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

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.

Conditions

• Social Anxiety Disorder (SAD)

Interventions

BEHAVIORAL

cognitive therapy

The CT-SAD-A manual developed by Clark and Leigh

Sponsors & Collaborators

• Helse Vest

  collaborator OTHER

• University of Oslo

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• University of Bergen

  collaborator OTHER

• Norwegian University of Science and Technology

  collaborator OTHER

• University of Tromso

  collaborator OTHER

• Yale University

  collaborator OTHER

• Linkoeping University

  collaborator OTHER_GOV

• University of Aarhus

  collaborator OTHER

• University Hospital, Akershus

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• Sykehuset Innlandet HF

  lead OTHER

Principal Investigators

• Einar R Heiervang, MD PhD · Sykehuset Innlandet HF

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-01

Primary Completion

2028-12-31

Completion

2035-12-31

Countries

• Norway

Study Locations