CBT for Adolescents With Excessive Worry

NCT02978963 | Completed

• 1 other identifier: EPN DNR 2016/1408-31/5
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Excessive Worry

Keywords

Excessive worry; Worry; Adolescents; Intolerance of uncertainty

Outcome Measures

Primary Outcomes (1)

• Penn State Worry Questionnaire for Children (PSWQ-C)

  Child and parent version

  At 12 weeks after treatment starts

Secondary Outcomes (10)

• Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)

  Baseline, 12 weeks after start of treatment and three month after treatment has ended.

• Clinical Global Impression - Severity (CGI-S)

  Baseline, 12 weeks after start of treatment and three month after treatment has ended.

• Clinical Global Impression - Improvement (CGI-I)

  At 12 weeks after start of treatment and three month after treatment has ended.

• Children's Global Assessment Scale (CGAS)

  Baseline, 12 weeks after start of treatment and three month after treatment has ended.

• Brief Intolerance of Uncertainty Scale (Brief IUS)

  Baseline, weekly during treatment, 12 weeks after treatment starts, and three months after treatment has ended

Study Arms (1)

Cognitive Behavioral Therapy

EXPERIMENTAL

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

Interventions

Cognitive behavioral therapy BEHAVIORAL

CBT focused on reducing intolerance of uncertainty

Also known as: CBT

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, 171 77, Sweden

Location

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Eva Serlachius, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 13, 2016
• First Posted: December 1, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 22, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)