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

NCT07125287 | Not Yet Recruiting

• 2 other identifiers: 2024-08344-01K 2025-5350
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Blood Injury Phobia; Injection Fear

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  Baseline (at treatment session 1), post-treatment (at treatment session 11), and follow-up at 1 month and 3 months post-treatment

Study Arms (1)

Treatment group

EXPERIMENTAL

Exposure based CBT

Behavioral: Exposure based CBT

Interventions

Exposure based CBT BEHAVIORAL

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.

Treatment group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Region Stockholm: lead

MeSH Terms

Conditions

Iatrophobia

Study Officials

• Mike Kemani, PhD

  Karolinska Universitetssjukhuset, Region Stockholm

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabet Werneman, Licensed Psychologist

CONTACT

+46739497718; elisabet.werneman@regionstockholm.se

Charlotte Gentili, Licensed Psychologist, PhD

CONTACT

+46760482895; charlotte.s.gentili@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lic Psychologist, PhD

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: August 15, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share