Internet-delivered Cognitive-behaviour Therapy for Adolescents With Body Dysmorphic Disorder (NCT05078320) | Clinical Trial Compass
CompletedNot Applicable
Internet-delivered Cognitive-behaviour Therapy for Adolescents With Body Dysmorphic Disorder
Sweden20 participantsStarted 2021-10-22
Plain-language summary
The purpose of this trial is to investigate whether a therapist-guided Internet-delivered cognitive behaviour therapy (ICBT) programme is feasible for adolescents with body dysmorphic disorder (BDD). The aim is to evaluate feasibility and provide preliminary efficacy data.
Who can participate
Age range12 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 12 to 17 years, confirmed by the caregiver and subsequently by the patient record system Take Care.
✓. 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.
✓. 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.
✓. 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.
✓. 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
✕. 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.
✕. Simultaneous psychological treatment for BDD, confirmed by the caregiver at the telephone screening and/or pre-treatment assessment.
✕. 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.
✕
What they're measuring
1
Treatment credibility questionnaire
Timeframe: Mid-treatment (3 weeks post-baseline)
2
Treatment satisfaction questionnaire
Timeframe: 3-month follow-up.
3
internet intervention Patient Adherence Scale (iiPAS) Mid-treatment
Timeframe: Mid-treatment (6 weeks post-baseline)
4
internet intervention Patient Adherence Scale (iiPAS) Post-treatment
. 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.
✕. 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.
✕. 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.
9
Ease of recruitment: Amount of participants accepting participation after screening
Timeframe: From start of recruitment until 20 participants have been included. Anticipated time frame: 2-3 months
10
Ease of recruitment: Amount of participants accepting participation after assessment
Timeframe: From start of recruitment until 20 participants have been included. Anticipated time frame: 2-3 months
11
Number of completed chapters in the internet treatment platform