Generalized Anxiety Disorder
Conditions
Keywords
GAD, Adolescents, Internet-delivered Cognitive behavioral therapy, ICBT, CBT
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.
Interventions
Therapist-supported CBT delivered online.
Sponsors
Region Stockholm
Karolinska Institutet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Penn State Worry Questionnaire for Children | 10 weeks after baseline | Self-assessment of excessive worry for individual analysis in multiple baseline evaluation |
| Penn State Worry Questionnaire for Children | 10, 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
| Measure | Time frame | Description |
|---|---|---|
| Revised Children's Anxiety and Depression Scale | 10, 14 and 22 weeks after baseline | Child and parent versions, lower values indicating decrease in anxiety and depression |
| Clinical Global Impression - Improvement | 10, 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 -IV | 10, 14 and 22 weeks after baseline | Diagnostic interview |
| Clinician Severity Rating | 10, 14 and 22 weeks after baseline | Clinician rated severity with lower values indicating lower level of severity of a disorder |
| Children's Global Assessment Scale | 10, 14 and 22 weeks after baseline | Clinician rated global functioning, higher values indicate higher functioning |
| Brief Intolerance of Uncertainty Scale | 10, 14 and 22 weeks after baseline | Child version, lower values indicating decrease in intolerance of uncertainty |
| Brief Cognitive Avoidance Questionnaire | 10, 14 and 22 weeks after baseline | Child version, lower values indicating decrease in cognitive avoidance |
| Negative Problem Orientation Questionnaire, abbreviated | 10, 14 and 22 weeks after baseline | Child version, lower values indicating decrease in negative problem orientation |
| Education, Work and Social Adjustment Scale | 10 and 22 weeks after baseline | Child and parent versions, , lower values indicating decreased impairment due to worry |
Other
| Measure | Time frame | Description |
|---|---|---|
| Internet intervention Patient Adherence Scale | 5 and 10 weeks after baseline | Clinician rated, 5-item scale ranging from 0-4 with higher scores indicating higher participant adherence to treatment. |
| Treatment credibility and expectancy scale (child and parent version) | 10 weeks after baseline | A 5-item scale, rated from 0-10, with higher scores indicating higher treatment credibility and expectancy. |
| Negative Events Questionnaire (child and parent version) | 10 weeks after baseline | The 5-item scale queries negative events during treatment and if the participants attributes the event to the intervention. |
| Client satisfaction questionnaire | 10 weeks after baseline | Child- and parent rated treatment satisfaction is rated on an eight items scale,ange 0-3, with higher score indicating higher satisfaction.. |
Countries
Sweden
Outcome results
None listed