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IRCT20260616069837N1 IRCT 2026-07-19 Kashan University of Medical Sciences The effectiveness of Acceptance and Commitment Therapy on individuals with substance use disorder. The effectiveness of acceptance and commitment therapy on craving, shame, self-control, and interpersonal sensitivity among men with Substance Use Disorders under methadone maintenance treatment. 2026-07-11 anticipated 60 Complete https://irct.ir/trial/90962 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Substance Use Disorder (SUD). Intervention 1: Intervention group: Participants in the intervention group will receive Methadone Maintenance Treatment (MMT) according to the treatment center's protocol, in addition to participating in eight weekly 90-minute group sessions of Acceptance and Commitment Therapy (ACT). The sessions will focus on acceptance of internal experiences, cognitive diffusion, mindfulness, self-as-context, values clarification, and committed action in accordance with personal values. All sessions will be conducted by a trained therapist, while methadone maintenance treatment will continue throughout the intervention period. Intervention 2: Control group: Participants in the control group will receive Methadone Maintenance Treatment (MMT) according to the treatment center's standard protocol and will not receive any psychological intervention during the study period. Upon completion of data collection, they will be offered Acceptance and Commitment Therapy (ACT) if they wish to participate. Yes - There is a plan to make this available What will be shared: De-identified individual participant data will be available after completion of the trial. Upon reasonable request from qualified researchers, access may be granted to raw data related to the primary outcome variables, including substance craving scores, shame scores, self-control scores, and interpersonal sensitivity scores. Personal identifying information will not be shared at any stage of data access. When: Access to de-identified individual participant data will begin 6 months after publication of the study results and will remain available for a period of 2 years thereafter. During this period, data will be shared with qualified researchers upon reasonable request and approval by the research team. To whom: De-identified individual participant data will be made available to qualified researchers. Requests will be accepted only from investigators affiliated with recognized academic institutions, research centers, or scientific organizations with a clear and relevant research purpose. Requests will be reviewed and approved by the study investigators. Access will not be granted to non-research individuals, commercial entities, or applicants outside the academic and scientific field. Conditions: De-identified individual participant data will be used solely for scientific and non-commercial research purposes. Data use is limited to statistical analyses consistent with or complementary to the objectives of the original study. Commercial use, marketing purposes, or any non-scientific applications are strictly prohibited. Data recipients must maintain confidentiality, avoid any attempt to re-identify participants, and are not permitted to share the data with third parties without written permission from the study investigators. Access will be granted only after approval by the principal investigators and in accordance with ethical research principles. Where to obtain: Requests for access to de-identified study data should be directed to the principal investigator or the study supervisor. Requests will be primarily handled via email. Additional correspondence may be conducted through the affiliated university if necessary. Principal Investigator: Razieh Shokri Supervisor: Dr.Zahra Zanjani Email:shokri-r@kaums.ac.ir Postal address: Faculty of Psychology and Educational Sciences, Kashan University, Iran How to obtain: Upon receipt of a request for access to de-identified individual participant data, the request will be reviewed by the principal investigator and the research team. The first step involves assessing the scientific merit and eligibility of the applicant. If preliminarily approved, the requester will be required to sign a data use agreement, including confidentiality and non-reidentification commitments. After completion of the required documentation, the requested data will be prepared and shared electronically with the applicant. Additional clarifications, if needed, will be handled via email correspondence. The entire process typically takes between 2 to 4 weeks. Comments:
public Razieh Shokri
Kashan – Qotb-e Ravandi Boulevard – Pezeshk Boulevard
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5510 9999 shokri-r@kaums.ac.ir Kashan University of Medical Sciences scientific Razieh Shokri
Kashan – Qotb-e Ravandi Boulevard – Pezeshk Boulevard
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5510 9999 shokri-r@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Provided informed consent and expressed willingness to participate in the study. Had a diagnosis of substance use disorder confirmed by a psychologist or psychiatrist. Had abstained from methadone use for at least one month prior to participation. Had no severe psychiatric disorders (e.g., psychotic disorders or bipolar disorder) based on the diagnosis of the center’s psychiatrist. Had no severe physical illnesses or conditions affecting physical appearance, such as cancer, multiple sclerosis, limb amputation, or physical disabilities. Had at least a middle school level of education. Were between 25 and 55 years of age. Had not received Acceptance and Commitment Therapy (ACT) within the two years preceding the study. Were not receiving any concurrent psychotherapy during the study period. 25 years 55 years Male Use of any medication or substance other than methadone. Emergence of suicidal ideation. Emergence of acute psychiatric symptoms. Failure to complete the study questionnaires. A positive urine drug screening test. F11 Opioid related disorders Rehabilitation Rehabilitation Intervention group: Participants in the intervention group will receive Methadone Maintenance Treatment (MMT) according to the treatment center's protocol, in addition to participating in eight weekly 90-minute group sessions of Acceptance and Commitment Therapy (ACT). The sessions will focus on acceptance of internal experiences, cognitive diffusion, mindfulness, self-as-context, values clarification, and committed action in accordance with personal values. All sessions will be conducted by a trained therapist, while methadone maintenance treatment will continue throughout the intervention period. Control group: Participants in the control group will receive Methadone Maintenance Treatment (MMT) according to the treatment center's standard protocol and will not receive any psychological intervention during the study period. Upon completion of data collection, they will be offered Acceptance and Commitment Therapy (ACT) if they wish to participate. Total score of substance craving. Timepoint: Baseline (before intervention) , Immediately after completion of the intervention , Three months after completion of the intervention. Method of measurement: Desires for Drug Questionnaire (DDQ). Total Shame Score. Timepoint: Baseline (before intervention) , Immediately after completion of the intervention , Three months after completion of the intervention. Method of measurement: Cohen et al. Shame Questionnaire. Total Self-Control Score. Timepoint: Baseline (before intervention) , Immediately after completion of the intervention , Three months after completion of the intervention. Method of measurement: Tangney Self-Control Scale (SCS). Total Interpersonal Sensitivity Score. Timepoint: Baseline (before intervention) , Immediately after completion of the intervention , Three months after completion of the intervention. Method of measurement: Boyce and Parker Interpersonal Sensitivity Measure (IPSM). Kashan University of Medical Sciences Approved 2026-06-08 Ethics committee of Kashan university of medical sciences Kashan – Qotb-e Ravandi Boulevard – Pezeshk Boulevard Kashan Isfehan Iran (Islamic Republic of)