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Internet-delivered CBT for Adolescents With GAD (BIPWorry)

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-Delivered Cognitive Behavioral Therapy
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring GAD, Adolescents, Internet-delivered Cognitive behavioral therapy, ICBT, CBT

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Internet-delivered CBT

Arm Description

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.

Outcomes

Primary Outcome Measures

Brief Penn State Worry Questionnaire for Children
Self-assessment of excessive worry for individual analysis in multiple baseline evaluation
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

Secondary Outcome Measures

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

Full Information

First Posted
December 20, 2017
Last Updated
May 2, 2019
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT03469453
Brief Title
Internet-delivered CBT for Adolescents With GAD
Acronym
BIPWorry
Official Title
Internet-delivered Cognitive Behavioral Therapy for Adolescents With Generalized Anxiety Disorder - a Multiple Baseline Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
August 28, 2018 (Actual)
Study Completion Date
August 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
GAD, Adolescents, Internet-delivered Cognitive behavioral therapy, ICBT, CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-delivered CBT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-Delivered Cognitive Behavioral Therapy
Other Intervention Name(s)
ICBT
Intervention Description
Therapist-supported CBT delivered online.
Primary Outcome Measure Information:
Title
Brief Penn State Worry Questionnaire for Children
Description
Self-assessment of excessive worry for individual analysis in multiple baseline evaluation
Time Frame
10 weeks after baseline
Title
Penn State Worry Questionnaire for Children
Description
Child and parent version, lower values indicating decrease in worry. Assessments used in group statistical analysis of clinical outcome
Time Frame
10, 14 and 22 weeks after baseline
Secondary Outcome Measure Information:
Title
Brief Intolerance of Uncertainty Scale
Description
Child version, lower values indicating decrease in intolerance of uncertainty
Time Frame
10, 14 and 22 weeks after baseline
Title
Brief Cognitive Avoidance Questionnaire
Description
Child version, lower values indicating decrease in cognitive avoidance
Time Frame
10, 14 and 22 weeks after baseline
Title
Negative Problem Orientation Questionnaire, abbreviated
Description
Child version, lower values indicating decrease in negative problem orientation
Time Frame
10, 14 and 22 weeks after baseline
Title
Revised Children's Anxiety and Depression Scale
Description
Child and parent versions, lower values indicating decrease in anxiety and depression
Time Frame
10, 14 and 22 weeks after baseline
Title
Education, Work and Social Adjustment Scale
Description
Child and parent versions, , lower values indicating decreased impairment due to worry
Time Frame
10 and 22 weeks after baseline
Title
Clinical Global Impression - Improvement
Description
Clinician rated, higher values indicate larger improvement after treatment
Time Frame
10, 14 and 22 weeks after baseline
Title
Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual -IV
Description
Diagnostic interview
Time Frame
10, 14 and 22 weeks after baseline
Title
Clinician Severity Rating
Description
Clinician rated severity with lower values indicating lower level of severity of a disorder
Time Frame
10, 14 and 22 weeks after baseline
Title
Children's Global Assessment Scale
Description
Clinician rated global functioning, higher values indicate higher functioning
Time Frame
10, 14 and 22 weeks after baseline
Other Pre-specified Outcome Measures:
Title
Treatment credibility and expectancy scale (child and parent version)
Description
A 5-item scale, rated from 0-10, with higher scores indicating higher treatment credibility and expectancy.
Time Frame
10 weeks after baseline
Title
Negative Events Questionnaire (child and parent version)
Description
The 5-item scale queries negative events during treatment and if the participants attributes the event to the intervention.
Time Frame
10 weeks after baseline
Title
Client satisfaction questionnaire
Description
Child- and parent rated treatment satisfaction is rated on an eight items scale,ange 0-3, with higher score indicating higher satisfaction..
Time Frame
10 weeks after baseline
Title
Internet intervention Patient Adherence Scale
Description
Clinician rated, 5-item scale ranging from 0-4 with higher scores indicating higher participant adherence to treatment.
Time Frame
5 and 10 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Serlachius, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
171 77
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Internet-delivered CBT for Adolescents With GAD

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