Generalized Anxiety DisorderBIPWorryNCT03469453
Internet-delivered CBT for Adolescents With GAD
A study testing Internet-Delivered Cognitive Behavioral Therapy in people with Generalized Anxiety Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Internet-Delivered Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSweden
- Study dates
- 28 Nov 2017to 28 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Being tested
- Internet-Delivered Cognitive Behavioral Therapy
- Keywords
- GAD, Adolescents, Internet-delivered Cognitive behavioral therapy, ICBT, CBT
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Delivered Cognitive Behavioral TherapyBehavioural
Also called ICBT
Therapist-supported CBT delivered online.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered CBT | Experimental | 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. Receives: Behavioral: Internet-Delivered Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Penn State Worry Questionnaire for Children
Self-assessment of excessive worry for individual analysis in multiple baseline evaluation
Measured: 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
Measured: 10, 14 and 22 weeks after baseline
Secondary outcomes (9)
Brief Intolerance of Uncertainty Scale
Child version, lower values indicating decrease in intolerance of uncertainty
Measured: 10, 14 and 22 weeks after baseline
Brief Cognitive Avoidance Questionnaire
Child version, lower values indicating decrease in cognitive avoidance
Measured: 10, 14 and 22 weeks after baseline
Negative Problem Orientation Questionnaire, abbreviated
Child version, lower values indicating decrease in negative problem orientation
Measured: 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
Measured: 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
Measured: 10 and 22 weeks after baseline
Clinical Global Impression - Improvement
Clinician rated, higher values indicate larger improvement after treatment
Measured: 10, 14 and 22 weeks after baseline
Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual -IV
Diagnostic interview
Measured: 10, 14 and 22 weeks after baseline
Clinician Severity Rating
Clinician rated severity with lower values indicating lower level of severity of a disorder
Measured: 10, 14 and 22 weeks after baseline
Children's Global Assessment Scale
Clinician rated global functioning, higher values indicate higher functioning
Measured: 10, 14 and 22 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start28 Nov 2017
- Primary completion28 Aug 2018
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Eva Serlachius, Karolinska Institutet
- Investigators
- Eva Serlachius, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469453
- Sponsor's protocol ID
- EPN DNR 2017/1879-31/5
- Acronym
- BIPWorry
- Status last verified
- May 2019
- First submitted
- 20 Dec 2017
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behavioral Therapy for Adolescents With Generalized Anxiety Disorder - a Multiple Baseline Evaluation
- ClinicalTrials.gov ID
- NCT03469453
- Acronym / sponsor ID
- BIPWorry / EPN DNR 2017/1879-31/5
- Conditions
- Generalized Anxiety Disorder
- Keywords
- GAD, Adolescents, Internet-delivered Cognitive behavioral therapy, ICBT, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered CBT | Experimental | Behavioral: Internet-Delivered Cognitive Behavioral TherapyInternet-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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Delivered Cognitive Behavioral TherapyAlso: ICBTTherapist-supported CBT delivered online. | Behavioural | Internet-delivered CBT |
Primary outcome
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
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
9 secondary outcomes
Brief Intolerance of Uncertainty Scale
Time frame: 10, 14 and 22 weeks after baseline
Brief Cognitive Avoidance Questionnaire
Time frame: 10, 14 and 22 weeks after baseline
Negative Problem Orientation Questionnaire, abbreviated
Time frame: 10, 14 and 22 weeks after baseline
Revised Children's Anxiety and Depression Scale
Time frame: 10, 14 and 22 weeks after baseline
Education, Work and Social Adjustment Scale
Time frame: 10 and 22 weeks after baseline
Clinical Global Impression - Improvement
Time frame: 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
Clinician Severity Rating
Time frame: 10, 14 and 22 weeks after baseline
Children's Global Assessment Scale
Time frame: 10, 14 and 22 weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Serlachius, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Delivered Cognitive Behavioral Therapy in people with Generalized Anxiety Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Penn State Worry Questionnaire for Children (time frame: 10 weeks after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.