiro.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366580
- Sponsor's protocol ID
- 2024.05050.BD
- Other IDs
- 2024.05050.BD
- Acronym
- TOUCHminds
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
World Health Organization. (2024, October 10). Mental health of adolescents. https://www.who.int/news-room/fact-sheets/detail/adolescent-mental-health
Woodward LJ, Fergusson DM. Life course outcomes of young people with anxiety disorders in adolescence. J Am Acad Child Adolesc Psychiatry. 2001 Sep;40(9):1086-93. doi: 10.1097/00004583-200109000-00018.
PubMed 11556633Wilson, C. J., Deane, F. P., Ciarrochi, J., & Rickwood, D. (2005). Measuring help-seeking intentions: Properties of the General Help-Seeking Questionnaire. Canadian Journal of Counselling, 39(1), 15-28.
Werner-Seidler A, Perry Y, Calear AL, Newby JM, Christensen H. School-based depression and anxiety prevention programs for young people: A systematic review and meta-analysis. Clin Psychol Rev. 2017 Feb;51:30-47. doi: 10.1016/j.cpr.2016.10.005. Epub 2016 Oct 24.
PubMed 27821267van Doorn M, Nijhuis LA, Egeler MD, Daams JG, Popma A, van Amelsvoort T, McEnery C, Gleeson JF, Ory FG, Avis KA, Ruigt E, Jaspers MWM, Alvarez-Jimenez M, Nieman DH. Online Indicated Preventive Mental Health Interventions for Youth: A Scoping Review. Front Psychiatry. 2021 Apr 29;12:580843. doi: 10.3389/fpsyt.2021.580843. eCollection 2021.
PubMed 33995136Tuijnman A, Kleinjan M, Olthof M, Hoogendoorn E, Granic I, Engels RC. A Game-Based School Program for Mental Health Literacy and Stigma on Depression (Moving Stories): Cluster Randomized Controlled Trial. JMIR Ment Health. 2022 Aug 17;9(8):e26615. doi: 10.2196/26615.
PubMed 35976200Strawn JR, Lu L, Peris TS, Levine A, Walkup JT. Research Review: Pediatric anxiety disorders - what have we learnt in the last 10 years? J Child Psychol Psychiatry. 2021 Feb;62(2):114-139. doi: 10.1111/jcpp.13262. Epub 2020 Jun 5.
PubMed 32500537Schlack R, Peerenboom N, Neuperdt L, Junker S, Beyer AK. The effects of mental health problems in childhood and adolescence in young adults: Results of the KiGGS cohort. J Health Monit. 2021 Dec 8;6(4):3-19. doi: 10.25646/8863. eCollection 2021 Dec.
PubMed 35146318Sawyer MG, Borojevic N, Ettridge KA, Spence SH, Sheffield J, Lynch J. Do help-seeking intentions during early adolescence vary for adolescents experiencing different levels of depressive symptoms? J Adolesc Health. 2012 Mar;50(3):236-42. doi: 10.1016/j.jadohealth.2011.06.009.
PubMed 22325128Rijo D, Brazao N, Barroso R, da Silva DR, Vagos P, Vieira A, Lavado A, Macedo AM. Mental health problems in male young offenders in custodial versus community based-programs: implications for juvenile justice interventions. Child Adolesc Psychiatry Ment Health. 2016 Nov 1;10:40. doi: 10.1186/s13034-016-0131-6. eCollection 2016.
PubMed 27822300Prochaska, J. O., & DiClemente, C. C. (1982). Transtheoretical therapy: Toward a more integrative model of change. Psychotherapy: Theory, Research & Practice, 19(3), 276-288. https://doi.org/10.1037/h0088437
Neto, D. D., Rocha, I., Figueiras, M. J., & Nunes Da Silva, A. (2021). Measuring Mental Health Literacy: Adaptation and Validation of the Portuguese Version of the Mental Health Literacy Scale (MHLS). European Journal of Mental Health, 16(1), 64-77. https://doi.org/10.5708/EJMH.16.2021.1.5
Neff, K. (2003). Self-Compassion: An Alternative Conceptualization of a Healthy Attitude Toward Oneself. Self and Identity, 2(2), 85-101. https://doi.org/10.1080/15298860309032
Miller, W. R., & Rollnick, S. (2013). Motivational interviewing: Helping people change (3rd ed.). Guilford Press.
McKeague L, Hennessy E, O'Driscoll C, Heary C. Peer Mental Health Stigmatization Scale: psychometric properties of a questionnaire for children and adolescents. Child Adolesc Ment Health. 2015 Sep;20(3):163-170. doi: 10.1111/camh.12088. Epub 2015 Feb 16.
PubMed 32680400
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOUCHMinds: An RCT on Help-seeking for Adolescent Anxiety
- ClinicalTrials.gov ID
- NCT07366580
- Acronym / sponsor ID
- TOUCHminds / 2024.05050.BD
- Conditions
- Anxiety Symptoms, Anxiety Disorders
- Keywords
- Anxiety, Adolescents, Help-seeking, Web-based intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Collaborators
- Foundation for Science and Technology
- Study start
- 8 May 2026 (actual)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 26 Jan 2026 (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.
Adolescents frequently experience clinical and subclinical anxiety symptoms, yet many avoid seeking professional help. While universal interventions exist to promote help-seeking, targeted programs for adolescents with elevated anxiety symptoms remain scarce. Therefore, accessible and tailored strategies are needed to effectively promote help-seeking among this group.
TOUCHminds is a web-based intervention designed to enhance help-seeking among adolescents with clinical or subclinical anxiety. The program consists of six self-guided modules featuring interactive activities (e.g., images, videos, simulation activities, and audio recordings), combined with three synchronous sessions led by a psychologist via videoconference. The intervention explicitly targets precursors of help-seeking, including mental health literacy, mental health stigma, self-compassion and readiness to change.
This research project comprises two studies. Study I, a feasibility study involving 10 adolescents aged 15 to 19, will assess recruitment procedures, dropout rates, usage patterns, therapist fidelity, acceptability, usability, satisfaction, and preliminary effects. Study II, a randomized controlled trial (RCT), intends to include 96 adolescents randomly assigned to four groups: clinical intervention, clinical control, subclinical intervention, and subclinical control. Clinical participants are those who meet diagnostic criteria for one or more anxiety disorders, whereas subclinical participants present high self-reported anxiety but no mental disorder diagnosis. Intervention effects will based on self-report assessments conducted at pre-intervention, post-intervention (9 weeks later), and at 3-month follow-up.
This research will provide evidence regarding the suitability and effectiveness of TOUCHminds in promoting help-seeking among adolescents experiencing different levels of anxiety symptoms. Findings will contribute to the field of empirically validated web-based interventions tailored specifically for adolescents.
Detailed description
Nearly 14% of adolescents experience mental health disorders, many of which remain unrecognized and untreated. Anxiety disorders, affecting approximately 5.5% of adolescents aged 15-19, commonly emerge during childhood or adolescence and are linked to anxiety persisting into adulthood, increased risk of other disorders such as substance abuse and major depressive disorder, and significant impairments across life domains, including reduced quality of life and lower educational attainment. Despite these risks, adolescents often show reluctance to seek help, particularly when symptoms are more severe. Barriers to help-seeking include lack of mental health literacy, which prevents from recognizing the severity of one's condition or from identifying it as a mental health issue, and mental health stigma, leading adolescents to conceal their struggles. Interventions often overlook additional barriers such as shame and low self-confidence. Promising facilitators for overcoming these barriers include fostering self-compassion, involving kindness and understanding towards oneself in difficult situations, and promoting well-being across emotional, psychological, and social dimensions. Additionally, enhancing readiness to change and utilizing motivational interviewing techniques, based on the transtheoretical model stages of change, may further facilitate adolescents' engagement in help-seeking behaviors by increasing motivation and managing ambivalence.
Interventions aimed at promoting adolescent help-seeking have typically been universal, potentially limiting their effectiveness for adolescents with clinical or subclinical symptoms who require more targeted support to recognize their need for professional help. Selective and indicated interventions, specifically tailored to these adolescents, have shown greater long-term efficacy but remain underexplored. Most existing programs primarily address barriers such as stigma and mental health literacy. Web-based interventions, particularly those that are multicomponent (e.g., psychoeducation, quizzes, vignettes) and involve minimal professional contact, have been suggested as effective in overcoming barriers such as stigma and low mental health literacy. However, key facilitators such as self-compassion, readiness for change and motivational interviewing techniques are largely absent from existing interventions, even though web-based interventions targeting self-compassion or integrating motivational interviewing appear to enhance their well-being and adolescents' engagement with mental health care.
TOUCHminds targets these gaps through a multicomponent web-based intervention, combined with synchronous psychologist-led sessions, addressing both help-seeking intentions and behaviors. The investigators will also assess changes in post-intervention and during follow-up, as the stability of change has been rarely explored in previous works targeting help-seeking. Additionally, the investigators aim to include adolescents with subclinical symptoms, often overlooked in existing programs. Finally, mechanisms of change remain unclear, particularly whether reduced stigma or improved mental health literacy drive help-seeking. Study I (feasibility) will assess recruitment procedures, dropout rates, usage patterns, therapist fidelity, acceptability, usability, satisfaction, and preliminary effects on help-seeking, in the precursors (mental health literacy, stigma, self-compassion, readiness for change) of help-seeking and in well-being. Study II (RCT) will compare intervention groups (clinical, subclinical) with control groups across three moments. Expected results include increases in help-seeking intentions (both intervention groups), behaviors (intervention group clinical), precursors, and well-being, and changes in those precursors will explain shifts in intentions/behaviors over time.
All procedures were approved by the Directorate-General for Education and the Ethics Committee for Clinical Research of the University of Aveiro; all aplicable General Data Protection Regulation procedures were also througougly considered and implemented. Adolescents will be recruited in portuguese schools; adolescents and their guardians will receive full study information, confidentiality assurances, and will provide parental consent and adolescent assent, with no incentives. Screening comprises the State-Trait Anxiety Inventory for Children (STAIC) and a sociodemographic form; participants scoring above the mean will be invited to a Mini-KID diagnostic interview via videoconference to confirm inclusion/exclusion (i.e., include primary anxiety disorder and no diagnosis; exclude psychotic symptoms and suicidal risk). After completing the Mini-KID interview, the psychologist will complete the Clinical Global Impression - Severity scale (CGI-S) to provide a baseline assessment of psychopathology severity. Eligible participants will then be emailed to register to the platform, while adolescents outside criteria (e.g., psychotic symptoms, suicidal risk, other primary disorders) will be referred to school psychology services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This investigation comprises two sequential studies. Study I (feasibility) is a single-arm, pre-post study design with two intervention groups (clinical, n=5; subclinical, n=5), both receiving the TOUCHminds. Study I will assess recruitment procedures, dropout rates, usage patterns, therapist fidelity, acceptability, usability, satisfaction, and preliminary effects. Study II (RCT) is a randomized, controlled, parallel-group trial evaluating the effectiveness of the TOUCHminds in adolescents with clinical and subclinical anxiety symptoms. Participants will be randomly assigned to one of four conditions: Clinical Intervention (n = 24), Clinical Control (n = 24), Subclinical Intervention (n = 24), or Subclinical Control (n = 24).
| Arm | Type | Receives |
|---|---|---|
| Experimental: Clinical Group (study I and study II) | Experimental | Behavioral: TOUCHminds - Web-Based InterventionAdolescents meeting diagnostic criteria for one or more anxiety disorders (study I n= 5; study II n = 24). Participants receive the TOUCHminds intervention. Assessments are conducted at pre-intervention (study I and II), post-intervention (9 weeks later; study I and II), and at 3-month follow-up (study II). |
| Control: Clinical Group (study II) | No intervention | –Adolescents meeting diagnostic criteria for one or more anxiety disorders (study II n = 24). Participants do not receive the intervention during the main study period but are assessed at the same time points as the intervention group: pre-intervention, post-intervention (9 weeks later), and 3-month follow-up. After completing the final assessment, they are granted access to the TOUCHminds intervention. |
| Experimental: Subclinical Group (study I and study II) | Experimental | Behavioral: TOUCHminds - Web-Based InterventionAdolescents presenting subclinical anxiety symptoms (i.e., high self-reported anxiety but no mental disorder diagnosis; study I n= 5; study II n = 24). Participants receive the TOUCHminds intervention. Assessments are conducted at pre-intervention (study I and II), post-intervention (9 weeks later; study I and II), and at 3-month follow-up (study II). |
| Control: Subclinical Group (study II) | No intervention | –Adolescents presenting subclinical anxiety symptoms (i.e., high self-reported anxiety but no mental disorder diagnosis; study II n = 24). Participants do not receive the intervention during the main study period but are assessed at the same time points as the intervention group: baseline (pre-intervention), post-intervention (9 weeks later), and 3-month follow-up. After completing the final assessment, they are granted access to the TOUCHminds intervention. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Aged between 15 and 19 years old at the time of screening;
- Fluent in Portuguese;
- Have access to a smartphone, tablet, or computer;
- Have reliable internet access.
- Must meet criteria for a primary diagnosis of at least one anxiety disorder, as assessed by the MINI-KID (Rijo et al., 2016).
Key exclusion criteria (4 listed)
- Psychotic symptoms or suicidal risk as assessed via the Mini-Kid (Rijo et al., 2016);
- Being part of the special needs teaching system.
- Currently receiving psychological counselling.
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 |
|---|---|---|
| TOUCHminds - Web-Based InterventionA web-based intervention designed to promote help-seeking in adolescents with clinical or subclinical anxiety symptoms. The program combines six self-guided online modules with three individual videoconference sessions with a trained psychologist. It integrates core components from Cognitive Behavioral Therapy (CBT), Acceptance and Commitment Therapy (ACT), Compassion-Focused Therapy (CFT), Motivational Interviewing, and the Transtheoretical Model of Change. The intervention is tailored to the developmental stage of adolescents and is delivered remotely to participants meeting the inclusion criteria. | Behavioural | Experimental: Clinical Group (study I and study II), Experimental: Subclinical Group (study I and study II) |
Primary outcome
General Help-Seeking Questionnaire (GHSQ).
Time frame: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).
The GHSQ is a 12-item self-report scale that assesses adolescents' intentions to seek help for personal-emotional problems from various sources. Responses are rated on a 7-point Likert scale (1 = 'extremely unlikely' to 7 = 'extremely likely'). Its items refer to formal help (e.g., mental health professionals), semi-formal help (e.g., priests), informal help (e.g., partner), and self-help (e.g., the internet). sources. Higher scores indicate stronger intentions to seek help. The GHSQ has been adapted for use in Portugal and, despite the lack of formal psychometric studies, has been widely applied in research. For this study, the scale is further adapted to better reflect adolescents' social context. The adapted version includes formal help (e.g., psychologist), semi-formal help (e.g., teacher), informal help (e.g., friend), and self-help (e.g., online websites) sources. In addition, the original response option "I would not seek help from anyone" will be retaine.
Adolescent Help-Seeking Behavior Scale (AHSBS).
Time frame: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).
The AHSBS is a 17-item self-report scale developed for this study to assess how often adolescents seek help for emotional or psychological difficulties. Using the same items as the adapted GHSQ, but with new instructions, participants are asked to indicate how frequently they have turned to various sources of help in recent weeks. Responses are given on a 5-point Likert scale (1 = 'never' to 5 = 'always'). Help sources are categorized into formal, semi-formal, informal, and self-help. The total score reflects overall help-seeking frequency, with sub-scores available for each category. The AHSBS is currently under study for its psychometric properties and is expected to show good internal consistency, a structure consistent with help-seeking categories (formal, informal, semi-formal, and self-help), and construct validity in relation help-seeking intentions, stigma, and well-being.
5 secondary outcomes
Mental Health Literacy Scale for Adolescents (MHLS-A)
Time frame: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).
Peer Mental Health Stigmatization Scale (PMHSS).
Time frame: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).
Self-Compassion Scale for Adolescents (SCS-A).
Time frame: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).
University of Rhode Island Change Assessment (URICA).
Time frame: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).
Mental Health Continuum - Short Form - for youth (MHC-SF).
Time frame: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- BackgroundWorld Health Organization. (2024, October 10). Mental health of adolescents. https://www.who.int/news-room/fact-sheets/detail/adolescent-mental-health
- Background: PubMed 11556633Woodward LJ, Fergusson DM. Life course outcomes of young people with anxiety disorders in adolescence. J Am Acad Child Adolesc Psychiatry. 2001 Sep;40(9):1086-93. doi: 10.1097/00004583-200109000-00018.
- BackgroundWilson, C. J., Deane, F. P., Ciarrochi, J., & Rickwood, D. (2005). Measuring help-seeking intentions: Properties of the General Help-Seeking Questionnaire. Canadian Journal of Counselling, 39(1), 15-28.
- Background: PubMed 27821267Werner-Seidler A, Perry Y, Calear AL, Newby JM, Christensen H. School-based depression and anxiety prevention programs for young people: A systematic review and meta-analysis. Clin Psychol Rev. 2017 Feb;51:30-47. doi: 10.1016/j.cpr.2016.10.005. Epub 2016 Oct 24.
- Background: PubMed 33995136van Doorn M, Nijhuis LA, Egeler MD, Daams JG, Popma A, van Amelsvoort T, McEnery C, Gleeson JF, Ory FG, Avis KA, Ruigt E, Jaspers MWM, Alvarez-Jimenez M, Nieman DH. Online Indicated Preventive Mental Health Interventions for Youth: A Scoping Review. Front Psychiatry. 2021 Apr 29;12:580843. doi: 10.3389/fpsyt.2021.580843. eCollection 2021.
- Background: PubMed 35976200Tuijnman A, Kleinjan M, Olthof M, Hoogendoorn E, Granic I, Engels RC. A Game-Based School Program for Mental Health Literacy and Stigma on Depression (Moving Stories): Cluster Randomized Controlled Trial. JMIR Ment Health. 2022 Aug 17;9(8):e26615. doi: 10.2196/26615.
- Background: PubMed 32500537Strawn JR, Lu L, Peris TS, Levine A, Walkup JT. Research Review: Pediatric anxiety disorders - what have we learnt in the last 10 years? J Child Psychol Psychiatry. 2021 Feb;62(2):114-139. doi: 10.1111/jcpp.13262. Epub 2020 Jun 5.
- Background: PubMed 35146318Schlack R, Peerenboom N, Neuperdt L, Junker S, Beyer AK. The effects of mental health problems in childhood and adolescence in young adults: Results of the KiGGS cohort. J Health Monit. 2021 Dec 8;6(4):3-19. doi: 10.25646/8863. eCollection 2021 Dec.
- Background: PubMed 22325128Sawyer MG, Borojevic N, Ettridge KA, Spence SH, Sheffield J, Lynch J. Do help-seeking intentions during early adolescence vary for adolescents experiencing different levels of depressive symptoms? J Adolesc Health. 2012 Mar;50(3):236-42. doi: 10.1016/j.jadohealth.2011.06.009.
- Background: PubMed 27822300Rijo D, Brazao N, Barroso R, da Silva DR, Vagos P, Vieira A, Lavado A, Macedo AM. Mental health problems in male young offenders in custodial versus community based-programs: implications for juvenile justice interventions. Child Adolesc Psychiatry Ment Health. 2016 Nov 1;10:40. doi: 10.1186/s13034-016-0131-6. eCollection 2016.
- BackgroundProchaska, J. O., & DiClemente, C. C. (1982). Transtheoretical therapy: Toward a more integrative model of change. Psychotherapy: Theory, Research & Practice, 19(3), 276-288. https://doi.org/10.1037/h0088437
- BackgroundNeto, D. D., Rocha, I., Figueiras, M. J., & Nunes Da Silva, A. (2021). Measuring Mental Health Literacy: Adaptation and Validation of the Portuguese Version of the Mental Health Literacy Scale (MHLS). European Journal of Mental Health, 16(1), 64-77. https://doi.org/10.5708/EJMH.16.2021.1.5
- Individual participant dataSharing planned: No
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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.
Catarina Monteiro, M.Sc. principal investigator
William James Center for Research, Department of Education and Psychology, University of Aveiro.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOUCHminds - Web-Based Intervention in people with Anxiety Symptoms and Anxiety Disorders, run by Aveiro University at 1 site in Portugal.
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 9 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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 Portugal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catarina Monteiro, M.Sc. (969232691 ext. 00351, catarinaamonteiro@ua.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Help-Seeking Questionnaire (GHSQ). (time frame: Administered one week before the intervention (T0), one week after completion (T1), and 3 months after completion (T2) in experimental groups (Studies I-II), and at corresponding times (9 weeks after T0 and 3 months later) in control groups (Study II).). 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 NCT07366580, which also lists 50 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 27 Oct 2026.