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Completed

NCT Number: NCT03247075

Internet-delivered CBT vs Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - An RCT

Social anxiety disorder among youth is highly prevalent and causes significant impairment in the lives of the affected. In spite of cognitive behavior therapy (CBT) being an effective treatment, research suggests that many young people with this disorder do not have access to good-quality CBT. Internet-delivered CBT could be an effective method to increase availability of evidence-based treatments for youth with social anxiety disorder. The primary objective of this study is to test the efficacy of internet-delivered CBT (ICBT) for youth (10 - 17 years) with social anxiety disorder. The investigators aim to conduct a randomized controlled trial with N = 101 participants. Participants will be randomized to either the active treatment arm (guided ICBT) or to a control condition (guided internet-delivered support and counseling). Follow-ups will be conducted at 3 and 12 months after post-assessment.

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BUP KFE

Stockholm, Stockholms County, 113 30, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A principal diagnosis of social anxiety disorder, as defined by DSM-5
  • Age between 10 and 17 years
  • Ability to read and write Swedish
  • Daily access to the internet through a computer or similar device
  • A parent or caregiver that is able to co-participate in the treatment
  • Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment

Exclusion criteria

  • Diagnosed with autism spectrum disorder, psychosis, bipolar disorder or severe eating disorder
  • Present risk of suicide
  • Ongoing alcohol or substance abuse
  • Occurrence of domestic violence
  • Completed CBT for any anxiety disorder within the last 6 months (defined as at least 5 sessions of CBT including in vivo exposure sessions)

Treatment and study plan

Cognitive Behavior Therapy

Behavioral

Guided Internet-delivered CBT includes exposure training, coping techniques and cognitive components, intended to reduce social anxiety symptoms

Support and Counseling

Behavioral

Guided Internet-delivered support and counseling includes educative material about social anxiety and health related issues such as physical activity, nutritious diet, sleep habits etc.

Primary outcomes

  1. Clinician Severity Rating (CSR)

    Time frame: 6 months (14 months including follow-up)

    A 0-8 rating by a professional assessor, specifying the severity of social anxiety

Secondary outcomes

  1. Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Social anxiety disorder

    Time frame: Measured over the course of 6 months (14 months including follow-up)

    Diagnostic status: Social anxiety disorder

  2. Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Comorbid disorders

    Time frame: Measured over the course of 6 months (14 months including follow-up)

    Diagnostic status: Comorbid psychiatric disorders

  3. Clinical Global Impression - Improvement (CGI-I)

    Time frame: Measured over the course of 3 months (12 months including follow-up)

    A 1-7 rating by a professional assessor, specifying the degree of improvement from treatment

  4. Children's Global Assessment Scale (CGAS)

    Time frame: Measured over the course of 6 months (14 months including follow-up)

    A 0-100 rating by a professional assessor, specifying global functioning

  5. Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Child version

    Time frame: 6 months (14 months including follow-up)

    A self-rated measure of severity of social anxiety

  6. Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Parent version

    Time frame: Measured over the course of 6 months (14 months including follow-up)

    A parent-rated measure of severity of social anxiety

  7. Revised Children´s Anxiety and Depression Scale - (RCADS) - Parent version

    Time frame: Measured over the course of 6 months (14 months including follow-up)

    A parent-rated measure of severity of anxiety and depression

  8. Revised Children´s Anxiety and Depression Scale - (RCADS) Depression sub scale - Child version

    Time frame: Measured over the course of 6 months (14 months including follow-up)

    A parent-rated measure of severity of anxiety and depression

  9. Anticipatory social behaviors scale (ASBQ)

    Time frame: Measured over the course of 6 months (14 months including follow-up)

    A self-rated measure of anticipatory anxiety before social situations

  10. Post-event processing questionnaire revised (PEPQ-R)

    Time frame: Measured over the course of 6 months (14 months including follow-up)

    A self-rated measure of anxiety and rumination experienced after social situations

  11. Focus of attention questionnaire (FAQ)

    Time frame: Measured over the course of 6 months (14 months including follow-up)

    A self-rated measure of self-focus in social situations

  12. The Subtle Avoidance Frequency Examination (SAFE)

    Time frame: Measured over the course of 6 months (14 months including follow-up)

    A self-rated measure of safety behaviors in social situations

  13. The Child Health Utility 9D (CHU 9D) - Child version

    Time frame: Measured over the course of 6 months (14 months including follow-up)

    A self-rated measure of quality of life

  14. Client Satisfaction Questionnaire (CSQ-) - Child version

    Time frame: Measured only at post-treatment

    A self-rated measure of treatment satisfaction

  15. Client Satisfaction Questionnaire (CSQ-) - Parent version

    Time frame: Measured only at post-treatment

    A parent-rated measure of treatment satisfaction

  16. Treatment credibility and expectancy - Child version

    Time frame: Measured at one time-point, at week three in the allocated intervention.

    A self-rated measure of credibility and expectancy of allocated treatment condition

  17. Treatment credibility and expectancy - Parent version

    Time frame: Measured at one time-point, at week three in the allocated intervention.

    A parent-rated measure of credibility and expectancy of allocated treatment condition

  18. Education, Work and Social Adjustment Scale (EWSAS) - Parent version

    Time frame: Measured over the course of 6 months (14 months including follow-up)

    A parent-rated measure of functioning in everyday life

  19. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Measured only at pre-treatments

    A self-rated measure of anxiety and depression among parents

  20. Alcohol Disorder Identification Test (AUDIT)

    Time frame: Measured over the course of 6 months (14 months including follow-up)

    A self-rated screening measure for hazardous and harmful alcohol consumption

  21. Drug Use Disorders Identification Test (DUDIT)

    Time frame: Measured over the course of 6 months (14 months including follow-up)

    A self-rated screening measure for drug-related problems

  22. Family Accommodation Scale-Anxiety (FASA)

    Time frame: Measured over the course of 6 months (14 months including follow-up)

    A parent-rated measure of parental accommodation to the child's anxiety

  23. Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) - Child version

    Time frame: Measured over the course of 6 months (14 months including follow-up)

    A parent-rated measure of direct and indirect costs related to psychiatric illness in children

  24. The Negative Effects Questionnaire (NEQ)

    Time frame: Measured only at post-treatment

    A self-rated measure of treatment related adverse and unwanted events

  25. Internet intervention Patient Adherence Scale (iiPAS)

    Time frame: Measured at mid-treatment (week 5) and at post-treatment (week 10)

    A clinician-rated measure of adherence to the allocated treatment

  26. School absenteeism

    Time frame: Measured over the course of 6 months (14 months including follow-up)

    A parent-rated measure of the frequency of school absenteeism

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Internet-delivered Cognitive Behavior Therapy Versus Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - A Randomized Controlled Trial

Acronym: SOFT RCT

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Aug 11, 2017
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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