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Exposure-Based CBT for Youth With Blood and Injection Phobia and Chronic Illness

Confront the Fear - Evaluation of a Novel Exposure-Based CBT for Youth With Blood and Injection Phobia and Concurrent Somatic Illness Requiring Injections

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07125287
Enrollment
30
Registered
2025-08-15
Start date
2025-09-01
Completion date
2027-12-31
Last updated
2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Injury Phobia, Injection Fear

Keywords

Phobia exposure, CBT, Needle exposure practice kit for home use

Brief 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 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.

Interventions

BEHAVIORALExposure based CBT

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.

Sponsors

Region Stockholm
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

1. Age 12-17 years; 2. Blood-Injection-Injury (BII) phobia; 3. Somatic disease or condition requiring regular injections and/or blood sampling; 4. Ability to read and write in Swedish.

Exclusion criteria

1. Significant cognitive or intellectual impairment; 2. Severe psychopathology (e.g., suicidality); 3. Acute trauma; 4. Ongoing or recently completed treatment for BII phobia.

Design outcomes

Primary

MeasureTime frameDescription
Behavior Avoidance Test (BAT)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)Baseline (at treatment session 1), post-treatment (at treatment session 11), and follow-up at 1 month and 3 months post-treatmentA 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.

Secondary

MeasureTime frameDescription
Revised Child Anxiety and Depression Scale 25 items (RCADS-25)Baseline (at treatment session 1), post-treatment (at treatment session 11), and follow-up at 1 month and 3 months post-treatmentThe 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.

Contacts

Primary ContactElisabet Werneman, Licensed Psychologist
elisabet.werneman@regionstockholm.se+46739497718
Backup ContactCharlotte Gentili, Licensed Psychologist, PhD
charlotte.s.gentili@regionstockholm.se+46760482895

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026