Comparing the Effectiveness of Mindfulness Based Stress Reduction and Acceptance and Commitment Therapy on Physiological and Psychological Symptoms in Inflammatory Bowel Disease
The aim of this study was to determine and compare the effectiveness of Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Stress Reduction (MBSR) on the physiological and psychological symptoms of inflammatory bowel disease.
Design
Subjects were selected by the convenience sampling method and randomly entered each of the experimental and control groups. Each of the two treatments was presented to the experimental groups in 8 sessions and the control group did not receive treatment
Settings and conduct
In this research project that is done in Kerman Gastroenterology and Liver Center, two psychological methods are tested as a group on people with colitis, which aims to improve their psychological and physiological status. This intervention is one-way blind and participants do not know how to intervene and the number of groups.
Participants/Inclusion and exclusion criteria
The target population included all patients with inflammatory bowel disease in Kerman province in Iran who have a medical record in the hospitals of this city.
Intervention groups
Each of the two treatments of ACT and mindfulness based-stress reduction was presented to the experimental groups in 8 sessions and the control group did not receive treatment.
Main outcome variables
Improving the psychological and physiological dimensions of people with colitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190708044156N1
Registration date:2020-12-23, 1399/10/03
Registration timing:retrospective
Last update:2020-12-23, 1399/10/03
Update count:0
Registration date
2020-12-23, 1399/10/03
Registrant information
Name
Fateme Sheikh Ali Saghaie
Name of organization / entity
The University of Shahid Bahonar Kerman
Country
Iran (Islamic Republic of)
Phone
+98 34 3281 9168
Email address
fateme.saghaie@ens.uk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-21, 1398/03/31
Expected recruitment end date
2020-03-04, 1398/12/14
Actual recruitment start date
2019-08-27, 1398/06/05
Actual recruitment end date
2020-07-13, 1399/04/23
Trial completion date
2020-08-12, 1399/05/22
Scientific title
Comparing the Effectiveness of Mindfulness Based Stress Reduction and Acceptance and Commitment Therapy on Physiological and Psychological Symptoms in Inflammatory Bowel Disease
Public title
effective of mindfulness and ACT on inflammatory bowel disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
inflammatory bowel disease patients who have inactive and under control disease
Exclusion criteria:
Patients under 18 years
Patients over 65 years
pregnant females
patients currently attending psychiatric services
patients currently receiving antidepressant medication
patients who have received steroid medications in the past three months
patients who have previously undergone a stress management programme (relaxation techniques, psycho dynamic psychotherapy, cognitive behavioral therapy, hypnosis)
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
160
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
in this study, we will use simple random sampling. participants get an identification number and after lottery, they will be in intervention number 1, intervention number 2 and control group
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding is used in this method of the first type, and the research is one-side blind, and we don't say to patients that they are in which groups study, and it is not necessary to tell patients how many groups in this study is there.
Placebo
Not used
Assignment
Parallel
Other design features
Each of the two treatments was presented to the experimental groups in 8 sessions. The Control group didn't receive any kind of treatment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences ethics committee
Street address
Kerman Medical Sciences Research Center, kerman, Somayeh Crossroads, at the beginning of Jihad Boulevard, at the beginning of Ibn Sina Street
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2019-08-24, 1398/06/02
Ethics committee reference number
IR.KMU.REC.1398.252
Health conditions studied
1
Description of health condition studied
Inflammatory bowel disease
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
Colitis physiological symptoms
Timepoint
before intervention, after intervention and 60 days after intervention
Method of measurement
Partial Mayo Scoring Index Assessment
2
Description
Stress
Timepoint
before intervention, after intervention and 60 days after intervention
Method of measurement
Depression, Anxiety and Stress Scale questionnaire (DASS-21)
3
Description
Anxiety
Timepoint
before intervention, after intervention and 60 days after intervention
Method of measurement
Depression, Anxiety and Stress Scale questionnaire (DASS-21)
4
Description
Depression
Timepoint
before intervention, after intervention and 60 days after intervention
Method of measurement
Depression, Anxiety and Stress Scale questionnaire (DASS-21)
5
Description
quality of life
Timepoint
before intervention, after intervention and 60 days after intervention
Method of measurement
world health quality of life questionnaire (BREF form)
6
Description
General Health
Timepoint
before intervention, after intervention and 60 days after intervention
Method of measurement
general health questionnaire (GHQ-28)
7
Description
pain perception
Timepoint
before intervention, after intervention and 60 days after intervention
Method of measurement
Mcgill pain perception questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
first Intervention group called "Acceptance and commitment therapy": it includes 8 psychological training sessions in 1.5 hours. each session is included one of these subjects: ACT introduction, creative hopelessness, acceptance, cognitive defusion, being in the present moment, self as a context, values, and committed action.
Category
Treatment - Other
2
Description
The second Intervention group called " Mindfulness-based stress reduction": includes 8 psychological training sessions in 1.5 hours. each session is included one of these subjects: MBSR introduction, creative perception, and reaction being body and mind in the present moment, the effect of perception conditioning on momentary and original experiences, stress and its communication with mindfulness, stressful communication, bringing practices to life texture, and continue with mindfulness.
Category
Treatment - Other
3
Description
Control group: Here we have 15 people who are pre-tested and post-tested but no intervention is done to compare with the experimental group.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology and Hepatology Research Center
Full name of responsible person
Bijan Ahmadi
Street address
Gastroenterology and Hepatology Research Center, Afzali-pour Educational and Therapeutic Center, Next to the Shahid Bahonar University, Emam Khomeini Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3325 7470
Fax
Email
paafzali@kmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences,Deputy of Research, Gastroenterology Research Center
Full name of responsible person
Bijan Ahmadi
Street address
Gastroenterology and Hepatology Research Center, Afzali-pour Educational and Therapeutic Center, Next to the Shahid Bahonar University, Emam Khomeini Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3325 7470
Email
paafzali@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences,Deputy of Research, Gastroenterology Research Center
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data obtained from the questionnaires each have a score that only the individual's score in the primary variables with its secondary variables is published and does not refer to the identity of the individual.
When the data will become available and for how long
The onset of the date of access to the information is 6 months after complete treatment and publication of the results.
To whom data/document is available
Only those who are in the field of gastrointestinal diseases and psychology researchers as well as educational centers in these fields and academic fields as well as those who want to complete this plan have the right to receive data and information.
Under which criteria data/document could be used
Researchers in the field of inflammatory bowel disease and all psychologists who seek a change in the brain wave of these individuals through with psychological approach.
From where data/document is obtainable
Refer to Kerman Physiological Research Science Center and Afzalipour Research Center.
What processes are involved for a request to access data/document
After 6 months of the complete process of treatment, if the person requesting the information was among the people who could provide information to him, by asking questions about the impact of this information on the scientific study process or raising his level of knowledge, Its provided to him/her, By consulting with another person who contributing in this schema.