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IRCT20260224068938N1 IRCT 2026-04-30 Islamic Azad University The Role of Psychological Therapies in Improving Psychological Adjustment and Self-Care in Diabetic Patients Effectiveness of cognitive‑behavioral group therapy on diabetes-related stress beliefs, diabetes self‑care, and dysfunctional beliefs about diabetes in patients with type 2 diabetes. 2026-05-22 anticipated 30 Complete https://irct.ir/trial/89507 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this clinical trial, participants were first selected through non‑random purposive sampling based on the inclusion and exclusion criteria from among patients diagnosed with type 2 diabetes. After completing the sampling stage, simple randomization was used to allocate participants to the intervention and control groups. No quasi‑random methods (such as allocation based on day of visit, medical record number, alphabetical order, etc.) were used. The unit of randomization was the individual, meaning that each eligible patient was independently entered into the randomization process and assigned to either the intervention or control group. Cluster randomization (based on treatment center, family, city, or other clusters) was not used in this study. The total sample size was 30 participants (15 in the intervention group and 15 in the control group). To generate the random sequence, a statistical software program (such as SPSS, Excel, or a similar tool) was used. After selecting the 30 eligible patients, each participant was assigned a unique code. Using statistical software (or a table of random numbers), a random allocation sequence was created for these codes. The random sequence was generated using labels “A” and “B” (intervention/control), ensuring that each group contained 15 participants. Based on this sequence, each patient was allocated to one of the two groups according to their assigned code. This study did not use block randomization or stratified randomization. To minimize allocation bias, allocation concealment was implemented as much as possible. The random sequence was generated by an individual not involved in participant screening or recruitment. Group codes (A/B) were placed inside opaque, sealed, sequentially numbered envelopes. After confirming eligibility and obtaining informed consent, the recruiter opened the next envelope in sequence and assigned the patient to the intervention or control group according to the label inside. Thus, the recruiter remained unaware of upcoming group assignments until the moment of allocation, reducing the risk of manipulation. No quasi‑random allocation methods (such as allocation based on even/odd days, order of admission, alphabetical order, medical record number, or bed number) were used in this study, and group assignment was performed strictly according to the software‑generated random sequence. N/A Type 2 Diabetes. Intervention 1: Intervention group:Session 1: Introduction, Group Formation, and Initial EducationIn the first session, group members and the therapist introduced themselves, and each participant briefly described their reasons for attending the group therapy sessions. The overall framework of cognitive–behavioral therapy, the goals of the group, the number of sessions, and mutual expectations were then explained.An introductory explanation about diabetes, diabetes‑related distress, depression, and quality of life and their interrelationships was also provided. Group rules such as confidentiality, mutual respect, active participation, and completing homework assignments were discussed.Homework: Writing down personal expectations from treatment and identifying the most important psychological challenges related to diabetes.Session 2: The Relationship Between Thoughts, Feelings, and BehaviorsIn this session, the cognitive model was introduced and the triadic relationship between thoughts, emotions, and behaviors was explained through educational material and examples related to diabetes. The differences between thoughts, emotions, and behaviors were clearly clarified.Common dysfunctional thinking styles and cognitive distortions (such as catastrophizing, all‑or‑nothing thinking, and overgeneralization) were introduced.Homework: Identifying daily situations related to diabetes and recording the associated thoughts, feelings, and behaviors in the ABC worksheet.Session 3: Cognitive RestructuringHomework from the previous session was first reviewed. Then symptoms of depression and diabetes‑related stress and the accompanying thoughts were examined.The four main steps of cognitive restructuring were taught: identifying dysfunctional thoughts, evaluating supporting and opposing evidence, replacing them with more rational thoughts, and examining the consequences of the revised thoughts.Homework: Completing a cognitive restructuring worksheet for at least two real-life situations.Session 4: Behavioral Chain (Antecedent–Behavior–Consequence)In this session, the concept of the behavioral chain (A‑B‑C) was examined in greater depth. Participants learned how behavioral consequences can themselves become antecedents for subsequent behaviors.Strategies for breaking maladaptive chains (such as changing antecedents, stopping behaviors, and modifying consequences) were presented.Homework: Identifying and recording a maladaptive behavioral chain related to diabetes self‑care.Session 5: Nutrition, Physical Activity, and Dysfunctional Beliefs About DiabetesBasic information about carbohydrate metabolism, the differences between type 1 and type 2 diabetes, and principles of healthy nutrition were presented. Common misconceptions about diabetes (e.g., “I can no longer enjoy life”) were examined and corrected.The role of physical activity in blood glucose control and mood improvement was explained, and suitable exercises were introduced.Homework: Recording weekly dietary patterns and physical activity and identifying inhibiting thoughts.Session 6: AssertivenessThe concept of assertive behavior and its differences from passive and aggressive behavior were explained. Situations in which individuals experience difficulty expressing their needs (for example in family or healthcare settings) were discussed.Positive self‑statements and behavioral exercises to increase assertiveness were introduced.Homework: Practicing one assertive behavior and recording the experience.Session 7: Impulsivity, Self‑Control, and Mood ImprovementIn this session, the concept of impulsivity and its role in maladaptive behaviors (such as overeating or discontinuing treatment) was discussed. Strategies to improve self‑control were taught.Increasing engagement in pleasant activities and its role in improving mood was also emphasized.Homework: Completing the pleasant activities worksheet and performing at least two enjoyable activities.Session 8: Stress Management and Problem SolvingThe concept of stress, diabetes‑related stressors, and their psychological and physical effects were discussed. Stress management skills including stepwise problem solving and progressive muscle relaxation were taught.Homework: Practicing relaxation techniques and applying the problem‑solving method to a real-life problem.Session 9: Self‑Esteem and Self‑ConceptIn this session, the concept of self‑esteem and its relationship with negative thoughts about oneself and one’s illness was discussed. Participants learned how negative self‑evaluations can reduce self‑esteem.Strategies to strengthen self‑acceptance and a positive self‑concept were presented.Homework: Completing the self‑concept worksheet and identifying personal strengths.Session 10: Diabetes Self‑CareDifferent dimensions of diabetes self‑care (blood glucose monitoring, nutrition, physical activity, medication adherence, foot care, and stress management) were discussed. Cognitive and emotional barriers to self‑care were identified and addressed.Homework: Designing a personal diabetes self‑care plan.Session 11: Integration of SkillsIn this session, the skills learned throughout the program were reviewed and integrated. Participants learned how to apply these skills simultaneously in everyday life situations.Homework: Implementing the integrated skills plan in a real-life situation.Session 12: Relapse Prevention and ConclusionIn the final session, participants’ progress was evaluated and a relapse prevention plan was developed. The importance of continued practice of the learned skills was emphasized and final feedback was provided.Finally, the effectiveness of cognitive‑behavioral group therapy on dysfunctional beliefs about diabetes, diabetes‑related distress, and self‑care behaviors in patients with type 2 diabetes was summarized. Intervention 2: Control group: Participants in the control group will not receive any structured psychological intervention throughout the study duration and will only continue to receive the usual medical care related to diabetes as provided by their physician or healthcare center. No Cognitive Behavioral Therapy (CBT) group sessions will be held for this group during this period.However, participants in this group will be assessed at the same time points as the intervention group (Baseline, Post-treatment, and 3-month Follow-up) using the research instruments, including the Diabetes Distress Scale (DDS), the Summary of Diabetes Self-Care Activities (SDSCA), and the Dysfunctional Attitudes Towards Diabetes Scale.To comply with ethical considerations, upon completion of data collection, a summary of the CBT educational content will be provided to the control group participants if they so desire. No - There is not a plan to make this available Justification or reason for not sharing IPD is Participants’ Lack of Willingness
public Bahram Mirzaeian
Sari
Sari Iran (Islamic Republic of) 4816633131 +98 11 3321 2767 bahrammirzaian@gmail.com Islamic Azad University scientific Bahram Mirzaeian
Sari
Sari Iran (Islamic Republic of) 4816633131 +98 11 3321 2767 bahrammirzaian@gmail.com Islamic Azad University Iran (Islamic Republic of) All patients (men and women) with type 2 diabetes who referred to endocrine clinics in the city of Sari during the summer of 1405 (2026) 20 years 50 years Both Presence of severe psychiatric disorders (such as psychosis or severe cognitive impairment) that would prevent participation in the therapy sessions. Concurrent participation in psychotherapy or similar psychological interventions during the study period. Absence from more than two therapy sessions Unwillingness to continue participation at any stage of the study. E11.9 Type 2 diabetes mellitus without complications Behavior Behavior Intervention group:Session 1: Introduction, Group Formation, and Initial EducationIn the first session, group members and the therapist introduced themselves, and each participant briefly described their reasons for attending the group therapy sessions. The overall framework of cognitive–behavioral therapy, the goals of the group, the number of sessions, and mutual expectations were then explained.An introductory explanation about diabetes, diabetes‑related distress, depression, and quality of life and their interrelationships was also provided. Group rules such as confidentiality, mutual respect, active participation, and completing homework assignments were discussed.Homework: Writing down personal expectations from treatment and identifying the most important psychological challenges related to diabetes.Session 2: The Relationship Between Thoughts, Feelings, and BehaviorsIn this session, the cognitive model was introduced and the triadic relationship between thoughts, emotions, and behaviors was explained through educational material and examples related to diabetes. The differences between thoughts, emotions, and behaviors were clearly clarified.Common dysfunctional thinking styles and cognitive distortions (such as catastrophizing, all‑or‑nothing thinking, and overgeneralization) were introduced.Homework: Identifying daily situations related to diabetes and recording the associated thoughts, feelings, and behaviors in the ABC worksheet.Session 3: Cognitive RestructuringHomework from the previous session was first reviewed. Then symptoms of depression and diabetes‑related stress and the accompanying thoughts were examined.The four main steps of cognitive restructuring were taught: identifying dysfunctional thoughts, evaluating supporting and opposing evidence, replacing them with more rational thoughts, and examining the consequences of the revised thoughts.Homework: Completing a cognitive restructuring worksheet for at least two real-life situations.Session 4: Behavioral Chain (Antecedent–Behavior–Consequence)In this session, the concept of the behavioral chain (A‑B‑C) was examined in greater depth. Participants learned how behavioral consequences can themselves become antecedents for subsequent behaviors.Strategies for breaking maladaptive chains (such as changing antecedents, stopping behaviors, and modifying consequences) were presented.Homework: Identifying and recording a maladaptive behavioral chain related to diabetes self‑care.Session 5: Nutrition, Physical Activity, and Dysfunctional Beliefs About DiabetesBasic information about carbohydrate metabolism, the differences between type 1 and type 2 diabetes, and principles of healthy nutrition were presented. Common misconceptions about diabetes (e.g., “I can no longer enjoy life”) were examined and corrected.The role of physical activity in blood glucose control and mood improvement was explained, and suitable exercises were introduced.Homework: Recording weekly dietary patterns and physical activity and identifying inhibiting thoughts.Session 6: AssertivenessThe concept of assertive behavior and its differences from passive and aggressive behavior were explained. Situations in which individuals experience difficulty expressing their needs (for example in family or healthcare settings) were discussed.Positive self‑statements and behavioral exercises to increase assertiveness were introduced.Homework: Practicing one assertive behavior and recording the experience.Session 7: Impulsivity, Self‑Control, and Mood ImprovementIn this session, the concept of impulsivity and its role in maladaptive behaviors (such as overeating or discontinuing treatment) was discussed. Strategies to improve self‑control were taught.Increasing engagement in pleasant activities and its role in improving mood was also emphasized.Homework: Completing the pleasant activities worksheet and performing at least two enjoyable activities.Session 8: Stress Management and Problem SolvingThe concept of stress, diabetes‑related stressors, and their psychological and physical effects were discussed. Stress management skills including stepwise problem solving and progressive muscle relaxation were taught.Homework: Practicing relaxation techniques and applying the problem‑solving method to a real-life problem.Session 9: Self‑Esteem and Self‑ConceptIn this session, the concept of self‑esteem and its relationship with negative thoughts about oneself and one’s illness was discussed. Participants learned how negative self‑evaluations can reduce self‑esteem.Strategies to strengthen self‑acceptance and a positive self‑concept were presented.Homework: Completing the self‑concept worksheet and identifying personal strengths.Session 10: Diabetes Self‑CareDifferent dimensions of diabetes self‑care (blood glucose monitoring, nutrition, physical activity, medication adherence, foot care, and stress management) were discussed. Cognitive and emotional barriers to self‑care were identified and addressed.Homework: Designing a personal diabetes self‑care plan.Session 11: Integration of SkillsIn this session, the skills learned throughout the program were reviewed and integrated. Participants learned how to apply these skills simultaneously in everyday life situations.Homework: Implementing the integrated skills plan in a real-life situation.Session 12: Relapse Prevention and ConclusionIn the final session, participants’ progress was evaluated and a relapse prevention plan was developed. The importance of continued practice of the learned skills was emphasized and final feedback was provided.Finally, the effectiveness of cognitive‑behavioral group therapy on dysfunctional beliefs about diabetes, diabetes‑related distress, and self‑care behaviors in patients with type 2 diabetes was summarized. Control group: Participants in the control group will not receive any structured psychological intervention throughout the study duration and will only continue to receive the usual medical care related to diabetes as provided by their physician or healthcare center. No Cognitive Behavioral Therapy (CBT) group sessions will be held for this group during this period.However, participants in this group will be assessed at the same time points as the intervention group (Baseline, Post-treatment, and 3-month Follow-up) using the research instruments, including the Diabetes Distress Scale (DDS), the Summary of Diabetes Self-Care Activities (SDSCA), and the Dysfunctional Attitudes Towards Diabetes Scale.To comply with ethical considerations, upon completion of data collection, a summary of the CBT educational content will be provided to the control group participants if they so desire. Diabetes Beliefs Scale - DBS. Timepoint: Measurement of dysfunctional beliefs about diabetes at three time points: 1. At the beginning of the study (Baseline), 2. Immediately after the completion of the last Cognitive Behavioral Therapy (CBT) group session, and 3. 3 months after the completion of the intervention. Method of measurement: Dysfunctional Attitudes Towards Diabetes Scale (DATDS) (Polonsky & Fisher, 2015). Diabetes Distress. Timepoint: Baseline (T0): Prior to randomization/intervention start.Post-treatment (T1): Immediately following the completion of the final CBT session.Follow-up (T2): Three months after the completion of the intervention.". Method of measurement: Diabetes Distress Scale (DDS) (Polonsky et al., 2005). Diabetes Self-Care. Timepoint: Baseline (T0): Prior to randomization/intervention start.Post-treatment (T1): Immediately following the completion of the final CBT session.Follow-up (T2): Three months after the completion of the intervention.". Method of measurement: Summary of Diabetes Self-Care Activities (SDSCA) (Toobert & Glasgow, 2002). Islamic Azad University Approved 2025-08-26 Ethics Committee of Islamic Azad University, Sari Branch Sari Sari Mazandaran Iran (Islamic Republic of)