Overall Objective:
To determine the effect of an acceptance and commitment-based intervention on the level of stigma in people with schizophrenia.
There are also minor goals.
Design
It is a simple randomization that places people in two groups of 30: control and intervention.
Settings and conduct
Eligible patients will be recruited from the Schizophrenia Patients Support Association (AHBA) and Roozbeh Psychiatric Center after confirming the inclusion and exclusion criteria. Written informed consent will be obtained before enrollment, and the study procedures will be explained to all participants. This study will be conducted using a single-blind design.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:• Minimum literacy level sufficient to complete the questionnaires.• Stable clinical condition or partial recovery.•Ability to understand instructions and participate in group sessions.•Written informed consent provided by the legal guardian.•Age ≥18 years.
Exclusion Criteria:
• Development of an acute psychotic disorder during the sessions.• Drug or alcohol use that affects the ability to participate in the sessions.• Participants who have missed more than two sessions.
Intervention groups
Participants in the intervention group will receive ACT , in addition to usual care, in the form of eight 90-minute semi-structured group sessions.Participants in the control group will receive usual care and routine treatment only during the study period and will not receive any ACT. Outcome assessments will be performed at the same time points as in the intervention group.
Main outcome variables
1. Acceptance and Commitment Therapy (ACT) intervention: Patient assigned to the intervention or control group for 8 90-minute sessions
2. Stigma score: Total score of the stigma questionnaire based on a four-point Likert scale from 1 (completely disagree) to 4 (completely agree)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260607069693N1
Registration date:2026-07-15, 1405/04/24
Registration timing:registered_while_recruiting
Last update:2026-07-15, 1405/04/24
Update count:0
Registration date
2026-07-15, 1405/04/24
Registrant information
Name
Dorsa Khayatali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2245 6663
Email address
dorsa.khayatali@iau.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-06-22, 1405/04/01
Expected recruitment end date
2026-07-23, 1405/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Acceptance and Commitment Therapy (ACT) on Stigma Levels in Individuals with Schizophrenia Disorders
Public title
Investigating the Effect of Acceptance and Commitment Therapy (ACT) on Stigma Levels in Individuals with Schizophrenia Disorders
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (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
2026-06-09, 1405/03/19
Ethics committee reference number
IR.IAU.TMU.REC.1405.074
Health conditions studied
1
Description of health condition studied
Schizophrenia spectrum disorders
ICD-10 code
F20-F29
ICD-10 code description
Schizophrenia, schizotypal and delusional disorders(F20-F29)
Primary outcomes
1
Description
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.
Secondary outcomes
1
Description
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
Intervention groups
1
Description
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.
Category
Other
2
Description
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.
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?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dorsa Khayatali
Position
Master's student in psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 6, Razaghi Alley, Qaem Residential Complex, Mini City, Tehran, Iran – 3rd Floor.