The Covideo Study - a Trial of Cognitive Therapy for Social Anxiety Disorder in Youth, Comparing Screen to Office Delivery
Covideo
The Covideo Study - a Randomized Controlled Trial of Cognitive Therapy for Social Anxiety Disorder in Youth, Comparing Screen to Office Delivery
2 other identifiers
interventional
200
1 country
5
Brief Summary
The main goal of this clinical trial is to examine screen delivery as an alternative for offering cognitive therapy to youth with social anxiety. It will examine its effectiveness compared to office delivery, but also its acceptability and sustainability, and identify factors important for the outcome of this approach. The main questions it aims to answer are: Does screen delivery show comparable effectiveness to office delivery? Is screen delivery well accepted by youth and therapists? Does screen delivery show economic and climate sustainability? Do credibility and therapeutic alliance predict therapy outcome? In the study researchers will compare screen delivery to office delivery of cognitive therapy for social anxiety disorders in 200 youth aged 14-18 years. After an initial screening in schools, eligible youth are assessed with a diagnostic interview. Those meeting inclusion criteria will be offered either screen or office therapy. This is decided by random selection (a draw). Participants will: Complete an initial short screening questionnaire. Respond to a diagnostic interview online. Meet their therapist first time in person. Attend 14 weekly 90-minutes therapy session. Complete weekly questionnaires during the therapy. Answer interview and questionnaires after the therapy, and also 6 months, 2 years and 4 years later. Parents are also interviewed and informed of the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2025
CompletedFirst Posted
Study publicly available on registry
March 28, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2035
March 28, 2025
March 1, 2025
3.8 years
February 28, 2025
March 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Liebowitz social anxiety scale for children and adolescents (LSAS-CA)
24 item scale rated in four response categories
From start of treatment until end of 14 weekly treatment sessions.
Anxiety and Related Disorders Interview Schedule for DSM-5 Chid and parent Version
Short name ADIS-5 C/P.
From start of treatment until end of 14 weekly treatment sessions.
Secondary Outcomes (3)
Revised Children´s Anxiety and Depression Scale RCADS
From start of treatment until end of 14 weekly treatment sessions.
Short Mood and Feelings Questionnaire SMFQ
From start of treatment until end of 14 weekly treatment sessions.
Strengths and Difficulties Questionnaire SDQ
From start of treatment until end of 14 weekly treatment sessions.
Study Arms (2)
Screen delivery
EXPERIMENTALCT by video/screen
Office delivery
ACTIVE COMPARATORInterventions
The CT-SAD-A manual developed by Clark and Leigh
Eligibility Criteria
You may qualify if:
- Social anxiety disorder primary
- Age 14 to 18 years.
- Norwegian fluency
You may not qualify if:
- Severe Depression
- Acute suicidality
- Substance abuse
- Psychosis
- Intellectual Disability
- More than 20% absence from school in previous three months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sykehuset Innlandet HFlead
- Helse Vestcollaborator
- University of Oslocollaborator
- St. Olavs Hospitalcollaborator
- University of Oxfordcollaborator
- University of Bergencollaborator
- Norwegian University of Science and Technologycollaborator
- University of Tromsocollaborator
- Yale Universitycollaborator
- Linkoeping Universitycollaborator
- University of Aarhuscollaborator
- University Hospital, Akershuscollaborator
- Helse Stavanger HFcollaborator
Study Sites (5)
Sykehuset Innlandet, Forskningsavdelingen, Sanderud Sykehus
Ottestad, Innlandet, 2313, Norway
Helse Vest
Førde, Norway
Helse SørØst
Hamar, Norway
Helse Nord
Tromsø, Norway
Helse Midt
Trondheim, Norway
Related Publications (1)
Leigh E, Clark DM. Understanding Social Anxiety Disorder in Adolescents and Improving Treatment Outcomes: Applying the Cognitive Model of Clark and Wells (1995). Clin Child Fam Psychol Rev. 2018 Sep;21(3):388-414. doi: 10.1007/s10567-018-0258-5.
PMID: 29654442BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Einar R Heiervang, MD PhD
Sykehuset Innlandet HF
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2025
First Posted
March 28, 2025
Study Start
April 1, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2035
Last Updated
March 28, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- February 10, 2025 - December 31, 2035
- Access Criteria
- Access to the above provided following information for use provided to the PI.
IPD for all participants will be shared anonymously with other researchers following reasonable requests.