search
Back to results

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

Primary Purpose

Social Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive Behavior Therapy
Support and Counseling
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Social anxiety disorder, Cognitive Behavior Therapy, Internet-delivered treatments, Children and adolescents, Randomized controlled trial

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • BUP KFE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Internet-delivered Cognitive Behavior Therapy

Internet-delivered Support and Counseling

Arm Description

10 weeks of guided Internet-delivered Cognitive Behavior Therapy

10 weeks of guided Internet-delivered support and counseling

Outcomes

Primary Outcome Measures

Clinician Severity Rating (CSR)
A 0-8 rating by a professional assessor, specifying the severity of social anxiety

Secondary Outcome Measures

Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Social anxiety disorder
Diagnostic status: Social anxiety disorder
Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Comorbid disorders
Diagnostic status: Comorbid psychiatric disorders
Clinical Global Impression - Improvement (CGI-I)
A 1-7 rating by a professional assessor, specifying the degree of improvement from treatment
Children's Global Assessment Scale (CGAS)
A 0-100 rating by a professional assessor, specifying global functioning
Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Child version
A self-rated measure of severity of social anxiety
Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Parent version
A parent-rated measure of severity of social anxiety
Revised Children´s Anxiety and Depression Scale - (RCADS) - Parent version
A parent-rated measure of severity of anxiety and depression
Revised Children´s Anxiety and Depression Scale - (RCADS) Depression sub scale - Child version
A parent-rated measure of severity of anxiety and depression
Anticipatory social behaviors scale (ASBQ)
A self-rated measure of anticipatory anxiety before social situations
Post-event processing questionnaire revised (PEPQ-R)
A self-rated measure of anxiety and rumination experienced after social situations
Focus of attention questionnaire (FAQ)
A self-rated measure of self-focus in social situations
The Subtle Avoidance Frequency Examination (SAFE)
A self-rated measure of safety behaviors in social situations
The Child Health Utility 9D (CHU 9D) - Child version
A self-rated measure of quality of life
Client Satisfaction Questionnaire (CSQ-) - Child version
A self-rated measure of treatment satisfaction
Client Satisfaction Questionnaire (CSQ-) - Parent version
A parent-rated measure of treatment satisfaction
Treatment credibility and expectancy - Child version
A self-rated measure of credibility and expectancy of allocated treatment condition
Treatment credibility and expectancy - Parent version
A parent-rated measure of credibility and expectancy of allocated treatment condition
Education, Work and Social Adjustment Scale (EWSAS) - Parent version
A parent-rated measure of functioning in everyday life
Hospital Anxiety and Depression Scale (HADS)
A self-rated measure of anxiety and depression among parents
Alcohol Disorder Identification Test (AUDIT)
A self-rated screening measure for hazardous and harmful alcohol consumption
Drug Use Disorders Identification Test (DUDIT)
A self-rated screening measure for drug-related problems
Family Accommodation Scale-Anxiety (FASA)
A parent-rated measure of parental accommodation to the child's anxiety
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) - Child version
A parent-rated measure of direct and indirect costs related to psychiatric illness in children
The Negative Effects Questionnaire (NEQ)
A self-rated measure of treatment related adverse and unwanted events
Internet intervention Patient Adherence Scale (iiPAS)
A clinician-rated measure of adherence to the allocated treatment
School absenteeism
A parent-rated measure of the frequency of school absenteeism

Full Information

First Posted
August 8, 2017
Last Updated
January 24, 2021
Sponsor
Karolinska Institutet
search

1. Study Identification

Unique Protocol Identification Number
NCT03247075
Brief Title
Internet-delivered CBT vs Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - An RCT
Acronym
SOFT RCT
Official Title
Internet-delivered Cognitive Behavior Therapy Versus Internet-delivered Support and Counseling for Youth With Social Anxiety Disorder - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 19, 2017 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
Social anxiety disorder, Cognitive Behavior Therapy, Internet-delivered treatments, Children and adolescents, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-delivered Cognitive Behavior Therapy
Arm Type
Experimental
Arm Description
10 weeks of guided Internet-delivered Cognitive Behavior Therapy
Arm Title
Internet-delivered Support and Counseling
Arm Type
Active Comparator
Arm Description
10 weeks of guided Internet-delivered support and counseling
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy
Intervention Description
Guided Internet-delivered CBT includes exposure training, coping techniques and cognitive components, intended to reduce social anxiety symptoms
Intervention Type
Behavioral
Intervention Name(s)
Support and Counseling
Intervention Description
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 Outcome Measure Information:
Title
Clinician Severity Rating (CSR)
Description
A 0-8 rating by a professional assessor, specifying the severity of social anxiety
Time Frame
6 months (14 months including follow-up)
Secondary Outcome Measure Information:
Title
Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Social anxiety disorder
Description
Diagnostic status: Social anxiety disorder
Time Frame
Measured over the course of 6 months (14 months including follow-up)
Title
Anxiety Disorder Interview Schedule for DSM-IV, child and parent versions (ADIS C/P) - Comorbid disorders
Description
Diagnostic status: Comorbid psychiatric disorders
Time Frame
Measured over the course of 6 months (14 months including follow-up)
Title
Clinical Global Impression - Improvement (CGI-I)
Description
A 1-7 rating by a professional assessor, specifying the degree of improvement from treatment
Time Frame
Measured over the course of 3 months (12 months including follow-up)
Title
Children's Global Assessment Scale (CGAS)
Description
A 0-100 rating by a professional assessor, specifying global functioning
Time Frame
Measured over the course of 6 months (14 months including follow-up)
Title
Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Child version
Description
A self-rated measure of severity of social anxiety
Time Frame
6 months (14 months including follow-up)
Title
Liebowitz social anxiety scale for children and adolescents (LSAS-CA) - Parent version
Description
A parent-rated measure of severity of social anxiety
Time Frame
Measured over the course of 6 months (14 months including follow-up)
Title
Revised Children´s Anxiety and Depression Scale - (RCADS) - Parent version
Description
A parent-rated measure of severity of anxiety and depression
Time Frame
Measured over the course of 6 months (14 months including follow-up)
Title
Revised Children´s Anxiety and Depression Scale - (RCADS) Depression sub scale - Child version
Description
A parent-rated measure of severity of anxiety and depression
Time Frame
Measured over the course of 6 months (14 months including follow-up)
Title
Anticipatory social behaviors scale (ASBQ)
Description
A self-rated measure of anticipatory anxiety before social situations
Time Frame
Measured over the course of 6 months (14 months including follow-up)
Title
Post-event processing questionnaire revised (PEPQ-R)
Description
A self-rated measure of anxiety and rumination experienced after social situations
Time Frame
Measured over the course of 6 months (14 months including follow-up)
Title
Focus of attention questionnaire (FAQ)
Description
A self-rated measure of self-focus in social situations
Time Frame
Measured over the course of 6 months (14 months including follow-up)
Title
The Subtle Avoidance Frequency Examination (SAFE)
Description
A self-rated measure of safety behaviors in social situations
Time Frame
Measured over the course of 6 months (14 months including follow-up)
Title
The Child Health Utility 9D (CHU 9D) - Child version
Description
A self-rated measure of quality of life
Time Frame
Measured over the course of 6 months (14 months including follow-up)
Title
Client Satisfaction Questionnaire (CSQ-) - Child version
Description
A self-rated measure of treatment satisfaction
Time Frame
Measured only at post-treatment
Title
Client Satisfaction Questionnaire (CSQ-) - Parent version
Description
A parent-rated measure of treatment satisfaction
Time Frame
Measured only at post-treatment
Title
Treatment credibility and expectancy - Child version
Description
A self-rated measure of credibility and expectancy of allocated treatment condition
Time Frame
Measured at one time-point, at week three in the allocated intervention.
Title
Treatment credibility and expectancy - Parent version
Description
A parent-rated measure of credibility and expectancy of allocated treatment condition
Time Frame
Measured at one time-point, at week three in the allocated intervention.
Title
Education, Work and Social Adjustment Scale (EWSAS) - Parent version
Description
A parent-rated measure of functioning in everyday life
Time Frame
Measured over the course of 6 months (14 months including follow-up)
Title
Hospital Anxiety and Depression Scale (HADS)
Description
A self-rated measure of anxiety and depression among parents
Time Frame
Measured only at pre-treatments
Title
Alcohol Disorder Identification Test (AUDIT)
Description
A self-rated screening measure for hazardous and harmful alcohol consumption
Time Frame
Measured over the course of 6 months (14 months including follow-up)
Title
Drug Use Disorders Identification Test (DUDIT)
Description
A self-rated screening measure for drug-related problems
Time Frame
Measured over the course of 6 months (14 months including follow-up)
Title
Family Accommodation Scale-Anxiety (FASA)
Description
A parent-rated measure of parental accommodation to the child's anxiety
Time Frame
Measured over the course of 6 months (14 months including follow-up)
Title
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P) - Child version
Description
A parent-rated measure of direct and indirect costs related to psychiatric illness in children
Time Frame
Measured over the course of 6 months (14 months including follow-up)
Title
The Negative Effects Questionnaire (NEQ)
Description
A self-rated measure of treatment related adverse and unwanted events
Time Frame
Measured only at post-treatment
Title
Internet intervention Patient Adherence Scale (iiPAS)
Description
A clinician-rated measure of adherence to the allocated treatment
Time Frame
Measured at mid-treatment (week 5) and at post-treatment (week 10)
Title
School absenteeism
Description
A parent-rated measure of the frequency of school absenteeism
Time Frame
Measured over the course of 6 months (14 months including follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Serlachius, PhD, MD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
BUP KFE
City
Stockholm
State/Province
Stockholms County
ZIP/Postal Code
113 30
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33978699
Citation
Nordh M, Wahlund T, Jolstedt M, Sahlin H, Bjureberg J, Ahlen J, Lalouni M, Salomonsson S, Vigerland S, Lavner M, Ost LG, Lenhard F, Hesser H, Mataix-Cols D, Hogstrom J, Serlachius E. Therapist-Guided Internet-Delivered Cognitive Behavioral Therapy vs Internet-Delivered Supportive Therapy for Children and Adolescents With Social Anxiety Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Jul 1;78(7):705-713. doi: 10.1001/jamapsychiatry.2021.0469.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs