CBT for Adolescents With Excessive Worry (BiPOro)

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

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.

Study Overview

• Status: Completed
• Conditions: Excessive Worry
• Intervention / Treatment: Behavioral: Cognitive behavioral therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 171 77
    • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: Cognitive behavioral therapy; CBT focused on reducing intolerance of uncertainty; Other Names: CBT

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: November 13, 2016
• First Submitted That Met QC Criteria: November 28, 2016
• First Posted (Estimate): December 1, 2016

Study Record Updates

• Last Update Posted (Actual): December 22, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Adolescents; Excessive worry; Worry; Intolerance of uncertainty
• Other Study ID Numbers: EPN DNR 2016/1408-31/5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No