CBT for Adolescents With Excessive Worry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cognitive Behavioral Therapy for Adolescents With Excessive Worry - a Case Series

Conditions
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Excessive Worry

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A score on PSWQ-C of at least 22 Age between 13 and 17 years Ability to read and write in Swedish A parent or caregiver that is able to co-participate in the treatment Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment Exclusion Criteria: Diagnosis of autism spectrum disorder, psychosis, bipolar disorder or severe eating disorder Present risk of suicide Ongoing substance dependence 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)

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy<br>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<br>* CBT focused on reducing intolerance of uncertainty<br>* Other names: CBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penn State Worry Questionnaire for Children (PSWQ-C) | Child and parent version | At 12 weeks after treatment starts | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) | Diagnostic interview | 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 | 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 | At 12 weeks after start of treatment and three month after treatment has ended. | 
| Children's Global Assessment Scale (CGAS) | Clinician rated global functioning | 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 | 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 | 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 | 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 | 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. | 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. | Baseline, 12 weeks after start of treatment and three month after treatment has ended. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Excessive worry, Worry, Adolescents, Intolerance of uncertainty