Blood Injury PhobiaNCT07125287
Exposure-Based CBT for Youth With Blood and Injection Phobia and Chronic Illness
A study testing Exposure based CBT in people with Blood Injury Phobia and Injection Fear, run by Region Stockholm.
Trial summary
More than half of all children fear needles, and hospitalized children often describe injections as the most frightening part of medical care. While mild needle fear can often be managed by healthcare staff using distraction and reassurance, these strategies are ineffective for children with blood-injection-injury… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Blood Injury Phobia, Injection Fear
- What is being tested?
- Exposure based CBT
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 31 Dec 2027
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 12-17 years;
- Blood-Injection-Injury (BII) phobia;
- Somatic disease or condition requiring regular injections and/or blood sampling;
- Ability to read and write in Swedish.
Who cannot join
- Significant cognitive or intellectual impairment;
- Severe psychopathology (e.g., suicidality);
- Acute trauma;
- Ongoing or recently completed treatment for BII phobia.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Charlotte Gentili, Licensed Psychologist, PhD contact
About this study
Official title: "Confront the Fear" - Evaluation of a Novel Exposure-Based CBT for Youth With Blood and Injection Phobia and Concurrent Somatic Illness Requiring Injections
More than half of all children fear needles, and hospitalized children often describe injections as the most frightening part of medical care. While mild needle fear can often be managed by healthcare staff using distraction and reassurance, these strategies are ineffective for children with blood-injection-injury phobia (BII phobia). Children with BII phobia and co-occurring chronic medical conditions often require repeated blood tests or injections, but their phobia may prevent essential treatment. In such cases, healthcare providers may be forced to use physical restraint, sedation, or general anesthesia-approaches that are distressing for the child and costly for the healthcare system.
Although exposure-based cognitive behavioral therapy (CBT) is an effective treatment for specific phobias in adults, there is very limited research on CBT for children with BII phobia, particularly those with serious medical conditions. At the Department of Behavioral Medicine at Karolinska University Hospital, we have developed an exposure-based CBT intervention tailored for children with BII phobia and co-occurring somatic illness. The program includes a home-based training kit with medical materials to support frequent and realistic exposure between clinic sessions. Clinical experience suggests the intervention improves fear responses and increases medical treatment adherence, but it has not yet been formally evaluated.
This study aims to evaluate the feasibility and effectiveness of this novel CBT intervention for children and adolescents with disabling BII phobia and chronic somatic conditions.
- Conditions
- Blood Injury Phobia, Injection Fear
- Being tested
- Exposure based CBT
- Keywords
- Phobia exposure, CBT, Needle exposure practice kit for home use
- Medical subject headings
- Iatrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure based CBTBehavioural
This intervention is an exposure-based CBT program developed for children with blood-injection-injury (BII) phobia and a co-occurring somatic illness. The treatment includes a structured home training kit with medical materials (e.g., syringes, swabs) related to the child's fear, enabling frequent and realistic exposure exercises at home between sessions, guided by parents. This allows for higher treatment intensity and continuity. The intervention is tailored to children who require regular medical procedures and whose phobia interferes with essential care. Unlike previous studies, this model integrates both clinical sessions and structured home practice to increase adherence and reduce fear in medical settings.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Exposure based CBT Receives: Behavioral: Exposure based CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior Avoidance Test (BAT)
An observational assessment in which the patient is asked to approach a feared situation or stimulus as far as they can, based on a predefined hierarchy of difficulty or anxiety levels. The BAT is commonly used to assess the degree of avoidance and fear in relation to specific phobia-related stimuli, and to evaluate treatment progress and outcomes. In this study, the BAT will be used to measure behavioral avoidance.
Measured: Baseline (prior to treatment session 1) and post-treatment (at treatment session 11)
Injection Phobia Scale (IPS)
A child-adapted version of the Injection Phobia Scale (Öst, Hellström \& Kåver, 1992). In this study, only the subscale measuring anxiety level is used. The original subscale has demonstrated high internal consistency, with a Cronbach's alpha of 0.86. The scale consists of 18 items, each rated on a five-point scale where the respondent indicates the amount of fear they would experience in different situations.
Measured: Baseline (at treatment session 1), post-treatment (at treatment session 11), and follow-up at 1 month and 3 months post-treatment
Secondary outcomes (1)
Revised Child Anxiety and Depression Scale 25 items (RCADS-25)
The Revised Child Anxiety and Depression Scale (RCADS) is a standardized self-report questionnaire designed to assess symptoms of anxiety and depression in children and adolescents. It includes multiple subscales that measure various anxiety disorders (such as generalized anxiety, social phobia, separation anxiety, panic disorder, and obsessive-compulsive disorder) as well as depression symptoms. The RCADS is widely used in clinical and research settings due to its strong psychometric properties, including good reliability and validity. Respondents rate the frequency of symptoms on a Likert-type scale, providing a comprehensive profile of internalizing symptoms.
Measured: Baseline (at treatment session 1), post-treatment (at treatment session 11), and follow-up at 1 month and 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Injury PhobiaStudies of the same condition, open and under way.
- More trials run by Region StockholmThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Charlotte S Gentili, Region Stockholm
- Investigators
- Mike Kemani, PhD, Principal investigator, Karolinska Universitetssjukhuset, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125287
- Sponsor's protocol ID
- 2024-08344-01
- Other IDs
- K 2025-5350
- Status last verified
- Aug 2025
- First submitted
- 27 Jun 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical approval conditions and applicable data protection laws, individual participant data (IPD) will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Confront the Fear" - Evaluation of a Novel Exposure-Based CBT for Youth With Blood and Injection Phobia and Concurrent Somatic Illness Requiring Injections
- ClinicalTrials.gov ID
- NCT07125287
- Acronym / sponsor ID
- 2024-08344-01
- Conditions
- Blood Injury Phobia, Injection Fear
- Keywords
- Phobia exposure, CBT, Needle exposure practice kit for home use
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Aug 2025 (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.
More than half of all children fear needles, and hospitalized children often describe injections as the most frightening part of medical care. While mild needle fear can often be managed by healthcare staff using distraction and reassurance, these strategies are ineffective for children with blood-injection-injury phobia (BII phobia). Children with BII phobia and co-occurring chronic medical conditions often require repeated blood tests or injections, but their phobia may prevent essential treatment. In such cases, healthcare providers may be forced to use physical restraint, sedation, or general anesthesia-approaches that are distressing for the child and costly for the healthcare system.
Although exposure-based cognitive behavioral therapy (CBT) is an effective treatment for specific phobias in adults, there is very limited research on CBT for children with BII phobia, particularly those with serious medical conditions. At the Department of Behavioral Medicine at Karolinska University Hospital, we have developed an exposure-based CBT intervention tailored for children with BII phobia and co-occurring somatic illness. The program includes a home-based training kit with medical materials to support frequent and realistic exposure between clinic sessions. Clinical experience suggests the intervention improves fear responses and increases medical treatment adherence, but it has not yet been formally evaluated.
This study aims to evaluate the feasibility and effectiveness of this novel CBT intervention for children and adolescents with disabling BII phobia and chronic somatic conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Exposure based CBTExposure based CBT |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 12-17 years;
- Blood-Injection-Injury (BII) phobia;
- Somatic disease or condition requiring regular injections and/or blood sampling;
- Ability to read and write in Swedish.
Key exclusion criteria (4 listed)
- Significant cognitive or intellectual impairment;
- Severe psychopathology (e.g., suicidality);
- Acute trauma;
- Ongoing or recently completed treatment for BII phobia.
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 |
|---|---|---|
| Exposure based CBTThis intervention is an exposure-based CBT program developed for children with blood-injection-injury (BII) phobia and a co-occurring somatic illness. The treatment includes a structured home training kit with medical materials (e.g., syringes, swabs) related to the child's fear, enabling frequent and realistic exposure exercises at home between sessions, guided by parents. This allows for higher treatment intensity and continuity. The intervention is tailored to children who require regular medical procedures and whose phobia interferes with essential care. Unlike previous studies, this model integrates both clinical sessions and structured home practice to increase adherence and reduce fear in medical settings. | Behavioural | Treatment group |
Primary outcome
Behavior Avoidance Test (BAT)
Time frame: Baseline (prior to treatment session 1) and post-treatment (at treatment session 11)
An observational assessment in which the patient is asked to approach a feared situation or stimulus as far as they can, based on a predefined hierarchy of difficulty or anxiety levels. The BAT is commonly used to assess the degree of avoidance and fear in relation to specific phobia-related stimuli, and to evaluate treatment progress and outcomes. In this study, the BAT will be used to measure behavioral avoidance.
Injection Phobia Scale (IPS)
Time frame: Baseline (at treatment session 1), post-treatment (at treatment session 11), and follow-up at 1 month and 3 months post-treatment
A child-adapted version of the Injection Phobia Scale (Öst, Hellström \& Kåver, 1992). In this study, only the subscale measuring anxiety level is used. The original subscale has demonstrated high internal consistency, with a Cronbach's alpha of 0.86. The scale consists of 18 items, each rated on a five-point scale where the respondent indicates the amount of fear they would experience in different situations.
1 secondary outcome
Revised Child Anxiety and Depression Scale 25 items (RCADS-25)
Time frame: Baseline (at treatment session 1), post-treatment (at treatment session 11), and follow-up at 1 month and 3 months post-treatment
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 15 Aug 2025.
- Individual participant dataSharing planned: No. Due to ethical approval conditions and applicable data protection laws, individual participant data (IPD) will not be shared with other researchers.
Related trials for Blood Injury Phobia
Enrolling by invitation
Use of Augmented Reality and Virtual Reality During Cognitive Behavioral Therapy for Needle Phobia
Needle Phobia, Virtual Reality
Recruiting
Impact of Blood Phobia on Fainting Susceptibility
Syncope, Vasovagal, Blood, Injection, Injury Type Phobia
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.
Charlotte Gentili, Licensed Psychologist, PhD contact
Mike Kemani, PhD principal investigator
Karolinska Universitetssjukhuset, Region Stockholm
Questions about this trial
What is this clinical trial studying?
A study testing Exposure based CBT in people with Blood Injury Phobia and Injection Fear, run by Region Stockholm.
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 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: opening soon, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Elisabet Werneman, Licensed Psychologist (+46739497718, elisabet.werneman@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior Avoidance Test (BAT) (time frame: Baseline (prior to treatment session 1) and post-treatment (at treatment session 11)). 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 15 Aug 2025.