Internet-delivered CBT for Adolescents With GAD (BIPWorry)

May 2, 2019 updated by: Eva Serlachius, Karolinska Institutet

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 171 77
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Brief Penn State Worry Questionnaire for Children
Time Frame: 10 weeks after baseline
Self-assessment of excessive worry for individual analysis in multiple baseline evaluation
10 weeks after baseline
Penn State Worry Questionnaire for Children
Time Frame: 10, 14 and 22 weeks after baseline
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brief Intolerance of Uncertainty Scale
Time Frame: 10, 14 and 22 weeks after baseline
Child version, lower values indicating decrease in intolerance of uncertainty
10, 14 and 22 weeks after baseline
Brief Cognitive Avoidance Questionnaire
Time Frame: 10, 14 and 22 weeks after baseline
Child version, lower values indicating decrease in cognitive avoidance
10, 14 and 22 weeks after baseline
Negative Problem Orientation Questionnaire, abbreviated
Time Frame: 10, 14 and 22 weeks after baseline
Child version, lower values indicating decrease in negative problem orientation
10, 14 and 22 weeks after baseline
Revised Children's Anxiety and Depression Scale
Time Frame: 10, 14 and 22 weeks after baseline
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
Time Frame: 10 and 22 weeks after baseline
Child and parent versions, , lower values indicating decreased impairment due to worry
10 and 22 weeks after baseline
Clinical Global Impression - Improvement
Time Frame: 10, 14 and 22 weeks after baseline
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
Time Frame: 10, 14 and 22 weeks after baseline
Diagnostic interview
10, 14 and 22 weeks after baseline
Clinician Severity Rating
Time Frame: 10, 14 and 22 weeks after baseline
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
Time Frame: 10, 14 and 22 weeks after baseline
Clinician rated global functioning, higher values indicate higher functioning
10, 14 and 22 weeks after baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment credibility and expectancy scale (child and parent version)
Time Frame: 10 weeks after baseline
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)
Time Frame: 10 weeks after baseline
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
Time Frame: 10 weeks after baseline
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
Time Frame: 5 and 10 weeks after baseline
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Region Stockholm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 28, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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