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IRCT20250923067331N2 IRCT 2026-08-04 Shahid Beheshti University of Medical Sciences Comparing the effectiveness of two psychotherapy approaches in elderly people with type 2 diabetes Comparing the effectiveness of acceptance and commitment therapy with mindfulness-based cognitive therapy on psychological flexibility, life satisfaction, life expectancy, and stress in elderly people with type 2 diabetes 2026-06-22 anticipated 68 Complete https://irct.ir/trial/88383 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After obtaining the ethics and clinical trial code, two centers are randomly selected from among the medical centers in Neyshabur city, and one center is randomly selected as the first experimental group and one center is randomly selected as the second experimental group. The subjects will initially be examined in terms of entry criteria and 34 people will be randomly selected from each center. The research objectives will be explained to the eligible individuals and written consent will be obtained. Participants are randomly assigned to one of two groups using simple computer randomization using Excel software random numbers, Blinding description: Data related to treatment groups are replaced with non-identifiable codes. Any information that associates participants with treatments, such as names or intervention details, is also removed from the data set presented to the analyst. The statistical analyst performs predetermined analyses without knowing which code refers to which treatment. N/A Type 2 diabetes in the elderly. Intervention 1: Intervention Group 1: Acceptance and Commitment Therapy (ACT): This therapy is an evidence-based approach from the third wave of cognitive-behavioral therapies whose main goal is to increase individuals' psychological flexibility. This therapy helps individuals to change their relationship with these experiences, accept them, and take action towards their personal values ​​and goals, instead of trying to eliminate or control unpleasant thoughts, emotions, and experiences. General structure of the intervention: This intervention will be implemented in a group setting in the form of 8 weekly sessions. Each session will last 60 minutes. The sessions will include teaching the main concepts of ACT, experiential exercises, group discussion, mindfulness exercises, therapeutic metaphors, and homework to generalize the skills learned to everyday situations. Content of the intervention sessions: Session One: Introduction to ACT therapy and the concept of psychological flexibility In this session, group members are introduced to the general principles of ACT therapy, treatment goals, the role of thoughts and emotions in human behavior, and the concept of psychological flexibility. The concept of experiential avoidance and its impact on psychological problems are taught, and participants identify personal patterns of avoiding unpleasant experiences. Session Two: Accepting internal experiences and reducing efforts to control emotions In this session, the concept of acceptance in ACT is introduced and the difference between active acceptance and surrender is explained. Participants learn how to face unpleasant thoughts, feelings, and memories without making excessive efforts to eliminate them. Experiential exercises related to observing and tolerating emotions are conducted. Session Three: Cognitive Dissociation In this session, participants learn to observe their thoughts as mental events, not as definitive facts. Techniques such as naming thoughts, observing thoughts separately from themselves, and cognitive exercises to reduce engagement with negative thoughts are taught. Session Four: Contact with the Present Moment and Mindfulness Training This session teaches the concept of being present in the present moment. Mindfulness exercises include observing thoughts, feelings, and sensory experiences without judgment, focusing on breathing, and increasing awareness of the current experience. Session Five: Self as Context This session teaches the concept of distinguishing between the “observing self” and the “experienced content.” The goal of this session is to help individuals distance themselves from roles, fleeting thoughts, and emotions and increase their observational perspective on personal experiences. Session 6: Clarifying Personal Values ​​In this session, individuals identify and prioritize the important values ​​in their lives in areas such as family, relationships, health, personal growth, and personal goals. The difference between values ​​and short-term goals is explained, and exercises are given to determine a value-based life path. Session 7: Committed Action in Alignment with Values ​​In this session, participants learn how to set practical and actionable goals in line with their values. Possible barriers, inhibiting thoughts, and difficult emotions are examined, and a plan is made for engaging in committed behaviors. Session 8: Integrating Skills and Relapse Prevention In the final session, the core concepts of ACT are reviewed, and participants integrate the skills of acceptance, cognitive dissonance, mindfulness, and committed action. A plan is also developed for using the skills in daily life and facing future problems. Homework: During the sessions, home exercises including recording thoughts and emotions, acceptance exercises, mindfulness exercises, performing values-based activities, and implementing committed actions will be provided to facilitate the transfer of therapeutic skills to the individual's living environment. Intervention 2: Intervention Group 2: Mindfulness-Based Cognitive Therapy: This therapy is an evidence-based group intervention that combines the principles of cognitive-behavioral therapy and mindfulness exercises. The main goal of this therapy is to increase the individual's awareness of thoughts, emotions, and bodily sensations, reduce rumination, create distance from negative thoughts, and prevent the return of maladaptive psychological patterns. In this approach, individuals learn to observe their thoughts and emotions as mental events, without automatically engaging with them or considering them as absolute reality. General structure of the intervention: This intervention will be implemented in a group setting and in the form of 8 weekly sessions. Each session will last 60 minutes. The sessions will include training in mindfulness concepts, formal mindfulness exercises (such as body scans, breathing exercises, sitting meditation, and conscious stretching), informal exercises in daily activities, training in cognitive concepts related to automatic thoughts, and daily homework. Content of the intervention sessions: Session 1: Introduction to mindfulness and the mind-body connection. In this session, the concept of mindfulness, treatment goals, and the role of attention in psychological experiences are introduced. Participants are introduced to the concept of living in an automatic state and its impact on thoughts, emotions, and behaviors. Introductory exercises include practicing mindful eating and paying attention to sensory experiences. Session 2: Body awareness and body scan exercise. In this session, participants are introduced to increasing awareness of physical sensations and their connection to emotions and thoughts. The body scan exercise is guided and participants learn to observe their physical experiences without judgment. Session Three: Focusing on Breathing and Sustained Attention Training This session teaches breathing focus exercises. The goal is to strengthen the ability to return attention to the present moment and observe thoughts and distractions without automatic reaction. The concept of accepting the current experience and repeatedly returning attention to the object of focus is taught. Session Four: Recognizing Automatic Thoughts and the Relationship Between Thoughts, Emotions, and Behaviors This session teaches the cognitive principles of cognitive-behavioral therapy. Participants learn to identify negative automatic thoughts, cognitive errors, and their impact on emotions and behavior. Thought recording and mental pattern observation are practiced. Session Five: Distancing from Thoughts and Reducing Cognitive Involvement This session teaches the concept of “thoughts are not reality.” Participants practice observing their thoughts as mental events and distance themselves from engaging and identifying with negative thoughts. Mindfulness exercises are performed for thoughts and emotions. Session 6: Accepting Unpleasant Emotions and Mindfully Facing Difficult Experiences This session teaches the concept of accepting internal experiences. Participants learn to face difficult emotions with an accepting and conscious approach instead of avoiding or suppressing them. Mindfulness exercises are performed for dealing with unpleasant emotions. Session 7: Using Mindfulness in Daily Life and Preventing Maladaptive Patterns This session examines the application of mindfulness skills in real-life situations. Participants learn how to recognize early signs of negative thoughts, rumination, and maladaptive behavioral patterns and choose more conscious responses. Session 8: Integrating Skills and a Relapse Prevention Program In the final session, all of the skills taught are reviewed and integrated. Participants develop a personal plan to continue mindfulness practices, manage difficult thoughts and emotions, and prevent relapse. Homework: Throughout the course, participants will be required to complete daily mindfulness practices including breathing exercises, body scans, sitting meditation, practicing being present in daily activities, recording thoughts and emotions, and practicing observing internal experiences without judgment. These practices are designed to increase the generalization of therapeutic skills to daily life. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is not ethical
public Mohsen Rafie
Shahid Beheshti University of Medical Sciences, Arabi Street, Daneshjoo Blvd, Velenjak
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 mohsenrafie7272@gmail.com Shahid Beheshti University of Medical Sciences scientific Mohsen Rafie
Shahid Beheshti University of Medical Sciences, Arabi Street, Daneshjoo Blvd, Velenjak
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 mohsenrafie7272@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Seniors over 65 years old Minimum educational qualification: Diploma Suffering from type 2 diabetes Not having neurological diseases or any disease that prevents cooperation. 65 years no limit Male Presence of other mental disorders, such as schizophrenia spectrum disorders, bipolar disorder, or depression with psychotic features Taking psychiatric medications that affect mood and anxiety Concurrent participation in another clinical trial or receiving organized psychological treatment in the past six months Inability to read or write or severe vision or hearing problems Alcohol, drug use, or active addiction, which may reduce adherence to treatment or confound outcomes Severe physical disability that prevents regular attendance at meetings E11 Type 2 diabetes mellitus Treatment - Other Treatment - Other Intervention Group 1: Acceptance and Commitment Therapy (ACT): This therapy is an evidence-based approach from the third wave of cognitive-behavioral therapies whose main goal is to increase individuals' psychological flexibility. This therapy helps individuals to change their relationship with these experiences, accept them, and take action towards their personal values ​​and goals, instead of trying to eliminate or control unpleasant thoughts, emotions, and experiences. General structure of the intervention: This intervention will be implemented in a group setting in the form of 8 weekly sessions. Each session will last 60 minutes. The sessions will include teaching the main concepts of ACT, experiential exercises, group discussion, mindfulness exercises, therapeutic metaphors, and homework to generalize the skills learned to everyday situations. Content of the intervention sessions: Session One: Introduction to ACT therapy and the concept of psychological flexibility In this session, group members are introduced to the general principles of ACT therapy, treatment goals, the role of thoughts and emotions in human behavior, and the concept of psychological flexibility. The concept of experiential avoidance and its impact on psychological problems are taught, and participants identify personal patterns of avoiding unpleasant experiences. Session Two: Accepting internal experiences and reducing efforts to control emotions In this session, the concept of acceptance in ACT is introduced and the difference between active acceptance and surrender is explained. Participants learn how to face unpleasant thoughts, feelings, and memories without making excessive efforts to eliminate them. Experiential exercises related to observing and tolerating emotions are conducted. Session Three: Cognitive Dissociation In this session, participants learn to observe their thoughts as mental events, not as definitive facts. Techniques such as naming thoughts, observing thoughts separately from themselves, and cognitive exercises to reduce engagement with negative thoughts are taught. Session Four: Contact with the Present Moment and Mindfulness Training This session teaches the concept of being present in the present moment. Mindfulness exercises include observing thoughts, feelings, and sensory experiences without judgment, focusing on breathing, and increasing awareness of the current experience. Session Five: Self as Context This session teaches the concept of distinguishing between the “observing self” and the “experienced content.” The goal of this session is to help individuals distance themselves from roles, fleeting thoughts, and emotions and increase their observational perspective on personal experiences. Session 6: Clarifying Personal Values ​​In this session, individuals identify and prioritize the important values ​​in their lives in areas such as family, relationships, health, personal growth, and personal goals. The difference between values ​​and short-term goals is explained, and exercises are given to determine a value-based life path. Session 7: Committed Action in Alignment with Values ​​In this session, participants learn how to set practical and actionable goals in line with their values. Possible barriers, inhibiting thoughts, and difficult emotions are examined, and a plan is made for engaging in committed behaviors. Session 8: Integrating Skills and Relapse Prevention In the final session, the core concepts of ACT are reviewed, and participants integrate the skills of acceptance, cognitive dissonance, mindfulness, and committed action. A plan is also developed for using the skills in daily life and facing future problems. Homework: During the sessions, home exercises including recording thoughts and emotions, acceptance exercises, mindfulness exercises, performing values-based activities, and implementing committed actions will be provided to facilitate the transfer of therapeutic skills to the individual's living environment. Intervention Group 2: Mindfulness-Based Cognitive Therapy: This therapy is an evidence-based group intervention that combines the principles of cognitive-behavioral therapy and mindfulness exercises. The main goal of this therapy is to increase the individual's awareness of thoughts, emotions, and bodily sensations, reduce rumination, create distance from negative thoughts, and prevent the return of maladaptive psychological patterns. In this approach, individuals learn to observe their thoughts and emotions as mental events, without automatically engaging with them or considering them as absolute reality. General structure of the intervention: This intervention will be implemented in a group setting and in the form of 8 weekly sessions. Each session will last 60 minutes. The sessions will include training in mindfulness concepts, formal mindfulness exercises (such as body scans, breathing exercises, sitting meditation, and conscious stretching), informal exercises in daily activities, training in cognitive concepts related to automatic thoughts, and daily homework. Content of the intervention sessions: Session 1: Introduction to mindfulness and the mind-body connection. In this session, the concept of mindfulness, treatment goals, and the role of attention in psychological experiences are introduced. Participants are introduced to the concept of living in an automatic state and its impact on thoughts, emotions, and behaviors. Introductory exercises include practicing mindful eating and paying attention to sensory experiences. Session 2: Body awareness and body scan exercise. In this session, participants are introduced to increasing awareness of physical sensations and their connection to emotions and thoughts. The body scan exercise is guided and participants learn to observe their physical experiences without judgment. Session Three: Focusing on Breathing and Sustained Attention Training This session teaches breathing focus exercises. The goal is to strengthen the ability to return attention to the present moment and observe thoughts and distractions without automatic reaction. The concept of accepting the current experience and repeatedly returning attention to the object of focus is taught. Session Four: Recognizing Automatic Thoughts and the Relationship Between Thoughts, Emotions, and Behaviors This session teaches the cognitive principles of cognitive-behavioral therapy. Participants learn to identify negative automatic thoughts, cognitive errors, and their impact on emotions and behavior. Thought recording and mental pattern observation are practiced. Session Five: Distancing from Thoughts and Reducing Cognitive Involvement This session teaches the concept of “thoughts are not reality.” Participants practice observing their thoughts as mental events and distance themselves from engaging and identifying with negative thoughts. Mindfulness exercises are performed for thoughts and emotions. Session 6: Accepting Unpleasant Emotions and Mindfully Facing Difficult Experiences This session teaches the concept of accepting internal experiences. Participants learn to face difficult emotions with an accepting and conscious approach instead of avoiding or suppressing them. Mindfulness exercises are performed for dealing with unpleasant emotions. Session 7: Using Mindfulness in Daily Life and Preventing Maladaptive Patterns This session examines the application of mindfulness skills in real-life situations. Participants learn how to recognize early signs of negative thoughts, rumination, and maladaptive behavioral patterns and choose more conscious responses. Session 8: Integrating Skills and a Relapse Prevention Program In the final session, all of the skills taught are reviewed and integrated. Participants develop a personal plan to continue mindfulness practices, manage difficult thoughts and emotions, and prevent relapse. Homework: Throughout the course, participants will be required to complete daily mindfulness practices including breathing exercises, body scans, sitting meditation, practicing being present in daily activities, recording thoughts and emotions, and practicing observing internal experiences without judgment. These practices are designed to increase the generalization of therapeutic skills to daily life. Psychological flexibility score in the Acceptance and Action Questionnaire, Second Edition (AAQ-II). Timepoint: Examining the level of psychological flexibility before the start of the intervention, 60 days and 180 days after the start of the intervention. Method of measurement: The score that the subject reports on the Questionnaire. Acceptance and Action Questionnaire, Second Edition (AAQ-II). Life expectancy score on the Schneider Life Expectancy Questionnaire (SHS). Timepoint: Examining life expectancy before the start of the intervention, 60 days and 180 days after the start of the intervention. Method of measurement: The score that the subject reports on the questionnaire. Schneider Life Expectancy Questionnaire (SHS). Life satisfaction score on the Diner Life Satisfaction Questionnaire. Timepoint: Assessing life satisfaction before the start of the intervention, 60 days and 180 days after the start of the intervention. Method of measurement: The score that the subject reports on the questionnaire. Diener Life Satisfaction Scale. Stress score on the Dass 21 questionnaire. Timepoint: Assessing stress levels before the start of the intervention, 60 days and 180 days after the start of the intervention. Method of measurement: The score that the subject reports on the questionnaire. Depression, Anxiety, and Stress Scale DASS-21. Shahid Beheshti University of Medical Sciences Approved 2025-12-14 Ethics Committee of the Vice Chancellor for Research and Technology, SBMU Fifth Floor, Building No.2, Shahid Arabi Street, Yemen Street, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)