Internet-delivered CBT for Adolescents With GAD (BIPWorry)

Internet-delivered Cognitive Behavioral Therapy for Adolescents With Generalized Anxiety Disorder - a Multiple Baseline Evaluation

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).

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Behavioral: Internet-Delivered Cognitive Behavioral Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• 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 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Behavioral: Internet-Delivered Cognitive Behavioral Therapy; Therapist-supported CBT delivered online.; Other Names: ICBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Penn State Worry Questionnaire for Children	Self-assessment of excessive worry for individual analysis in multiple baseline evaluation	10 weeks after baseline
Penn State Worry Questionnaire for Children	Child and parent version, lower values indicating decrease in worry. Assessments used in group statistical analysis of clinical outcome	10, 14 and 22 weeks after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Intolerance of Uncertainty Scale	Child version, lower values indicating decrease in intolerance of uncertainty	10, 14 and 22 weeks after baseline
Brief Cognitive Avoidance Questionnaire	Child version, lower values indicating decrease in cognitive avoidance	10, 14 and 22 weeks after baseline
Negative Problem Orientation Questionnaire, abbreviated	Child version, lower values indicating decrease in negative problem orientation	10, 14 and 22 weeks after baseline
Revised Children's Anxiety and Depression Scale	Child and parent versions, lower values indicating decrease in anxiety and depression	10, 14 and 22 weeks after baseline
Education, Work and Social Adjustment Scale	Child and parent versions, , lower values indicating decreased impairment due to worry	10 and 22 weeks after baseline
Clinical Global Impression - Improvement	Clinician rated, higher values indicate larger improvement after treatment	10, 14 and 22 weeks after baseline
Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual -IV	Diagnostic interview	10, 14 and 22 weeks after baseline
Clinician Severity Rating	Clinician rated severity with lower values indicating lower level of severity of a disorder	10, 14 and 22 weeks after baseline
Children's Global Assessment Scale	Clinician rated global functioning, higher values indicate higher functioning	10, 14 and 22 weeks after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment credibility and expectancy scale (child and parent version)	A 5-item scale, rated from 0-10, with higher scores indicating higher treatment credibility and expectancy.	10 weeks after baseline
Negative Events Questionnaire (child and parent version)	The 5-item scale queries negative events during treatment and if the participants attributes the event to the intervention.	10 weeks after baseline
Client satisfaction questionnaire	Child- and parent rated treatment satisfaction is rated on an eight items scale,ange 0-3, with higher score indicating higher satisfaction..	10 weeks after baseline
Internet intervention Patient Adherence Scale	Clinician rated, 5-item scale ranging from 0-4 with higher scores indicating higher participant adherence to treatment.	5 and 10 weeks after baseline

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 28, 2017
• Primary Completion (ACTUAL): August 28, 2018
• Study Completion (ACTUAL): August 28, 2018

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (ACTUAL): March 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Adolescents; CBT; GAD; ICBT; Internet-delivered Cognitive behavioral therapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: EPN DNR 2017/1879-31/5

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No