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IRCT20141012019511N4 IRCT 2018-07-12 Islamic Azad University Mindfulness-Based Cognitive Therapy for the Treatment of primary Chronic Headache Pain An Empirical Examination of the Mindfulness‐Based Cognitive Therapy on cognitive adjustment and management of chronic pain in the patient with primary Headache Pain 2017-12-21 anticipated 70 Complete https://irct.ir/trial/30736 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization was the Simple randomization assignment. The Unit of randomization was individual. Random sequence was created via a web-based random number sequencer (http://www.randomizer.org). in order to Hide the random allocation, the individual involved in the implementation of the randomization process was separated from other researchers in order to reduce the probable bias. N/A Primary Headache Pain. Intervention 1: Intervention group: The MBCT for pain approach incorporates one of the strengths of CBT protocols in that cognitive exercises are included that train the mind to be more aware, more often, of cognitions, emotions, behaviors, and pain, and the links between them. Unlike in CBT however, the CBT‐orientedexercises in the MBCT protocol are not aimed toward changing any of these aspects of the moment‐to‐moment experience. Rather they are geared toward simply heightening awareness, thereby providing an entry point to stepping out of automatic pilot and doing mode, and into being mode. In The MBCT protocol, the first half of treatment is focused on enhancing awareness of our habitual patterns, and this awareness is built upon in the second half of treatment to enhance skillful, wise responding (i.e., choosing to intentionally respond rather than react—this is what is meant by “skillful” here).The main modules of MBCT for chronic pain Include session 1; Stepping Out of Automatic Pain Habits, session 2; Facing the Challenge. session 3; The Breath as an Anchor, session 4; Learning to Stay Present, session 5; Active Acceptance, session 6; Seeing Thoughts as Just Thoughts, session 7; Taking Care of Myself, session 8; Harnessing the Power of the Mind for Chronic Pain Management. Intervention 2: Control group: Attention Placebo Control group (APC): Control group that serves as a baseline for comparison for assessment of the effects of the particular intervention. While persons in the treatment group receive the experimental treatment being studied, the attention placebo control group receives a treatment that mimics the amount of time and attention received by the treatment group but is thought not to have a specific effect upon the subjects. Yes - There is a plan to make this available What will be shared: The only part of the data, such as information on the main outcome, that in the present study, is the severity of pain and Some of the secondary outcomes (Depression) variable will be shared. When: Starting the access period from 1399 To whom: Data will only be available to researchers in academia and universities. Conditions: The application of the present study documents is permitted in the development of clinical research and referral in the compilations. Where to obtain: Dr Sarah Namjoo, No 12, Moazzen Blvd, Rajaee Shahr, Karaj, Alborz. Postal code: namjoopsy@gmail.com How to obtain: The applicant for research information can receive a documentation of study at the end of 2018-2019 by email to Dr. Sarah Namjoo. Comments:
public Farhad Assarehzadegan
Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, shahid shahriari Floor, Yaman Ave., Shahid Chamran., Tehran Town
Tehran Iran (Islamic Republic of) 1985717443 +98 23871 fassarzadegan@gmail.com Shahid Beheshti University of Medical Sciences scientific sarah Namjoo
Islamic Azad University of Alborz, Moazen Boulevared, Rajai Street, Karaj, Alborz
Alborz Iran (Islamic Republic of) 1411713135 +98 26 3418 2580 namjoopsy@gmail.com Islamic Azad University Iran (Islamic Republic of) At least 19 years of age At least 3 pain days per month (for the past 3 month) due to a primary headache pain type headache pain was the primary source of pain if currently using psychotropic or headache medications, use of these medications must have begun at least 4 weeks before baseline assessment reading ability was sufficient to comprehend self-monitoring forms 19 years 65 years Both human immunodeficiency virus-related pain and cancer pain because these are associated with malignant disease history of seizure or facial neuralgia, as these conditions might preclude the accurate diagnosis of headache significant cognitive impairment Behavior Placebo Intervention group: The MBCT for pain approach incorporates one of the strengths of CBT protocols in that cognitive exercises are included that train the mind to be more aware, more often, of cognitions, emotions, behaviors, and pain, and the links between them. Unlike in CBT however, the CBT‐orientedexercises in the MBCT protocol are not aimed toward changing any of these aspects of the moment‐to‐moment experience. Rather they are geared toward simply heightening awareness, thereby providing an entry point to stepping out of automatic pilot and doing mode, and into being mode. In The MBCT protocol, the first half of treatment is focused on enhancing awareness of our habitual patterns, and this awareness is built upon in the second half of treatment to enhance skillful, wise responding (i.e., choosing to intentionally respond rather than react—this is what is meant by “skillful” here).The main modules of MBCT for chronic pain Include session 1; Stepping Out of Automatic Pain Habits, session 2; Facing the Challenge. session 3; The Breath as an Anchor, session 4; Learning to Stay Present, session 5; Active Acceptance, session 6; Seeing Thoughts as Just Thoughts, session 7; Taking Care of Myself, session 8; Harnessing the Power of the Mind for Chronic Pain Management. Control group: Attention Placebo Control group (APC): Control group that serves as a baseline for comparison for assessment of the effects of the particular intervention. While persons in the treatment group receive the experimental treatment being studied, the attention placebo control group receives a treatment that mimics the amount of time and attention received by the treatment group but is thought not to have a specific effect upon the subjects. Pain interference. Timepoint: From baseline until 6 months. Method of measurement: The Brief Pain Inventory (BPI). Pain-Related Cognitive Processes. Timepoint: From baseline until 6 months. Method of measurement: Pain-Related Cognitive Processes Questionnaire. Pain intensity. Timepoint: From baseline until 6 months. Method of measurement: Numerical Rating Scale (NRS). Pain intensity. Timepoint: From baseline until 6 months. Method of measurement: The Brief Pain Inventory (BPI). Mindfulness. Timepoint: From baseline until 6 months. Method of measurement: Mindful Attention Awareness Scale (MAAS). Negative Emotions and Affects. Timepoint: From baseline until 6 months. Method of measurement: Depression Anxiety and Stress Scales (DASS-21). Cognitive flexibility. Timepoint: Before the intervention. Method of measurement: Cognitive Flexibility Inventory (CFI). Alexithymia. Timepoint: Before the intervention. Method of measurement: Toronto Alexithymia Scale. Pain Self Efficacy. Timepoint: From baseline until 6 months. Method of measurement: Pain Self Efficacy Questionnaire (PSEQ). Pain Acceptance. Timepoint: From baseline until 6 months. Method of measurement: Chronic Pain Acceptance Questionnaire (CPAQ). Pain Catastrophizing. Timepoint: From baseline until 6 months. Method of measurement: Pain Catastrophizing Scale (PCS). Islamic Azad University Approved 2018-04-18 Ethics committee of Alborz Islamic Azad University of Medical Sciences Islamic Azad University of Alborz, Moazen Boulevared, Rajai Street, Karaj, Alborz Karaj Alborz Iran (Islamic Republic of)