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IRCT20260721070278N1 IRCT 2026-09-13 Islamic Azad University “Examining the effect of Mindfulness-Based Stress Reduction (MBSR) on anxiety, stress, and depression in psychiatric patient MBSR “Examining the effect of Mindfulness-Based Stress Reduction (MBSR) on anxiety, stress, and depression in psychiatric patient 2026-08-23 anticipated 94 Complete https://irct.ir/trial/92709 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After selecting up to 94 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 Psychiatric patients. Intervention 1: Intervention GroupIn addition to receiving usual psychiatric treatments, participants in the intervention group will receive Mindfulness-Based Stress Reduction (MBSR) in semi-structured group sessions. The intervention will consist of eight 2-hour sessions and will be delivered by the researcher, who has completed a university-based specialized MBSR training course according to the relevant protocol.The sessions will be conducted as follows:Introduction to mindfulness: Familiarization with the concept of mindfulness and its relationship with stress and automatic thoughts; practice of mindful breathing.Awareness of the body and physiological sensations: Practice of body scan meditation.Mindful movement and gentle yoga: Focusing on breathing and bodily sensations during movement.Awareness of thoughts and emotions: Observing thoughts as transient events rather than absolute reality.Mindful responses to stress: Replacing automatic reactions with mindful pausing and observation.Mindful communication: Practicing active listening, nonjudgmental speaking, and loving-kindness meditation.Integrating mindfulness into daily life: Applying mindfulness to eating, walking, and interactions with others; reviewing common barriers.Course summary: Reviewing the personal mindfulness journey, conducting a full meditation practice, and planning for continued practice. Intervention 2: Control group: Participants in the control group will receive only usual psychiatric care throughout the study, including pharmacotherapy, routine clinical visits, and other daily services. Outcome assessments will be conducted at the same time points as those for 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 No further information is available.
public Mohammad Hosseini Ashtiani
No. 133, 4th Floor, Taherpnah Alley, Mazaher Street, Masoudieh, Tehran, Iran
Tehran Iran (Islamic Republic of) 1786838315 +98 21 3387 0199 m.hosseini863@iau.ir Islamic Azad University scientific Ladan Fattahmoghaddam
2nd Floor, No. 4, Ghasrdashti Alley, Sadaf Street, Sarv-e Gharbi, Saadat Abad, Tehran, Iran
Tehran Iran (Islamic Republic of) 1998764763 +98 21 2207 1942 lfatah@iautmu.ac.ir Islamic Azad University Iran (Islamic Republic of) Age 18 or older Diagnosis of a psychiatric disorder by a psychiatrist Ability to attend weekly sessions 18 years no limit Male Patients with exacerbation of acute psychiatric disorders or acute physical illness Any stressful life event F20–F29 Schizophrenia, schizotypal and delusional disorders Other Other Intervention GroupIn addition to receiving usual psychiatric treatments, participants in the intervention group will receive Mindfulness-Based Stress Reduction (MBSR) in semi-structured group sessions. The intervention will consist of eight 2-hour sessions and will be delivered by the researcher, who has completed a university-based specialized MBSR training course according to the relevant protocol.The sessions will be conducted as follows:Introduction to mindfulness: Familiarization with the concept of mindfulness and its relationship with stress and automatic thoughts; practice of mindful breathing.Awareness of the body and physiological sensations: Practice of body scan meditation.Mindful movement and gentle yoga: Focusing on breathing and bodily sensations during movement.Awareness of thoughts and emotions: Observing thoughts as transient events rather than absolute reality.Mindful responses to stress: Replacing automatic reactions with mindful pausing and observation.Mindful communication: Practicing active listening, nonjudgmental speaking, and loving-kindness meditation.Integrating mindfulness into daily life: Applying mindfulness to eating, walking, and interactions with others; reviewing common barriers.Course summary: Reviewing the personal mindfulness journey, conducting a full meditation practice, and planning for continued practice. Control group: Participants in the control group will receive only usual psychiatric care throughout the study, including pharmacotherapy, routine clinical visits, and other daily services. Outcome assessments will be conducted at the same time points as those for the intervention group Changes in participants’ anxiety scores on the DASS-21 questionnaire. Timepoint: Measurement of anxiety scores at baseline (before the initiation of the intervention) and after completion of Session 8 (the final session), which took place two months after the start of the intervention. Method of measurement: The anxiety subscale of the 21-item Depression, Anxiety and Stress Scales (DASS-21) consists of 7 items. The anxiety subscale is rated on a four-point Likert scale ranging from 0 (not at all) to 3 (very much). The minimum and maximum possible scores for each subscale are 0 and 21, respectively. Changes in participants’ stress scores on the DASS-21 questionnaire. Timepoint: Measurement of stress scores at baseline (before the initiation of the intervention) and after completion of Session 8 (the final session), which took place two months after the start of the intervention. Method of measurement: The stress subscale of the 21-item Depression, Anxiety and Stress Scales (DASS-21) consists of 7 items. The stress subscale is rated on a four-point Likert scale ranging from 0 (not at all) to 3 (very much). The minimum and maximum possible scores for each subscale are 0 and 21, respectively. Changes in participants’ depression scores on the DASS-21 questionnaire. Timepoint: Measurement of depression scores at baseline (before the initiation of the intervention) and after completion of Session 8 (the final session), which took place two months after the start of the intervention. Method of measurement: The depression subscale of the 21-item Depression, Anxiety and Stress Scales (DASS-21) consists of 7 items. The depression subscale is rated on a four-point Likert scale ranging from 0 (not at all) to 3 (very much). The minimum and maximum possible scores for each subscale are 0 and 21, respectively. Islamic Azad University Approved 2026-05-27 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)