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IRCT20250923067331N3 IRCT 2026-08-28 Shahid Beheshti University of Medical Sciences Comparing the effectiveness of two psychotherapy approaches in male substance abusers Comparing the effectiveness of reality therapy with acceptance and commitment therapy on craving, self-control, hope, and distress tolerance in male substance abusers undergoing treatment in residential addiction treatment centers 2026-09-22 anticipated 68 Recruiting https://irct.ir/trial/92839 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After obtaining the ethics code and clinical trial code, two centers will be randomly selected from among the medical centers in Neyshabur city, and one center will be randomly selected as the first experimental group and one center 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 eligible individuals and written consent will be obtained. Participants will be randomly assigned to one of the two groups using simple computer random numbers in Excel software, Blinding description: Data relating to treatment groups are replaced with non-identifiable codes. Any information relating participants to treatments, such as names or details of the intervention, is also removed from the data set presented to the analyst. The statistical analyst performs the pre-specified analyses without knowing which code refers to which treatment. N/A Substance abuse. Intervention 1: Intervention Group 1: Reality Therapy: An approach proposed by William Glasser and based on “Choice Theory.” Its basic assumption is that humans choose behaviors to satisfy their basic needs, and that psychological and interpersonal problems are largely created when a person uses ineffective strategies to satisfy these needs. Therefore, instead of focusing on the past and unconscious causes for a long time, reality therapy focuses mainly on the present, current behavior, choice, responsibility, relationships, and creating more effective behaviors. The goal of therapy is not for the therapist to tell the client what the “right” choice is; rather, it helps the client see for himself what the consequences of his current choices are and whether they bring him closer to his desired life. In Choice Theory, Glasser proposes five basic needs: survival, love and belonging, power, freedom, and recreation. Humans are constantly trying to satisfy these needs. Each person also has a “quality world”—a set of mental images of the people they love, the relationships they want, the conditions they value, and the lifestyle they want. When there is a gap between what they want and what they experience in reality, frustration occurs. The person then chooses behaviors to close this gap, but these behaviors may be ineffective. For example, a person with a strong need for love and belonging may choose to be aggressive, threatening, or controlling rather than effective communication when they feel rejected. This behavior may create a sense of control in the short term, but in the long term, it will damage the relationship and further distance them from their desired world. The therapist here tries to help the person understand this cycle. One of the central concepts of reality therapy is responsibility. Responsibility does not mean that the person is to blame for everything that happens in their life; rather, it means that the person examines what is within their sphere of choice and control in the current situation. For example, if a person’s spouse is behaving inappropriately, the client cannot directly control the spouse’s behavior, but they can decide how to respond, set boundaries, communicate, distance themselves, or seek help. So the therapist constantly shifts the focus from “others need to change” to “what choices do I have?” The practical core of reality therapy is the WDEP model. W stands for Wants, D stands for Doing or Direction, E stands for Evaluation, and P stands for Planning. These four stages are not strictly linear and rigid, and the therapist moves between them constantly throughout the course of therapy. The most important stage is E, or Self-Evaluation; That is, the client examines how much the current behavior contributes to his goal. In a short-term eight-session protocol, the first session is usually dedicated to establishing the therapeutic relationship, assessing the current problem, specifying the goal of treatment, and introducing the logic of choice theory. The therapist begins with questions such as “What made you come to therapy?”, “What would you like to change if the treatment was successful?”, “What is the most important thing you want right now?”, and “What do you do when you encounter this problem?” In this same session, the therapist introduces the concepts of basic needs, choice, and responsibility in simple language, and an initial goal for treatment is specified. The main techniques of this session include establishing a relationship, active listening, questioning, clarifying desires, and introducing choice theory. At the end, a simple task is usually assigned to observe current behaviors and situations in which the problem arises. In the second session, the focus is more on the client’s basic needs and desired world. The therapist examines which need the current problem is most closely related to; for example, belonging, power, freedom, or security. Then the client is asked to provide a picture of their desired life: “What would your relationship be like if life went the way you want it to?”, “How would you like others to treat you?”, “What would your desired life be like?”. This session uses the techniques of need exploration, Quality World identification, questioning, and goal clarification. The goal is to determine exactly what the client is looking for and how far the current problem has come from their desired life. In the third session, the focus is on W and D, current wants and behaviors. The therapist helps to transform general wants into more specific goals. For example, if the client says, “I want my partner to pay more attention to me,” the therapist asks, “What exactly would change in the relationship if you received more attention?” Then, it is examined what the client is currently doing to achieve this goal. Questions such as “What do you do when you feel ignored?”, “What happens next?”, and “What is the usual outcome of this behavior?” help identify the behavioral cycle. Techniques in this session include focusing on the current behavior, analyzing the behavior, questioning, and identifying the direction of the person’s movement. In the fourth session, the E or Evaluation section becomes more important. At this stage, the therapist invites the client to evaluate his or her own behavior. For example, if the person is angry to get his or her partner’s attention, the therapist does not say “Being angry is bad,” but asks: “How much has being angry brought you closer to the relationship you want?”, “Has this behavior met your need for belonging?”, “If you continue this behavior, your relationship is likely to fail.”. Intervention 2: Intervention Group 2: Acceptance and Commitment Therapy (ACT): This therapy usually begins by establishing a therapeutic relationship based on acceptance, empathy, collaboration, and experience-centeredness. In ACT, the therapist does not necessarily have the role of an expert who is supposed to tell the client which thoughts are right and which are wrong; rather, he or she examines with the client what results his or her current strategies in life have produced. One of the basic questions the therapist asks is: “Is what you are doing to control this experience going to create the life you want for you in the long run?” If the answer is no, the therapy moves toward building flexibility and value-based behaviors. In a short-term protocol of 8 sessions, the first session is usually dedicated to establishing a therapeutic relationship, introducing the ACT model, and assessing the problem pattern. The therapist first identifies what the client has a problem with, what unpleasant experiences he or she is experiencing, and what he or she is doing to cope with them. Then, the concept of “control” is examined. For example, if the client says, “No matter what I do, my anxiety doesn’t go away,” the therapist asks, “What have you done so far to control your anxiety, and what have these actions done in the short and long term?” This introduces the concept of ineffective emotional control; that is, sometimes trying to control one’s own internal experience has become part of the problem. One important exercise in this session can be examining the “cost of control”; the client writes on paper what they have done to get rid of anxiety, depression, unpleasant thoughts or memories, and what the short-term benefits of each were and what the long-term costs were. The goal of the first session is for the client to realize that the problem is not necessarily the presence of an unpleasant thought or feeling, but rather their inflexible relationship with that experience. In the second session, the focus is more on ineffective control and experiential avoidance. Using examples and experiential exercises, the therapist shows the client that trying to eliminate a mental experience may itself make it stronger. For example, the therapist can ask the client to try not to think about a particular thought for a few moments and then examine what happened. In this way, the concept that “the mind is not always controllable” is examined experientially. The concept of acceptance is then introduced; acceptance does not mean liking, approving, or giving in to circumstances, but rather creating a mental space to experience thoughts and emotions without unnecessarily fighting them. Exercises such as observing the emotion, paying attention to bodily sensations, and allowing the unpleasant experience to be without immediately trying to eliminate it can be used in this session. Homework can be to record situations in which the person has tried to control or suppress their unpleasant experience and what the results of this effort were. In the third session, the focus on acceptance and contact with the present moment deepens. The therapist explains that acceptance does not mean becoming passive; The person can accept the unpleasant experience and at the same time take action to change the external circumstances. Then mindfulness exercises enter the treatment. For example, the therapist can invite the client to a short breathing and thought observation exercise: “Close your eyes and just notice the in and out of your breath. If a thought comes, you don’t have to eliminate it; just notice that a thought has come and bring your attention back to the present experience.” In this session, the client learns to connect with the present experience instead of getting lost in the past or future. The main techniques include mindfulness, nonjudgmental observation, paying attention to bodily sensations, practicing acceptance, and connecting with the present moment. The main focus of the fourth session is cognitive defusion. In ACT, the goal is not to prove the content of the thought to be right or wrong; rather, the person learns to create a distance between “thought” and “reality.” For example, a person who thinks, “I am worthless” often identifies with this thought and accepts it as the absolute truth. The therapist can ask the person to change the sentence from “I am worthless” to “I am experiencing the thought that I am worthless.” This small change changes the person’s relationship with the thought. Techniques such as labeling thoughts, repeating a word until it becomes a meaningless sound, observing the thought as a mental event, the metaphor of a leaf on water, and distancing oneself from the mental story can be used. The goal is not to make the thought disappear; the goal is to make the thought no longer automatically determine the person’s behavior. In the fifth session, the focus is on the self-as-context. At this stage, the client learns to distinguish between the “I” and the content of his or her experiences. For example, instead of saying, “I am an anxious person,” one can move to “I am a person who is currently experiencing anxiety.” Through observational exercises, mindfulness, and reviewing various life experiences, the therapist shows that the person’s thoughts, emotions, roles, and even self-perception have changed over time, but there is an observing capacity for these experiences. The goal of this section is to reduce attachment to fixed identities and limiting stories about oneself. In this session, the Self-as-Observer exercise, observing thoughts and feelings from the observer’s position, and experiential exercises can be used. In the sixth session, therapy enters the Values ​​axis. Values ​​are different from goals. A goal is something that can be achieved; values ​​are more indicative of the direction of life. For example, “passing an exam” is a goal, but “growth, learning, and competence” can be values. The therapist examines different areas of life such as relationships, family, career, personal growth, health, friendships, and social participation and asks: "If fear and anxiety were not your obstacle, how would you like to be in this area?", "I would like to. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is not ethical
public Mohsen Rafee
Shahid Beheshti University of Medical Sciences, Shahid Arabi Street, Yemen Street, Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 mohsenrafie7272@gmail.com Shahid Beheshti University of Medical Sciences scientific Mohsen Rafee
Shahid Beheshti University of Medical Sciences, Shahid Arabi Street, Yemen Street, Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1985717443 +98 21 23871 mohsenrafie7272@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) People with substance use disorders Age between 18 and 60 years old Minimum educational qualification: Diploma No neurological disorders or any disease that prevents cooperation. 18 years 60 years Male The presence of other mental disorders, such as schizophrenia, bipolar disorder, or depression with psychotic features Discharge or exit from a residential addiction treatment center in a way that makes it impossible to regularly participate in intervention sessions and research assessments. 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 F19.2 Other psychoactive substance dependence Treatment - Other Treatment - Other Intervention Group 1: Reality Therapy: An approach proposed by William Glasser and based on “Choice Theory.” Its basic assumption is that humans choose behaviors to satisfy their basic needs, and that psychological and interpersonal problems are largely created when a person uses ineffective strategies to satisfy these needs. Therefore, instead of focusing on the past and unconscious causes for a long time, reality therapy focuses mainly on the present, current behavior, choice, responsibility, relationships, and creating more effective behaviors. The goal of therapy is not for the therapist to tell the client what the “right” choice is; rather, it helps the client see for himself what the consequences of his current choices are and whether they bring him closer to his desired life. In Choice Theory, Glasser proposes five basic needs: survival, love and belonging, power, freedom, and recreation. Humans are constantly trying to satisfy these needs. Each person also has a “quality world”—a set of mental images of the people they love, the relationships they want, the conditions they value, and the lifestyle they want. When there is a gap between what they want and what they experience in reality, frustration occurs. The person then chooses behaviors to close this gap, but these behaviors may be ineffective. For example, a person with a strong need for love and belonging may choose to be aggressive, threatening, or controlling rather than effective communication when they feel rejected. This behavior may create a sense of control in the short term, but in the long term, it will damage the relationship and further distance them from their desired world. The therapist here tries to help the person understand this cycle. One of the central concepts of reality therapy is responsibility. Responsibility does not mean that the person is to blame for everything that happens in their life; rather, it means that the person examines what is within their sphere of choice and control in the current situation. For example, if a person’s spouse is behaving inappropriately, the client cannot directly control the spouse’s behavior, but they can decide how to respond, set boundaries, communicate, distance themselves, or seek help. So the therapist constantly shifts the focus from “others need to change” to “what choices do I have?” The practical core of reality therapy is the WDEP model. W stands for Wants, D stands for Doing or Direction, E stands for Evaluation, and P stands for Planning. These four stages are not strictly linear and rigid, and the therapist moves between them constantly throughout the course of therapy. The most important stage is E, or Self-Evaluation; That is, the client examines how much the current behavior contributes to his goal. In a short-term eight-session protocol, the first session is usually dedicated to establishing the therapeutic relationship, assessing the current problem, specifying the goal of treatment, and introducing the logic of choice theory. The therapist begins with questions such as “What made you come to therapy?”, “What would you like to change if the treatment was successful?”, “What is the most important thing you want right now?”, and “What do you do when you encounter this problem?” In this same session, the therapist introduces the concepts of basic needs, choice, and responsibility in simple language, and an initial goal for treatment is specified. The main techniques of this session include establishing a relationship, active listening, questioning, clarifying desires, and introducing choice theory. At the end, a simple task is usually assigned to observe current behaviors and situations in which the problem arises. In the second session, the focus is more on the client’s basic needs and desired world. The therapist examines which need the current problem is most closely related to; for example, belonging, power, freedom, or security. Then the client is asked to provide a picture of their desired life: “What would your relationship be like if life went the way you want it to?”, “How would you like others to treat you?”, “What would your desired life be like?”. This session uses the techniques of need exploration, Quality World identification, questioning, and goal clarification. The goal is to determine exactly what the client is looking for and how far the current problem has come from their desired life. In the third session, the focus is on W and D, current wants and behaviors. The therapist helps to transform general wants into more specific goals. For example, if the client says, “I want my partner to pay more attention to me,” the therapist asks, “What exactly would change in the relationship if you received more attention?” Then, it is examined what the client is currently doing to achieve this goal. Questions such as “What do you do when you feel ignored?”, “What happens next?”, and “What is the usual outcome of this behavior?” help identify the behavioral cycle. Techniques in this session include focusing on the current behavior, analyzing the behavior, questioning, and identifying the direction of the person’s movement. In the fourth session, the E or Evaluation section becomes more important. At this stage, the therapist invites the client to evaluate his or her own behavior. For example, if the person is angry to get his or her partner’s attention, the therapist does not say “Being angry is bad,” but asks: “How much has being angry brought you closer to the relationship you want?”, “Has this behavior met your need for belonging?”, “If you continue this behavior, your relationship is likely to fail.” Intervention Group 2: Acceptance and Commitment Therapy (ACT): This therapy usually begins by establishing a therapeutic relationship based on acceptance, empathy, collaboration, and experience-centeredness. In ACT, the therapist does not necessarily have the role of an expert who is supposed to tell the client which thoughts are right and which are wrong; rather, he or she examines with the client what results his or her current strategies in life have produced. One of the basic questions the therapist asks is: “Is what you are doing to control this experience going to create the life you want for you in the long run?” If the answer is no, the therapy moves toward building flexibility and value-based behaviors. In a short-term protocol of 8 sessions, the first session is usually dedicated to establishing a therapeutic relationship, introducing the ACT model, and assessing the problem pattern. The therapist first identifies what the client has a problem with, what unpleasant experiences he or she is experiencing, and what he or she is doing to cope with them. Then, the concept of “control” is examined. For example, if the client says, “No matter what I do, my anxiety doesn’t go away,” the therapist asks, “What have you done so far to control your anxiety, and what have these actions done in the short and long term?” This introduces the concept of ineffective emotional control; that is, sometimes trying to control one’s own internal experience has become part of the problem. One important exercise in this session can be examining the “cost of control”; the client writes on paper what they have done to get rid of anxiety, depression, unpleasant thoughts or memories, and what the short-term benefits of each were and what the long-term costs were. The goal of the first session is for the client to realize that the problem is not necessarily the presence of an unpleasant thought or feeling, but rather their inflexible relationship with that experience. In the second session, the focus is more on ineffective control and experiential avoidance. Using examples and experiential exercises, the therapist shows the client that trying to eliminate a mental experience may itself make it stronger. For example, the therapist can ask the client to try not to think about a particular thought for a few moments and then examine what happened. In this way, the concept that “the mind is not always controllable” is examined experientially. The concept of acceptance is then introduced; acceptance does not mean liking, approving, or giving in to circumstances, but rather creating a mental space to experience thoughts and emotions without unnecessarily fighting them. Exercises such as observing the emotion, paying attention to bodily sensations, and allowing the unpleasant experience to be without immediately trying to eliminate it can be used in this session. Homework can be to record situations in which the person has tried to control or suppress their unpleasant experience and what the results of this effort were. In the third session, the focus on acceptance and contact with the present moment deepens. The therapist explains that acceptance does not mean becoming passive; The person can accept the unpleasant experience and at the same time take action to change the external circumstances. Then mindfulness exercises enter the treatment. For example, the therapist can invite the client to a short breathing and thought observation exercise: “Close your eyes and just notice the in and out of your breath. If a thought comes, you don’t have to eliminate it; just notice that a thought has come and bring your attention back to the present experience.” In this session, the client learns to connect with the present experience instead of getting lost in the past or future. The main techniques include mindfulness, nonjudgmental observation, paying attention to bodily sensations, practicing acceptance, and connecting with the present moment. The main focus of the fourth session is cognitive defusion. In ACT, the goal is not to prove the content of the thought to be right or wrong; rather, the person learns to create a distance between “thought” and “reality.” For example, a person who thinks, “I am worthless” often identifies with this thought and accepts it as the absolute truth. The therapist can ask the person to change the sentence from “I am worthless” to “I am experiencing the thought that I am worthless.” This small change changes the person’s relationship with the thought. Techniques such as labeling thoughts, repeating a word until it becomes a meaningless sound, observing the thought as a mental event, the metaphor of a leaf on water, and distancing oneself from the mental story can be used. The goal is not to make the thought disappear; the goal is to make the thought no longer automatically determine the person’s behavior. In the fifth session, the focus is on the self-as-context. At this stage, the client learns to distinguish between the “I” and the content of his or her experiences. For example, instead of saying, “I am an anxious person,” one can move to “I am a person who is currently experiencing anxiety.” Through observational exercises, mindfulness, and reviewing various life experiences, the therapist shows that the person’s thoughts, emotions, roles, and even self-perception have changed over time, but there is an observing capacity for these experiences. The goal of this section is to reduce attachment to fixed identities and limiting stories about oneself. In this session, the Self-as-Observer exercise, observing thoughts and feelings from the observer’s position, and experiential exercises can be used. In the sixth session, therapy enters the Values ​​axis. Values ​​are different from goals. A goal is something that can be achieved; values ​​are more indicative of the direction of life. For example, “passing an exam” is a goal, but “growth, learning, and competence” can be values. The therapist examines different areas of life such as relationships, family, career, personal growth, health, friendships, and social participation and asks: "If fear and anxiety were not your obstacle, how would you like to be in this area?", "I would like to Craving score on the Samosa Craving Questionnaire (BSCS). Timepoint: Examining the level of craving 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. Samosa Craving Questionnaire(BSCS). Self-control score on the Tangji Self-Control Questionnaire. Timepoint: Examining the level of self-control 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. Tangji Self-Control Questionnaire. Life expectancy score on the Schneider Life Expectancy Questionnaire. 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. Distress Tolerance Score on the Simmons and Gahr Questionnaire (DTS). Timepoint: Examining distress tolerance 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. Simmons and Gahr Distress Tolerance Questionnaire (DTS). Shahid Beheshti University of Medical Sciences Approved 2025-12-13 Ethics Committee of the Vice Chancellor for Research and Technology, Shahid Beheshti University of M 5th Floor, Building No. 2, Shahid Arabi Street, Yemen Street, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)