An interventional study of Cognitive Behavioral Therapy (CBT) in Body Dysmorphic Disorder, Steroid Abuse and Body Dysmorphic Disorder (BDD), Subtype: Muscle Dysmorphia, sponsored by Uskudar University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by Uskudar University · Not applicable, Interventional, and Treatment
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.
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.
56 studies on the registry are indexed under Body Dysmorphic Disorders; 11 are open to participants now.
This study's enrollment of 71 is above the median of 52 across 44 interventional studies indexed under Body Dysmorphic Disorders.
Browse Body Dysmorphic Disorders studies →Uskudar University is the lead sponsor of 170 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Male participants aged 18-65. Regular gym attendance (minimum three times per week). Use of 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 criteria.
Willingness to participate in 12 weekly one-on-one online cognitive behavioral therapy (CBT) sessions.
Ability to provide 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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
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.
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.
Time frame: Baseline, post-intervention (12 weeks), and three-month follow-up (24 weeks).
Reduction in Psychological Distress
Change in psychological distress, as measured by the Kessler Psychological Distress Scale (K10), from baseline to post-intervention and three-month follow-up.
Time frame: Baseline, post-intervention (12 weeks), and three-month follow-up (24 weeks).
Improvement in General Psychological Well-being
Change in general psychological well-being, assessed using the Patient Health Questionnaire (PHQ), from baseline to post-intervention and three-month follow-up.
Time frame: Baseline, post-intervention (12 weeks), and three-month follow-up (24 weeks).
Reduction in Risky Body Image Behaviors
Change in risky body image behaviors, as measured by the Bodybuilder Image Grid (BIG), from baseline to post-intervention and three-month follow-up.
Time frame: Baseline, post-intervention (12 weeks), and three-month follow-up (24 weeks).
Reduction in Eating Disorder Symptoms
Change in eating disorder symptoms, as measured by the Eating Disorder Examination Questionnaire (EDE-Q), from baseline to post-intervention and three-month follow-up.
Time frame: Baseline, post-intervention (12 weeks), and three-month follow-up (24 weeks).
Reduction in Exercise Addiction Symptoms
Change in symptoms of exercise addiction, assessed using the Exercise Addiction Inventory (EAI), from baseline to post-intervention and three-month follow-up.
Time frame: Baseline, post-intervention (12 weeks), and three-month follow-up (24 weeks)
Dropout Rates
Percentage of participants in the experimental group who attend fewer than 75% of sessions.
Time frame: End of the intervention phase (12 weeks).
Plan to share: Yes — De-identified individual participant data (IPD) related to the study's primary and secondary outcome measures will be shared with other researchers upon reasonable request. The shared data will include de-identified demographic information, baseline characteristics, and assessment scores. Data will be made available following publication of the study results and can be accessed by submitting a request to the corresponding author. Requests must include a detailed research proposal and comply with all applicable ethical and legal requirements. The data will be shared in a secure format to ensure participant confidentiality.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
No publications or documents are linked to this record.
Ran from Sep 2024 to primary completion in Apr 2025, 7 months.
Of 26 interventional studies with no phase under Body Dysmorphic Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.