Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT05078320
Eligibility Criteria:
Inclusion Criteria:
1. Age 12 to 17 years, confirmed by the caregiver and subsequently by the patient record system Take Care.
2. A diagnosis of BDD, based on the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), confirmed by the assessor at the pre-treatment assessment.
3. A total BDD severity score on the BDD-YBOCS-A ≥24. confirmed by the clinician-reported BDD-YBOCS-A performed at the pre-treatment assessment.
4. A minimum of one available caregiver (parent) to support the child/adolescent throughout the treatment. Confirmed by the caregiver at the telephone screening or/and pre-treatment assessment.
5. Regular access to a desktop or laptop computer connected to the Internet, with the ability to receive e-mails, as well as a mobile phone to receive SMS (one of each per family is enough). Confirmed by the caregiver at the telephone screening or/and pre-treatment assessment.
Exclusion Criteria:
1. Previous CBT for BDD for a minimum of eight sessions with a qualified therapist within the 12 months prior to assessment. Confirmed by the caregiver at the telephone screening and/or pre-treatment assessment.
2. Simultaneous psychological treatment for BDD, confirmed by the caregiver at the telephone screening and/or pre-treatment assessment.
3. Initiation, adjustment or change of any selective serotonin reuptake inhibitors (SSRI) within the six weeks prior to the pre-treatment assessment. Confirmed by the caregiver at the telephone screening and/or pre-treatment assessment.
4. A diagnosis of organic brain disorder, intellectual disability or a psychiatric disorder (such as psychosis, bipolar disorder or eating disorder) that could interfere with the completion of the treatment. Confirmed by the caregiver at the telephone screening and/or pre-treatment assessment, with help of information from the caregiver and the child/adolescent, and the MINI-KID interview.
5. Immediate risk to self or others requiring urgent medical attention, such as current risk of suicide or self-injurious behaviours. Confirmed by the assessor at the telephone screening and/or face-to-face or video conference pre-treatment assessment, with help of information from the caregiver and the child/adolescent, and the suicide questions on the MINI-KID interview.
6. Child and caregiver not able to read and communicate in Swedish. Confirmed by the caregiver or assessor at the telephone screening and/or pre-treatment assessment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT05078320
Study Brief:
Protocol Section:
NCT05078320