NCT07036744

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

June 16, 2025

Last Update Submit

June 25, 2025

Conditions

Keywords

Body Dysmorphic DisorderDysmorphic ConcernAcceptance and Commitment TherapyCompassionPsychological Flexibilityonline group intervention

Outcome Measures

Primary Outcomes (2)

  • Appearance Anxiety Inventory

    The Appearance Anxiety Inventory (AAI) is a brief 10 item self-report scale that assesses the cognitive and behavioral aspects of BDD in particular. This scale was specifically developed by the original authors as both an outcome and process measure, since it can track changes in these processes and behaviors during treatment. Besides its global score, the AAI includes three subscales: threat monitoring, camouflaging, and avoidance. Each item is scored on a 4-point scale ranging from not at all (0) to much more than most people (3). A score equal or above 21 is considered high risk body image anxiety and/or Body Dysmorphic Disorder.

    Baseline, Weeks 1-8, 3-month follow-up

  • Dysmorphic Concern Questionnaire

    The DCQ measures a person's degree of dysmorphic concern (i.e., the excessive preoccupation or concern with a perceived minor defect in one's physical appearance). This is a self-report measure with seven items, reporting on cognitive and behavioural aspects of dysmorphic concern. Each item is phrased with the question, "Have you ever…?" (e.g., "…been very concerned about some aspect of your physical appearance"). Each item is scored on a 4-point scale ranging from not at all (0) to much more than most people (3).

    Baseline, Week 8, 3-month follow-up

Secondary Outcomes (5)

  • Patient Health Questionnaire - 9

    Baseline, Week 8, 3-month follow-up

  • Change in the Multidimensional Psychological Flexibility Inventory - 24

    Baseline, Week 8, 3-month follow-up

  • Self-compassion Scale

    Baseline, Week 8, Follow-Up 3 Months

  • Psychological Flexibility for Body Image

    Baseline, Week 8, Follow-Up 3 Months

  • Forms of Self-criticizing/Attacking and Self-reassuring Scale

    Baseline, Week 8, Follow-Up 3 Months

Other Outcomes (2)

  • Emotion Recognition Task

    Baseline and Follow-Up 3 Months

  • Emotional Stroop task

    Baseline and Follow-Up 3 Months

Study Arms (2)

Control group

NO INTERVENTION

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.

Intervention group

EXPERIMENTAL

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.

Behavioral: MIND-over-MIRROR

Interventions

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 group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Coimbra, Coimbra District, 3000-115, Portugal

RECRUITING

MeSH Terms

Conditions

Body Dysmorphic Disorders

Condition Hierarchy (Ancestors)

Somatoform DisordersMental Disorders

Study Officials

  • Maria Coimbra, MSc

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

    PRINCIPAL INVESTIGATOR
  • Cláudia Ferreira, PhD

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

    PRINCIPAL INVESTIGATOR
  • Ana Ganho-Ávila, Ph.D.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Coimbra, MSc

CONTACT

Cláudia Ferreira, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This project will follow a longitudinal design. Adults presenting with BDD symptomatology will be randomly allocated to the Control Group (no intervention; n ≥ 8) or to the Intervention Group (Mind-over-Mirror group intervention; n ≥ 8).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist; PhD Fellow

Study Record Dates

First Submitted

June 16, 2025

First Posted

June 25, 2025

Study Start

January 29, 2025

Primary Completion

January 30, 2026

Study Completion

January 30, 2026

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Individual Participant Data (IPD) will not be shared in order to protect participant confidentiality and in accordance with data protection regulations.

Locations