When The Mirror Is Wrong

NCT ID: NCT07036744

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-29
• Study Completion Date: 2026-01-30

Brief Summary

Body Dysmorphic Disorder (BDD) is a severe psychiatric condition characterized by persistent and intrusive preoccupations with perceived flaws in physical appearance, which are typically unnoticeable or appear minor to others. BDD is associated with significant psychological distress, functional impairment, and reduced quality of life. Despite its prevalence and clinical severity, BDD remains frequently underdiagnosed and misdiagnosed. While Cognitive Behavioural Therapy (CBT) and Selective Serotonin Reuptake Inhibitors (SSRIs) are currently considered standard treatments, emerging evidence suggests that third-wave psychotherapies, such as Acceptance and Commitment Therapy (ACT) and Compassion-Focused Interventions, may offer additional benefits.

This project aims to advance clinical care and scientific understanding of BDD by developing, implementing, and evaluating the preliminary efficacy of MIND-over-MIRROR-a novel group-based psychological intervention integrating ACT and compassion-based strategies for individuals exhibiting high levels of BDD symptomatology. The intervention consists of eight weekly sessions and one follow-up booster session, delivered in an online or hybrid format. A randomized feasibility study will be conducted to examine the intervention's acceptability, practicality, and preliminary clinical efficacy in adults aged 18 to 65 years. A multi-method assessment framework will be employed, with self-report measures collected at baseline, post-intervention, and 3-month follow-up. Additionally, participants from experimental and control groups will report on their weekly BDD symptomatology.

Participants in the intervention group who consent will also undergo computerized behavioural tasks and functional neuroimaging using functional near-infrared spectroscopy (fNIRS) to explore neural and cognitive correlates of treatment outcomes. Improvements are expected in core clinical outcomes, including BDD symptom severity, and it is hypothesized that changes in targeted psychological processes (e.g., self-compassion) will mediate these effects. This study will contribute novel and clinically relevant data regarding the feasibility and potential effectiveness of contextual behavioural therapies for BDD, with implications for both research and practice.

Detailed Description

Body dysmorphic disorder (BDD) is a mental disorder described by an excessive preoccupation or obsession with a perceived defect or imperfection in one's physical appearance or body functionality that is either imperceptible or barely noticeable by others, as defined in the DSM-5. While general appearance concerns are normal, in BDD these concerns are taken to the extreme and have a great impact on the individual's daily functioning and quality of life. To match diagnostic criteria, individuals must also engage in repetitive activities/compulsions (e.g., mirror checking, skin plucking, and excessive grooming). BDD is also known to be associated with poor cognitive flexibility, impulsivity, and affective processing, showing specific neural correlates. BDD is a serious mental condition that can cause a great deal of distress. However, BDD has been globally overlooked and in Portugal, before the current project, screening or assessment measures had not yet been validated, and no specialised treatment options are currently available. BDD has long been underdiagnosed, since it usually involves a lack of insight, delusional beliefs, and is highly associated with shame and severe body-image problems, leading to symptom concealment.

In the last decades, pharmacological (Serotonin reuptake inhibitors) and Cognitive Behavioural Therapy (CBT) interventions have been successfully developed for the treatment of BDD, but with some limitations, specifically regarding relapse rates. More recently, 3rd generation interventions, such as Acceptance and Compassion-based therapy, have shown promising results in BDD-related disorders (e.g., obsessive-compulsive and eating disorders) as well as with non-clinical samples (e.g., body dissatisfaction).

Despite its promising results, the application of 3rd generation interventions in BDD is still limited. So far, only pilot studies have tested such interventions in adults with BDD symptomatology. In addition, several authors have recommended integrating compassion in the treatment of BDD, working to increase and specifically target shame and self-criticism, but no studies test the efficacy of compassion skills/strategies for BDD. Our hypothesis is that by targeting specific processes involved in the development of BDD, not only will symptoms improve, but overall quality of life and relapse rates will be positively impacted. This project aims to foster the assessment and treatment of BDD while contributing to the progress of 3rd generation interventions.

Thus, we will adapt, implement, and investigate the feasibility and preliminary efficacy of the online version of the Mind-over-Mirror, an innovative programme, which combines ACT and compassion-strategies, to be delivered in group format to individuals presenting BDD symptomatology. The programme's feasibility and preliminary efficacy will be evaluated within a parallel arm study comparing against a control condition/waiting list (individuals with BDD symptomatology who will not receive any type of psychological intervention during the course of the trial). A longitudinal and multi-methods outcomes approach will be implemented (primary outcome: BDD symptomatology; secondary outcomes: general mental health [depression] and ACT, and compassion-related psychological processes [self-compassion, body-specific and general psychological flexibility, and self-criticism]; other non-mandatory and exploratory outcomes: cognitive functioning [Emotional Stroop Task and Emotion Recognition Task] and associated brain activity changes using functional Near-Infrared Spectroscopy (fNIRS). All participants will be assessed at three moments (baseline, post-intervention and 3-month follow-up), as well as report weekly BDD symptomatology.

All procedures inherent to this project were approved by the Ethics Committee of the Faculty of Psychology and Educational Sciences, University of Coimbra. Informed consent from each participant was required prior to any data collection. The voluntary, confidential and pseudo-anonymised nature of the project was clearly explained, as well as the option to decline or withdraw at any moment without any negative consequence.

Conditions

Body Dysmorphic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Participants who present significant Body Dysmorphia Symptomatology, as assessed during the screening stage (n ≥ 8) not subjected to any clinical psychology intervention during the period of the current trial. Participants in this group will be assessed at baseline, post-intervention \[immediately after session 8\], and at the 3-month follow-up. They will also be asked to monitor their weekly symptoms through a short self-report assessment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

Participants who present significant Body Dysmorphia Symptomatology, as assessed during the screening stage (n ≥ 8) subjected to an online manualized group psychological intervention - Mind-over-Mirror. This group will be assessed at baseline, post-intervention \[immediately after session 8\], and at the 3-month follow-up). They will also be asked to monitor their weekly symptoms through a short self-report assessment.

Group Type: EXPERIMENTAL

MIND-over-MIRROR

Intervention Type: BEHAVIORAL

An eight session (plus one follow-up booster session) on Acceptance and Commitment Therapy (ACT) with compassion developed specifically for BDD, in a group setting and applied remotely or in hybrid format.

Interventions

MIND-over-MIRROR

An eight session (plus one follow-up booster session) on Acceptance and Commitment Therapy (ACT) with compassion developed specifically for BDD, in a group setting and applied remotely or in hybrid format.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged between 18-65 years;
• Fluent Portuguese speakers;
• Over the cut-off score for the AAI (≥ 21) and the DCQ (≥ 9);

Exclusion Criteria

• Pregnant;
• If medicated, not stabilized for at least 2 months
• Currently under other clinical psychology intervention;
• Current suicidal ideation;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Foundation for Science and Technology, Portugal

OTHER

Sponsor Role: collaborator

University of Coimbra

OTHER

Sponsor Role: lead

Responsible Party

Maria Coimbra

Clinical Psychologist; PhD Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Coimbra, MSc

Role: PRINCIPAL_INVESTIGATOR

CINEICC, Faculty of Psychology and Educational Sciences, University of Coimbra

Cláudia Ferreira, PhD

Role: PRINCIPAL_INVESTIGATOR

CINEICC, Faculty of Psychology and Educational Sciences, University of Coimbra

Ana Ganho-Ávila, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

CINEICC, Faculty of Psychology and Educational Sciences, University of Coimbra

Locations

CINEICC, Faculty of Psychology and Educational Sciences of the University of Coimbra

Coimbra, Coimbra District, Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Maria Coimbra, MSc

Role: CONTACT

maria.rcoimbra@gmail.com

+351916775055

Cláudia Ferreira, Ph.D.

Role: CONTACT

claudiaferreira@fpce.uc.pt

Facility Contacts

Maria Coimbra

Role: primary

maria.rcoimbra@gmail.com

+351916775055

Cláudia Ferreira

Role: backup

claudiaferreira@fpce.uc.pt

Other Identifiers

2022.12380.BD

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2022.12380.BD

Identifier Type: -

Identifier Source: org_study_id