NCT06489639 School-based Treatment of Social Anxiety With Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder
| NCT ID | NCT06489639 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Klaus Ranta |
| Condition | Social Anxiety Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 156 participants |
| Start Date | 2023-03-20 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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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 156 participants in total. It began in 2023-03-20 with a primary completion date of 2027-12-31.
⚠ 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
The goal of this randomized controlled trial is to find out whether the brief, 10-session Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder (DOCT-SAD) is more effective than standard counseling (SC) to treat Social Anxiety Disorder (SAD) among 12 to 17-year-old adolescents with SAD. Potential participants for the study are identified from school health and well-being services (SHWS). The DOCT-SAD is delivered by method-trained school psychologists working in the SHWS. SC will be provided by non-method-trained SHWS professionals (i.e. school nurses, social workers or school psychologists) according to their routine counselling practice. The main research questions of the study are: 1. Is DOCT-SAD more effective than SC for alleviating symptoms of social anxiety? 2. Is DOCT-SAD more effective than SC to produce diagnostic remission from primary SAD and alleviating symptom severity associated with SAD? 3. Is DOCT-SAD more effective than SC for alleviating co-occurring depressive symptoms, interference in daily functioning due to worry or fears, and for increasing general well-being, positive mental health, and for improving the quality of life among adolescents with SAD? Researchers will compare DOCT-SAD with SC to see if DOCT-SAD is effective in the treatment of SAD in adolescents. Participants will: * be treated either with DOCT-SAD or SC for 10 weeks. * be followed up and assessed clinically at six-month and twelve-month follow-up points.
Eligibility Criteria
Inclusion criteria: * age 13-17 years * diagnosis of DSM-5 SAD (Social Anxiety Disorder) * SAD is the primary mental health disorder * motivation of the adolescent and parent to attend DOCT-SAD / SC as described in the study protocol * good command of the Finnish language. Exclusion criteria: * intellectual deficit * presence of primary autism spectrum disorder * marked psychotic symptoms or psyhotic disorder * severe eating disorder, depression or primary other anxiety disorder requiring acute treatment which need to be prioritized above treatment of social anxiety * acute suicidality or suicide risk * substance use or substance use disorder requiring child protection measures * presence of contextual/environmental risk factors in the participants surroundings which require child protection measures
Contact & Investigator
Klaus Ranta, MD, PhD
STUDY DIRECTOR
Tampere University
Frequently Asked Questions
Who can join the NCT06489639 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 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 NCT06489639 currently recruiting?
Yes, NCT06489639 is actively recruiting participants. Contact the research team at klaus.ranta@tuni.fi for enrollment information.
Where is the NCT06489639 trial being conducted?
This trial is being conducted at Tampere, Finland.
Who is sponsoring the NCT06489639 clinical trial?
NCT06489639 is sponsored by Klaus Ranta. The principal investigator is Klaus Ranta, MD, PhD at Tampere University. The trial plans to enroll 156 participants.
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