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IRCT20200219046553N1 IRCT 2020-04-03 Kashan University of Medical Sciences Effect of mindfulness-based cognitive therapy in patients with inflammatory bowel disease Effect of mindfulness-based cognitive therapy on quality of Life , emotional symptom , dimensions of pain , dispositional mindfulness and disease activity in patients with inflammatory bowel disease 2020-06-21 anticipated 50 Complete https://irct.ir/trial/46526 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: As the patients in this study are patients with inflammatory bowel disease are active phase , these patients are subdivided into mild to moderate and moderate to severe subgroups (the severity of symptoms and medications used varies). In this regard, intervention and control groups will be matched, Randomization description: In this study people are placed in two groups, the intervention group and the control group, using simple randomization method. random number table is used for implement this method. First, the researcher determines the direction of reading the numbers. The researcher then considers even numbers for the intervention group and odd numbers for the control group. The researcher lays his hand on one of the numbers and moves in a predetermined direction, recording the numbers and assigning them to the groups. N/A Condition 1: Mindfulness-based cognitive therapy(MBCT). Condition 2: Crohn's disease. Condition 3: Ulcerative colitis. Condition 4: Depression. Condition 5: Anxiety. Intervention 1: Intervention group:These people receive mindfulness-based cognitive therapy in addition to their usual medical treatment.Mindfulness-based cognitive therapy (MBCT) is an evidence-based psychological group program designed to help manage stress and depressive symptoms. MBCT is an 8-week, facilitator-led, group-based psychological intervention. In addition to the 2-h weekly group sessions, there is a guided home practice component for up to 45 min a day. Within the 8 weeks, participants practice a series of mindfulness meditation, cognitive-behavioural therapy and stretching exercises within the group and at home. During the programme, participants become more aware of their body sensations, thoughts and emotions and their interrelatedness. Intervention 2: Control group: People in the control group receive their usual medical treatment as before, and during the study period follow-up sessions are held to monitor the status of these patients (including the possibility of exacerbation of symptoms). The sessions also explain the inflammatory bowel disease and its complications, and participants discuss the symptoms they are experiencing. Yes - There is a plan to make this available What will be shared: Participant data file available after the people's identity was removed.This data includes consent, blood test and questionnaires completed by participants before and after the intervention. The study protocol and the results of the statistical analysis of the data and the results of the study are also published. How to perform the intervention will be available in the form of audio files from the sessions, if possible.The data dictionary will also be shared. When: The start of the data access period is after the results are published To whom: Researchers working in academic and scientific institutions, people working in health centers, participants in this study Conditions: Use of data from this study for new studies is permitted by citing the source.Also, The data from this study will be made available to health centers to improve treatment plans if necessary. Study results will also be made available to participants Where to obtain: Applicants should send an email to the following email address for the required documentation. hosseinpoor.sarah74@gmail.com How to obtain: After submitting a request and reviewing how the study documentation and data will be used, the data will be made available to applicants. Comments:
public Sara Hosseinpoor
Takhti Blvd
Bruojerd Iran (Islamic Republic of) 6915735457 +98 66 4250 7777 hosseinpoor.sarah74@gmail.com Kashan University of Medical Sciences scientific Sara Hosseinpoor
Takhti Blvd
Bruojerd Iran (Islamic Republic of) 6915735457 +98 66 4250 7777 hosseinpoor.sarah74@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) - Having informed consent to participate in research - Age 18-60 years - Confirmed diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) (by a physician) - Patients should be in the active phase of IBD disease (Mild to moderate, moderate to severe) , not in the remission ,that accompanied by a decrease in symptoms - In the Anxiety, Depression, Stress DASS-21 questionnaire, the individual's score on the depression scale of 10 or higher and / or on the anxiety scale of 8 or higher and / or on the stress scale of 15 or higher - Ability to do light exercise (for example, to lift arms above the head or bend knees) because part of the practices in the program require this movement - Able to commit to attend the eight sessions (participants should consider their personal circumstances to assess if this is practical and feasible for them) - To be able to commit to do home practice of up to 45 minutes daily over the 8 weeks of the study (this is a core component of the program) - No change of antidepressants (dose or type) within the last 3 months 18 years 60 years Both - Major psychiatric illness.(The treatment for a major psychiatric illness may interfere with the program) - Active alcohol or drug dependency -Scheduled for major surgery in the next 3 months - Participation in a pharmacological study or psychological intervention study within the last 6 months or intention to participate in a pharmacological study during the duration of this study - Have recently (within the last 3 months) been prescribed antidepressants - Exacerbation of symptoms and need for change in IBD medication (dose or type) during the study K50 K51 F32.0 F41.9 Crohn's disease [regional enteritis] Ulcerative colitis Major depressive disorder, single episode, mild Anxiety disorder, unspecified Treatment - Other Other Intervention group:These people receive mindfulness-based cognitive therapy in addition to their usual medical treatment.Mindfulness-based cognitive therapy (MBCT) is an evidence-based psychological group program designed to help manage stress and depressive symptoms. MBCT is an 8-week, facilitator-led, group-based psychological intervention. In addition to the 2-h weekly group sessions, there is a guided home practice component for up to 45 min a day. Within the 8 weeks, participants practice a series of mindfulness meditation, cognitive-behavioural therapy and stretching exercises within the group and at home. During the programme, participants become more aware of their body sensations, thoughts and emotions and their interrelatedness Control group: People in the control group receive their usual medical treatment as before, and during the study period follow-up sessions are held to monitor the status of these patients (including the possibility of exacerbation of symptoms). The sessions also explain the inflammatory bowel disease and its complications, and participants discuss the symptoms they are experiencing Quality of life. Timepoint: Before the intervention, after the intervention. Method of measurement: This variable is measured by the short form of the disease-specific IBD quality of life questionnaire (IBDQ-9) . Depression. Timepoint: Before the intervention, after the intervention. Method of measurement: This variable is measured by the depression, anxiety, stress questionnaire (DASS-21). Anxiety. Timepoint: Before the intervention, after the intervention. Method of measurement: This variable is measured by the depression, anxiety, stress questionnaire (DASS-21). Stress. Timepoint: Before the intervention, after the intervention. Method of measurement: This variable is measured by the depression, anxiety, stress Questionnaire (DASS-21). Abdominal pain. Timepoint: Before the intervention, after the intervention. Method of measurement: This variable is measured by the McGill Pain Questionnaire. Pain catastrophizing scale. Timepoint: Before the intervention, after the intervention. Method of measurement: This variable is measured by the Catastrophizing Pain Scale (PCS). Dispositional mindfulness. Timepoint: Before the intervention, after the intervention. Method of measurement: This variable is measured by the mindful, attention, awareness scale (MAAS). Disease activity. Timepoint: Before the intervention, after the intervention. Method of measurement: 1_Clinical index :Crohn's disease activity index (CDAI) and Simple clinical colitis activity index (SCCAI) 2_ Blood sampling from each individual to measure each of the following: 1:CBC (Red blood cell count M/MCL, white blood cell count K/MCL, hematocrit) 2: CRP (C reactive protein level in the blood Mg/L) 3: ESR ( Erythrocyte sedimentation rate per unit time mm/h) 4: Albumin g/dL. Kashan University of Medical Sciences Approved 2020-02-17 Ethics committee of Kashan University of Medical Sciences Unit Three., Taban Building., Hedayati Ave., Takhti Blvd Broujerd Lorestan Iran (Islamic Republic of)