AsthmaNCT06657807
Online Cognitive Behavior Therapy for Anxiety Related to Pediatric Asthma
A study testing Online CBT in people with Asthma and Anxiety, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Asthma is a chronic condition affecting approximately 5-15% of all Swedish children. Research has shown that asthma may be associated with increased anxiety and worry, with children who have asthma being twice as likely to experience anxiety compared to those without asthma. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- What is being tested?
- Online CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 8-17 years
- A diagnosis of asthma made by a physician and confirmed by the parents
- Some anxiety related to asthma reported by either parent of child ("Do you feel stressed or worried about your asthma?" yes/no) and/or some restriction by asthma in daily life, which could indicate a pattern of avoidance behavior ("Do you feel hindered by your asthma in your daily life?" yes/no)
Who cannot join
- Presence of severe psychiatric disorders such as severe depression or suicidal ideation.
- Concurrent psychological treatment
- Presence of severe somatic disorder that could interfere with participation in the CBT-treatment
- Other respiratory disease than asthma
- Psychotropic medication should be stable for at least 1 month before entering the study.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care
Stockholm
About this study
Official title: Online Cognitive Behavior Therapy for Anxiety Related to Pediatric Asthma: A Feasibility Study
Asthma is a chronic condition affecting approximately 5-15% of all Swedish children. Research has shown that asthma may be associated with increased anxiety and worry, with children who have asthma being twice as likely to experience anxiety compared to those without asthma. The coexistence of anxiety and asthma can worsen asthma symptoms and heighten anxiety, as it can be challenging to distinguish between the two conditions. Cognitive behavioral therapy (CBT) is a recommended treatment for anxiety in children, but few studies have examined the effectiveness of CBT in children with both asthma and anxiety. Our research group has previously developed internet-delivered CBT (Internet-CBT) targeting anxiety in asthma for adults, yielding promising results. Internet-CBT can significantly improve access to treatment and has been shown to be both effective and safe for other medical conditions.
The primary aim of this project is to investigate whether Internet-CBT can contribute to improved quality of life, better asthma control, and reduced anxiety in children and adolescents whose asthma is complicated by their own or their parents' anxiety. We have previously developed Internet-CBT for adults with asthma and anxiety with promising outcomes. For this study, we have adapted the treatment for children, adolescents, and their parents and will evaluate its feasibility and clinical effectiveness.
Read the detailed description
This study will use an uncontrolled pretest-posttest design, all participants will receive the intervention. The intervention consists of 8 weekly modules delivered over internet with guided support from an experienced CBT-trained psychologist.
Assessments will be made pretreatment, weekly during treatment for the primary outcome and potential mediators, posttreatment, at the primary endpoint 2 months after treatment completion and at follow up 6 months after treatment completion. Thirty participants (aged 8-17 years) will be included. All outcome data will be collected digitally and include for feasibility: treatment credibility, working alliance, compliance with the treatment (number of modules completed) and with asthma medications as prescribed by the child´s physician, any adverse events, subjective overall relief and satisfaction with treatment. For potential efficacy, the clinical effect in the group will be analyzed on pre- to post-measurements, including weekly measurements and 2 months follow up after treatment termination (primary endpoint). The participants will be followed 6 months after treatment completion to analyze longer term clinical effects.
Recruitment and inclusion procedure Participants will be self-recruited through advertisements in social media and posters at pediatric health care clinics. Potential participants will undergo an online self-report screening of eligible criteria. The parents and adolescents 15 and older, will receive digital information about the study and leave their written consent online. The screening will be followed by an evaluation with a clinical psychologist using a structured interview based on the DSM diagnostic. During the clinical interview, the children (>age 15) will receive information about the study and leave their informed consent orally. The families will have the opportunity to ask questions about the study and confirm previous written consent.
After inclusion, participants may start their treatment immediately.
- Being tested
- Online CBT
- Keywords
- Internet-CBT, Adolescent, Children, Parents
- Medical subject headings
- Asthma, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online CBTBehavioural
Also called Internet-CBT, Internet-delivered cognitive behavior therapy
Online CBT targeting anxiety in pediatric asthma
| Study group | Role | What they receive |
|---|---|---|
| Internet-CBT | Experimental | Internet-CBT including 8 weekly modules Receives: Behavioral: Online CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PedsQL Asthma Module
Questionnarie about asthma symptoms. Participants report how much of a problem asthma have been for them the past month on a scale ranging from 0 (never) to 5 (almost always).
Measured: From pretreatment to 16 weeks
Secondary outcomes (13)
PedsQL Quality of Life Inventory
Questionnaire about Quality of Life. Participants report how much of a problem they/their child has with psychical, emotional, social and study functioning for them the past month on a scale ranging from 0 (never) to 5 (almost always).
Measured: From pretreatment to 16 weeks
Asthma Control Test
Asthma Severity
Measured: From pretreatment to 16 weeks
Asthma Behavior Checklist
Avoidance behavior due to fear of asthma
Measured: From pretreatment to 16 weeks
Fear of Asthma Symptoms Scale
Fear of bodily symptoms of Asthma. Questionnaire where the scale ranges from 0 (never) to 5 (always). A higher score means worse outcome.
Measured: From pretreatment to 16 weeks
Youth Asthma Related Anxiety Scale
Anxiety related to asthma. Questionnaire where the scale ranges from 0 (never) to 5 (always). A higher score means worse outcome.
Measured: From pretreatment to 16 weeks
Subjective Adequate Relief Questionnaire
Subjective Adequate Relief Questionnaire measures self-perceived change in symptoms as a result of the treatment. The scale consists of 2 items rated from 0 (much worse) to 6 (much better).
Measured: Week 8
Client Satisfaction Questionnaire
Measured: Week 8
Working Alliance Inventory
Questionnaire used to assess perceived alliance with the online therapist. The questions are scored on a scale from 1 (never) to 7 (always). A higher score means better outcome.
Measured: Week 3
Credibility Rating Scale
The Credibility Scale was developed to assess the participant's expectations of the treatment. The scale ranges from 0 (not at all) to 10 (very much). A higher score means better outcome.
Measured: Week 2
Adverse events
Measured: Week 8
Spence Children's Anxiety Scale
Spence Children's Anxiety Scale is used to assess symptoms of anxiety and is specifically developed for children. The scale ranges from never (0) to always (3). A higher score means worse outcome.
Measured: From pretreatment to 16 weeks
Child Depression Inventory
Measured: From pretreatment to 16 weeks
Adult responses to children's symptoms
Questionnaire used to assess how parents respond to their children when they have symptoms. The questions are scored on a scale from 0 (never) to 4 (always). A higher score means worse outcome.
Measured: From pretreatment to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Model description
- Uncontrolled feasibility study using pretest-posttest design with 2 mo FU as primiary endpoint.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Bonnert, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657807
- Sponsor's protocol ID
- EPM Dnr: 2023-01304-01
- Status last verified
- May 2026
- First submitted
- 3 Oct 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Cognitive Behavior Therapy for Anxiety Related to Pediatric Asthma: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06657807
- Acronym / sponsor ID
- EPM Dnr: 2023-01304-01
- Keywords
- Internet-CBT, Adolescent, Children, Parents
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Oct 2024 (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.
Asthma is a chronic condition affecting approximately 5-15% of all Swedish children. Research has shown that asthma may be associated with increased anxiety and worry, with children who have asthma being twice as likely to experience anxiety compared to those without asthma. The coexistence of anxiety and asthma can worsen asthma symptoms and heighten anxiety, as it can be challenging to distinguish between the two conditions. Cognitive behavioral therapy (CBT) is a recommended treatment for anxiety in children, but few studies have examined the effectiveness of CBT in children with both asthma and anxiety. Our research group has previously developed internet-delivered CBT (Internet-CBT) targeting anxiety in asthma for adults, yielding promising results. Internet-CBT can significantly improve access to treatment and has been shown to be both effective and safe for other medical conditions.
The primary aim of this project is to investigate whether Internet-CBT can contribute to improved quality of life, better asthma control, and reduced anxiety in children and adolescents whose asthma is complicated by their own or their parents' anxiety. We have previously developed Internet-CBT for adults with asthma and anxiety with promising outcomes. For this study, we have adapted the treatment for children, adolescents, and their parents and will evaluate its feasibility and clinical effectiveness.
Detailed description
This study will use an uncontrolled pretest-posttest design, all participants will receive the intervention. The intervention consists of 8 weekly modules delivered over internet with guided support from an experienced CBT-trained psychologist.
Assessments will be made pretreatment, weekly during treatment for the primary outcome and potential mediators, posttreatment, at the primary endpoint 2 months after treatment completion and at follow up 6 months after treatment completion. Thirty participants (aged 8-17 years) will be included. All outcome data will be collected digitally and include for feasibility: treatment credibility, working alliance, compliance with the treatment (number of modules completed) and with asthma medications as prescribed by the child´s physician, any adverse events, subjective overall relief and satisfaction with treatment. For potential efficacy, the clinical effect in the group will be analyzed on pre- to post-measurements, including weekly measurements and 2 months follow up after treatment termination (primary endpoint). The participants will be followed 6 months after treatment completion to analyze longer term clinical effects.
Recruitment and inclusion procedure Participants will be self-recruited through advertisements in social media and posters at pediatric health care clinics. Potential participants will undergo an online self-report screening of eligible criteria. The parents and adolescents 15 and older, will receive digital information about the study and leave their written consent online. The screening will be followed by an evaluation with a clinical psychologist using a structured interview based on the DSM diagnostic. During the clinical interview, the children (>age 15) will receive information about the study and leave their informed consent orally. The families will have the opportunity to ask questions about the study and confirm previous written consent.
After inclusion, participants may start their treatment immediately.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Uncontrolled feasibility study using pretest-posttest design with 2 mo FU as primiary endpoint.
| Arm | Type | Receives |
|---|---|---|
| Internet-CBT | Experimental | Behavioral: Online CBTInternet-CBT including 8 weekly modules |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 8-17 years
- A diagnosis of asthma made by a physician and confirmed by the parents
- Some anxiety related to asthma reported by either parent of child ("Do you feel stressed or worried about your asthma?" yes/no) and/or some restriction by asthma in daily life, which could indicate a pattern of avoidance behavior ("Do you feel hindered by your asthma in your daily life?" yes/no)
Key exclusion criteria (5 listed)
- Presence of severe psychiatric disorders such as severe depression or suicidal ideation.
- Concurrent psychological treatment
- Presence of severe somatic disorder that could interfere with participation in the CBT-treatment
- Other respiratory disease than asthma
- Psychotropic medication should be stable for at least 1 month before entering the study.
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 |
|---|---|---|
| Online CBTAlso: Internet-CBT, Internet-delivered cognitive behavior therapyOnline CBT targeting anxiety in pediatric asthma | Behavioural | Internet-CBT |
Primary outcome
PedsQL Asthma Module
Time frame: From pretreatment to 16 weeks
Questionnarie about asthma symptoms. Participants report how much of a problem asthma have been for them the past month on a scale ranging from 0 (never) to 5 (almost always).
13 secondary outcomes
PedsQL Quality of Life Inventory
Time frame: From pretreatment to 16 weeks
Asthma Control Test
Time frame: From pretreatment to 16 weeks
Asthma Behavior Checklist
Time frame: From pretreatment to 16 weeks
Fear of Asthma Symptoms Scale
Time frame: From pretreatment to 16 weeks
Youth Asthma Related Anxiety Scale
Time frame: From pretreatment to 16 weeks
Subjective Adequate Relief Questionnaire
Time frame: Week 8
Client Satisfaction Questionnaire
Time frame: Week 8
Working Alliance Inventory
Time frame: Week 3
Credibility Rating Scale
Time frame: Week 2
Adverse events
Time frame: Week 8
Spence Children's Anxiety Scale
Time frame: From pretreatment to 16 weeks
Child Depression Inventory
Time frame: From pretreatment to 16 weeks
Adult responses to children's symptoms
Time frame: From pretreatment to 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Undecided
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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 Online CBT in people with Asthma and Anxiety, 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
PedsQL Asthma Module (time frame: From pretreatment to 16 weeks). 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 14 May 2026.