An interventional study of Internet-Delivered Cognitive Behavioral Therapy in Generalized Anxiety Disorder, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-05-06.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
146 studies on the registry are indexed under Generalized Anxiety Disorder; 86 are open to participants now.
This study's enrollment of 13 is below the median of 100 across 120 interventional studies indexed under Generalized Anxiety Disorder.
Browse Generalized Anxiety Disorder studies →Karolinska Institutet is the lead sponsor of 1,146 studies on the registry; 275 are open to participants now.
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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
Therapist-supported CBT delivered online.
Also known as: ICBT
Brief Penn State Worry Questionnaire for Children
Self-assessment of excessive worry for individual analysis in multiple baseline evaluation
Time frame: 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
Time frame: 10, 14 and 22 weeks after baseline
Brief Intolerance of Uncertainty Scale
Child version, lower values indicating decrease in intolerance of uncertainty
Time frame: 10, 14 and 22 weeks after baseline
Brief Cognitive Avoidance Questionnaire
Child version, lower values indicating decrease in cognitive avoidance
Time frame: 10, 14 and 22 weeks after baseline
Negative Problem Orientation Questionnaire, abbreviated
Child version, lower values indicating decrease in negative problem orientation
Time frame: 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
Time frame: 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
Time frame: 10 and 22 weeks after baseline
Clinical Global Impression - Improvement
Clinician rated, higher values indicate larger improvement after treatment
Time frame: 10, 14 and 22 weeks after baseline
Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual -IV
Diagnostic interview
Time frame: 10, 14 and 22 weeks after baseline
Clinician Severity Rating
Clinician rated severity with lower values indicating lower level of severity of a disorder
Time frame: 10, 14 and 22 weeks after baseline
Children's Global Assessment Scale
Clinician rated global functioning, higher values indicate higher functioning
Time frame: 10, 14 and 22 weeks after baseline
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.
Time frame: 10 weeks after baseline
Negative Events Questionnaire (child and parent version)
The 5-item scale queries negative events during treatment and if the participants attributes the event to the intervention.
Time frame: 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..
Time frame: 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.
Time frame: 5 and 10 weeks after baseline
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Aug 2018, 9 months.
Of 66 non-industry interventional studies with no phase under Generalized Anxiety Disorder, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 67. This study's 9 months is below that.
Counting every sponsor, half of 69 studies reached it within 33 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Generalized Anxiety Disorder →