CBT for Adolescents With Excessive Worry

Not Applicable

Completed

• Conditions: Excessive Worry
• Interventions: Behavioral: Cognitive behavioral therapy

• Registration Number: NCT02978963
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-11-13
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-12-01
• Primary Completion: 2017-06
• Study Completion: 2017-10
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-20
• Last Update Posted: 2017-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy	Cognitive behavioral therapy	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.

Primary Outcome Measures

Name	Time	Method
Penn State Worry Questionnaire for Children (PSWQ-C)	At 12 weeks after treatment starts	Child and parent version

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression - Severity (CGI-S)	Baseline, 12 weeks after start of treatment and three month after treatment has ended.	Clinician rated severity of symptoms
Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)	Baseline, 12 weeks after start of treatment and three month after treatment has ended.	Diagnostic interview
Brief Why Worry-II (Brief WW2)	Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended	Self rated positive assumptions of worry
Revised Children´s Anxiety and Depression Scale (RCADS-C)	Baseline, 12 weeks after start of treatment and three month after treatment has ended.	Child and parent version.
Brief Intolerance of Uncertainty Scale (Brief IUS)	Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended	Self rated tolerance to treatment
Negative Problem Orientation Questionnaire (NPOQ)	Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended	Self rated negative problem orientation
Education, Work and Social Adjustment Scale (EWSAS)	Baseline, 12 weeks after start of treatment and three month after treatment has ended.	Child and parent version.
Clinical Global Impression - Improvement (CGI-I)	At 12 weeks after start of treatment and three month after treatment has ended.	Clinician rated improvement after treatment
Children's Global Assessment Scale (CGAS)	Baseline, 12 weeks after start of treatment and three month after treatment has ended.	Clinician rated global functioning
Brief Cognitive Avoidance Questionnaire (Brief CAQ)	Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended	Self rated cognitive avoidance

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden