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Body Dysmorphic DisorderNCT06781853

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

A study testing Cognitive Behavioral Therapy (CBT) in people with Body Dysmorphic Disorder and Steroid Abuse, run by Uskudar University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, men only
What is being tested?
Cognitive Behavioral Therapy (CBT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2024to 15 Jun 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Üsküdar University, İstanbul, Türkiye

    Istanbul, 34277

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluating the Effectiveness of Cognitive Behavioral Therapy for Muscle Dysmorphia and Steroid Abuse: A Randomized Controlled Trial

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.

Read more

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.

Read the 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.

Being tested
Cognitive Behavioral Therapy (CBT)
Keywords
Cognitive Behavioral Therapy (CBT), Muscle Dysmorphia, Body Dysmorphic Disorder (BDD), Steroid Abuse, Performance-Enhancing Drugs (PEDs)
Medical subject headings
Body Dysmorphic Disorders, Brachydactyly, Type D

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Therapy (CBT)Behavioural

    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.

Study groups in NCT06781853
Study groupRoleWhat they receive
CBT Interventional GroupExperimentalParticipants 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.
Receives: Behavioral: Cognitive Behavioral Therapy (CBT)
Control GroupNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)
  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2025
  2. Study start1 Sep 2024
  3. Primary completion15 Apr 2025
  4. Study completion15 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06781853
Sponsor's protocol ID
61351342/20-318
Status last verified
Jun 2025
First submitted
13 Jan 2025
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy (CBT) in people with Body Dysmorphic Disorder and Steroid Abuse, run by Uskudar University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in Muscle Dysmorphia Symptoms (time frame: Baseline, post-intervention (12 weeks), and three-month follow-up (24 weeks).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.

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