Actively Recruiting

Phase Not Applicable
Age: 14Years - 18Years
All Genders
ID06901128

The Covideo Study - a Randomized Controlled Trial of Cognitive Therapy for Social Anxiety Disorder in Youth Comparing Screen to Office Delivery

Led by Sykehuset Innlandet HF · Updated on 2025-03-28

200

Participants Needed

5

Research Sites

365 weeks

Total Duration

On this page

Sponsors

S

Sykehuset Innlandet HF

Lead Sponsor

H

Helse Vest

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating screen delivery as an alternative to traditional office delivery for cognitive therapy in youth aged 14 to 18 years with social anxiety disorder (SAD). This study aims to compare the effectiveness, acceptability, and sustainability of these two delivery methods and identify factors that influence therapy outcomes. The study is a randomized controlled trial involving 200 youth and addresses important questions about therapy access, economic and climate benefits, and therapeutic alliance. Participants will receive cognitive therapy based on the CT-SAD-A manual, delivered either by video screen or in an office setting. Therapy consists of 14 weekly 90-minute sessions plus a booster session six months after treatment. Therapists involved have specialized training and participate in supervision, with sessions recorded and stored securely. The study also includes a feasibility phase with feedback from therapists, youth, and parents. During the trial, participants complete questionnaires weekly and attend interviews at multiple time points: before treatment, after therapy, and at 6 months, 2 years, and 4 years post-treatment. Parents also provide information through interviews. Researchers monitor therapy adherence, therapeutic competence, and safety, including suicidality and mood symptoms. Overall participation spans several years, with data collected to assess therapy effectiveness and long-term outcomes.

CONDITIONS

Brief Title

The Covideo Study - a Trial of Cognitive Therapy for Social Anxiety Disorder in Youth, Comparing Screen to Office Delivery

Who Can Participate

Age: 14Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary diagnosis of social anxiety disorder
  • Age between 14 and 18 years
  • Fluency in Norwegian
Not Eligible

You will not qualify if you...

  • Severe depression
  • Acute suicidality
  • Substance abuse
  • Psychosis
  • Intellectual disability
  • More than 20% absence from school in the past three months

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Outpatient Treatment

Duration - 14 weeks

Participants receive weekly cognitive therapy sessions for social anxiety disorder, delivered either via video/screen or in an office setting.

Weekly therapy sessions for 14 weeks

Follow-up

Duration - 1 day (booster session at 6 months post-treatment)

Participants are offered a booster therapy session 6 months after completing the treatment to support long-term benefits.

1 booster session visit

Trial Site Locations

Total: 5 locations

1

Sykehuset Innlandet, Forskningsavdelingen, Sanderud Sykehus

Ottestad, Innlandet, Norway, 2313

Actively Recruiting

2

Helse Vest

Førde, Norway

Actively Recruiting

3

Helse SørØst

Hamar, Norway

Actively Recruiting

4

Helse Nord

Tromsø, Norway

Actively Recruiting

5

Helse Midt

Trondheim, Norway

Actively Recruiting

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Research Team

E

Einar R Heiervang, MD PhD

G

Grethe E Roer, Master

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Understanding Social Anxiety Disorder in Adolescents and Improving Treatment Outcomes: Applying the Cognitive Model of Clark and Wells (1995).

Eleanor Leigh, David M Clark

https://pubmed.ncbi.nlm.nih.gov/29654442