Clinical trial NCT06781853: CBT for Muscle Dysmorphia and Steroid Abuse: a Randomized Controlled Trial
Official title: Evaluating the Effectiveness of Cognitive Behavioral Therapy for Muscle Dysmorphia and Steroid Abuse: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Body Dysmorphic Disorder
Steroid Abuse
Body Dysmorphic Disorder (BDD), Subtype: Muscle Dysmorphia
Keywords: Cognitive Behavioral Therapy (CBT)
Muscle Dysmorphia
Body Dysmorphic Disorder (BDD)
Steroid Abuse
Performance-Enhancing Drugs (PEDs)
Lead sponsor: Uskudar University
Sponsor class: OTHER
Collaborators: name: Beykoz University
name: Istanbul Nisantasi University
First posted: 2025-01-17
Enrollment: 71
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study employs a randomized controlled trial (RCT) with a parallel assignment model to evaluate the effectiveness of cognitive behavioral therapy (CBT) for men diagnosed with muscle dysmorphia (MD) and steroid/PED abuse. Participants will be randomly assigned to an experimental group (12 weekly online CBT sessions) or a control group (no intervention). Assessments will occur at baseline, post-intervention, and three-month follow-up to measure changes in MD symptoms, psychological distress, and related behaviors. Therapists will be supervised by clinical psychologists and psychiatrists, with adherence monitored by an external committee to ensure fidelity to the CBT protocol. This design ensures a robust evaluation of the intervention's impact while addressing accessibility and stigma-related barriers.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the effectiveness of cognitive behavioral therapy (CBT) in treating muscle dysmorphia (MD) under body dysmorphic disorder (BDD) and steroid/performance-enhancing drug (PED) abuse in men aged 18-65 who regularly attend the gym. The main questions it aims to answer are:

Does CBT reduce the symptoms of muscle dysmorphia in this population? Does CBT improve psychological well-being and reduce reliance on steroids or PEDs? Researchers will compare participants receiving CBT to a control group that does not receive any intervention to determine the therapy's effectiveness.

Participants will:

Undergo a formal diagnosis of muscle dysmorphia (Under BDD) and steroid/PED abuse based on DSM-5-TR criteria through online clinical interviews.

Complete 12 weekly one-on-one online CBT sessions (50 minutes each) for those in the experimental group.

Complete psychological assessments at three time points: before the intervention, after the intervention, and at a 3-month follow-up.

This study uses validated scales to measure changes in symptoms of MD, psychological distress, and other related outcomes. The results will help determine if CBT is an effective treatment for muscle dysmorphia and associated steroid/PED abuse.

Detailed description: This randomized controlled trial is designed to evaluate the effectiveness of cognitive behavioral therapy (CBT) for men diagnosed with muscle dysmorphia (MD) under body dysmorphic disorder (BDD) and steroid or performance-enhancing drug (PED) abuse. Muscle dysmorphia is a subtype of BDD characterized by a pathological preoccupation with insufficient muscularity, often accompanied by steroid/PED use. Despite the physical and psychological risks associated with these behaviors, individuals with MD and steroid abuse rarely seek treatment due to stigma and the psychological effects of steroid use.

Study Design:

The trial will recruit male participants aged 18-65 who regularly attend the gym (at least three times per week) and have been using steroids or PEDs for at least one year. Recruitment will be conducted across 20 districts in Istanbul, targeting a diverse range of socioeconomic populations. Survey teams will approach gym-goers outside fitness clubs to introduce the study, explain its confidentiality, and emphasize the benefits of participation, including free psychiatric diagnosis and CBT sessions.

Participants will be asked to complete a sociodemographic questionnaire, and formal diagnoses of muscle dysmorphia and steroid/PED abuse will be made via online clinical interviews conducted by a psychiatrist using DSM-5-TR criteria.

Randomization and Intervention:

Participants who meet the inclusion criteria will be randomly assigned to one of two groups:

Experimental Group: Participants will receive 12 weekly one-on-one CBT sessions (50 minutes each) conducted online via Microsoft Teams. Therapy will be structured to address MD symptoms, maladaptive thought patterns, and behaviors associated with steroid/PED use.

Control Group: Participants will not receive any intervention during the study period.

Therapy sessions will be delivered by clinical psychology master's students who have completed a minimum of 250 hours of CBT training and will undergo an additional 100 hours of specialized training on MD, BDD, and steroid/PED abuse prior to the study. The therapy process will be supervised by experienced clinical psychologists and a psychiatrist to ensure adherence to the treatment protocol.

Outcome Measures:

Participants in both groups will be assessed at three time points: baseline (pre-intervention), post-intervention, and three-month follow-up. The following validated scales will be used:

Muscle Dysmorphic Disorder Inventory (MDDI) Patient Health Questionnaire (PHQ) Kessler Psychological Distress Scale (K10) Bodybuilder Image Grid (BIG) Eating Disorder Examination Questionnaire (EDE-Q) Exercise Addiction Inventory (EAI)

Monitoring and Supervision:

To maintain fidelity to the CBT protocol, an external monitoring committee will review recordings of therapy sessions. The committee will include two CBT-trained clinical psychologists, one clinical psychology PhD assistant professor, and one psychiatrist. Feedback will be provided to therapists to ensure consistency and adherence to the protocol.

Challenges and Mitigation:

Recognizing the stigma associated with steroid use and MD, the study incorporates strategies to build trust and encourage participation, including emphasizing confidentiality, offering free psychiatric diagnosis and therapy, and using trained survey teams to engage participants effectively. To minimize dropout rates, reminders and follow-ups will be implemented throughout the study period.

Significance:

This trial aims to address a critical gap in the treatment of muscle dysmorphia and steroid/PED abuse. By evaluating the efficacy of structured CBT delivered online, the study will provide valuable insights for developing accessible and effective interventions for this underserved and stigmatized population.

Eligibility criteria: Inclusion Criteria:

Male participants aged 18-65. Regular gym attendance (minimum three times per week). Use of steroids or performance-enhancing drugs (PEDs) for at least one year. Formal diagnosis of muscle dysmorphia (MD) under body dysmorphic disorder (BDD) and steroid/PED abuse, based on DSM-5-TR criteria.

Willingness to participate in 12 weekly one-on-one online cognitive behavioral therapy (CBT) sessions.

Ability to provide informed consent and complete assessments at baseline, post-intervention, and three-month follow-up.

Exclusion Criteria:

Diagnoses of substance use disorders (e.g., heroin, cannabis). Diagnoses of bipolar disorder or antisocial personality disorder. Use of steroids or PEDs for medical purposes. Use of medications that could interfere with the study outcomes. Participation in any other psychotherapy or psychological intervention during the study period.

Inability to access the internet or participate in online therapy sessions.

Primary outcomes:
measure: Reduction in Muscle Dysmorphia Symptoms
timeFrame: Baseline, post-intervention (12 weeks), and three-month follow-up (24 weeks).
Secondary outcomes:
measure: Reduction in Psychological Distress
timeFrame: Baseline, post-intervention (12 weeks), and three-month follow-up (24 weeks).
measure: Improvement in General Psychological Well-being
timeFrame: Baseline, post-intervention (12 weeks), and three-month follow-up (24 weeks).
measure: Reduction in Risky Body Image Behaviors
timeFrame: Baseline, post-intervention (12 weeks), and three-month follow-up (24 weeks).
measure: Reduction in Eating Disorder Symptoms
timeFrame: Baseline, post-intervention (12 weeks), and three-month follow-up (24 weeks).
measure: Reduction in Exercise Addiction Symptoms
timeFrame: Baseline, post-intervention (12 weeks), and three-month follow-up (24 weeks)
Other outcomes:
measure: Dropout Rates
timeFrame: End of the intervention phase (12 weeks).
Locations:
city: İstanbul
country: Turkey
facility: Üsküdar University, İstanbul, Türkiye
Study officials:
affiliation: Üsküdar University
name: Selami Varol Ülker, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Nisantasi University
name: Metin Çınaroğlu, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Beykoz University
name: Eda Yılmazer, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Üsküdar University
name: Gokben Hızlı Sayar, Professor
role: STUDY_CHAIR
References: