CBT for Muscle Dysmorphia and Steroid Abuse: A Randomized Controlled Trial

NCT ID: NCT06781853

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-06-15

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 6 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 3 side-principle investigators (authors of the study) and assistant professors in psychology who have BDD/MD and steroid abuse experinces . The therapy process will be supervised by psychiatry professor (one of the author) 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.

Conditions

Body Dysmorphic Disorder; Steroid Abuse; Body Dysmorphic Disorder (BDD), Subtype: Muscle Dysmorphia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT Interventional Group

Participants in this group will receive 12 weekly one-on-one cognitive behavioral therapy (CBT) sessions, each lasting 50 minutes, delivered online via Microsoft Teams. The intervention will target symptoms of muscle dysmorphia (MD), maladaptive thoughts, and behaviors related to steroid and performance-enhancing drug (PED) abuse. Therapy will be conducted by three assistant professors in psychology supervised by senior author psychiatrist.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy (CBT)

Intervention Type: BEHAVIORAL

The intervention consists of 12 weekly one-on-one online CBT sessions, each lasting 50 minutes, delivered via Microsoft Teams. The sessions will focus on addressing symptoms of muscle dysmorphia (MD), maladaptive thought patterns, and behaviors associated with steroid and performance-enhancing drug (PED) use. The therapy is based on structured CBT techniques and will include psychoeducation, cognitive restructuring, behavioral experiments, and relapse prevention strategies. The sessions will be conducted by trained clinical psychology master's students under the supervision of experienced clinical psychologists and a psychiatrist. The intervention is designed to reduce MD symptoms and improve psychological well-being.

Control Group

Participants in this group will not receive any intervention during the study period. They will complete the same assessments as the experimental group at baseline, post-intervention, and three-month follow-up to evaluate changes in muscle dysmorphia symptoms, psychological distress, and related behaviors for comparison. After the study, participants in this group will be offered an intensive 8-session CBT program if requested.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Behavioral Therapy (CBT)

The intervention consists of 12 weekly one-on-one online CBT sessions, each lasting 50 minutes, delivered via Microsoft Teams. The sessions will focus on addressing symptoms of muscle dysmorphia (MD), maladaptive thought patterns, and behaviors associated with steroid and performance-enhancing drug (PED) use. The therapy is based on structured CBT techniques and will include psychoeducation, cognitive restructuring, behavioral experiments, and relapse prevention strategies. The sessions will be conducted by trained clinical psychology master's students under the supervision of experienced clinical psychologists and a psychiatrist. The intervention is designed to reduce MD symptoms and improve psychological well-being.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Beykoz University

OTHER

Sponsor Role: collaborator

Istanbul Nisantasi University

OTHER

Sponsor Role: collaborator

Uskudar University

OTHER

Sponsor Role: lead

Responsible Party

Selami Varol Ülker

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selami Varol Ülker, Phd

Role: PRINCIPAL_INVESTIGATOR

Üsküdar University

Metin Çınaroğlu, Phd

Role: PRINCIPAL_INVESTIGATOR

Istanbul Nisantasi University

Eda Yılmazer, Phd

Role: PRINCIPAL_INVESTIGATOR

Beykoz University

Gokben Hızlı Sayar, Professor

Role: STUDY_CHAIR

Üsküdar University

Locations

Üsküdar University, İstanbul, Türkiye

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

61351342/20-318

Identifier Type: -

Identifier Source: org_study_id