CBT for Adolescents With Excessive Worry

Excessive Worry Clinical Trial

— BiPOro  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02978963
• Other study ID #: EPN DNR 2016/1408-31/5
• Status: Completed
• Phase: N/A
• First received: November 13, 2016
• Last updated: December 20, 2017
• Start date: October 2016
• Est. completion date: October 2017

Study information

• Verified date: December 2017
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Excessive Worry

Intervention

Behavioral:
• Cognitive behavioral therapy
CBT focused on reducing intolerance of uncertainty

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Penn State Worry Questionnaire for Children (PSWQ-C)	Child and parent version	At 12 weeks after treatment starts
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Children's Global Assessment Scale (CGAS)	Clinician rated global functioning	Baseline, 12 weeks after start of treatment and three month after treatment has ended.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.