NCT03469453

Brief Summary

This multiple baseline evaluation aims to test the feasibility and preliminary effectiveness of Internet-delivered cognitive behavioral therapy (ICBT) for adolescents with Generalized Anxiety Disorder (GAD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2017

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2018

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

9 months

First QC Date

December 20, 2017

Last Update Submit

May 2, 2019

Conditions

Generalized Anxiety Disorder

Keywords

GADAdolescentsInternet-delivered Cognitive behavioral therapyICBTCBT

Outcome Measures

Primary Outcomes (2)

  • Brief Penn State Worry Questionnaire for Children

    Self-assessment of excessive worry for individual analysis in multiple baseline evaluation

    10 weeks after baseline

  • Penn State Worry Questionnaire for Children

    Child and parent version, lower values indicating decrease in worry. Assessments used in group statistical analysis of clinical outcome

    10, 14 and 22 weeks after baseline

Secondary Outcomes (9)

  • Brief Intolerance of Uncertainty Scale

    10, 14 and 22 weeks after baseline

  • Brief Cognitive Avoidance Questionnaire

    10, 14 and 22 weeks after baseline

  • Negative Problem Orientation Questionnaire, abbreviated

    10, 14 and 22 weeks after baseline

  • Revised Children's Anxiety and Depression Scale

    10, 14 and 22 weeks after baseline

  • Education, Work and Social Adjustment Scale

    10 and 22 weeks after baseline

  • +4 more secondary outcomes

Other Outcomes (4)

  • Treatment credibility and expectancy scale (child and parent version)

    10 weeks after baseline

  • Negative Events Questionnaire (child and parent version)

    10 weeks after baseline

  • Client satisfaction questionnaire

    10 weeks after baseline

  • +1 more other outcomes

Study Arms (1)

Internet-delivered CBT

EXPERIMENTAL

Internet-delivered Cognitive Behavioral Therapy (ICBT) for GAD, 10 weeks. Patients and their parents work with separate programs via the Internet. Both have contact with a therapist. Participants practice awareness of worry through daily worry monitoring. They identify their own behaviors that reinforce worry, i.e. control and avoidance behaviors. The program gives a rationale for behavior change, which is then implemented. Participants practice problem solving and exposure to uncertainty inducing situations and thoughts. Parents receive support and psycho education about worry. They practice alternative parental behaviors, which decrease focus on worry while validating the child's feelings. Treatment contains planning for maintenance of treatment gains for both patients and parents.

Behavioral: Internet-Delivered Cognitive Behavioral Therapy

Interventions

Internet-Delivered Cognitive Behavioral TherapyBEHAVIORAL

Therapist-supported CBT delivered online.

Also known as: ICBT
Internet-delivered CBT

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • A score on the Penn State Worry Questionnaire for Children (PSWQ-C) of \> 30
  • Fulfilling DSM-5 criteria for Generalized Anxiety Disorder
  • No other disorder or symptoms present in need of more urgent treatment
  • Aged between 13 and 17 years
  • Ability to read and write in Swedish
  • A parent or caregiver that is able to participate in the treatment
  • Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment
  • No other ongoing psychological treatment for any disorder

You may not qualify if:

  • The presence of symptoms suggestive of a current diagnosis of Autistic Spectrum Disorder, Schizophrenia, Bipolar Disorder, Anorexia Nervosa, Bulimia, or Substance Use Disorder
  • Present risk of suicide
  • Present 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 171 77, Sweden

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Eva Serlachius, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 20, 2017

First Posted

March 19, 2018

Study Start

November 28, 2017

Primary Completion

August 28, 2018

Study Completion

August 28, 2018

Last Updated

May 6, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)