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IRCT20251008067556N1 IRCT 2026-06-08 Islamic Azad University Evaluating the effectiveness of Acceptance and Commitment Therapy (ACT) in patients with psoriasis The effectiveness of acceptance and commitment therapy (ACT) on improving quality of life, reducing symptoms of anxiety and depression, and enhancing psychological flexibility in patients with psoriasis. 2026-06-20 anticipated 60 Complete https://irct.ir/trial/86736 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, participants will be allocated into intervention and control groups using a simple randomization method based on a random numbers table in SPSS software. First, the list of eligible participants will be entered into SPSS software. Then, a random variable with uniform distribution will be generated using the following command: Compute Random = RV.UNIFORM(0,1) After generating the random variable, the data will be sorted from the smallest to the largest random number, and participants will be assigned to the intervention and control groups according to the resulting order, Blinding description: Given the nature of the intervention (Acceptance and Commitment Therapy), complete blinding was not feasible, as both the therapist and participants were aware of the type of intervention. However, to minimize bias in the data analysis process, partial (single) blinding was implemented; that is, the individual responsible for data entry and statistical analysis was unaware of group assignments (experimental or control). Furthermore, participants were not informed about the exact research hypothesis or the expected outcomes to prevent the occurrence of the expectancy effect. N/A Psoriasis. Intervention 1: The intervention group receives Acceptance and Commitment Therapy (ACT) in a face-to-face, group format. The intervention consists of eight 60‑minute group sessions delivered over eight weeks (one session per week). Session content is based on the six core ACT processes and includes: theoretical education, acceptance exercises, cognitive defusion practices, mindfulness exercises for present‑moment awareness, values clarification, values‑based goal setting, and committed action planning with homework assignments. Educational materials include presentation slides, a homework booklet, and simple practice files. The sessions are delivered by a clinical psychologist trained in ACT. To ensure treatment fidelity, sessions are reviewed by a senior researcher or clinical supervisor using a fidelity checklist, and participants’ homework assignments are documented and evaluated. Intervention 2: Control group: The control group receives routine care and does not receive any additional psychological intervention. Routine care includes standard medical follow‑up, general dermatological advice, and prescribed medications provided by the dermatologist. To maintain structural equivalence, the control group receives only minimal contact during the study period (limited to necessary follow‑up calls for scheduling assessments), and no educational or therapeutic sessions are provided. After data collection is completed, participants in the control group are offered a brief educational package on stress management and self‑care if they wish. 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 I have not yet decided whether to make the participants’ data file publicly available.
public Alireza Azizi
Ayatollah Amoli Branch, Islamic Azad University, before Komdereh Village, Kilometer 6, Old Amol-Babol Road, Amol
Amol Iran (Islamic Republic of) 4713655365 +98 11 3222 3594 name@azizi.a.re Babol University of Medical Sciences scientific Mahta Abdoli
Ayatollah Amoli Branch, Islamic Azad University, before Komdereh Village, Kilometer 6, Old Amol-Babol Road, Amol
Amol Iran (Islamic Republic of) 4613856348 +98 11 4324 5937 name@mhta.abdoli98 Islamic Azad University Iran (Islamic Republic of) Diagnosis of psoriasis skin disease according to a physician's diagnosis Age range between 20-40 years Reading and writing The willingness and consent of consciousness to enter the research project 20 years 40 years Both Diagnosis of severe psychiatric disorders based on medical records or psychiatrist evaluation. Receiving concurrent similar psychological interventions at the time of enrollment. Unwillingness to participate in the study or failure to provide informed consent. L40 Psoriasis Behavior Behavior The intervention group receives Acceptance and Commitment Therapy (ACT) in a face-to-face, group format. The intervention consists of eight 60‑minute group sessions delivered over eight weeks (one session per week). Session content is based on the six core ACT processes and includes: theoretical education, acceptance exercises, cognitive defusion practices, mindfulness exercises for present‑moment awareness, values clarification, values‑based goal setting, and committed action planning with homework assignments. Educational materials include presentation slides, a homework booklet, and simple practice files. The sessions are delivered by a clinical psychologist trained in ACT. To ensure treatment fidelity, sessions are reviewed by a senior researcher or clinical supervisor using a fidelity checklist, and participants’ homework assignments are documented and evaluated. Control group: The control group receives routine care and does not receive any additional psychological intervention. Routine care includes standard medical follow‑up, general dermatological advice, and prescribed medications provided by the dermatologist. To maintain structural equivalence, the control group receives only minimal contact during the study period (limited to necessary follow‑up calls for scheduling assessments), and no educational or therapeutic sessions are provided. After data collection is completed, participants in the control group are offered a brief educational package on stress management and self‑care if they wish. Quality of life in patients with psoriasis. Timepoint: Before the intervention and after completion of the treatment sessions. Method of measurement: Measured using the Dermatology Life Quality Index (DLQI). Anxiety level in patients with psoriasis. Timepoint: Before the intervention and after completion of the treatment sessions. Method of measurement: Measured using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS‑A). Depression level in patients with psoriasis. Timepoint: Before the intervention and after completion of the treatment sessions. Method of measurement: Measured using the Depression subscale of the Hospital Anxiety and Depression Scale (HADS‑D). Cognitive flexibility in patients with psoriasis. Timepoint: Before the intervention and after completion of the treatment sessions. Method of measurement: Measured using the Cognitive Flexibility Inventory (CFI) by Dennis & Vander Wal. Islamic Azad University Approved 2025-09-13 Ethics Committee of Ayatollah Amoli University of Science and Research No. 2, Parsa 2 Alley, Rahimi Alley, Emam Reza Street, Amol Amol Mazandaran Iran (Islamic Republic of)