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

NCT06781853 | Active Not Recruiting DMC

• 1 other identifier: 61351342/20-318
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• Reduction in Muscle Dysmorphia Symptoms

  Change in muscle dysmorphia symptoms, as measured by the Muscle Dysmorphic Disorder Inventory (MDDI), from baseline to post-intervention and three-month follow-up.

  Baseline, post-intervention (12 weeks), and three-month follow-up (24 weeks).

Secondary Outcomes (5)

• Reduction in Psychological Distress

  Baseline, post-intervention (12 weeks), and three-month follow-up (24 weeks).

• Improvement in General Psychological Well-being

  Baseline, post-intervention (12 weeks), and three-month follow-up (24 weeks).

• Reduction in Risky Body Image Behaviors

  Baseline, post-intervention (12 weeks), and three-month follow-up (24 weeks).

• Reduction in Eating Disorder Symptoms

  Baseline, post-intervention (12 weeks), and three-month follow-up (24 weeks).

• Reduction in Exercise Addiction Symptoms

  Baseline, post-intervention (12 weeks), and three-month follow-up (24 weeks)

Other Outcomes (1)

• Dropout Rates

  End of the intervention phase (12 weeks).

Study Arms (2)

CBT Interventional Group

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioral Therapy (CBT)

Control Group

NO INTERVENTION

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.

Interventions

Cognitive Behavioral Therapy (CBT) 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.

CBT Interventional Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uskudar University: lead
• Beykoz University: collaborator
• Istanbul Nisantasi University: collaborator

Study Sites (1)

Üsküdar University, İstanbul, Türkiye

Istanbul, 34277, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Body Dysmorphic Disorders; Brachydactyly, Type D

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Selami Varol Ülker, Phd

  Üsküdar University

  PRINCIPAL INVESTIGATOR

• Metin Çınaroğlu, Phd

  Istanbul Nisantasi University

  PRINCIPAL INVESTIGATOR

• Eda Yılmazer, Phd

  Beykoz University

  PRINCIPAL INVESTIGATOR

• Gokben Hızlı Sayar, Professor

  Üsküdar University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: September 1, 2024
• Primary Completion: April 15, 2025
• Study Completion: June 15, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The IPD and supporting information will be available starting 6 months after publication of the study results and will remain accessible for 5 years.
• Access Criteria: Access to the de-identified IPD and supporting information will be granted to qualified researchers upon reasonable request. Requests must include a detailed research proposal outlining the intended use of the data and compliance with applicable ethical and legal standards. Access will be provided after review and approval by the study's data-sharing committee. Researchers will be required to sign a data use agreement to ensure the confidentiality of the participants and appropriate use of the data. Requests can be submitted to the corresponding author via email.

Locations

TU (1)