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IRCT20210901052355N1 IRCT 2021-10-13 Islamic Azad University Comparison of the effectiveness of compassion-based emotion-focused combination therapy package with compassion-based therapy on quality of life in patients with primary headache symptoms Comparison of the effectiveness of compassion-based emotion-focused combination therapy package with compassion-based therapy on quality of life in patients with primary headache symptoms 2021-09-19 anticipated 45 Complete https://irct.ir/trial/58644 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 45 patients from the community of patients with primary headache symptoms of Khatam Al-Anbia Hospital will be purposefully selected based on sample adequacy (Sarmad, Hejazi and Bazargan, (1997) in experimental and quasi-experimental research recommend at least 15 to 20 people for each group). The assignment of both experimental groups, including compassion-based emotion therapy and compassion-based therapy, and the control group will be a simple random lottery. In this way, each sample person is given a special code and then the codes are poured into a bag or container and mixed. It then pulls out the codes one by one, writes down their number, and so on until the groups are completed. Then, for random and unpredictable allocation of 15 people in the first, second and third groups for two experimental groups and one control group, coin toss will be used, Blinding description: This study is a three-way blind. In this study, three sample groups, treatment administrators and an evaluation group that analyzed the obtained data, were kept blind. In this study, the facilitator, participants, treatment executives, and the assessment team did not already have any knowledge or physical, telephone, or online contact with each other. In this study, three groups of samples are kept blind to each other and to the treatment. Also, the executors of the treatments and the information evaluation team are outside the treatment plan team. N/A Primary headache. Intervention 1: Intervention group1:Emotion-based therapy group is based on compassion. The experimental group or the first intervention received compassion-based emotion therapy therapy for 10 sessions one day a week for 60 minutes. The first group intervention based on the protocol developed by Behvandi, Khayatan and Golparvar (1399) based on the need-based inductive thematic analysis (theme) (based on the needs of patients with primary headache symptoms) and interviews with patients with symptoms Initial headache, then adaptation of needs to emotion-based and compassionate treatment texts, and finally obtaining specialized agreement and approval of initial executive preparation were prepared. The content of emotion-based therapy includes: 1. Creating awareness, regulation and emotional transformation as three principles of emotional change 2. Intervening in disturbances to deal with emotions and 3. Cultivating compassion and soothing system in patients with early headache symptoms Help. Intervention 2: Intervention group2: The treatment group is based on compassion. The experimental group or the second intervention received compassion-based treatment for 8 sessions one day a week for 60 minutes. Compassion therapy sessions were prepared based on the validated and tested protocol of Gilbert (2010). The content of compassion-based sessions includes: introduction to emotional regulation systems, familiarity with the conscious brain, familiarity with the characteristics of compassion and cognition of the compassionate person, compassionate reasoning and compassionate attention, compassionate visualization and compassionate sensory experience, compassionate feeling and compassionate behavior. Intervention 3: Control group: without receiving any treatment. Yes - There is a plan to make this available What will be shared: Dissemination of information at the individual or private level: For each of the participants in the present study, the files related to that person and also the main outcome of the study in which the person participated are prepared as a personal file and if requested as a CD file or email Will be provided to them. Dissemination of information at the public level: The results of the present study will be published in the form of articles, lectures and other forms of public media in the form of identifiable information and maintaining the confidentiality and privacy of study participants When: Access to the data will start 4 months after the results are published and in 1400 To whom: Anyone interested in psychological studies in the field of headache and its symptoms can benefit from the information published in this study. Researchers and students with studies related to the present study, if they need more information about the research process and more information about the results obtained, can be informed through the email address and phone number of the responsible author Conditions: 1.Researchers and researchers can refer to the present study by citing the source 2. Researchers and researchers can compare the treatments used in the present study with other studies by mentioning the reference or by referring to the reference as a new protocol Where to obtain: Applicants can refer to the following e-mail address and contact numbers to receive the required documents or data. F.khayatan@yahoo.com; Nedabehvandy@gmail.com 09131289531 09902175301 09388481122 031- 35002612 How to obtain: 1. Sending an official e-mail or telephone call requesting a respectful and formal request on the subject of the research requesting the documents and the reason for the need for the documents 2. Receive valid details from the applicant for documents, including complete and valid personal details, valid email address, valid contact number to verify the validity of the request of the document applicant 3.Check emails and calls within 48 hours and if the request of the applicant is confirmed, send the documents while maintaining the privacy and confidentiality in the form of email, fax and post for the applicant Comments:
public Dr.Felor Khayatan
University Blvd, Arqavanieh, Jey Street, Isfahan Azad University
Isfahan Iran (Islamic Republic of) ۳۹۹۹۸-۸۱۵۵۱ +98 913 128 9531 F.khayatan@yahoo.com Isfahan Azad University scientific Dr.Felor Khayatan
Isfahan Azad University
Isfahan Iran (Islamic Republic of) ۳۹۹۹۸-۸۱۵۵۱ +98 913 128 9531 F.Khayatan@yahoo.com Isfahan Azad University Iran (Islamic Republic of) Conscious satisfaction of the subjects and willingness to participate and continue to participate in treatment Being in the age group of 18 to 45 years according to the disability assessment questionnaire caused by headache Diagnosis of primary headache by a specialist and having a record Do not undergo parallel psychiatric and psychological treatments 18 years 45 years Both Dissatisfaction and unwillingness to participate and continue to participate in treatment Do have secondary headaches Absence of three consecutive or non-consecutive sessions Undergo other psychiatric and psychological treatments. G43؛ G44.2 Migraine؛ Tension type headache؛ Cluster headache syndrome Behavior Behavior N/A Intervention group1:Emotion-based therapy group is based on compassion. The experimental group or the first intervention received compassion-based emotion therapy therapy for 10 sessions one day a week for 60 minutes. The first group intervention based on the protocol developed by Behvandi, Khayatan and Golparvar (1399) based on the need-based inductive thematic analysis (theme) (based on the needs of patients with primary headache symptoms) and interviews with patients with symptoms Initial headache, then adaptation of needs to emotion-based and compassionate treatment texts, and finally obtaining specialized agreement and approval of initial executive preparation were prepared. The content of emotion-based therapy includes: 1. Creating awareness, regulation and emotional transformation as three principles of emotional change 2. Intervening in disturbances to deal with emotions and 3. Cultivating compassion and soothing system in patients with early headache symptoms Help Intervention group2: The treatment group is based on compassion. The experimental group or the second intervention received compassion-based treatment for 8 sessions one day a week for 60 minutes. Compassion therapy sessions were prepared based on the validated and tested protocol of Gilbert (2010). The content of compassion-based sessions includes: introduction to emotional regulation systems, familiarity with the conscious brain, familiarity with the characteristics of compassion and cognition of the compassionate person, compassionate reasoning and compassionate attention, compassionate visualization and compassionate sensory experience, compassionate feeling and compassionate behavior Control group: without receiving any treatment In the present study, the outcome variable is a quality of life score below 40 in the Quality of Ware & Sherbourne Questionnaire, which indicates a low quality of life. Timepoint: Before the intervention and 80 days later (completion of the intervention) and then 60 days later (follow-up). Method of measurement: The tool for measuring the outcome variable is the quality of Life Ware & Sherbourne Questionnaire. The quality of life variable is measured in three stages before the intervention, after the intervention (80 days after the start of the intervention) and in the follow-up stage (60 days after the end of the intervention). In the instrument of measuring the quality of life Ware & Sherbourne , the maximum scores are 100 and the minimum scores are zero. High scores mean high quality of life and low scores mean low quality of life. Islamic Azad University Approved 2020-06-10 Ethics Committee of Islamic Azad University University Blvd, Arqavanieh, Jey Street, Isfahan Azad University Isfahan Isfehan Iran (Islamic Republic of)