Internet-delivered Cognitive-behaviour Therapy for Adolescents With Body Dysmorphic Disorder

NCT05078320 | Completed

• 1 other identifier: 2021-01942
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Body Dysmorphic Disorders; Dysmorphophobia

Keywords

Body dysmorphic disorder; Dysmorphophobia; Cognitive-behavioral therapy; Internet-delivered treatments; Adolescents; Treatment outcomes

Outcome Measures

Primary Outcomes (12)

• Treatment credibility questionnaire

  Questionnaire developed by the research team. Used to assess treatment credibility. Separate versions for the child/adolescent and the parent are used. Range: 0-12, high scores means better outcome.

  Mid-treatment (3 weeks post-baseline)

• Treatment satisfaction questionnaire

  Questionnaire developed by the research team. Used to assess treatment satisfaction. Separate versions for the child/adolescent and the parent are used. Range: 0-36, high scores means better outcome.

  3-month follow-up.

• internet intervention Patient Adherence Scale (iiPAS) Mid-treatment

  Used to assess the child/adolescent's adherence to the internet-delivered treatment. Range: 0-20, high scores means better outcome.

  Mid-treatment (6 weeks post-baseline)

• internet intervention Patient Adherence Scale (iiPAS) Post-treatment

  Used to assess the child/adolescent's adherence to the internet-delivered treatment. Range: 0-20, high scores means better outcome.

  Week 14.

• Negative effects questionnaire - Mid-treatment

  Used to assess side effects/adverse events for the child/adolescent. Parent-reported. Range: 0-100, low scores means better outcome.

  Week 6

• Negative effects questionnaire - Post-treatment

  Used to assess side effects/adverse events for the child/adolescent. Parent-reported. Range: 0-100, low scores means better outcome.

  Week 14

• Negative effects questionnaire - 3 months follow-up

  Used to assess side effects/adverse events for the child/adolescent. Parent-reported. Range: 0-100, low scores means better outcome.

  3 months follow-up

• Ease of recruitment: Time to recruit

  Time to recruit 20 participants.

  From start of recruitment until 20 participants have been included. Anticipated time frame: 2-3 months

• Ease of recruitment: Amount of participants accepting participation after screening

  Amount of participants accepting/declining participation after telephone screening

  From start of recruitment until 20 participants have been included. Anticipated time frame: 2-3 months

• Ease of recruitment: Amount of participants accepting participation after assessment

  Amount of participants accepting/declining participation after initial assessment.

  From start of recruitment until 20 participants have been included. Anticipated time frame: 2-3 months

• Number of completed chapters in the internet treatment platform

  Number of completed chapters is automatically logged in the internet treatment platform. Separate data for children and parents.

  Week 14

• Participant retention

  Number of included participants completing treatment.

  Week 14.

Secondary Outcomes (11)

• Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder, Adolescent version (BDD-YBOCS-A)

  Baseline; week 14; 1-, 2-, 3-, 6- and 12-month follow-up.

• Clinical Global Impression - Severity (CGI-S)

  Baseline; week 14; 3-, 6- and 12-month follow-up.

• Clinical Global Impression - Improvement (CGI-I)

  Week 14; 3-, 6- and 12-month follow-up.

• Children's Global Assessment Scale (CGAS)

  Baseline; week 14; 3-, 6- and 12-month follow-up.

• Appearance Anxiety Index (AAI)

  Baseline; week 3, 6, 9, 14; 3-, 6- and 12-month follow-up.

Other Outcomes (2)

• Therapist platform time

  Week 14

• Therapist telephone time

  Week 14

Study Arms (1)

Internet-delivered cognitive-behaviour therapy for adolescents with body dysmorphic disorder

EXPERIMENTAL

Cognitive-behaviour therapy, Exposure and response prevention (ERP)

Behavioral: Exposure and response prevention (ERP)

Interventions

Exposure and response prevention (ERP) BEHAVIORAL

The treatment is Internet-delivered and therapist-guided, involving both the adolescent and at least one parent. The treatment consists of two separate sets of modules, one for the adolescent and one for the parent, each with separate logins. The ICBT intervention consists of 12 modules, delivered over a maximum of 14 weeks. The main goal of treatment is to help the young person to stop avoiding anxiety-provoking situations by undertaking exposure tasks and to stop doing unhelpful repetitive behaviours and rituals, known as response prevention. Every module also contains homework tasks that mainly consists of exposure and response prevention (ERP). Parents are also often involved in the patients' rituals and avoidant behaviours (known as family accommodation), which may contribute to maintain the BDD symptoms. Involving parents facilitates modification of these unhelpful patterns.

Internet-delivered cognitive-behaviour therapy for adolescents with body dysmorphic disorder

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, 11330, Sweden

Location

Related Publications (1)

• Mataix-Cols D, Fernandez de la Cruz L, Isomura K, Anson M, Turner C, Monzani B, Cadman J, Bowyer L, Heyman I, Veale D, Krebs G. A Pilot Randomized Controlled Trial of Cognitive-Behavioral Therapy for Adolescents With Body Dysmorphic Disorder. J Am Acad Child Adolesc Psychiatry. 2015 Nov;54(11):895-904. doi: 10.1016/j.jaac.2015.08.011. Epub 2015 Sep 3.

  PMID: 26506580 BACKGROUND

MeSH Terms

Conditions

Body Dysmorphic Disorders

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Lorena Fernández de la Cruz, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 14, 2021
• Study Start: October 22, 2021
• Primary Completion: September 6, 2022
• Study Completion: June 26, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)