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IRCT20191106045356N1 IRCT 2021-04-14 Yazd University of Medical Sciences Evaluation of the effects of sertraline and Acceptance and Commitment Therapy (ACT) enriched with Compassion Focus Therapy (CFT) on depression, stress, and anxiety Comparison of the effectiveness of pharmacotherapy with sertraline versus Acceptance and Commitment Therapy (ACT) enriched with Compassion Focus Therapy (CFT) on depression, stress, and anxiety in addict patients undergoing Methadone Maintenance Therapy (MMT) 2021-05-22 anticipated 60 Complete https://irct.ir/trial/49662 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomize the samples in each group, the subjects are divided into three groups A, B and C using the RAN() function of Excel software, and according to the type of intervention, drug use and participation in mental training classes. It is a treatment, there is no possibility of blindness, there is no intervener and the subjects, and only the statistical analyst does not know what kind of intervention was done by each group. 3 in addict patients undergoing Methadone Maintenance Therapy. Intervention 1: Intervention group: Acceptance and Commitment Therapy + Compassionate therapy, group-based acceptance and commitment sessions will be held in 8 1-hour sessions, once a week. The training course will last for two months. At the end of each session, a task is given. In this section, the titles and general structure of the sessions are briefly mentioned. The general framework of acceptance and commitment therapy sessions is based on Hayes et al.'s (1999) and Tohi (2007) Therapeutic Guidelines. The description of the sessions is as follows: Session 1: Familiarity with group members and establishing therapeutic relationship, determining the rules governing the therapy sessions, clarifying the therapeutic relationship, introducing and measuring emotion, starting creative helplessness and presenting homework, Session 2: reviewing homework and receiving feedback from Previous session (done in each session), Continuation of creative helplessness, metaphor of the hole and presentation of the task of the third session, introduction of control as a problem, discussion of the inner world and its difference with the outer world, metaphor of the polygraph and presentation of the task, fourth session : Introducing acceptance and desire as an alternative to control, guest metaphor and expression of pure and unclean feelings, Session 5: Familiarity with the hidden features of language that cause fusion, expression of fault, bus metaphor, Session 6: Introduction of its types, chess metaphor Introduction to the conceptualized past and future, Session 7: Moving towards a valuable life with a receptive and observant self, Identifying values ​​and measuring the values ​​of references, Session 8: Commitment to action and values ​​despite obstacles, metaphor of seedlings, Evaluation of commitment to action, providing a permanent assignment, filling in a compassion-focused post-test: In this study, treatment-focused sessions Compassion will be held in 8 sessions of 120 minutes in a group and once a week. The treatment sessions were based on Gilbert's treatment plan (21). Description of compassion-focused therapy sessions:  Session 1: Establishing a therapeutic relationship, familiarizing members with each other, explaining group rules, a brief explanation of CFT, a brief explanation of emotions, Training and implementation of mindfulness breathing exercises and homework  Session 2: Review of the previous session's practice, introduction of three emotional regulation systems and how they interact with each other, familiarity with negative and threatening emotions from CFT perspective, the nature of compassion and homework  Session Third: Reviewing the practice of the previous session, getting acquainted with the characteristics of people with compassion (kindness, empathy, tolerating distress, not judging), cultivating and understanding that others have flaws and problems, cultivating a sense of human commonality in the face of self-destructive feelings and shame, presentation Homework  Session 4: Review of the previous session's practice, self-compassion training (wisdom, strength, kindness, not judging yourself and responsibility), how to illustrate about self-compassion, self-compassion growth training and homework, session 5: Review the previous session practice, practice compassion skills (compassionate behavior, compassionate mental image, compassionate feeling) and empathy training, session Sixth: Reviewing the practice of the previous session, cultivating compassion for others, teaching forgiveness, focusing oneself compassionately on others  Session 7: Training to accept problems and face different challenges and changes ahead, homework Reviewing the practice of the previous session, Identify thoughts that hinder the cultivation of compassion and work on them, learn to write compassionate letters, session eight: for yourself and others, do compassion color exercises, compassion sound and image, homework, review and practice the skills presented in the sessions Prior and summary concepts reviewed. Intervention 2: Intervention group: Intervention group: Acceptance and commitment therapy + Compassion Focus Therapy + treatment with Sertraline. Intervention 3: Intervention group: Sertraline. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr. Mohsen Zabihi
Alem sq.
Yazd Iran (Islamic Republic of) ۸۹۱۵۱۷۳۱۴۹ +98 35 3820 3419 mzabihi100@gmail.com Yazd University of Medical Sciences scientific Dr. Mohsen Zabihi
Alem sq.
Yazd Iran (Islamic Republic of) ۸۹۱۵۱۷۳۱۴۹ +98 35 3820 3419 mzabihi100@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) duration of methadon use for at least the 6 months the age range of20_45 years 20 years 45 years Male Existence of severe mental disorder such as psychosis Existence of instant psychosis due to psychotropic consumption. Simultaneous use of NA and similar classes. Having chronic physical illnesses that affect mood and emotions. Use of opiates and morphine Not doing homework at home Failure to complete the questionnaire in pre-test and post-test F06.31 Mood disorder due to known physiological condition with depressive features Other Treatment - Drugs Other Intervention group: Acceptance and Commitment Therapy + Compassionate therapy, group-based acceptance and commitment sessions will be held in 8 1-hour sessions, once a week. The training course will last for two months. At the end of each session, a task is given. In this section, the titles and general structure of the sessions are briefly mentioned. The general framework of acceptance and commitment therapy sessions is based on Hayes et al.'s (1999) and Tohi (2007) Therapeutic Guidelines. The description of the sessions is as follows: Session 1: Familiarity with group members and establishing therapeutic relationship, determining the rules governing the therapy sessions, clarifying the therapeutic relationship, introducing and measuring emotion, starting creative helplessness and presenting homework, Session 2: reviewing homework and receiving feedback from Previous session (done in each session), Continuation of creative helplessness, metaphor of the hole and presentation of the task of the third session, introduction of control as a problem, discussion of the inner world and its difference with the outer world, metaphor of the polygraph and presentation of the task, fourth session : Introducing acceptance and desire as an alternative to control, guest metaphor and expression of pure and unclean feelings, Session 5: Familiarity with the hidden features of language that cause fusion, expression of fault, bus metaphor, Session 6: Introduction of its types, chess metaphor Introduction to the conceptualized past and future, Session 7: Moving towards a valuable life with a receptive and observant self, Identifying values ​​and measuring the values ​​of references, Session 8: Commitment to action and values ​​despite obstacles, metaphor of seedlings, Evaluation of commitment to action, providing a permanent assignment, filling in a compassion-focused post-test: In this study, treatment-focused sessions Compassion will be held in 8 sessions of 120 minutes in a group and once a week. The treatment sessions were based on Gilbert's treatment plan (21). Description of compassion-focused therapy sessions:  Session 1: Establishing a therapeutic relationship, familiarizing members with each other, explaining group rules, a brief explanation of CFT, a brief explanation of emotions, Training and implementation of mindfulness breathing exercises and homework  Session 2: Review of the previous session's practice, introduction of three emotional regulation systems and how they interact with each other, familiarity with negative and threatening emotions from CFT perspective, the nature of compassion and homework  Session Third: Reviewing the practice of the previous session, getting acquainted with the characteristics of people with compassion (kindness, empathy, tolerating distress, not judging), cultivating and understanding that others have flaws and problems, cultivating a sense of human commonality in the face of self-destructive feelings and shame, presentation Homework  Session 4: Review of the previous session's practice, self-compassion training (wisdom, strength, kindness, not judging yourself and responsibility), how to illustrate about self-compassion, self-compassion growth training and homework, session 5: Review the previous session practice, practice compassion skills (compassionate behavior, compassionate mental image, compassionate feeling) and empathy training, session Sixth: Reviewing the practice of the previous session, cultivating compassion for others, teaching forgiveness, focusing oneself compassionately on others  Session 7: Training to accept problems and face different challenges and changes ahead, homework Reviewing the practice of the previous session, Identify thoughts that hinder the cultivation of compassion and work on them, learn to write compassionate letters, session eight: for yourself and others, do compassion color exercises, compassion sound and image, homework, review and practice the skills presented in the sessions Prior and summary concepts reviewed Intervention group: Intervention group: Acceptance and commitment therapy + Compassion Focus Therapy + treatment with Sertraline Intervention group: Sertraline Depression score. Timepoint: 28 days after intervention. Method of measurement: Examination of the patient and based on a standard questionnaire. Depression, stress, and anxiety. Timepoint: Before and after treatment. Method of measurement: DASS-21. Yazd University of Medical Sciences Approved 2020-11-10 thics committee of ُ Shahid Sadoughi University of Medical Sciences Alem sq. Yazd Yazd Iran (Islamic Republic of)