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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-Delivered Cognitive Behavioral Therapy | Behavioral | Therapist-supported CBT delivered online. |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment credibility and expectancy scale (child and parent version) | A 5-item scale, rated from 0-10, with higher scores indicating higher treatment credibility and expectancy. | 10 weeks after baseline |
| Negative Events Questionnaire (child and parent version) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Serlachius, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Stockholm | 171 77 | Sweden |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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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 |
The 5-item scale queries negative events during treatment and if the participants attributes the event to the intervention. |
| 10 weeks after baseline |
| Client satisfaction questionnaire | Child- and parent rated treatment satisfaction is rated on an eight items scale,ange 0-3, with higher score indicating higher satisfaction.. | 10 weeks after baseline |
| Internet intervention Patient Adherence Scale | Clinician rated, 5-item scale ranging from 0-4 with higher scores indicating higher participant adherence to treatment. | 5 and 10 weeks after baseline |