Comparative of dialectic therapy and mindfulness-based cognitive therapy (MBCT) on reduction of anxiety disorder and conversion disorder in patients with heart-like symptoms
Determination of dialectical therapy and mindfulness-based cognitive therapy (MBCT) on reduction of anxiety disorders in patients with heart-like symptoms
Design
The clinical trial will have a control group with randomized parallel groups.
First, based on inclusion and exclusion criteria, the subjects will be selected by available sampling and then the researcher will give each person a special code or number and the subjects will be placed in three groups through simple random sampling using random numbers table. The sample size in each group was 26 (two experimental groups and one control group).
Settings and conduct
This research is semi-experimental on all patients with cardiac-like symptoms referred to Ahmadiye Clinic.The IAS and SCL-90-R questionnaires will be completed by three groups. The experimental group will be performed in 8 sessions of 90 minutes.
Participants/Inclusion and exclusion criteria
Entry criteria:
Lack of cardiac symptoms, high score of conversion disorders and anxiety of the disease, Not participating in other treatment programs at the same time.
Exclusion criteria:
Not receiving individual counseling, not receiving psychotherapy drugs during study, reluctance to participate in research.
Intervention groups
Two experimental groups (dialectic therapy and cognitive therapy based) and one control group
Comparative of dialectic therapy and mindfulness-based cognitive therapy (MBCT) on reduction of anxiety disorder and conversion disorder in patients with heart-like symptoms
Public title
Comparison of DBT and MBCT on reduction of anxiety disorder and conversion disorder comparing dialectical therapy and mindfulness on reduction of anxiety disorder and conversion disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of cardiac symptoms based on the diagnosis of a cardiologist, high score of conversion disorders and anxiety of the disease, Not participating in other treatment programs at the same time
Exclusion criteria:
Not receiving individual counseling, not receiving psychotherapy drugs during study, unwillingness to participate in research
Age
From 20 years old to 70 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
First, based on inclusion and exclusion criteria, the subjects will be selected by available sampling and then the researcher will give each person a special code or number and the subjects will be placed in three groups through simple random sampling using random numbers table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Torbat Heydariyeh University of Medical Sciences
Street address
Razi Ave, Ferdowsi Blvd
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
7323546785
Approval date
2022-05-24, 1401/03/03
Ethics committee reference number
IR.THUMS.REC.1401.007
Health conditions studied
1
Description of health condition studied
Anxiety disorder
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
2
Description of health condition studied
Conversion disorder
ICD-10 code
F44
ICD-10 code description
Dissociative and conversion disorders
Primary outcomes
1
Description
Anxiety of the disease
Timepoint
3 months
Method of measurement
Attitude to Disease Scale
2
Description
Conversion disorder
Timepoint
3 months
Method of measurement
Mental Disorder Questionnaire
Secondary outcomes
1
Description
Anxiety disorder, developmental disorder
Timepoint
3 months
Method of measurement
Attitude to Disease Scale and Mental Disorder Questionnaire
Intervention groups
1
Description
Intervention Group 1: Dialectical behavior is a method based on four components of mind awareness, dyslexia tolerance, emotional regulation and interpersonal efficacy and can reduce the suffering of people involved in problems of disease anxiety and conversion disorder. One of the main skills of dialectical behavioral is emotion regulation skills that can improve mental disorders such as anxiety, conversion disorder, depression. Implementation of this intervention by training sessions based on the content of Linhan protocol including: 1.Emotion dominance 2.Reduction of physical and cognitive vulnerability 3.Increase in positive emotions 4.Lack of judgment 5.Problem solving 6.Feedback will be held for 8 sessions 90 minutes two sessions per week.
Category
Behavior
2
Description
Intervention Group 2: Mindfulness-based therapy is a method that focuses on the present in a purposeful and judgment-free manner. The main part of mindfulness focuses on mindfulness training and its applications in coping with anxiety, conversion disorders and pain. Mindfulness has shown some successes in improving quality of life, resilience, reducing anxiety, acquiring self-control skills, and emotional regulation. The implementation of this intervention will be conducted by training sessions based on the content of Crane's treatment protocol including: 1.acceptance 2. Living at the moment 3.Creating a good sense 4.Cognitive dissociation strategies 5.Clarification of values 6.Committed action will be held for 8 sessions of 90 minutes two sessions per week.
Category
Behavior
3
Description
Control group: No intervention is received.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahmadiyya Specialized Clinic of Torbat Heydarieh University of Medical Sciences
Full name of responsible person
Dr. Babak Mashayekhi
Street address
Shura Street, Ferdowsi Boulevard
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
6578332456
Phone
+98 51 5222 6016
Email
ghodratia1@thums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rezaei Manesh
Street address
Shura Street, Ferdowsi Boulevard
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
5968334587
Phone
+98 51 5222 6013
Email
rezayimaneshmr1@thums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Torbate-Heidaria University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Abbas Ghodrati
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Razi Street, Ferdowsi Boulevard
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
4456783456
Phone
+98 51 5222 6015
Email
ghodratita171@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Abbas Ghodrati
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Razi Street, Ferdowsi Boulevard
City
تریت حیدریه
Province
Razavi Khorasan
Postal code
5567897654
Phone
+98 51 5222 6015
Email
ghodratita171@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Abbas Ghodrati
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Razi Street, Ferdowsi Boulevard
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
5589767894
Phone
+98 51 5222 6015
Email
ghodratita171@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD