Internet-delivered CBT for Adolescents With GAD

NCT ID: NCT03469453

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-28
• Study Completion Date: 2018-08-28

Brief Summary

This multiple baseline evaluation aims to test the feasibility and preliminary effectiveness of Internet-delivered cognitive behavioral therapy (ICBT) for adolescents with Generalized Anxiety Disorder (GAD).

Detailed Description

This pilot study aims to test Internet-delivered Cognitive Behavioral Therapy (ICBT) for adolescents with Generalized Anxiety Disorder (GAD)

The study has a single case research design (multiple baseline) and will include 12 participants with GAD according to a semi structured diagnostic interview.

Participants will be randomized to either two, six or ten weeks baseline measurements prior to starting treatment, and will thus work as their own controls.

Primary outcome measures will be collected at 10 weeks after treatment start. Follow-up assessments will be made three month after treatment.

Conditions

Generalized Anxiety Disorder

Study Design

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

Study Groups

Internet-delivered CBT

Internet-delivered Cognitive Behavioral Therapy (ICBT) for GAD, 10 weeks. Patients and their parents work with separate programs via the Internet. Both have contact with a therapist. Participants practice awareness of worry through daily worry monitoring. They identify their own behaviors that reinforce worry, i.e. control and avoidance behaviors. The program gives a rationale for behavior change, which is then implemented. Participants practice problem solving and exposure to uncertainty inducing situations and thoughts. Parents receive support and psycho education about worry. They practice alternative parental behaviors, which decrease focus on worry while validating the child's feelings. Treatment contains planning for maintenance of treatment gains for both patients and parents.

Group Type: EXPERIMENTAL

Internet-Delivered Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

Therapist-supported CBT delivered online.

Interventions

Internet-Delivered Cognitive Behavioral Therapy

Therapist-supported CBT delivered online.

Intervention Type: BEHAVIORAL

Other Intervention Names

ICBT

Eligibility Criteria

Inclusion Criteria

• A score on the Penn State Worry Questionnaire for Children (PSWQ-C) of > 30
• Fulfilling DSM-5 criteria for Generalized Anxiety Disorder
• No other disorder or symptoms present in need of more urgent treatment
• Aged between 13 and 17 years
• Ability to read and write in Swedish
• A parent or caregiver that is able to participate in the treatment
• Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment
• No other ongoing psychological treatment for any disorder

Exclusion Criteria

• The presence of symptoms suggestive of a current diagnosis of Autistic Spectrum Disorder, Schizophrenia, Bipolar Disorder, Anorexia Nervosa, Bulimia, or Substance Use Disorder
• Present risk of suicide
• Present 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 2017/1879-31/5

Identifier Type: -

Identifier Source: org_study_id