An interventional study of TTM-Based Intervention for AAS Use Reduction A structured, multi-session counseling intervention grounded in the Transtheoretical Model. Content and techniques (e.g., consciousness raising, decisional in Anabolic Androgenic Steroid Use and Substance-Related Disorders, sponsored by Alaa Yousif Ayed Ahmed. Not yet recruiting at 1 site in Iraq. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Alaa Yousif Ayed Ahmed · Not applicable, Interventional, and Prevention
This randomized controlled trial will evaluate the efficacy of a Transtheoretical Model (TTM)-based behavior-change intervention, delivered through stage-matched counseling sessions, on anabolic-androgenic steroid (AAS) use among gym-goers, compared with a control group receiving standard health education. Non-medical AAS use is a growing public health concern in gym and fitness settings and is associated with serious cardiovascular, endocrine, hepatic, and psychiatric harms. Participants will be randomly assigned to either a TTM-based intervention group or a control group. The intervention will tailor counseling content to each participant's stage of change (precontemplation, contemplation, preparation, action, or maintenance) regarding AAS use. The findings of this study will provide evidence on the effectiveness of stage-based behavioral counseling in reducing AAS use and progressing gym-goers toward safer, drug-free training practices.
Anabolic-androgenic steroid (AAS) use for aesthetic and performance-enhancing purposes has become an increasingly recognized problem among recreational and competitive gym-goers worldwide, with prevalence reported to be substantially higher in bodybuilding and fitness-center populations than in the general population. Non-medical AAS use is associated with cardiovascular disease, hepatotoxicity, endocrine disruption, and psychiatric sequelae including depression, aggression, and dependence. Despite this burden, few theory-driven behavioral interventions targeting AAS use in gym settings have been rigorously evaluated.
The Transtheoretical Model (TTM) proposes that behavior change unfolds through a sequence of stages (precontemplation, contemplation, preparation, action, and maintenance), and that interventions matched to an individual's current stage - using stage-specific processes of change, decisional balance, and self-efficacy strategies - are more effective than generic, one-size-fits-all education. TTM-based interventions have demonstrated efficacy in other health behaviors such as smoking cessation, weight management, and physical activity promotion, but their application to AAS use reduction among gym-goers remains limited.
This study will be conducted as a randomized controlled trial at fitness centers/gyms in Mosul city, Iraq. A total of [N, e.g., 120] adult gym-goers who report current or recent non-medical AAS use, or who are identified as being at risk of AAS use, will be enrolled and randomly assigned to one of two groups: a TTM-based intervention group or a control group. The intervention group will receive a structured, multi-session program of individualized counseling matched to participants' baseline stage of change, incorporating motivational interviewing techniques, decisional-balance exercises, and self-efficacy building strategies delivered over [e.g., 8 weeks]. The control group will receive standard printed health education materials on the risks of AAS use.
Data will be collected using validated self-report questionnaires assessing stage of change (e.g., a URICA-type or AAS-adapted staging algorithm), decisional balance (pros and cons of AAS use), self-efficacy to resist AAS use, and self-reported AAS use behavior (frequency, dose, and duration). Assessments will occur at baseline, immediately post-intervention, and at a follow-up time point. The study will compare the effect of the TTM-based intervention versus control on stage progression and AAS use behavior, and will examine the relationship between stage of change, decisional balance, self-efficacy, and actual reduction or cessation of AAS use.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 120 is above the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →This is the only study on the registry with Alaa Yousif Ayed Ahmed as lead sponsor.
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● Adult gym members regularly attending the study fitness center(s)
● Male or female, aged 18 years or older
● Current or past-year non-medical use of anabolic-androgenic steroids, or identified as at risk of initiating use
● Willing to participate and provide
● Able to attend the assigned intervention sessions and complete study assessments
Exclusion Criteria:
● Nurses/participants who do not agree to participate in the study
● Use of AAS under current medical supervision/prescription for a diagnosed condition
● Not available during the study intervention or follow-up period
● Unable to attend the assigned intervention sessions
● Do not complete the required study assessments
● Participated in the pilot study
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.
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.
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 will receive an individualized, stage-matched behavioral counseling program targeting reduction and cessation of nonmedical anabolic-androgenic steroid use.
Behavioral: TTM-Based Intervention for AAS Use Reduction A structured, multi-session counseling intervention grounded in the Transtheoretical Model. Content and techniques (e.g., consciousness raising, decisional
Participants will receive standard printed health education materials on the risks of anabolic-androgenic steroid use, without stage-matched counseling.
Behavioral: TTM-Based Intervention for AAS Use Reduction A structured, multi-session counseling intervention grounded in the Transtheoretical Model. Content and techniques (e.g., consciousness raising, decisional
Participants receive a standard pamphlet/handout describing the physical and psychological risks of AAS use, consistent with routine health promotion practice at the study site.
primary outcome meaure
Stage of change for anabolic-androgenic steroid use Stage of change will be assessed using a validated, AAS-adapted staging algorithm based on the Transtheoretical Model (precontemplation, contemplation, preparation, action, maintenance). This outcome will evaluate participants' readiness to reduce or discontinue AAS use. Forward stage progression indicates a positive treatment effect.
Time frame: Baseline, immediately after completion of the assigned intervention (post-test 1), and 8 weeks after completion of the intervention (post-test 2).]
Change in Anabolic-Androgenic Steroid Use Behavior
The primary outcome is the change in anabolic-androgenic steroid use behavior from baseline to the end of the intervention, assessed using a validated questionnaire.
Time frame: Baseline to 6 months after randomization
Change Behavior
2\. Self-reported anabolic-androgenic steroid use behavior AAS use will be assessed using a self-report questionnaire capturing frequency, dose, and duration of use over the preceding period. This outcome will measure change in actual use behavior. Lower frequency/dose indicates reduced use. \[Time Frame: Immediately after completion of the assigned intervention (post-test 1) and 8 weeks after completion of the intervention (post-test 2).\] 3. Decisional balance regarding anabolic-androgenic steroid use Decisional balance (perceived pros and cons of AAS use) will be assessed using the study questionnaire. This outcome will measure the shift in the balance of perceived benefits versus risks of AAS use. A decrease in perceived pros relative to cons indicates a positive treatment effect. \[Time Frame: Immediately after completion of the assigned intervention (post-test 1) and 8 weeks after completion of the intervention (post-test 2).\] 4. Self-efficacy to resist anabolic-androgenic steroid u
Time frame: Immediately after completion of the assigned intervention (post-test 1) and 8 weeks after completion of the intervention (post-test
Plan to share: No — Individual participant data will not be shared because the study involves a relatively small sample from specific gym/fitness-center settings, and data sharing may increase the risk of participant identification even after de-identification.
Start is estimated for Jul 2026; primary completion for Mar 2027, 7 months later.
Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's planned 7 months is below that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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