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Efficacy and cost-effectiveness of Internet-delivered cognitive-behavior therapy for children and adolescents with body dysmorphic disorder : study protocol for a randomized controlled trial

Fernández de la Cruz, Lorena ; Birovecz, Anita ; Andrén, Per LU orcid ; Melin, Karin ; Aspvall, Kristina ; Cervin, Matti LU ; Andersson, Erik ; Silverberg-Mörse, Maria ; Gumpert, Martina and Wickberg, Frida , et al. (2026) In Trials 27. p.1-16
Abstract

BACKGROUND: Body dysmorphic disorder (BDD) is a prevalent and impairing mental disorder that typically onsets in adolescence. Cognitive-behavior therapy (CBT) may be effective for adolescent BDD, although the supporting evidence is currently limited. CBT for BDD is a highly specialized treatment, creating a considerable gap in access to care for young people. Therapist-guided Internet-delivered CBT (ICBT) may help bridge this gap. The primary aim of this study is to determine the efficacy of a therapist-guided ICBT program for children and adolescents with BDD versus an active comparator. Secondary aims are to examine the 6-month durability of the treatment effects and to evaluate its relative cost-effectiveness from multiple... (More)

BACKGROUND: Body dysmorphic disorder (BDD) is a prevalent and impairing mental disorder that typically onsets in adolescence. Cognitive-behavior therapy (CBT) may be effective for adolescent BDD, although the supporting evidence is currently limited. CBT for BDD is a highly specialized treatment, creating a considerable gap in access to care for young people. Therapist-guided Internet-delivered CBT (ICBT) may help bridge this gap. The primary aim of this study is to determine the efficacy of a therapist-guided ICBT program for children and adolescents with BDD versus an active comparator. Secondary aims are to examine the 6-month durability of the treatment effects and to evaluate its relative cost-effectiveness from multiple perspectives.

METHODS: This is a 3-site superiority randomized controlled trial including 154 young people (12-17 years) with BDD recruited throughout Sweden. Participants are randomized 1:1 to 12 weekly modules of either therapist-supported ICBT primarily based on exposure with response prevention or an active comparator consisting of therapist-supported Internet-delivered relaxation training. Data will be collected at baseline, mid-treatment, post-treatment, and 1 month (primary endpoint), 3 months, and 6 months post-treatment. The primary outcome is BDD symptom severity measured with the Yale-Brown Obsessive-Compulsive Scale Modified for Body Dysmorphic Disorder, Adolescent version. All study personnel who can be blinded to study aims/hypotheses and group allocation will be blinded. Assessors conducting post-treatment and follow-up assessments will be external to the research team and blinded to study aims/hypotheses and group allocation at all assessment points. Analyses will be conducted according to the intention-to-treat principle and will follow a pre-specified statistical and health economic analysis plan.

DISCUSSION: Participant recruitment started on 22 February 2024 and is currently ongoing. Data analysis for the primary aim will commence after the last participant reaches the primary endpoint.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06262412. Registered on 16 February 2024, https://clinicaltrials.gov/study/NCT06262412 .

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publication status
published
subject
keywords
Humans, Cognitive Behavioral Therapy/economics, Adolescent, Child, Body Dysmorphic Disorders/therapy, Cost-Benefit Analysis, Treatment Outcome, Internet-Based Intervention/economics, Equivalence Trials as Topic, Adolescent Behavior, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Child Behavior, Sweden, Female, Male, Time Factors, Internet, Health Care Costs, Cost-Effectiveness Analysis, Mental Health Teletherapy
in
Trials
volume
27
article number
557
pages
1 - 16
publisher
BioMed Central (BMC)
external identifiers
  • scopus:105048986357
  • pmid:42675507
ISSN
1745-6215
DOI
10.1186/s13063-026-09974-z
language
English
LU publication?
yes
additional info
© 2026. The Author(s).
id
7aa7408d-72b9-4b7f-8c5a-4161fb8e37d4
date added to LUP
2026-10-06 15:54:08
date last changed
2026-10-08 03:29:25
@article{7aa7408d-72b9-4b7f-8c5a-4161fb8e37d4,
  abstract     = {{<p>BACKGROUND: Body dysmorphic disorder (BDD) is a prevalent and impairing mental disorder that typically onsets in adolescence. Cognitive-behavior therapy (CBT) may be effective for adolescent BDD, although the supporting evidence is currently limited. CBT for BDD is a highly specialized treatment, creating a considerable gap in access to care for young people. Therapist-guided Internet-delivered CBT (ICBT) may help bridge this gap. The primary aim of this study is to determine the efficacy of a therapist-guided ICBT program for children and adolescents with BDD versus an active comparator. Secondary aims are to examine the 6-month durability of the treatment effects and to evaluate its relative cost-effectiveness from multiple perspectives.</p><p>METHODS: This is a 3-site superiority randomized controlled trial including 154 young people (12-17 years) with BDD recruited throughout Sweden. Participants are randomized 1:1 to 12 weekly modules of either therapist-supported ICBT primarily based on exposure with response prevention or an active comparator consisting of therapist-supported Internet-delivered relaxation training. Data will be collected at baseline, mid-treatment, post-treatment, and 1 month (primary endpoint), 3 months, and 6 months post-treatment. The primary outcome is BDD symptom severity measured with the Yale-Brown Obsessive-Compulsive Scale Modified for Body Dysmorphic Disorder, Adolescent version. All study personnel who can be blinded to study aims/hypotheses and group allocation will be blinded. Assessors conducting post-treatment and follow-up assessments will be external to the research team and blinded to study aims/hypotheses and group allocation at all assessment points. Analyses will be conducted according to the intention-to-treat principle and will follow a pre-specified statistical and health economic analysis plan.</p><p>DISCUSSION: Participant recruitment started on 22 February 2024 and is currently ongoing. Data analysis for the primary aim will commence after the last participant reaches the primary endpoint.</p><p>TRIAL REGISTRATION: ClinicalTrials.gov NCT06262412. Registered on 16 February 2024, https://clinicaltrials.gov/study/NCT06262412 .</p>}},
  author       = {{Fernández de la Cruz, Lorena and Birovecz, Anita and Andrén, Per and Melin, Karin and Aspvall, Kristina and Cervin, Matti and Andersson, Erik and Silverberg-Mörse, Maria and Gumpert, Martina and Wickberg, Frida and Bottai, Matteo and Serlachius, Eva and Rautio, Daniel and Mataix-Cols, David}},
  issn         = {{1745-6215}},
  keywords     = {{Humans; Cognitive Behavioral Therapy/economics; Adolescent; Child; Body Dysmorphic Disorders/therapy; Cost-Benefit Analysis; Treatment Outcome; Internet-Based Intervention/economics; Equivalence Trials as Topic; Adolescent Behavior; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; Child Behavior; Sweden; Female; Male; Time Factors; Internet; Health Care Costs; Cost-Effectiveness Analysis; Mental Health Teletherapy}},
  language     = {{eng}},
  month        = {{08}},
  pages        = {{1--16}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{Trials}},
  title        = {{Efficacy and cost-effectiveness of Internet-delivered cognitive-behavior therapy for children and adolescents with body dysmorphic disorder : study protocol for a randomized controlled trial}},
  url          = {{http://dx.doi.org/10.1186/s13063-026-09974-z}},
  doi          = {{10.1186/s13063-026-09974-z}},
  volume       = {{27}},
  year         = {{2026}},
}