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The Effectiveness of Integrative Therapy, Acceptance and Commitment-Based Therapy, Short-term Psychoanalysis in Alexithymia, Distress and Psychosomatic Symptoms in Gastrointestinal Disorder Patients with High Score in the personality type D

Protocol summary

Study aim
The effectiveness of various treatments in reducing psychosomatic symptoms in patients with gastrointestinal dysfunction type D
Design
A clinical trial with a control group, with parallel, randomized groups, on 48 patients.
Settings and conduct
The statistical population in this study was among all patients with gastrointestinal dysfunction (FGID) who had referred to Hamrah Psychological Institute from September to March.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient cooperation to participate in the research, and complete the consent form, First referral, Minimum 9 years education, Age 60-18 years, Patients with gastrointestinal dysfunction according to ROME III criteria by a gastroenterologist for referral patients, Diagnosis of gastrointestinal dysfunction (IBS), functional indigestion (FD), or both. Do not take psychiatric drugs with the main purpose of reducing emotions (anxiety, etc.). Exclusion criteria: A history of substance abuse or dependence is currently on record during the four months before treatment, Use of any type of psychiatric medication based on the record in the four months before the first treatment session, Use of any kind of psychological and counseling services for any mental disorder I and II,
Intervention groups
Three treatment groups (integrated therapy), (acceptance and commitment therapy) and (short-term psychoanalysis) and a control group were assigned. First, Alexithymia (Toronto-20 Alexithymia Questionnaires), distress (mental distress with general health questionnaire), and assessment of psychosomatic symptoms (Takata and Sakata Psychosomatic Complaints Scale) completed, and then interventions were performed.
Main outcome variables
Anxiety; psychosomatic symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201107049294N1
Registration date: 2021-07-20, 1400/04/29
Registration timing: retrospective

Last update: 2021-07-20, 1400/04/29
Update count: 0
Registration date
2021-07-20, 1400/04/29
Registrant information
Name
Ali Bakhshi Bejestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
ali_bakhshi110@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-05, 1399/06/15
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
2020-09-10, 1399/06/20
Actual recruitment end date
2021-03-10, 1399/12/20
Trial completion date
2021-04-30, 1400/02/10
Scientific title
The Effectiveness of Integrative Therapy, Acceptance and Commitment-Based Therapy, Short-term Psychoanalysis in Alexithymia, Distress and Psychosomatic Symptoms in Gastrointestinal Disorder Patients with High Score in the personality type D
Public title
The effectiveness of various treatments in reducing psychosomatic symptoms in patients with gastrointestinal dysfunction type D
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient cooperation to participate in the research complete the consent form First referral Minimum cycle education Age 60-18 years Patients with gastrointestinal dysfunction according to ROME III criteria by a gastroenterologist for patients referred to a psychiatric clinic Diagnosis of gastrointestinal dysfunction with irritable bowel syndrome (IBS) dyspepsia (FD) or both Do not take psychiatric drugs with the main purpose of reducing emotions (anxiety, etc.)
Exclusion criteria:
A history of substance abuse or dependence is currently on record during the four months prior to treatment Use of any type of psychiatric and psychiatric medication based on the record in the four months before the first treatment session Use of any kind of psychological and counseling services for any mental disorder I and II
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Actual sample size reached: 48
Randomization (investigator's opinion)
Randomized
Randomization description
All 48 participants were sorted alphabetically into a list of 48 people by surname and first name, then using one of the eight random blocks, among possible compositions, which were selected randomly, assigned individuals to 4 groups (three treatment groups and one control group).
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
Ethics Committee of Birjand University of Medical Sciences
Street address
South Khorasan Province, Birjand County, Ayatollah Ghaffari St., University of Medical Sciences
City
Birjand
Province
North Khorasan
Postal code
9717853577
Approval date
2020-07-11, 1399/04/21
Ethics committee reference number
IR.BUMS.REC.1399.163

Health conditions studied

1

Description of health condition studied
Diseases of oesophagus, stomach and duodenum
ICD-10 code
K20-K31
ICD-10 code description
Diseases of oesophagus, stomach and duodenum

Primary outcomes

1

Description
Alexithymia
Timepoint
Before starting, after finishing, two months after finishing.
Method of measurement
Toronto Alexithymia Scale

2

Description
Stress-Anxiety
Timepoint
Before starting, after finishing, two months after finishing.
Method of measurement
DASS-21 Stress-Anxiety-Depression Inventory

3

Description
Psychosomatic Symptoms
Timepoint
Before starting, after finishing, two months after finishing.
Method of measurement
Takata and Sakata Psychosomatic Complaints Scale

4

Description
Gastrointestinal Dysfunction
Timepoint
Before starting, after finishing, two months after finishing.
Method of measurement
ROME-III questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: First group therapy (integrated treatment).Integrated protocol by integrated protocol by Mollajafar et al. (2017) which is a combination of three therapies (cognitive-behavioral, spiritual therapy and therapy based on acceptance and commitment), in eight sessions of one and a half hours and two sessions per week for A month is formed. The following are the steps of the treatment separately for the training sessions.
Category
Behavior

2

Description
Intervention group: Intervention group: Second group therapy (acceptance and commitment based therapy).For acceptance-based behavior therapy, a therapeutic guide was used in the book Acceptance-Based Behavior Therapy by Hysacleton, Roemer, and Arsillo (2011). The treatment sessions consisted of 8 sessions (two sessions per week). The first 4 sessions were aimed at guiding and placing clients in the path of the treatment model, with a time of 90 minutes. The remaining 4 sessions were one hour.
Category
Behavior

3

Description
Intervention group: Intervention group: Third group therapy (short-term psychoanalysis).The content of the sessions according to the short-term psychotherapy psychotherapy guideline, ie the seven stages of questions about problems, pressure, challenge, transfer resistance, direct access to the unconscious, transfer analysis, and scanning in the unconscious (Fooladi et al., 2017), are described in Table 4. Is. These sessions were held for two months (two sessions per week).
Category
Behavior

4

Description
Control group: Only support counseling program
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Institute of Psychology Hamdam Hamrah
Full name of responsible person
Bakhshi
Street address
Tehran - Dolab Head Mill Square. Shiva Street. Haji Amiri Alley. No. 77. The second unit
City
Tehran
Province
Tehran
Postal code
1748873673
Phone
+98 21 3305 5284
Email
ali_bakhshi110@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Majid Aliabadi
Street address
South Khorasan, Birjand city, at the end of Ayatollah Ghaffari Boulevard
City
Birjand
Province
South Khorasan
Postal code
1234567890
Phone
+98 56 3234 5591
Email
ali_bakhshi110@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
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
Islamic Azad University
Full name of responsible person
Ali Bakhshi
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 77, Hadadi Alley, Shiva St., Dolab Head Mill. second floor
City
Tehran
Province
Tehran
Postal code
1764873673
Phone
+98 21 3305 5284
Email
ali_bakhshi110@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Bakhshi
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 77, 2nd Floor, Hadadi Alley, Shiva Alley, Doolab Mill Square
City
Tehran
Province
Tehran
Postal code
1764873673
Phone
+98 21 3305 5284
Email
ali_bakhshi110@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Bakhshi
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 77, 2nd Floor, Hadadi Alley, Shiva Alley, Doolab Mill Square
City
Tehran
Province
Tehran
Postal code
1764873673
Phone
+98 21 3305 5284
Email
ali_bakhshi110@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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