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IRCT20211031052927N1 IRCT 2022-04-20 Semnan University of Medical Sciences The Effectiveness of Meta-Cognitive Therapy on Cognitive-Attention Syndrome, Pain Catastrophizing and Pain Intensity in Women with Fibromyalgia The Effectiveness of Meta-Cognitive Therapy on Cognitive-Attention Syndrome, Pain Catastrophizing and Pain Intensity in Women with Fibromyalgia 2022-04-25 anticipated 42 Complete https://irct.ir/trial/59717 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Participants in this study are divided into experimental and control groups. Psychological intervention is performed on the experimental group and participants in the control group participate in only pre-tests and post-tests, Randomization description: Patients who meet the conditions to take part in the research are randomly assigned to one of the two groups in a random order by an analyst who is not involved in the participation of the patients. The method used to conceal the diagnosis is the use of a non-transparent sealed envelope. Each random sequence is recorded on a card, and the cards are placed inside the envelopes in order. Based on the order of the entry of eligible participants in the study, one of the envelopes is opened at the beginning of the registration and the assigned group of the participant is revealed. N/A Fibromyalgia. Intervention 1: In this study, metacognitive therapy will be performed on the experimental group members individually and the control group members will participate only in the pre-test and post-test trials. The metacognitive therapy protocol is 8 to 10 weekly sessions of 45-60 minutes; due to the fact that this study is based on three variables and also these patients generally suffer from a lot of pain and bad mood and high anxiety, psychological interventions will be in 10 weekly sessions of 60 minutes. The title of the techniques and activities of each treatment session will be as follows; Session 1: Generate case formulation. Socialize to model. Run suppression experiment. Introduce worry (about pain) postponement. Practice detached mindfulness (DM). Homework: DM and worry postponement. Session 2: Review homework. Continue socialization (if necessary). Begin challenging uncontrollability belief (about pain). Practice detached mindfulness (DM). Attention training technique (ATT) practice. Complete ATT summary sheet. Homework: Postponement of worry (about pain), DM, ATT. Session 3: Review homework. Continue to challenge uncontrollability belief (about pain); giving counterevidence. Explore and ban thought suppression. Explore and ban maladaptive control/avoidance behaviors. Attention training technique (ATT) practice. Homework: Postponement of worry (about pain), DM, ATT. Session 4: Review homework. Continue to challenge uncontrollability belief (about pain), (If necessary). Broaden application of worry/rumination postponement. Continue to explore and ban maladaptive control/avoidance behaviors. Attention training technique (ATT) practice. Homework: Postponement of worry (about pain) and rumination, broaden application of DM, ATT, schedule activities. Session 5: Review homework. Begin to challenge positive beliefs about worry (about pain). Review activity levels and suggest enhancements (explore and ban other unhelpful coping, e.g., excessive sleep, alcohol). Attention training technique (ATT) practice. (increase difficulty). Homework: Postponement of worry (about pain) and rumination, broaden application of DM, ATT, increased activities. Session 6: Review homework. Continue to challenge positive beliefs about worry (about pain). Challenging negative beliefs about worry (about symptoms). Continue reviewing activity levels and suggest enhancements (explore and ban other unhelpful coping, e.g., excessive sleep, alcohol). Attention training technique (ATT) practice. Homework: Postponement of worry (about pain) and rumination, ATT, maintain activities. Session 7: Review homework. Run advantages–disadvantages analysis of threat monitoring. Challenge positive beliefs about threat monitoring. Ban threat monitoring. Suggest alternatives. Attention training technique (ATT) practice. Homework: Practice awareness and abandonment of threat monitoring, ATT, increased activities. Session 8: Review homework. Continue challenging positive beliefs about threat monitoring, banning threat monitoring and suggesting alternatives (If necessary). Work on residual beliefs. Begin work on therapy blueprint. Homework: Patient writes brief summary of treatment. Continue ban on worry/rumination, threat monitoring. Session 9: Review homework. Write out new plan for dealing with intrusions and symptoms.Complete therapy blueprint. Explore and modify fears of recurrence.Homework: Practice implementing new plan. Session 10: Review homework. Reinforce new plan and illustrate with a hypothetical future example. Check for any residual beliefs. Schedule booster session. Homework: Specify continued application. Intervention 2: Control group: The members will participate only in pre-test and post-test. Yes - There is a plan to make this available What will be shared: At the end of the intervention, the data about the participants will be presented separately but without mentioning their identity details. When: August to September of 2022 To whom: University lecturers, university students, researchers, psychologists, psychiatrists, orthopedists, rheumatologists Conditions: No special condition is considered Where to obtain: Sending an email to researcher`s email address. How to obtain: The request must be sent via email and will be answered within a week Comments:
public Dr. Isaac Rahimian Boogar
Faculty of Psychology and Educational Sciences, Semnan University, Darband, Mahdishahr, Semnan
Semnan Iran (Islamic Republic of) 3564111556 +98 23 3362 4250 i_rahimian@semnan.ac.ir Semnan University of Medical Sciences scientific Dr. Isaac Rahimian Boogar
Faculty of Psychology and Educational Sciences, Semnan University, Darband, Mahdishahr, Semnan
Semnan Iran (Islamic Republic of) 3564111556 +98 23 3362 4250 i_rahimian@semnan.ac.ir Semnan University of Medical Sciences Iran (Islamic Republic of) The definitive diagnosis of fibromyalgia in the patient by a rheumatologist or orthopedist based on the criteria of the American College of Rheumatology (ACR) 20 years 55 years Female The dismissal of the existence of rheumatoid arthritis and inflammatory arthritis Pregnant women, women with a history of hospitalization due to psychotic disorders, women with a history of orthopedic surgery, and patients with multiple sclerosis cannot take part in the research. M79.7 Fibromyalgia Treatment - Other Treatment - Other In this study, metacognitive therapy will be performed on the experimental group members individually and the control group members will participate only in the pre-test and post-test trials. The metacognitive therapy protocol is 8 to 10 weekly sessions of 45-60 minutes; due to the fact that this study is based on three variables and also these patients generally suffer from a lot of pain and bad mood and high anxiety, psychological interventions will be in 10 weekly sessions of 60 minutes. The title of the techniques and activities of each treatment session will be as follows; Session 1: Generate case formulation. Socialize to model. Run suppression experiment. Introduce worry (about pain) postponement. Practice detached mindfulness (DM). Homework: DM and worry postponement. Session 2: Review homework. Continue socialization (if necessary). Begin challenging uncontrollability belief (about pain). Practice detached mindfulness (DM). Attention training technique (ATT) practice. Complete ATT summary sheet. Homework: Postponement of worry (about pain), DM, ATT. Session 3: Review homework. Continue to challenge uncontrollability belief (about pain); giving counterevidence. Explore and ban thought suppression. Explore and ban maladaptive control/avoidance behaviors. Attention training technique (ATT) practice. Homework: Postponement of worry (about pain), DM, ATT. Session 4: Review homework. Continue to challenge uncontrollability belief (about pain), (If necessary). Broaden application of worry/rumination postponement. Continue to explore and ban maladaptive control/avoidance behaviors. Attention training technique (ATT) practice. Homework: Postponement of worry (about pain) and rumination, broaden application of DM, ATT, schedule activities. Session 5: Review homework. Begin to challenge positive beliefs about worry (about pain). Review activity levels and suggest enhancements (explore and ban other unhelpful coping, e.g., excessive sleep, alcohol). Attention training technique (ATT) practice. (increase difficulty). Homework: Postponement of worry (about pain) and rumination, broaden application of DM, ATT, increased activities. Session 6: Review homework. Continue to challenge positive beliefs about worry (about pain). Challenging negative beliefs about worry (about symptoms). Continue reviewing activity levels and suggest enhancements (explore and ban other unhelpful coping, e.g., excessive sleep, alcohol). Attention training technique (ATT) practice. Homework: Postponement of worry (about pain) and rumination, ATT, maintain activities. Session 7: Review homework. Run advantages–disadvantages analysis of threat monitoring. Challenge positive beliefs about threat monitoring. Ban threat monitoring. Suggest alternatives. Attention training technique (ATT) practice. Homework: Practice awareness and abandonment of threat monitoring, ATT, increased activities. Session 8: Review homework. Continue challenging positive beliefs about threat monitoring, banning threat monitoring and suggesting alternatives (If necessary). Work on residual beliefs. Begin work on therapy blueprint. Homework: Patient writes brief summary of treatment. Continue ban on worry/rumination, threat monitoring. Session 9: Review homework. Write out new plan for dealing with intrusions and symptoms.Complete therapy blueprint. Explore and modify fears of recurrence.Homework: Practice implementing new plan. Session 10: Review homework. Reinforce new plan and illustrate with a hypothetical future example. Check for any residual beliefs. Schedule booster session. Homework: Specify continued application. Control group: The members will participate only in pre-test and post-test Cognitive-Attention Syndrome score based on a special questionnaire of Attentive Cognitive Syndrome Scale (CAS-1). Timepoint: Before beginning the intervention and 7 days after the end of the intervention. Method of measurement: Cognitive-Attention Syndrome score will be based on score and evaluation of the special questionnaire of Attentive Cognitive Syndrome Scale (CAS-1). Pain intensity score in the chronic pain questionnaire of Vonkorff et al. Timepoint: Before beginning the intervention and 7 days after finishing the intervention. Method of measurement: Pain intensity score will be based on the score obtained as a result of the Vonkorff et al (1992) chronic pain questionnaire. Pain Catastrophizing Score Obtained from pain Catastrophizing questionnaire of Sullivan et al. Timepoint: Before beginning the intervention and 7 days after finishing the intervention. Method of measurement: Pain Catastrophizing score will be based on the score obtained from the Sullivan et al. (1995) Pain Catastrophizing Questionnaire. Semnan University of Medical Sciences Approved 2021-10-26 Semnan University of Medical Sciences (Research Ethics Committee) Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran. Semnan Semnan Iran (Islamic Republic of)