Comparing the Effectiveness of Dug Therapy with Selective Serotonin Reuptake Inhibitors with Inferenced based Therapy Among Obsessive Compulsive Disorder Patients with Good Insight
The current study aims to compare the effectiveness of two drug therapy with selective serotonin reuptake inhibitors and inference based therapy on the recovery of patients with obsessive-compulsive disorder with good insight.
Design
A controlled clinical trial, with parallel groups, purposive sampling, phase 3 on 45 patients. Simple randomization was done.
Settings and conduct
The trial is conducted at the hospital. SSRI within the dose range approved by the Food and Drug Organization of the country starts from the lowest dose and gradually increases. Inference-based therapy is also applied based on the IBT protocol during 12 sessions of 45 minutes.
Participants/Inclusion and exclusion criteria
inclusion criteria: at least third middle school education, no diagnosis of psychotic disorders, no use of psychiatric drugs, no chronic physical illness, age range from 18 to 60 years, and voluntary consent of the patient.
exclusion criteria: comorbidity with personality disorders, chronic physical illness, mental disability, and substance abuse.
Intervention groups
There are 3 levels of intervention:
1. Drug therapy with SSRI and inference-based therapy
2. Drug therapy with SSRI and placebo
3. Control or waiting list group, which receives none of the treatments and placebo.
Main outcome variables
score on the Yale Brown Obsessive Compulsive Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231029059893N1
Registration date:2023-11-25, 1402/09/04
Registration timing:registered_while_recruiting
Last update:2023-11-25, 1402/09/04
Update count:0
Registration date
2023-11-25, 1402/09/04
Registrant information
Name
Samaneh Karbakhsh ravari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3372 3936
Email address
elahe.dori1364@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-11, 1402/08/20
Expected recruitment end date
2024-05-09, 1403/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Dug Therapy with Selective Serotonin Reuptake Inhibitors with Inferenced based Therapy Among Obsessive Compulsive Disorder Patients with Good Insight
Public title
Comparing the Effectiveness of Dug Therapy with Selective Serotonin Reuptake Inhibitors with Inferenced based Therapy Among Obsessive Compulsive Disorder Patients with Good Insight
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obsessive Compulsive Disorder (OCD) Sufferers with Good Insight
At least third middle school education
No diagnosis of psychotic disorders
Not taking psychiatric drugs
Lack of chronic physical illness
Age range from 18 to 60 years
Voluntary consent of the patient
Exclusion criteria:
Comorbidity with personality disorders
chronic physical illness
mental disability
drug abuse
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Among the obsessive-compulsive disorder sufferers with good insight, 45 people will be selected by purposive sampling and will be placed in three groups of (each group, 15 people) drug therapy and inference-based therapy, drug therapy and placebo, and the control group (waiting list) as a simple random replacement. .
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Faculty of Education and Psychology -Shiraz University
Street address
Faculty of Education and Psychology, Shiraz University, Eram Square, Daneshjoo Blvd
City
Shiraz
Province
Fars
Postal code
۸۴۳۳۴ - ۷۱۹۴۶
Approval date
2023-04-18, 1402/01/29
Ethics committee reference number
IR.US.PSYEDU.REC.1402.022
Health conditions studied
1
Description of health condition studied
Obsessive Compulsive Disorder
ICD-10 code
F42.2
ICD-10 code description
Mixed obsessional thoughts and acts
Primary outcomes
1
Description
The patient's score on the Yale Brown Obsessive-Compulsive Scale
Timepoint
Before the start of the intervention and after the end of the intervention
Method of measurement
Yale-Brown Obsessive-Compulsive Scale
Secondary outcomes
1
Description
The patient's score on the World Health Organization Quality of Life questionnaire
Timepoint
Before the start of the intervention and after the end of the intervention
Method of measurement
World Health Organization Quality of Life questionnaire
Intervention groups
1
Description
First intervention group: Drug therapy with SSRIs and inference-based therapy Inference-based therapy is a cognitive therapy that takes place in 24 sessions of 45 minutes over 6 months. The focus of this treatment is on the concept of doubt and the process of inferential confusion, as well as providing therapy assignments at the end of each session to increase the effectiveness of the treatment. Drug therapy is done with sertraline tablets from the class of SSRI drugs. The chemical composition of this pill is in the form of hydrochloride. The dosage is 100 to 200 mg once or twice a day. The minimum usage time is 6 months.
Category
Treatment - Other
2
Description
Second intervention group: Drug therapy with SSRIs and placebo Drug therapy is done with sertraline tablets from the class of SSRI drugs. The chemical composition of this pill is in the form of hydrochloride. The dosage is 100 to 200 mg once or twice a day. The minimum usage time is 6 months. The placebo group will receive 24 sessions of 45 minutes without receiving treatment and inference-based treatment training will undergo formal psychotherapy.
Category
Treatment - Other
3
Description
Control group: Wait list and not receiving any type of treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebne Sina Hospital
Full name of responsible person
Samaneh Karbakhsh Ravari
Street address
next to Bostan 13 Aban, Hafez St.
City
shiraz
Province
Fars
Postal code
7144676541
Phone
+98 71 3228 9604
Email
elahe.dori1364@gmail.com
Web page address
https://ebnesina.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
shiraz university
Full name of responsible person
Mohammad hadi sadeghi
Street address
Faculty of Educational Sciences and Psychology, Shiraz University, Eram Square, Daneshjoo Boulevard
City
shiraz
Province
Fars
Postal code
۸۴۳۳۴ - ۷۱۹۴۶
Phone
+98 71 3613 4000
Email
pr@shirazu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz University of Medical Sciences
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
shiraz university
Full name of responsible person
samaneh karbakhsh ravari
Position
phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Educational Sciences and Psychology, Shiraz University, Eram Square, daneshjoo Boulevard,
City
shiraz
Province
Fars
Postal code
۸۴۳۳۴ - ۷۱۹۴۶
Phone
+98 71 3613 4000
Email
elahe.ori1364@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
shiraz university
Full name of responsible person
Samaneh Karbakhsh ravari
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Educational Sciences and Psychology,Shiraz University, Eram Square,daneshjoo Boulevard
City
Shiraz
Province
Fars
Postal code
۸۴۳۳۴ - ۷۱۹۴۶
Phone
+98 71 3613 4000
Fax
Email
elahe.dori1364@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
shiraz university
Full name of responsible person
samaneh karbakhsh ravari
Position
phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Educational Sciences and Psychology, Shiraz University, Eram Square, daneshjoo Boulevard,
City
shiraz
Province
Fars
Postal code
۸۴۳۳۴ - ۷۱۹۴۶
Phone
+98 71 3613 4000
Email
elahe.ori1364@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available