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IRCT20250223064825N1 IRCT 2025-03-29 Islamic Azad University, Semnan branch The effectiveness of cognitive-behavioral therapy on the quality of life and psychological capital of patients with bipolar disorder The effectiveness of cognitive-behavioral therapy on the quality of life and psychological capital of patients with bipolar disorder 2025-04-12 anticipated 30 Complete https://irct.ir/trial/82374 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 30 people will be randomly divided into two groups: intervention and control. For this purpose, a simple random assignment method will be used. First, each participant will be assigned a number. Then, these numbers will be entered into a random number generation software and based on the generated numbers, the people will be divided into two groups. People whose numbers are randomly assigned to the first group will be entered into the intervention group, and the rest will be assigned to the control group. To ensure the correct implementation of randomization and to prevent any type of bias, the allocation process will be carried out by an independent person who is not involved in the research. This randomization method ensures that each participant has an equal chance of being placed in one of the groups and that the balance in the number of people in each group is maintained. N/A Bipolar disorder. Intervention 1: Intervention group: The experimental group will undergo a cognitive-behavioral therapy (CBT) intervention, which will be held in 8 weekly 90-minute sessions. This intervention is designed to improve the quality of life and increase the psychological capital of patients with bipolar disorder. Initially, participants will be introduced to the basic concepts of cognitive-behavioral therapy, including the role of thoughts, feelings, and behaviors in everyday experiences. Then, techniques such as identifying and correcting irrational thoughts, cognitive restructuring, and evaluating evidence are taught to change negative thought patterns. In the following stages, participants will practice emotion regulation strategies, problem-solving skills, and effective coping methods to manage their emotional reactions in stressful situations. Also, techniques to increase hope, self-efficacy, and cognitive flexibility are provided to strengthen the psychological capital of patients. Finally, the skills learned to increase quality of life, create emotional balance, prevent relapse, and improve functioning in personal and social areas are reviewed and consolidated. Intervention 2: Control group: This group does not receive any intervention and serves only as a comparison. Individuals in this group continue with the usual, standard care they would normally receive and do not receive any cognitive-behavioral treatment or intervention during the study. Yes - There is a plan to make this available What will be shared: All data can be shared after identifying information is removed and ensured to be non-identifiable. When: Data can be made available one week after the results are published. To whom: Study data and documentation are available to relevant academic and industrial researchers after the request is submitted and approved. Conditions: Data and documents can be used for the purpose of studying or conducting research, provided the source is cited. Where to obtain: If you need data, please contact kiana.emadii@gmail.com. How to obtain: Upon receipt of the request, the principal investigator reviews it. If approved, the data will be sent to the requester within one week, along with a commitment to maintain the privacy of the participants, maintain confidentiality, and not publish the data without mentioning the principal investigator's name. Comments:
public Kiana Emadi
Unit 1, Imam Reza Complex, Piroozi Blvd., Imam Reza Square
Semnan Iran (Islamic Republic of) 3515767961 +98 23 3337 3652 kiana.emadii@gmail.com Islamic Azad University, Semnan Branch scientific Maryam Salehyan
Islamic Azad University, University Town, Semnan
Semnan Iran (Islamic Republic of) 3513137111 +98 23 3365 4040 maryam.salehyan@gmail.com Islamic Azad University, Semnan Branch Iran (Islamic Republic of) Diagnosis of bipolar disorder by a psychiatrist or clinical psychologist. Age range between 20 and 50 years. Ability to participate in therapy sessions, complete questionnaires, and benefit from psychotherapy interventions. Informed consent to participate in the research and the possibility of follow-up after the end of the intervention. Ability to communicate verbally and understand Persian. 20 years 50 years Both Absence of concomitant psychiatric disorders (such as schizophrenia or severe personality disorders) that would prevent participation in the intervention. Having a substance use disorder or severe dependence on alcohol and drugs Having a history of suicide attempts in the past six months Receiving other similar psychological treatments at the same time (such as cognitive-behavioral therapy or other psychotherapeutic interventions) Having a debilitating physical illness that prevents you from attending therapy sessions Having severe cognitive disability or low IQ that prevents understanding and implementing therapeutic techniques F31 Bipolar disorder Treatment - Other Treatment - Other Intervention group: The experimental group will undergo a cognitive-behavioral therapy (CBT) intervention, which will be held in 8 weekly 90-minute sessions. This intervention is designed to improve the quality of life and increase the psychological capital of patients with bipolar disorder. Initially, participants will be introduced to the basic concepts of cognitive-behavioral therapy, including the role of thoughts, feelings, and behaviors in everyday experiences. Then, techniques such as identifying and correcting irrational thoughts, cognitive restructuring, and evaluating evidence are taught to change negative thought patterns. In the following stages, participants will practice emotion regulation strategies, problem-solving skills, and effective coping methods to manage their emotional reactions in stressful situations. Also, techniques to increase hope, self-efficacy, and cognitive flexibility are provided to strengthen the psychological capital of patients. Finally, the skills learned to increase quality of life, create emotional balance, prevent relapse, and improve functioning in personal and social areas are reviewed and consolidated. Control group: This group does not receive any intervention and serves only as a comparison. Individuals in this group continue with the usual, standard care they would normally receive and do not receive any cognitive-behavioral treatment or intervention during the study. Quality of life. Timepoint: Before the start of the intervention and after completing 8 intervention sessions. Method of measurement: World Health Organization Quality of Life Questionnaire (WHOQOL-BREF). Psychological capital. Timepoint: Before the start of the intervention and after completing 8 intervention sessions. Method of measurement: Luthans Psychological Capital Questionnaire (2007). Islamic Azad University, Semnan branch Approved 2024-12-30 Ethics Committee of Semnan Azad University Islamic Azad University, University Town, Semnan Semnan Semnan Iran (Islamic Republic of)