NCT05906849 Where We All Meet: ACT Approach to Adolescents Anxiety Disorders
| NCT ID | NCT05906849 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Coimbra |
| Condition | Social Anxiety Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 87 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 87 participants in total. It began in 2023-01-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Transdiagnostic approaches have been proposed as more truthfully representing mental health problems. Acceptance and Commitment Therapy (ACT) is a transdiagnostic approach that proposes Psychological Inflexibility/Flexibility (PI/PF) as the root of human suffering/flourishing. ACT has been recognized as conceptually and clinically relevant for adult disorders. However, during adolescence, when anxiety disorders are highly prevalent, the same evidence is scarce. Specifically, methodologically robust designs investigating ACT's efficacy on adolescents' ADs are scarce and mechanisms underlying change during ACT for adolescents with ADs have not been investigated. Therefore, this study aims to adapt, implement, and investigate the efficacy of an online delivered (through videoconference) ACT intervention to adolescents presenting SAD or GAD, thus contributing to amplifying the transdiagnostic application of ACT to these disorders. A Randomized Controlled Trial (RCT) with 3 groups (i.e., Control, GAD intervention, and SAD intervention groups) of adolescents aged between 14 and 18 years old will be conducted. Outcome measurement will be assessed at pre-intervention, post-intervention, and at 3- and 6-month follow-ups. The investigators expect improvements in outcome variables (e.g., anxiety symptoms) at post-treatment for intervention groups. When comparing changes in outcome variables between the control and the intervention groups, improvements are expected only in the groups receiving intervention. Additionally, similar effects on outcome measures are expected in both intervention groups with gains being maintained over time (i.e., at 3- and 6-months follow-up). Finally, changes in PI/PF processes are expected to predict changes in outcome variables in both intervention groups. This RCT will provide valuable insights that can potentially enhance the efficacy of treatment modalities, contributing to improved well-being for adolescents with ADs.
Eligibility Criteria
Inclusion Criteria: * Healthy adolescent's sample: No mental health diagnosis; * Adolescents with SAD sample: Main diagnosis of SAD; * Adolescents with GAD sample: Main diagnosis of GAD. Note: adolescents presenting both GAD and SAD will be excluded as its inclusion could confound the projects' results and conclusions. Exclusion criteria: 1. Cognitive impairment (assessed through a clinical interview; MINI-KID \[37,38\]); 2. Presence of psychotic symptoms or suicidal ideation (according to the MINI-KID \[37,38\]); 3. Undergoing another treatment (e.g., medication) for a psychiatric condition.
Contact & Investigator
Diana V Figueiredo, M.Sc.
PRINCIPAL INVESTIGATOR
Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), FPCE-UC
Frequently Asked Questions
Who can join the NCT05906849 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 18 Years, studying Social Anxiety Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05906849 currently recruiting?
Yes, NCT05906849 is actively recruiting participants. Contact the research team at diana.v.figueiredo@fpce.uc.pt for enrollment information.
Where is the NCT05906849 trial being conducted?
This trial is being conducted at Coimbra, Portugal.
Who is sponsoring the NCT05906849 clinical trial?
NCT05906849 is sponsored by University of Coimbra. The principal investigator is Diana V Figueiredo, M.Sc. at Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), FPCE-UC. The trial plans to enroll 87 participants.
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