An interventional study of Cognitive behavioral therapy in Excessive Worry, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-12-22.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
This case series aims to test the feasibility and acceptability of streamlined cognitive behavioral therapy (CBT) for adolescents with excessive worry. The treatment protocol focuses on reducing intolerance of uncertainty and the hypothesis is that this will help reduce worry.
This pilot study aims to test a new form of Cognitive Behavioral Therapy for adolescents with excessive worry. The investigators will include 12 participants with excessive worry and test the treatment which focuses on reducing intolerance of uncertainty (IU) in order to reduce worry.
Participants will be randomized to either one, two or three weeks of weekly baseline measurements prior to starting treatment, and will thus work as their on controls in this case series design.
Primary outcome measures will be collected at 12 weeks after treatment start. Participants will be followed up at three months after treatment.
Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All participants will receive cognitive behavioral therapy for excessive worry. Focus in treatment will be on reducing participants' intolerance uncertainty through in vivo and imaginary exposure to uncertainty inducing situations and thoughts. Treatment will also contain psycho education about anxiety and worry, as well as planning for maintenance of treatment gains. Parents of the participants will receive support and education about worry through an internet-delivered program.
Behavioral: Cognitive behavioral therapy
CBT focused on reducing intolerance of uncertainty
Also known as: CBT
Penn State Worry Questionnaire for Children (PSWQ-C)
Child and parent version
Time frame: At 12 weeks after treatment starts
Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
Diagnostic interview
Time frame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
Clinical Global Impression - Severity (CGI-S)
Clinician rated severity of symptoms
Time frame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
Clinical Global Impression - Improvement (CGI-I)
Clinician rated improvement after treatment
Time frame: At 12 weeks after start of treatment and three month after treatment has ended.
Children's Global Assessment Scale (CGAS)
Clinician rated global functioning
Time frame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
Brief Intolerance of Uncertainty Scale (Brief IUS)
Self rated tolerance to treatment
Time frame: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended
Brief Cognitive Avoidance Questionnaire (Brief CAQ)
Self rated cognitive avoidance
Time frame: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended
Brief Why Worry-II (Brief WW2)
Self rated positive assumptions of worry
Time frame: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended
Negative Problem Orientation Questionnaire (NPOQ)
Self rated negative problem orientation
Time frame: Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended
Revised Children´s Anxiety and Depression Scale (RCADS-C)
Child and parent version.
Time frame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
Education, Work and Social Adjustment Scale (EWSAS)
Child and parent version.
Time frame: Baseline, 12 weeks after start of treatment and three month after treatment has ended.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet