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IRCT20260607069693N1 IRCT 2026-07-15 Islamic Azad University Investigating the Effect of Acceptance and Commitment Therapy (ACT) on Stigma Levels in Individuals with Schizophrenia Disorders Investigating the Effect of Acceptance and Commitment Therapy (ACT) on Stigma Levels in Individuals with Schizophrenia Disorders 2026-06-22 anticipated 60 Complete https://irct.ir/trial/90746 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After selecting up to 60 eligible participants through purposive sampling and obtaining written informed consent, participants will be randomly allocated to the intervention and control groups using simple randomization with a 1:1 allocation ratio. The unit of randomization is the individual participant. The random allocation sequence will be generated using SPSS statistical software. Based on the generated random sequence, each participant will be assigned to either the intervention or the control group after completion of the baseline assessment. To ensure allocation concealment, the randomization sequence will be placed in sequentially numbered, opaque, sealed envelopes (SNOSE). After enrollment and baseline assessment, the corresponding envelope will be opened in sequence to reveal the participant's group assignment, Blinding description: In a single-blind study, information that could skew the results of the experiment is hidden from the participant, but the person conducting the experiment is aware of it. 2-3 Schizophrenia spectrum disorders. Intervention 1: Intervention group: Participants in this group will receive Acceptance and Commitment Therapy (ACT) in addition to routine psychiatric care. The intervention will be delivered as eight 90-minute semi-structured group sessions, conducted twice weekly over four weeks. The sessions will be conducted by the principal investigator, who has completed formal training in Acceptance and Commitment Therapy (ACT), according to the university-approved treatment protocol. The intervention includes psychoeducation about the ACT model, acceptance of thoughts and emotions, mindfulness, cognitive defusion, self-as-context, values clarification, committed action, skills practice, and relapse prevention. Intervention 2: Control group: Participants in this group will receive routine psychiatric care only, including pharmacotherapy, regular psychiatric follow-up, and other standard clinical services provided by the treatment center. They will not receive Acceptance and Commitment Therapy (ACT) during the study period. Outcome assessments will be performed at the same time points as those in the intervention group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dorsa Khayatali
No. 6, Razaghi Alley, Qaem Residential Complex, Mini City, Tehran, Iran – 3rd Floor.
Tehran Iran (Islamic Republic of) 1955867571 +98 21 2245 6663 Dorsa.khayatali@iau.ir Islamic Azad University scientific Jamileh Mohatsami
No. 67, Boojarian St., Madaen Area, Narmak, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1649746841 +98 21 7744 0770 beh@iau.ac.ir Islamic Azad University Iran (Islamic Republic of) Age 18 years and older Minimum literacy level sufficient to complete the questionnaires Stable clinical condition or partial recovery. Ability to understand instructions and cooperate in group sessions. Informed and written consent to participate in the study from the guardian of individuals with schizophrenia disorders 18 years no limit Both Development of an acute psychotic disorder during the sessions. Drug or alcohol use that affects the ability to participate in the sessions. Development of severe physical complications or chronic illness that prevents regular attendance at sessions, unwillingness or withdrawal from continuing cooperation during the study. Participation in other concurrent psychotherapy interventions that may affect the results of the ACT. Severe cognitive problems that make it impossible to complete the questionnaire. Participants who have missed more than two sessions. F20-F29 Schizophrenia, schizotypal and delusional disorders(F20-F29) Other Other Intervention group: Participants in this group will receive Acceptance and Commitment Therapy (ACT) in addition to routine psychiatric care. The intervention will be delivered as eight 90-minute semi-structured group sessions, conducted twice weekly over four weeks. The sessions will be conducted by the principal investigator, who has completed formal training in Acceptance and Commitment Therapy (ACT), according to the university-approved treatment protocol. The intervention includes psychoeducation about the ACT model, acceptance of thoughts and emotions, mindfulness, cognitive defusion, self-as-context, values clarification, committed action, skills practice, and relapse prevention. Control group: Participants in this group will receive routine psychiatric care only, including pharmacotherapy, regular psychiatric follow-up, and other standard clinical services provided by the treatment center. They will not receive Acceptance and Commitment Therapy (ACT) during the study period. Outcome assessments will be performed at the same time points as those in the intervention group. 1. Acceptance and Commitment Therapy (ACT) intervention, assigning the patient to the intervention or control group for 8 sessions of 90 minutes. 2. Stigma level: total score of the stigma questionnaire based on a four-point Likert scale from 1 (completely disagree) to 4 (completely agree). Timepoint: At the beginning of the study, a questionnaire is filled out. After completion of the work, the subject is immediately re-measured and the questionnaire is filled out again after a month. Method of measurement: the Internalized Stigma of Patients with Mental Disorders (ISMI) questionnaire.To measure the level of stigma in patients with schizophrenia, the Internalized Stigma of Patients with Mental Disorders (ISMI) questionnaire is used.This questionnaire was designed by Ritsher et al. in 2003 and is considered one of the most valid tools for assessing stigma in psychiatric patients. The ISMI questionnaire consists of 29 items and assesses five main components: alienation, acceptance of stereotypes, experience of discrimination, social withdrawal, and resistance to stigma. Internalized stigma score. Outcome measure: Internalized Stigma of Mental Illness (ISMI) questionnaire. Timepoint: At baseline, immediately after the intervention, and one month after the intervention. Timepoint: At the beginning of the work. Method of measurement: Using a demographic information questionnaire. Islamic Azad University Approved 2026-06-09 Ethics Committee of Tehran Islamic Azad University of Medical Sciences Islamic Azad University, Tehran Medical Sciences Branch Khalili Dead End, South Roudaki St., Khaghani St., Shariati St. Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)