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IRCT20160103025817N6 IRCT 2022-04-06 Kermanshah University of Medical Sciences The Study of Effectiveness of Mindfulness integrated Cognitive Behavior Therapy on Psychopathology indicators in females with breast cancer The Study of Effectiveness of Mindfulness integrated Cognitive Behavior Therapy on Psychopathology indicators in females with breast cancer: Randomized controlled trial 2022-02-20 anticipated 30 Complete https://irct.ir/trial/61672 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: random quadratic blocking method-The four blocks of intervention (A) and control (B) groups will be defined (AABB, ABAB, ABBA, BBAA, BABA, BAAB) and numbers 1 to 6 will be written on the cards. The cards are then placed in an envelope. Finally, the cards are randomly selected and a random string is created from the sequence of selected cards. N/A Condition 1: depression. Condition 2: anxiety. Intervention 1: Intervention group: Cognitive-behavioral therapy integrated with mindfulness is a regular therapeutic approach that integrates mindfulness meditation with the basic components of cognitive and behavioral techniques and will be performed individually on the intervention group for 8 sessions of 60 minutes per week (for two months). The Curriculum for MiCBT Sessions include: Session 1-Introductory presentation about the sessions and rules, an overview of MiCBT, the concept and principles of mindfulness,mindful breathing. Session 2 -Mindful breathing (continued), an overview of a few MiCBT concepts (such as situation, sensory perception, evaluation, body sensations and reaction), the internal causes of intrusive thoughts and their extinction, part-by-part body scanning. Session 3 -Part-by-part body scanning (continued), explaining about body sensations , informal practice. Session 4 -Body scanning exercises (continued), introducing some CBT components in MiCBT (like exposure methods), encountering unpleasant sensations using Subjective Units of Distress Scale(SUDS) (a kind of form that is used for exposure to target events)through bipolar exposure (imaginary exposure to unpleasant situations). Session 5- review of SUDS, Body scanning exercises (continued).Session 6 -Body scanning exercises (continued), interpersonal skills,assertiveness and role-playing. Session 7-Introducing the concepts of compassion and empathy,loving-kindness meditation.Session 8- Review and evaluation. Intervention 2: Control group: The control group will be given psychological training along with a book on breast cancer and will be taught about the course and process of cancer and medication. Training will be individual and in one session. No - There is not a plan to make this available Justification or reason for not sharing IPD is Participants are not yet known.
public Dr. AA. parvizifard
Department of Clinical Psychology, School of Medicine, Razi Blvd.
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 4617 Parvizia@yahoo.com Kermanshah University of Medical Sciences scientific Dr. A.A parvizifard
Department of Clinical Psychology, School of Medicine, Zakaria Azi Blvd.
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 4617 Parvizia@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Being in the age group of 30 to 60 years Ability to read and write and participate in treatment sessions More than 6 months have passed since the diagnosis of cancer Having informed consent to participate in research and completing the informed consent form Non-development of chronic physical diseases such as diabetes and thyroid disorders Do not attend psychotherapy sessions for six months before starting treatment Have no other cancers No problems with hearing and vision Non-abuse of drugs Non-development of severe mental illnesses including schizophrenia, bipolar type 1 disorders and severe personality disorders 30 years 60 years Female Participate in psychotherapy sessions and other support groups at the same time as the research period F33.1 F06.4 Major depressive disorder, recurrent, moderate Anxiety disorder due to known physiological condition Behavior Behavior Intervention group: Cognitive-behavioral therapy integrated with mindfulness is a regular therapeutic approach that integrates mindfulness meditation with the basic components of cognitive and behavioral techniques and will be performed individually on the intervention group for 8 sessions of 60 minutes per week (for two months). The Curriculum for MiCBT Sessions include: Session 1-Introductory presentation about the sessions and rules, an overview of MiCBT, the concept and principles of mindfulness,mindful breathing. Session 2 -Mindful breathing (continued), an overview of a few MiCBT concepts (such as situation, sensory perception, evaluation, body sensations and reaction), the internal causes of intrusive thoughts and their extinction, part-by-part body scanning. Session 3 -Part-by-part body scanning (continued), explaining about body sensations , informal practice. Session 4 -Body scanning exercises (continued), introducing some CBT components in MiCBT (like exposure methods), encountering unpleasant sensations using Subjective Units of Distress Scale(SUDS) (a kind of form that is used for exposure to target events)through bipolar exposure (imaginary exposure to unpleasant situations). Session 5- review of SUDS, Body scanning exercises (continued).Session 6 -Body scanning exercises (continued), interpersonal skills,assertiveness and role-playing. Session 7-Introducing the concepts of compassion and empathy,loving-kindness meditation.Session 8- Review and evaluation. Control group: The control group will be given psychological training along with a book on breast cancer and will be taught about the course and process of cancer and medication. Training will be individual and in one session. Depression. Timepoint: Before the intervention, after the end of the intervention and two months after the end of the intervention. Method of measurement: DASS Depression Inventory. Anxiety. Timepoint: Before the intervention, after the end of the intervention and two months after the end of the intervention. Method of measurement: DASS Anxiety Inventory. Stress. Timepoint: Before the intervention, after the end of the intervention and two months after the end of the intervention. Method of measurement: DASS Stress Inventory. Sleep quality. Timepoint: Before the intervention, after the end of the intervention and two months after the end of the intervention. Method of measurement: Pittsburgh Sleep Quality Index. Sexual function. Timepoint: Before the intervention, after the end of the intervention and two months after the end of the intervention. Method of measurement: Rosen Sexual Function Questionnaire. Body image. Timepoint: Before the intervention, after the end of the intervention and two months after the end of the intervention. Method of measurement: Hopwood body image Questionnaire. Demoralization. Timepoint: Before the intervention, after the end of the intervention and two months after the end of the intervention. Method of measurement: kissane demoralization Questionnaire. Kermanshah University of Medical Sciences Approved 2021-12-12 Ethics committee of Kermanshah University of Medical Sciences Kermanshah, Shahid Beheshti Blvd., Building No. 2, University of Medical Sciences Kermanshah Kermanshah Iran (Islamic Republic of)