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IRCT20251201068177N1 IRCT 2025-12-31 Islamic Azad University, Najafabad Branch The Efficacy of Schema Therapy in the treatment of diabetes The Efficacy of Schema Therapy on Alexithymia, Cognitive Flexibility, Body Image and Food Craving Individuals with Type 2 Diabetes 2025-10-12 anticipated 50 Complete https://irct.ir/trial/88014 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study will be conducted as a randomized controlled clinical trial (RCT). Participants will be randomly allocated to either the intervention group (schema therapy) or the control group (standard care) using a computer-generated simple random sequence. Allocation concealment will be ensured through the use of sequentially numbered, sealed, and opaque envelopes, which will be opened only after each participant has been enrolled. The randomization sequence will be generated by an independent statistician and will remain concealed from the study implementer until the time of allocation, thereby minimizing selection bias. Data analysis will be performed using SPSS software version 26. Descriptive and appropriate inferential statistical methods will be applied to analyze the data, and a significance level of p < 0.05 will be considered statistically significant, Blinding description: The interventions in both groups will be designed to be sufficiently similar in terms of implementation schedule and delivery format to allow participant-level blinding. Accordingly, this study will be conducted as a single-blind trial. Participants will not be informed of their group allocation and will be unaware of whether they receive schema therapy or standard care. Due to the nature of the interventions, the therapist delivering the sessions will not be blinded. N/A Type 2 diabetes mellitus. Intervention 1: Intervention groups: Participants allocated to the intervention group will receive group-based schema therapy in addition to standard medical care. The intervention will consist of eight 90-minute sessions conducted according to Young’s schema therapy model. The sessions will focus on identification and modification of early maladaptive schemas, enhancement of emotional awareness, cognitive restructuring, experiential techniques (including imagery rescripting), and development of adaptive coping strategies. All sessions will be delivered by a trained therapist under professional supervision, and treatment fidelity will be maintained throughout the study period. Intervention 2: Control group: Participants assigned to the control group will receive standard care only. Standard care will include routine diabetes education, general health counseling, and non-specific supportive group sessions routinely provided by the clinic. No structured psychological intervention or schema therapy–based techniques will be administered to this group during the study period. This control condition is designed to reflect usual clinical practice. No - There is not a plan to make this available Justification or reason for not sharing IPD is Sensitive personal data includes clinical information and psychological questionnaires, and there are currently no plans to share them publicly.
public Zahra Fathi
No.46, Dead End 6, Alireza Akbari Alley, Yazdabad, Isfahan
isfehan Iran (Islamic Republic of) 8178916892 +98 31 3744 8620 zahra.fathi2280@gmail.com Islamic Azad University, Najafabad Branch scientific Zahra Fathi
No.46, Dead End 6, Alireza Akbari Alley, Yazdabad, Isfahan
Isfahan Iran (Islamic Republic of) 8178916892 +98 31 3744 8620 zahra.fathi2280@gmail.com Islamic Azad University, Najafabad Branch Iran (Islamic Republic of) Eligible individuals must be between 30 and 60 years old. Have at least a high school diploma Registration will only be done after participants provide written informed consent. Patients with current psychiatric disorders or taking psychotropic medications are not eligible to participate in the study. 30 years 60 years Both Unforeseen or unexpected events occur Absence of more than 2 sessions E11 Type 2 diabetes mellitus Behavior Behavior Intervention groups: Participants allocated to the intervention group will receive group-based schema therapy in addition to standard medical care. The intervention will consist of eight 90-minute sessions conducted according to Young’s schema therapy model. The sessions will focus on identification and modification of early maladaptive schemas, enhancement of emotional awareness, cognitive restructuring, experiential techniques (including imagery rescripting), and development of adaptive coping strategies. All sessions will be delivered by a trained therapist under professional supervision, and treatment fidelity will be maintained throughout the study period. Control group: Participants assigned to the control group will receive standard care only. Standard care will include routine diabetes education, general health counseling, and non-specific supportive group sessions routinely provided by the clinic. No structured psychological intervention or schema therapy–based techniques will be administered to this group during the study period. This control condition is designed to reflect usual clinical practice. The average score obtained from the alexithymia questionnaire in the study subjects is considered as the primary outcome of the study, the sample size is also calculated in the initial proposal based on this variable, and other variables are examined as secondary outcomes. Timepoint: Baseline (pre-intervention) and immediately post-intervention (after 8 weeks of schema therapy). Method of measurement: Valid Persian version of the Toronto Alexithymia Scale-20. Average score obtained from the Cognitive Flexibility Questionnaire in adults with type 2 diabetes after an 8-week schema therapy intervention. Timepoint: Baseline (pre-intervention) and immediately post-intervention (after 8 weeks of schema therapy). Method of measurement: Valid Persian version of Dennis and Vanderwaal's Cognitive Flexibility Questionnaire. Average score obtained from the Body Image Concern Questionnaire in adults with type 2 diabetes after an 8-week schema therapy intervention. Timepoint: Pre-test (before intervention) and immediate post-test after intervention (after 8 weeks of schema therapy). Method of measurement: Valid Persian version of Littleton's body image concerns. Average score obtained from the Food Craving Questionnaire in adults with type 2 diabetes after an 8-week schema therapy intervention. Timepoint: Baseline (pre-intervention) and immediately post-intervention (after 8 weeks of schema therapy). Method of measurement: Valid Persian version of the Sidabnitto Food Craving Trait Questionnaire (PFQ_T). This study was will be conducted without any external financial support or sponsorship. Approved 2025-07-15 Ethics Committee of Islamic Azad University, Najafabad Branch No.46, Dead End 6, Alireza Akbari Alley, Yazdababd, Shahr-e Abrisham Isfahan Isfehan Iran (Islamic Republic of)