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IRCT20240104060609N1 IRCT 2024-02-17 Urmia university Effectiveness of cognitive behavioral therapy for insomnia and exposure therapy for fibromyalgia patients Comparison of the effectiveness of exposure therapy and cognitive behavioral therapy for insomnia on psychological distress and well-being in women with fibromyalgia 2024-02-14 anticipated 60 Complete https://irct.ir/trial/75045 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Considering that we previously had a research with the cooperation of fibromyalgia patients and we have access to them through social networks, first, to achieve the goals of the research and according to the specified inclusion criteria, 60 people will be selected based on Purposive sampling. Then to achieve equality in the number of members of the groups, block randomization method will be done with a block size of 3. For each of the 6 possible modes, the numbers will be assigned as follows: ABC(1), ACB(2), BAC(3), BCA(4), CAB(5), CBA(6). Random sequence will be generated using random number table and the following website (www.graphpad.com/quickcalcs/randomize1/). numbers will be selected for each block, and based on that, the group (exposure therapy, cognitive behavioral therapy for insomnia, control) is determined for each participant, Blinding description: First, the participants will be explained about the objectives of the study, and after they agree to participate in the study, they will be selected as the study samples. In this study, only the person responsible for analyzing the data will be kept blind. N/A Fibromyalgia. Intervention 1: Intervention group 1: An important feature of exposure therapy is that avoidance is defined by the function of the behavior, not its topography. That is, behaviors that act as avoidance for some people, may not act as avoidance for others. In fact, in many cases, the same behavior that acts as avoidance for some patients (for example, physical activity), is considered a form of exposure for other patients. Participants in the exposure therapy group will receive eight online intervention sessions. The content is mainly based on text and is divided into 8 parts, which the participants will gradually access by completing the assignments. Treatment progress will be Carefully monitored by a therapist, and participants will be contacted regularly (about 1-3 times per week) via asynchronous text messages (no chat or video conferencing will be used). The main task of the therapist will be to guide the participants during the treatment and help to solve the problems if needed. The therapist responds to people's messages 24 hours a day on working days. If a participant is inactive for 4 days, the therapist will text or call the participant to remind and encourage them to continue treatment and to contact the therapist to resolve any potential issues. Sessions include description of treatment, presentation of psychoeducation (general knowledge) about fibromyalgia and exposure-based therapy, role of avoidance behaviors and their impact on hypervigilance, attention, and long-term consequences on pain-related distress. Exercises and worksheets: Encourage and train participants to identify their avoidance behaviors and place them in the context of therapy. Participants also record their behaviors daily and practice mindfulness as a way to direct attention to physical symptoms. Addressing the role of cognitions and emotions in relation to fibromyalgia symptoms and/or pain-related distress will also be taught and intervened. Intervention 2: Intervention group 2: 8 sessions (each session 50 minutes) of cognitive behavioral therapy for insomnia will be done in a group through the Internet on the google meet platform. Session 1: sleep education: participants will be taught about the stages of sleep. Session 2: sleep hygiene: sleep hygiene is discussed and participants are told to follow the following rules: (1) avoid caffeine in the afternoon, (2) avoid exercise, nicotine, alcohol, and heavy meals 2 hours before sleep (3) avoid watching screen 1 hour before sleep. The goal of sleep hygiene is to eliminate sleep-disturbing behaviors. Session 3: stimulus control and brief relaxation: stimulus control is discussed and participants are asked to adhere to advice such as: do not use the bed/bedroom for anything other than sleep (or sex). Session 4: sleep restriction: a sleep duration prescription is adjusted based on the reported daily average of total sleep time plus 30 minutes. If this value is less than 5 hours, the sleep duration is set to 5 hours. The purpose of sleep restriction is to regulate the sleep-wake cycle and reduce the time of waking up in bed. Session 5: monitoring automatic thoughts. Session 6: challenging/replacing negative thoughts. Session 7: practical recommendations. Session 8: review and maintenance. Intervention 3: Control group: No intervention. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to confidentiality and privacy of personal data
public Amir Ghorbanzade BorBor
Urmia, Valfajr Blvd. 2 - Seda and Sima St
Urmia Iran (Islamic Republic of) 5756151818 +98 44 3336 4500 a.ghorbanzadeh@urmia.ac.ir Urmia University scientific Amir Ghorbanzade BorBor
Urmia, Valfajr Blvd. 2 - Seda and Sima St
Urmia Iran (Islamic Republic of) 5756151818 +98 44 3336 4500 a.ghorbanzadeh@urmia.ac.ir Urmia University Iran (Islamic Republic of) Female gender At least 18 years old Diagnosis of fibromyalgia by a specialist Willingness and informed consent to participate in research Education at least diploma 18 years no limit Female Patients who are receiving a psychological intervention, or who have received this within the preceding 6 months Suffering from a severe mental or physical illness such as schizophrenia, cancer, addiction M79.7 Fibromyalgia Treatment - Other Treatment - Other Treatment - Other Intervention group 1: An important feature of exposure therapy is that avoidance is defined by the function of the behavior, not its topography. That is, behaviors that act as avoidance for some people, may not act as avoidance for others. In fact, in many cases, the same behavior that acts as avoidance for some patients (for example, physical activity), is considered a form of exposure for other patients. Participants in the exposure therapy group will receive eight online intervention sessions. The content is mainly based on text and is divided into 8 parts, which the participants will gradually access by completing the assignments. Treatment progress will be Carefully monitored by a therapist, and participants will be contacted regularly (about 1-3 times per week) via asynchronous text messages (no chat or video conferencing will be used). The main task of the therapist will be to guide the participants during the treatment and help to solve the problems if needed. The therapist responds to people's messages 24 hours a day on working days. If a participant is inactive for 4 days, the therapist will text or call the participant to remind and encourage them to continue treatment and to contact the therapist to resolve any potential issues. Sessions include description of treatment, presentation of psychoeducation (general knowledge) about fibromyalgia and exposure-based therapy, role of avoidance behaviors and their impact on hypervigilance, attention, and long-term consequences on pain-related distress. Exercises and worksheets: Encourage and train participants to identify their avoidance behaviors and place them in the context of therapy. Participants also record their behaviors daily and practice mindfulness as a way to direct attention to physical symptoms. Addressing the role of cognitions and emotions in relation to fibromyalgia symptoms and/or pain-related distress will also be taught and intervened. Intervention group 2: 8 sessions (each session 50 minutes) of cognitive behavioral therapy for insomnia will be done in a group through the Internet on the google meet platform. Session 1: sleep education: participants will be taught about the stages of sleep. Session 2: sleep hygiene: sleep hygiene is discussed and participants are told to follow the following rules: (1) avoid caffeine in the afternoon, (2) avoid exercise, nicotine, alcohol, and heavy meals 2 hours before sleep (3) avoid watching screen 1 hour before sleep. The goal of sleep hygiene is to eliminate sleep-disturbing behaviors. Session 3: stimulus control and brief relaxation: stimulus control is discussed and participants are asked to adhere to advice such as: do not use the bed/bedroom for anything other than sleep (or sex). Session 4: sleep restriction: a sleep duration prescription is adjusted based on the reported daily average of total sleep time plus 30 minutes. If this value is less than 5 hours, the sleep duration is set to 5 hours. The purpose of sleep restriction is to regulate the sleep-wake cycle and reduce the time of waking up in bed. Session 5: monitoring automatic thoughts. Session 6: challenging/replacing negative thoughts. Session 7: practical recommendations. Session 8: review and maintenance Control group: No intervention Psychological distress based on DASS21 scale score. Timepoint: Before the start of the intervention - immediately after the end of the intervention - one month after the end of the intervention. Method of measurement: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21). Well-being score in keyes Mental health continuum short form (MHC-SF). Timepoint: Before the start of the intervention - immediately after the end of the intervention - one month after the end of the intervention. Method of measurement: Mental health continuum short form (MHC-SF). Urmia university Approved 2023-05-31 Research Ethics Committees of Urmia University 11th km of SERO Blvd. Urmia, West Azarbayjan, Iran Urmia West Azarbaijan Iran (Islamic Republic of)