Comparison of emotional schemas therapy augmented exposure and response prevention, drug therapy and exposure and response prevention treatment on obsessive-compulsive, anxiety and depression symptoms, obsessional beliefs and quality of life in people with obsessive - compulsive disorder
-Compilation, validation and initial impact of the STERP protocol.
- Determining the difference in the effectiveness of treatment of STERP in obsessive compulsive disorder
Design
The present study has been developed in two stages: protocol development, validation, and clinical testing.
In the first stage, after integrating the two protocols and evaluating by experts, for the purpose of validating the protocols, the protocol will be implemented using a case study on 3 patients with Obsessive-compulsive disorder (OCD).
In the next step, after coordinating with the centers, patients are referred based on a psychiatrist's diagnosis and a research associate, evaluates patients with SCID-5-CV and SCID-5-PD. Finally, according to the inclusion criteria, 45 patients with Obsessive-compulsive disorder (OCD) are selected through targeted sampling.then,15 patients are randomly assigned to Emotional Schemas Therapy augmented exposure and response prevention, and 15 patients of prevention and response prevention, and 15 receive only drug treatment.
Settings and conduct
This study will be carried out at Psychiatric Institute and Imam Hossein Hospital in Tehran.
The main therapist and patients do not know how to allocate to treatment groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diagnosis of obsessive-compulsive disorder(OCD); being at the age of 18 to 50 years.
Exclusion criteria: suicidal thoughts; psychotic disorder based on SCID-5-CV; substance abuse and dependence; severe personality disorders based on SCID-5-PD
Intervention groups
Intervention group 1:Emotional Schemas Therapy augmented exposure and response prevention.
Intervention group 2:exposure and response prevention treatment.
Control group: drug therapy.
Main outcome variables
Anxiety - Obsessive beliefs - Quality of life - Obsessive symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141108019855N7
Registration date:2019-01-28, 1397/11/08
Registration timing:registered_while_recruiting
Last update:2019-01-28, 1397/11/08
Update count:0
Registration date
2019-01-28, 1397/11/08
Registrant information
Name
Samira Masumian
Name of organization / entity
Tehran Psychiatry Institue
Country
Iran (Islamic Republic of)
Phone
+98 21 3349 6990
Email address
samira.masumian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of emotional schemas therapy augmented exposure and response prevention, drug therapy and exposure and response prevention treatment on obsessive-compulsive, anxiety and depression symptoms, obsessional beliefs and quality of life in people with obsessive - compulsive disorder
Public title
The effect of emotional Schemas Therapy augmented exposure and response prevention on obsessive - compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having Diagnostic Criteria for Obsessive-Compulsive Disorder
Having at least a cycle education level
Having a minimum age of 18 and a maximum of 50 years
Exclusion criteria:
Suicidal thoughts
Psychotic disorder based on SCID-5-CV
Substance use and abuse and dependence on any substance
severe personality disorders
Age
From 18 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Patients enter the treatment groups based on the lottery
Blinding (investigator's opinion)
Double blinded
Blinding description
In addition to the original researcher, the evaluator is also blind.
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
Next to Milad Tower, Hemat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶-۱۴۵۳۵
Approval date
2018-10-23, 1397/08/01
Ethics committee reference number
IR.IUMS.REC.1397.175
Health conditions studied
1
Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Obsessive symptoms
Timepoint
Before, immediately after and two months after treatment
Intervention group: Emotional Schemas Therapy augmented exposure and response prevention: In the initial stage (sessions 1-3), establishing a therapeutic relationship, measuring and evaluating emotional schemas, formulating the case, providing treatment logic and therapeutic goals, teaching on obsessive-compulsive disorder, and presenting a model of anthropology and explaining the treatment of emotional schema Preliminary explanation and presentation of the logic of confrontation and prevention of a brief response, attention to the patient's adaptive and non-adaptive emotions, and the presentation of the task of emotional functioning are emphasized.In the changing phase (sessions 4-10), addressing the patient's painful excitement and patient emotional schemas, and designing behavioral experiments to challenge them, presenting the task, describing emotions and challenges with troublesome emotional schemas (accepting emotions, validating emotions ) Is considered. Also, confrontational meetings begin by identifying anxiety and hierarchy.In the final phase (sessions 10-14), focusing on transferring new skills and achievements to the living environment and preventing recurrence is carried out, and the final summing up of the lessons is assessed and reassessed.
Category
Treatment - Other
2
Description
Intervention group 2: exposure and response prevention; The focus of these meetings is on: Reviewing the patient's reactions to the previous treatment session, Assessing the task of the previous session, logic of treatment and self-review forms, Collecting detailed information from obsessive-compulsive symptoms, Providing a hierarchy of all anxious situations, Performing confrontation with initial cases in a hierarchy (starting to confront situations with moderate anxiety), Providing treatment plan, Providing final summaries and feedback.
Category
Treatment - Other
3
Description
Control group: drug therapy: the patients in the control group received SSRIs.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hosein Hospital
Full name of responsible person
Samira Masumian
Street address
Mansouri Alley, Nayesh Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1616
Email
samira.masumian@yahoo.com
2
Recruitment center
Name of recruitment center
Institute of Psychiatry
Full name of responsible person
Samira Masumian
Street address
Mansouri Alley, Nayesh Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1616
Email
samira.masumian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
samira masumian
Street address
Mansouri Alley, Nayesh Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1616
Email
samira.masumian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Samira Masumian
Position
PhD candidate in clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Mansouri Alley, Nayesh Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1616
Email
samira.masumian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samira Masumian
Position
PhD candidate in Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Mansouri Alley, Nayesh Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1616
Email
samira.masumian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samira Masumian
Position
PhD candidate in Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Mansouri Alley, Nayesh Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 3349 6990
Email
samira.masumian@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
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only information about the outcome
When the data will become available and for how long
2019
To whom data/document is available
Therapists and Clinical Specialists
Under which criteria data/document could be used
Treatment
From where data/document is obtainable
Tehran Psychiatric Institute
What processes are involved for a request to access data/document