Determining the effect of Mindfulness-Based Stress Reduction (MBSR) program on the levels of anxiety, stress, and depression in psychiatric patients
Design
Simple randomization will be used to allocate participants into two groups: an intervention group and a control group, with 48 participants in each group.
Settings and conduct
In this study, eligible patients will first be identified among inpatients at Razi Psychiatric Teaching Hospital. The inclusion and exclusion criteria will be carefully assessed to ensure the selection of a homogeneous and appropriate sample for the study. After eligible patients have been identified, written informed consent will be obtained from the participants. The objectives, procedures, benefits, and requirements of the study will be fully explained to them to ensure that they participate with complete awareness. The study will be conducted using a single-blind design.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Age over 18 years
- Diagnosis of a psychiatric disorder by a psychiatrist
- Ability to attend weekly sessions
Exclusion criteria:
- Patients experiencing an exacerbation of acute psychiatric disorders or suffering from an acute physical illness
- Any stressful life event
Intervention groups
The intervention group will receive the MBSR intervention in addition to usual care and treatments. The intervention will be delivered in semi-structured group sessions, consisting of eight 2-hour sessions.
The control group will receive only usual care and treatments throughout the study period, and no MBSR intervention will be provided. Outcome assessments will be conducted at the same time points as in the intervention group.
Main outcome variables
**Mindfulness-Based Stress Reduction (MBSR)**
General information
Reason for update
Acronym
MBSR
IRCT registration information
IRCT registration number:IRCT20260721070278N1
Registration date:2026-09-13, 1405/06/22
Registration timing:registered_while_recruiting
Last update:2026-09-13, 1405/06/22
Update count:0
Registration date
2026-09-13, 1405/06/22
Registrant information
Name
Mohammad Hosseini ashtiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3387 0199
Email address
m.hosseini863@iau.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-08-23, 1405/06/01
Expected recruitment end date
2026-09-23, 1405/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
“Examining the effect of Mindfulness-Based Stress Reduction (MBSR) on anxiety, stress, and depression in psychiatric patient
Public title
“Examining the effect of Mindfulness-Based Stress Reduction (MBSR) on anxiety, stress, and depression in psychiatric patient
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 or older
Diagnosis of a psychiatric disorder by a psychiatrist
Ability to attend weekly sessions
Exclusion criteria:
Patients with exacerbation of acute psychiatric disorders or acute physical illness
Any stressful life event
Age
From 18 years old
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran Islamic Azad University of Medical Sciences
Street address
Islamic Azad University, Tehran Medical Sciences Branch Khalili Dead End, South Roudaki St., Khaghani St., Shariati St. Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2026-05-27, 1405/03/06
Ethics committee reference number
IR.IAU.TMU.REC.1405.020
Health conditions studied
1
Description of health condition studied
Psychiatric patients
ICD-10 code
F20–F29
ICD-10 code description
Schizophrenia, schizotypal and delusional disorders
Primary outcomes
1
Description
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.
2
Description
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.
3
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Other
2
Description
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
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
**Razi Psychiatric Teaching and Treatment Center (Aminabad)**
Full name of responsible person
Hossein Akhavan Zanjani
Street address
Razi Psychiatric Teaching and Treatment Center, Shahid Rastegar Boulevard, Taqiabad Three-Way Junction, Shahr-e Rey, Tehran, Iran
City
Shahr-e Rey
Province
Tehran
Postal code
1867612016
Phone
+98 21 3340 1220
Email
razi@uswr.ac.ir
Web page address
https://razi.uswr.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Seyed Ali Abtahi
Street address
Floors 7 and 9, Block 6, Central Organization of Islamic Azad University, Shohada-ye Hesarak Boulevard, Shahid Mohammad Mehdi Tehranchi Square, End of Shahid Sattari Expressway (North), Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1477893780
Phone
+98 21 4791 6949
Email
med@iau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?