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Internet-delivered CBT for Adolescents With GAD

Not Applicable
Completed
Conditions
Generalized Anxiety Disorder
Interventions
Behavioral: Internet-Delivered Cognitive Behavioral Therapy
Registration Number
NCT03469453
Lead Sponsor
Karolinska Institutet
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).

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
13
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
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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)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Internet-delivered CBTInternet-Delivered Cognitive Behavioral TherapyInternet-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.
Primary Outcome Measures
NameTimeMethod
Brief Penn State Worry Questionnaire for Children10 weeks after baseline

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

Penn State Worry Questionnaire for Children10, 14 and 22 weeks after baseline

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

Secondary Outcome Measures
NameTimeMethod
Children's Global Assessment Scale10, 14 and 22 weeks after baseline

Clinician rated global functioning, higher values indicate higher functioning

Brief Intolerance of Uncertainty Scale10, 14 and 22 weeks after baseline

Child version, lower values indicating decrease in intolerance of uncertainty

Brief Cognitive Avoidance Questionnaire10, 14 and 22 weeks after baseline

Child version, lower values indicating decrease in cognitive avoidance

Negative Problem Orientation Questionnaire, abbreviated10, 14 and 22 weeks after baseline

Child version, lower values indicating decrease in negative problem orientation

Revised Children's Anxiety and Depression Scale10, 14 and 22 weeks after baseline

Child and parent versions, lower values indicating decrease in anxiety and depression

Education, Work and Social Adjustment Scale10 and 22 weeks after baseline

Child and parent versions, , lower values indicating decreased impairment due to worry

Clinical Global Impression - Improvement10, 14 and 22 weeks after baseline

Clinician rated, higher values indicate larger improvement after treatment

Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual -IV10, 14 and 22 weeks after baseline

Diagnostic interview

Clinician Severity Rating10, 14 and 22 weeks after baseline

Clinician rated severity with lower values indicating lower level of severity of a disorder

Trial Locations

Locations (1)

Karolinska Institutet

🇸🇪

Stockholm, Sweden

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