Anxiety DisordersNCT02535403
Internet-based Cognitive Behavioral Therapy (CBT) for Adolescents With Anxiety Disorders
A study testing ICBT in people with Anxiety Disorders, run by University of Aarhus at 1 site in Denmark.
Trial summary
Cognitive behavioral therapy (CBT) is a well-documented and effective method for the treatment of children and adolescents with anxiety disorders. Lately there has been an increase in the development and use of internet-based CBT programs (ICBT), as a means to reduce costs and enhance accessibility of psychological… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- ICBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2015to Jul 2016
- 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 primary diagnosis of separation anxiety disorder, generalized anxiety disorder, social phobia, specific phobia, obsessive compulsive disorder or panic disorder
- age between 13 and 17 years
- ability to read and write in Danish
- direct access to a home computer and internet
Who cannot join
- high degree of comorbid depression (CSR above 5 as measured with ADIS-IV)
- substance abuse
- current self-harm or suicidal ideation
- pervasive developmental disorder
- learning disorder
- intellectual disability
- psychotic symptoms
- All participants are asked not to make changes to their medication status during the course of the trial
Trial locations and contacts
1 site in 1 country.
About this study
Cognitive behavioral therapy (CBT) is a well-documented and effective method for the treatment of children and adolescents with anxiety disorders. Lately there has been an increase in the development and use of internet-based CBT programs (ICBT), as a means to reduce costs and enhance accessibility of psychological interventions. ICBT has proven efficacious towards adults with anxiety disorders. Research in the field of ICBT with children and adolescents is still in its infancy though and to date, no program targeting anxiety disorders has been developed nor evaluated in Denmark. The primary objective of this study is to investigate the efficacy of a newly developed internet-based treatment program for adolescents with anxiety disorders. The effect will be examined in a randomized controlled trial comparing ICBT to a wait-list control condition.
Read the detailed description
Within the context of a research and teaching clinic at the Department of Psychology and Behavioral Sciences, Aarhus University, Denmark, 70 adolescents aged 13-17 with a primary anxiety disorder as assessed by the ADIS C/P will be randomly allocated to either a 3 month wait-list control condition or a treatment condition.
The treatment consists of an internet-based self-help program for adolescents with anxiety disorders called 'Chilled Out', based on material from the well-established manualised group-treatment Cool Kids Program: Adolescent version. It consists of 8 CBT-inspired modules of approximately 30 minutes each distributed over a 14-week period. The program is interactive using a combination of different media (text, audio, illustrations, cartoons, and videos) to deliver psychoeducation and CBT-inspired techniques, activities and exercises for adolescents to manage their anxiety. In addition, the adolescent will receive a limited amount of therapist support calls.
Participants (youth and parents) are assessed with semi-structured diagnostic interviews and self-report measures before treatment, after 14 weeks (post treatment) and 3 months after treatment (follow-up).
Participants are assessed at pre, post and 3-month follow up.
- Conditions
- Anxiety Disorders
- Being tested
- ICBT
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICBTBehavioural
| Study group | Role | What they receive |
|---|---|---|
| ICBT | Experimental | 14 weeks of internet-based cognitive behavioral therapy with therapist support Receives: Behavioral: ICBT |
| Wait-list | No intervention | 14 weeks wait-list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Anxiety Disorder Interview Schedule for DSM-IV, Parent and Child Versions (ADIS-IV c/p)
Measures clinician rated anxiety symptoms through Clinician Severity Rating (CSR)
Measured: Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
Change in Spence Child Anxiety Scale (SCAS-C/P)
Measures self-rated youth anxiety symptoms
Measured: Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
Secondary outcomes (12)
Change in Children's Anxiety Life Inference Scale (CALIS)
Measures life interference and impairment associated with the anxiety disorder(s) as assessed by parents and youths
Measured: Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
Change in Self-Efficacy Questionnaire for Children (SEQ-c)
Measures youth self-efficacy
Measured: Pre- (baseline) and post- (14 weeks) treatment
Change in the Short version of the Mood and Feelings Questionnaire (S-MFQ-c/p)
Measures youth depressive symptoms as assessed by parents and youths
Measured: Pre- (baseline) and post- (14 weeks) treatment
Change in WHO Quality of Life (5 items)
A short version of The World Health Organization Quality of Life questionnaire (WHOQOL) measuring youth quality of life
Measured: Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
Change in Strength and Difficulties Questionnaire for Youth (SDQ)
Measures youth strengths and difficulties as assessed by youths and parents
Measured: Pre- (baseline) and post- (14 weeks) treatment
Change in Working Alliance Inventory - Short form (WAI-S)
Measures the therapeutic alliance between youth and therapist
Measured: Mid- (4 and 8 weeks) and post- (14 weeks) treatment
Experience of Service Questionnaire (ESQ)
Measures youths' and parents' satisfaction with the treatment
Measured: Post- (14 weeks) treatment
Adherence to the program I
Degree of program completion (number of completed modules)
Measured: Post- (14 weeks) treatment
Adherence to the program II
Total amount of log ins to the program
Measured: Post- (14 weeks) treatment
Adherence to the program III
Average time spent per week on program relevant activities (online)
Measured: Post- (14 weeks) treatment
Adherence to the program IV
Average time spent per week on program relevant activities (offline)
Measured: Post- (14 weeks) treatment
Parent support
Parents' average time spent per week helping their child with program relevant activities (on- and offline)
Measured: Post- (14 weeks) treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535403
- Sponsor's protocol ID
- Chilled Out DK
- Status last verified
- Jan 2017
- First submitted
- 21 Aug 2015
- Last updated
- 27 Jan 2017
- Results posted
- No
Publications
Stjerneklar S, Hougaard E, McLellan LF, Thastum M. A randomized controlled trial examining the efficacy of an internet-based cognitive behavioral therapy program for adolescents with anxiety disorders. PLoS One. 2019 Sep 18;14(9):e0222485. doi: 10.1371/journal.pone.0222485. eCollection 2019.
PubMed 31532802
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive Behavioral Therapy (CBT) for Adolescents With Anxiety Disorders
- ClinicalTrials.gov ID
- NCT02535403
- Acronym / sponsor ID
- Chilled Out DK
- Conditions
- Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 Aug 2015 (estimated)
- 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.
Cognitive behavioral therapy (CBT) is a well-documented and effective method for the treatment of children and adolescents with anxiety disorders. Lately there has been an increase in the development and use of internet-based CBT programs (ICBT), as a means to reduce costs and enhance accessibility of psychological interventions. ICBT has proven efficacious towards adults with anxiety disorders. Research in the field of ICBT with children and adolescents is still in its infancy though and to date, no program targeting anxiety disorders has been developed nor evaluated in Denmark. The primary objective of this study is to investigate the efficacy of a newly developed internet-based treatment program for adolescents with anxiety disorders. The effect will be examined in a randomized controlled trial comparing ICBT to a wait-list control condition.
Detailed description
Within the context of a research and teaching clinic at the Department of Psychology and Behavioral Sciences, Aarhus University, Denmark, 70 adolescents aged 13-17 with a primary anxiety disorder as assessed by the ADIS C/P will be randomly allocated to either a 3 month wait-list control condition or a treatment condition.
The treatment consists of an internet-based self-help program for adolescents with anxiety disorders called 'Chilled Out', based on material from the well-established manualised group-treatment Cool Kids Program: Adolescent version. It consists of 8 CBT-inspired modules of approximately 30 minutes each distributed over a 14-week period. The program is interactive using a combination of different media (text, audio, illustrations, cartoons, and videos) to deliver psychoeducation and CBT-inspired techniques, activities and exercises for adolescents to manage their anxiety. In addition, the adolescent will receive a limited amount of therapist support calls.
Participants (youth and parents) are assessed with semi-structured diagnostic interviews and self-report measures before treatment, after 14 weeks (post treatment) and 3 months after treatment (follow-up).
Participants are assessed at pre, post and 3-month follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICBT | Experimental | Behavioral: ICBT14 weeks of internet-based cognitive behavioral therapy with therapist support |
| Wait-list | No intervention | –14 weeks wait-list control |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- a primary diagnosis of separation anxiety disorder, generalized anxiety disorder, social phobia, specific phobia, obsessive compulsive disorder or panic disorder
- age between 13 and 17 years
- ability to read and write in Danish
- direct access to a home computer and internet
Key exclusion criteria (8 listed)
- high degree of comorbid depression (CSR above 5 as measured with ADIS-IV)
- substance abuse
- current self-harm or suicidal ideation
- pervasive developmental disorder
- learning disorder
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 |
|---|---|---|
| ICBT | Behavioural | ICBT |
Primary outcome
Change in The Anxiety Disorder Interview Schedule for DSM-IV, Parent and Child Versions (ADIS-IV c/p)
Time frame: Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
Measures clinician rated anxiety symptoms through Clinician Severity Rating (CSR)
Change in Spence Child Anxiety Scale (SCAS-C/P)
Time frame: Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
Measures self-rated youth anxiety symptoms
12 secondary outcomes
Change in Children's Anxiety Life Inference Scale (CALIS)
Time frame: Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
Change in Self-Efficacy Questionnaire for Children (SEQ-c)
Time frame: Pre- (baseline) and post- (14 weeks) treatment
Change in the Short version of the Mood and Feelings Questionnaire (S-MFQ-c/p)
Time frame: Pre- (baseline) and post- (14 weeks) treatment
Change in WHO Quality of Life (5 items)
Time frame: Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up
Change in Strength and Difficulties Questionnaire for Youth (SDQ)
Time frame: Pre- (baseline) and post- (14 weeks) treatment
Change in Working Alliance Inventory - Short form (WAI-S)
Time frame: Mid- (4 and 8 weeks) and post- (14 weeks) treatment
Experience of Service Questionnaire (ESQ)
Time frame: Post- (14 weeks) treatment
Adherence to the program I
Time frame: Post- (14 weeks) treatment
Adherence to the program II
Time frame: Post- (14 weeks) treatment
Adherence to the program III
Time frame: Post- (14 weeks) treatment
Adherence to the program IV
Time frame: Post- (14 weeks) treatment
Parent support
Time frame: Post- (14 weeks) treatment
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 27 Jan 2017.
- Derived from this study: PubMed 31532802Stjerneklar S, Hougaard E, McLellan LF, Thastum M. A randomized controlled trial examining the efficacy of an internet-based cognitive behavioral therapy program for adolescents with anxiety disorders. PLoS One. 2019 Sep 18;14(9):e0222485. doi: 10.1371/journal.pone.0222485. eCollection 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICBT in people with Anxiety Disorders, run by University of Aarhus at 1 site in Denmark.
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 4 inclusion and 8 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 27 Jan 2017. 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 Denmark. 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?
Change in The Anxiety Disorder Interview Schedule for DSM-IV, Parent and Child Versions (ADIS-IV c/p) (time frame: Pre- (baseline) and post- (14 weeks) treatment + 3 months follow-up). 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?
On the ClinicalTrials.gov record for NCT02535403, which also lists 1 linked publication.
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 27 Jan 2017.