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IRCT20210714051894N1 IRCT 2021-09-15 Islamic Azad University Comparison of the effectiveness of cognitive-behavioral therapy of insomnia and mindfulness treatment in insomnia Evaluation and comparison of the effectiveness of cognitive-behavioral therapy of insomnia (CBT-I) and mindfulness therapy (MBSR) on sleep quality, insomnia severity, emotional regulation and sleep dysfunctional beliefs in people with insomnia 2020-02-23 anticipated 30 Complete https://irct.ir/trial/57547 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sampling method was random allocation assigned by lot by selecting a paper lot from the bag. Among the patients referred to the Sleep Disorders Clinic of Hazrat Rasool Akram Hospital (PBUH) and private clinics, patients who were diagnosed with insomnia disorder by a psychiatrist and sleep fellowship based on the characteristics mentioned in DSM-5 were selected. Then, out of 68 patients with insomnia, one number was assigned randomly to each group (group 1: CBT-I, group 2: mindfulness, and group 3: control) and these numbers were recorded on paper lotteries and each patient has randomly selected a lottery. N/A Insomnia. Intervention 1: Intervention group: CBT-I: Session 1 (Insomnia assessment) Complete assessment of the nature of insomnia, teaching the patient how to monitor the baseline of sleep through a table of sleep reports for two weeks by the patient (before treatment). Session 2 (Introduction of the components of primary behavioral therapy) A: Introduction of therapeutic logic and criteria of sleep education: Introduction of sleep rules. Insomnia Behavioral Regime: Calculating the Time Allowed to Stay in Bed: Providing Basic Health Training's Sleep: Managing Patient Expectations and Adherence to Treatment G: Homework Session 3 (Introducing Cognitive Therapy Strategies) A: Reviewing and Commenting on Sleep Notes Patient and Demonstration Progress: The Basis and Logic of Cognitive Therapy for the Patient: A discussion of constructive concern techniques. Session 4 (Continuation of cognitive therapy) Review the pre-treatment session, review the findings of the sleep report form and the process of progress and follow the treatment instructions, how to record thoughts related to insomnia, review common cognitive errors in people with insomnia such as all or Nothing, catastrophic, mind-reading. Session 5 (follow-up / problem solving) A: Review and comment on the work of the constructive concern and record the patient's thoughts and show progress B: Adjust the recommendations regarding the time allowed to stay in bed: Review and encourage adherence to the treatment plan: Solve Problem - Behavioral part: Problem solving - Cognitive part. Session 6 (reviewing the end of the treatment period) Reviewing previous assignments, troubleshooting in the areas of cognitive components of treatment, patient homework is reviewed in each session and the necessary instructions are provided. The patient's completed sleep schedule is reviewed weekly and the patient's average sleep efficiency is completed in the previous week. Intervention 2: Intervention group: Mindfulness: 1- Initiating mind: Remember that every night is a new night. Be open and try something different! What you have done so far probably does not work well. 2- Working on changing the patient's mental perspective Lack of effort: Sleep is a process that can not be forced. But instead of letting it be seen, more effort to sleep longer or better will not work. Awareness of the patient of the importance of accepting existing conditions to make a change. This is counterproductive and contradicts the natural process of daily letting go that allows you to fall asleep. Trying to reduce the anxiety caused by the consequences of insomnia 4. Lack of judgment: You can easily judge that waking state is negative and pessimistic, especially if you do not sleep well for a few nights. However, this negative energy can disrupt the sleep process. A clear relationship with sleep can be a useful relaxation topic. Trying to Make a Better Relationship With Sleep 5. Acceptance: Recognizing and accepting your current situation is the first important step in choosing how to respond. If you can accept that you are not drowsy and will probably not fall asleep soon, why not get out of bed? Many people who have trouble sleeping avoid getting out of bed. Unfortunately, spending too much time waking up in bed can keep you awake. Trying to accept the existing conditions in order to start the change process. 6. Trust: Trust your sleep system and let it work for you! Make sure your mind and body can adjust to losing sleep. Knowing that short naps often make you feel more satisfied with fragmented sleep can help you build confidence in your sleep system. Also, sleep deprivation can cause good sleep as long as it is not accompanied by increased effort to sleep well. Confidence in your current sleep state 7. Patience: Be patient! It is unlikely that both the quality and quantity of your sleep will improve immediately. Intervention 3: Control group: In the control group, no intervention was performed simultaneously with the experimental group, but at the end of the intervention in the experimental group, the same treatment was performed for the control group. Yes - There is a plan to make this available What will be shared: In this study, none of the patients' personal studies will be shared and only data related to the main outcome of the intervention will be shared. When: March 2020 to March 2021 To whom: Researchers and researchers Conditions: For further analysis (meta-analysis) Where to obtain: Masoomeh yarahmadi 09123197245 Yarahmady.1980@yahoo.com How to obtain: Data on the variables of insomnia severity, sleep quality, emotional regulation and sleep dysfunctional thoughts were collected and analyzed separately. Comments:
public Masoomeh Yarahmady
Sattar Khan St. - Niayesh St.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6347 1269 Yarahmady.1980@yahoo.com Islamic Azad University scientific Fariba Hafezi
Ahvaz- Kianpars
Ahvaz Iran (Islamic Republic of) 163-61555 +98 61 1443 5288 Febram315@yahoo.com Islamic Azad University Iran (Islamic Republic of) Informed consent to participate in a clinical trial Receiving a lower than average score in the Sleep Quality and Emotional Regulation Questionnaire and a higher than average score in the Insomnia Intensity Questionnaire and dysfunctional sleep beliefs Age between 20 to 50 years Minimum literacy, primary education Lack of sleep drug during the study 20 years 50 years Both Use of psychiatric and hypnotic drugs Taking traditional medicines such as sleeping pills Addiction and alcohol consumption Failure to perform cognitive-behavioral exercises for insomnia and mindfulness exercises G47.0 Insomnia Treatment - Other Treatment - Other Other Intervention group: CBT-I: Session 1 (Insomnia assessment) Complete assessment of the nature of insomnia, teaching the patient how to monitor the baseline of sleep through a table of sleep reports for two weeks by the patient (before treatment). Session 2 (Introduction of the components of primary behavioral therapy) A: Introduction of therapeutic logic and criteria of sleep education: Introduction of sleep rules. Insomnia Behavioral Regime: Calculating the Time Allowed to Stay in Bed: Providing Basic Health Training's Sleep: Managing Patient Expectations and Adherence to Treatment G: Homework Session 3 (Introducing Cognitive Therapy Strategies) A: Reviewing and Commenting on Sleep Notes Patient and Demonstration Progress: The Basis and Logic of Cognitive Therapy for the Patient: A discussion of constructive concern techniques. Session 4 (Continuation of cognitive therapy) Review the pre-treatment session, review the findings of the sleep report form and the process of progress and follow the treatment instructions, how to record thoughts related to insomnia, review common cognitive errors in people with insomnia such as all or Nothing, catastrophic, mind-reading. Session 5 (follow-up / problem solving) A: Review and comment on the work of the constructive concern and record the patient's thoughts and show progress B: Adjust the recommendations regarding the time allowed to stay in bed: Review and encourage adherence to the treatment plan: Solve Problem - Behavioral part: Problem solving - Cognitive part. Session 6 (reviewing the end of the treatment period) Reviewing previous assignments, troubleshooting in the areas of cognitive components of treatment, patient homework is reviewed in each session and the necessary instructions are provided. The patient's completed sleep schedule is reviewed weekly and the patient's average sleep efficiency is completed in the previous week. Intervention group: Mindfulness: 1- Initiating mind: Remember that every night is a new night. Be open and try something different! What you have done so far probably does not work well. 2- Working on changing the patient's mental perspective Lack of effort: Sleep is a process that can not be forced. But instead of letting it be seen, more effort to sleep longer or better will not work. Awareness of the patient of the importance of accepting existing conditions to make a change. This is counterproductive and contradicts the natural process of daily letting go that allows you to fall asleep. Trying to reduce the anxiety caused by the consequences of insomnia 4. Lack of judgment: You can easily judge that waking state is negative and pessimistic, especially if you do not sleep well for a few nights. However, this negative energy can disrupt the sleep process. A clear relationship with sleep can be a useful relaxation topic. Trying to Make a Better Relationship With Sleep 5. Acceptance: Recognizing and accepting your current situation is the first important step in choosing how to respond. If you can accept that you are not drowsy and will probably not fall asleep soon, why not get out of bed? Many people who have trouble sleeping avoid getting out of bed. Unfortunately, spending too much time waking up in bed can keep you awake. Trying to accept the existing conditions in order to start the change process. 6. Trust: Trust your sleep system and let it work for you! Make sure your mind and body can adjust to losing sleep. Knowing that short naps often make you feel more satisfied with fragmented sleep can help you build confidence in your sleep system. Also, sleep deprivation can cause good sleep as long as it is not accompanied by increased effort to sleep well. Confidence in your current sleep state 7. Patience: Be patient! It is unlikely that both the quality and quantity of your sleep will improve immediately. Control group: In the control group, no intervention was performed simultaneously with the experimental group, but at the end of the intervention in the experimental group, the same treatment was performed for the control group. Severe insomnia. Timepoint: At the beginning of the intervention and 8 weeks after the intervention. Method of measurement: Questionnaire Insomnia Severity Index (ISI). Sleep Quality. Timepoint: At the beginning of the intervention and 8 weeks after the intervention. Method of measurement: Pittsburgh Questionnaire. Emotional Regulation. Timepoint: At the beginning of the intervention and 8 weeks after the intervention. Method of measurement: Gross Questionnaire (ERQ). Dysfunctional Sleep Thoughts. Timepoint: At the beginning of the intervention and 8 weeks after the intervention. Method of measurement: Maureen Questionnaire. Islamic Azad University Approved 2020-11-18 Islamic Azad University, Ahvaz Research Sciences Branch Kianpars Ahvaz Khouzestan Iran (Islamic Republic of)