Clinical trial NCT03469453: Internet-delivered CBT for Adolescents With GAD
Official title: Internet-delivered Cognitive Behavioral Therapy for Adolescents With Generalized Anxiety Disorder - a Multiple Baseline Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: GAD
Adolescents
Internet-delivered Cognitive behavioral therapy
ICBT
CBT
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2018-03-19
Enrollment: 13
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Brief Penn State Worry Questionnaire for Children
timeFrame: 10 weeks after baseline
measure: Penn State Worry Questionnaire for Children
timeFrame: 10, 14 and 22 weeks after baseline
Secondary outcomes:
measure: Brief Intolerance of Uncertainty Scale
timeFrame: 10, 14 and 22 weeks after baseline
measure: Brief Cognitive Avoidance Questionnaire
timeFrame: 10, 14 and 22 weeks after baseline
measure: Negative Problem Orientation Questionnaire, abbreviated
timeFrame: 10, 14 and 22 weeks after baseline
measure: Revised Children's Anxiety and Depression Scale
timeFrame: 10, 14 and 22 weeks after baseline
measure: Education, Work and Social Adjustment Scale
timeFrame: 10 and 22 weeks after baseline
measure: Clinical Global Impression - Improvement
timeFrame: 10, 14 and 22 weeks after baseline
measure: Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual -IV
timeFrame: 10, 14 and 22 weeks after baseline
measure: Clinician Severity Rating
timeFrame: 10, 14 and 22 weeks after baseline
measure: Children's Global Assessment Scale
timeFrame: 10, 14 and 22 weeks after baseline
Other outcomes:
measure: Treatment credibility and expectancy scale (child and parent version)
timeFrame: 10 weeks after baseline
measure: Negative Events Questionnaire (child and parent version)
timeFrame: 10 weeks after baseline
measure: Client satisfaction questionnaire
timeFrame: 10 weeks after baseline
measure: Internet intervention Patient Adherence Scale
timeFrame: 5 and 10 weeks after baseline
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Eva Serlachius, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: