Effectiveness of Intensive Short term Dynamic Psychotherapy (ISTDP) on the Difficulty in Emotion Regulation, Defense Mechanisms, Quality of Life and Outcome of Treatment in Patients with Irritable Bowel Syndrome
Effectiveness of Intensive Short term Dynamic Psychotherapy (ISTDP) Patients with Irritable Bowel Syndrome
Design
Clinical trial, with control and experimental groups, parallel, one-sided blind, randomized, on 36 patients. A randomization table is used for randomization
Settings and conduct
Gastroenterology Clinic of Rasoul Akram Hospital
Participants/Inclusion and exclusion criteria
Having irritable bowel syndrome based on the diagnosis of a gastroenterologist
affected from Severe physical illness
Intervention groups
In the experimental group, short-term psychodynamic psychotherapy will be used based on John Frederickson's protocol. Both experimental and control groups will complete these questioners before and after the treatment and three months after the treatment : Bowel symptoms severity-frequency scale (BSS-FS) Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL) Difficulties in Emotion Regulation Scale (DERS) Defensive Styles Questionnaire
Main outcome variables
Irritable bowel syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221101056369N1
Registration date:2023-07-25, 1402/05/03
Registration timing:retrospective
Last update:2023-07-25, 1402/05/03
Update count:0
Registration date
2023-07-25, 1402/05/03
Registrant information
Name
Faezeh Shafiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8601 3776
Email address
shafiei.fae@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-07, 1400/07/15
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
2021-10-12, 1400/07/20
Actual recruitment end date
2022-05-15, 1401/02/25
Trial completion date
2023-02-11, 1401/11/22
Scientific title
Effectiveness of Intensive Short term Dynamic Psychotherapy (ISTDP) on the Difficulty in Emotion Regulation, Defense Mechanisms, Quality of Life and Outcome of Treatment in Patients with Irritable Bowel Syndrome
Public title
Effectiveness of Intensive Short term Dynamic Psychotherapy (ISTDP) on the irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having irritable bowel syndrome based on the diagnosis of gastroenterologists and Rome III diagnostic criteria
age between 20-50
education level at least diploma
Exclusion criteria:
Having a significant physical illness based on the interview and history taking from the person
Having a severe psychiatric disorder according to the fifth edition of the Diagnostic and Statistical Manual of Mental Illnesses DSM-5
Absence of more than two sessions in treatment
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
15
Actual sample size reached:
15
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the Restricted Randomization method of block randomization will be used. Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process, so that the number of samples assigned to each of the study groups become equal and in this study, we will have 4 blocks. Random allocation software is used that this random sequence generation software in addition to simple randomization are able to generate random sequence by blocking method. Allocation concealment is also used, which is the method used to execute a random sequence on study participants. In such a way that the assigned group is not known before the individual is assigned. Using Sequentially numbered, sealed, opaque envelopes, each random sequence created is recorded on a card. And the cards are placed in the envelopes of the letter, respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Evaluator and statistical analysts are blind to the research process. Statistical analyst is blind to research so that data analysis can be done without bias
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran university of Medical Sciences
Street address
Iran Univesity of Medical Sciences fifth floor
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-09-21, 1400/06/30
Ethics committee reference number
IR.IUMS.REC.1400.566
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
Difficulties in emotion regulation
Timepoint
before the intervention, last session 3 months after the intervention
Method of measurement
Difficulties in Emotion Regulation Scale
2
Description
Irritable bowel syndrome
Timepoint
before the intervention, last session 3 months after the intervention
Method of measurement
Irritable bowel symptoms severity and frequency scale
3
Description
Defense mechanisms
Timepoint
before the intervention, last session 3 months after the intervention
Method of measurement
Defensive Styles Questionnaire
4
Description
Quality of life questionnaire
Timepoint
before the intervention, last session 3 months after the intervention
Method of measurement
Quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Short-term psychodynamic Psychotherapy based on the John Frederickson protocol: At first participants will complete the questionnairs as a pretest. Then they enter the treatment based on the mentioned approach for 6 months. Individual sessions are held weekly. participants will then complete the questionnaires as a post-test. in follow-up phase participants will complete the research questionnaire after 3 months.
Category
Treatment - Other
2
Description
Control group: First, the participants complete the research questionnaires as a pre-test. The control group received no intervention. After 6 months, they will complete the questionnaires as a post-test. In the follow-up phase, after 3 months, the participants will complete the research questionnaires again.