Internet-delivered CBT for Adolescents With GAD

Study Overview
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Brief Summary
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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).

Detailed Description
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This pilot study aims to test Internet-delivered Cognitive Behavioral Therapy (ICBT) for adolescents with Generalized Anxiety Disorder (GAD) The study has a single case research design (multiple baseline) and will include 12 participants with GAD according to a semi structured diagnostic interview. Participants will be randomized to either two, six or ten weeks baseline measurements prior to starting treatment, and will thus work as their own controls. Primary outcome measures will be collected at 10 weeks after treatment start. Follow-up assessments will be made three month after treatment.

Official Title
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Internet-delivered Cognitive Behavioral Therapy for Adolescents With Generalized Anxiety Disorder - a Multiple Baseline Evaluation

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: Internet-Delivered Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-delivered CBT<br>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<br>* Therapist-supported CBT delivered online.<br>* Other names: ICBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Intolerance of Uncertainty Scale | Child version, lower values indicating decrease in intolerance of uncertainty | 10, 14 and 22 weeks after baseline | 
| Brief Cognitive Avoidance Questionnaire | Child version, lower values indicating decrease in cognitive avoidance | 10, 14 and 22 weeks after baseline | 
| Negative Problem Orientation Questionnaire, abbreviated | Child version, lower values indicating decrease in negative problem orientation | 10, 14 and 22 weeks after baseline | 
| Revised Children's Anxiety and Depression Scale | Child and parent versions, lower values indicating decrease in anxiety and depression | 10, 14 and 22 weeks after baseline | 
| Education, Work and Social Adjustment Scale | Child and parent versions, , lower values indicating decreased impairment due to worry | 10 and 22 weeks after baseline | 
| Clinical Global Impression - Improvement | Clinician rated, higher values indicate larger improvement after treatment | 10, 14 and 22 weeks after baseline | 
| Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual -IV | Diagnostic interview | 10, 14 and 22 weeks after baseline | 
| Clinician Severity Rating | Clinician rated severity with lower values indicating lower level of severity of a disorder | 10, 14 and 22 weeks after baseline | 
| Children's Global Assessment Scale | Clinician rated global functioning, higher values indicate higher functioning | 10, 14 and 22 weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GAD, Adolescents, Internet-delivered Cognitive behavioral therapy, ICBT, CBT