CBT for Adolescents With Excessive Worry

NCT ID: NCT02978963

Last Updated: 2017-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-10-31

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.

Conditions

Excessive Worry

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive behavioral therapy

Intervention Type: BEHAVIORAL

CBT focused on reducing intolerance of uncertainty

Interventions

Cognitive behavioral therapy

CBT focused on reducing intolerance of uncertainty

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT

Eligibility Criteria

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)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Eva Serlachius

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva Serlachius, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

EPN DNR 2016/1408-31/5

Identifier Type: -

Identifier Source: org_study_id