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

NCT ID: NCT07125287

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Exposure based CBT

Group Type: EXPERIMENTAL

Exposure based CBT

Intervention Type: 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.

Interventions

Exposure 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: lead

Responsible Party

Charlotte S Gentili

Lic Psychologist, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mike Kemani, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Universitetssjukhuset, Region Stockholm

Central Contacts

Elisabet Werneman, Licensed Psychologist

Role: CONTACT

elisabet.werneman@regionstockholm.se

+46739497718

Charlotte Gentili, Licensed Psychologist, PhD

Role: CONTACT

charlotte.s.gentili@regionstockholm.se

+46760482895

Other Identifiers

K 2025-5350

Identifier Type: OTHER

Identifier Source: secondary_id

2024-08344-01

Identifier Type: -

Identifier Source: org_study_id