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Active, Not Recruiting

NCT Number: NCT06657807

Online Cognitive Behavior Therapy for Anxiety Related to Pediatric Asthma

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Treatment and study plan

Online CBT

Behavioral

Online CBT targeting anxiety in pediatric asthma

Other names: Internet-CBT, Internet-delivered cognitive behavior therapy

Primary outcomes

  1. 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).

Secondary outcomes

  1. PedsQL Quality of Life Inventory

    Time frame: From pretreatment to 16 weeks

    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).

  2. Asthma Control Test

    Time frame: From pretreatment to 16 weeks

    Asthma Severity

  3. Asthma Behavior Checklist

    Time frame: From pretreatment to 16 weeks

    Avoidance behavior due to fear of asthma

  4. Fear of Asthma Symptoms Scale

    Time frame: From pretreatment to 16 weeks

    Fear of bodily symptoms of Asthma. Questionnaire where the scale ranges from 0 (never) to 5 (always). A higher score means worse outcome.

  5. Youth Asthma Related Anxiety Scale

    Time frame: From pretreatment to 16 weeks

    Anxiety related to asthma. Questionnaire where the scale ranges from 0 (never) to 5 (always). A higher score means worse outcome.

  6. Subjective Adequate Relief Questionnaire

    Time frame: Week 8

    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).

  7. Client Satisfaction Questionnaire

    Time frame: Week 8

  8. Working Alliance Inventory

    Time frame: Week 3

    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.

  9. Credibility Rating Scale

    Time frame: Week 2

    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.

  10. Adverse events

    Time frame: Week 8

  11. Spence Children's Anxiety Scale

    Time frame: From pretreatment to 16 weeks

    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.

  12. Child Depression Inventory

    Time frame: From pretreatment to 16 weeks

  13. Adult responses to children's symptoms

    Time frame: From pretreatment to 16 weeks

    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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Online Cognitive Behavior Therapy for Anxiety Related to Pediatric Asthma: A Feasibility Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 24, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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