Comparison of the efficacy of acceptance and commitment therapy in reducing anxiety and obsessive-compulsive symptoms in people with obsessive-compulsive disorder with control group
The main goal of this study is to determine the effectiveness of Acceptance and Commitment Therapy in adolescents with Obsessive-Compulsive disorder.
Design
randomized controlled clinical trial
Settings and conduct
All participants completed demographic questionnaires and Yale Brown's obsessive-compulsive scales for children and anxiety inventory questionnaires before and after the interventions and then immediately after the completion of the course. The intervention is based on the Armstrong and Twohig program (2011). This program runs for 8 sessions per hour in the clinic of the Tehran Psychiatric Institute. The experimental group is in the intervention of this program. And the control group remain in waiting list. The total time of this study will be about one year.
Participants/Inclusion and exclusion criteria
the inclusion criteria will be the 12 to 17 year-old adolescents who are referred to the clinic of the Tehran Psychiatric Institute (Faculty of Behavioral Sciences and Mental Health) and have received OCD diagnosis.
Exclusion criteria include: getting a new psychiatric drug for the past thirty days, or the possibility of changing and starting a new drug during the study, a psychotic disorder, and any cognitive impairment that prevents from participating in the research.
Intervention groups
The intervention group will receive treatment based on acceptance and commitment therapy.
The control group does not receive any intervention and remains in the waiting list.
Main outcome variables
Providing an effective and evidence-based treatment for obsessive-compulsive disorder in adolescents with OCD disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141108019855N5
Registration date:2018-08-24, 1397/06/02
Registration timing:prospective
Last update:2018-08-24, 1397/06/02
Update count:0
Registration date
2018-08-24, 1397/06/02
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
The costs of this study will be provided by the Student Research Committee of Iran University of Medical Sciences.
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of acceptance and commitment therapy in reducing anxiety and obsessive-compulsive symptoms in people with obsessive-compulsive disorder with control group
Public title
Acceptance and commitment therapy for adolescent with obsessive - compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
the 12 to 17 year-old adolescents who are referred to the clinic of the Tehran Psychiatric Institute (Faculty of Behavioral Sciences and Mental Health)
receiving OCD diagnosis by psychiatrist
confirming OCD diagnosis by K-SADS test
Exclusion criteria:
getting a new psychiatric drug for the past thirty days
the possibility of changing and starting a new drug during the study
a psychotic disorder
any cognitive impairment that prevents from participating in the research
Age
From 12 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The present study will include 12 to 17 year-old adolescents who are referred to the clinic of the Tehran Psychiatric Institute (Faculty of Behavioral Sciences and Mental Health) and have received OCD. Once diagnosed by the psychiatrist, to confirm the diagnosis, the K-SADS test will be run by a trained and experienced psychologist.The final sample will consist of 30 participants who will be randomly assigned in either control or experiment groups. To this purpose , the names of all participants will be written and placed in a container. And the other container will contain 30 sheets, on 15 of which will be written control and 15 other experiment. Then two sheets will be drawn from each container.Finally, the name of the individual and the selected group will be written in a list. This work is repeated so that everyone were placed in the control and experiment groups.
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
Iran University of Medical Sciences
Street address
Hemat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-09-10, 1396/06/19
Ethics committee reference number
IR.IUMS.REC 1396.29976
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
anxiety
Timepoint
pretest. one month after beginning, posttest (at the end of 8 session)
Method of measurement
Cattle anxiety scale
2
Description
OCD symtoms
Timepoint
pretest, one month after begining, AND posttest (at the end of 8 session)
Method of measurement
Yale-Brown Obsessive Compulsive Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Acceptance and Commitment Therapy is based on the Armstrong and Twohig Model (2011) will be perform. This intervention is administered in eight weekly sessions lasting one hour .
Category
Treatment - Other
2
Description
Control group: waiting list
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Behavioral Sciences and Mental Health
Full name of responsible person
Mehri moradi, PhD student if clinical psychology
Street address
Faculty of Behavioral Sciences and Mental Health, Shahid Mansouri avenue, Sattarkhan
City
Tehran
Province
Tehran
Postal code
1449614535
Email
mehri.moradi87@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Center for Student Research and Technology Committees
Full name of responsible person
Zahra Mirzaee
Street address
Hemmat highway, Iran University of medical sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Email
mehri.moradi87@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Center for Student Research and Technology Committees
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
Faculty of Behavioral Sciences and Mental Health
Full name of responsible person
Mehri Moradi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Street address
Faculty of Behavioral Sciences and Mental Health, Shahid Mansouri avenue, Sattarkhan
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 4447 9826
Fax
Email
mehri.moradi878@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Behavioral Sciences and Mental Health
Full name of responsible person
Mehri Moradi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Street address
Faculty of Behavioral Sciences and Mental Health, Shahid Mansouri avenue, Sattarkhan
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 4447 9826
Fax
Email
mehri.moradi87@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Behavioral Sciences and Mental Health
Full name of responsible person
Mehri Moradi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Street address
Faculty of Behavioral Sciences and Mental Health, shahid Mansouri avenue, Sattarkhan
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 4447 9826
Fax
Email
mehri.moradi87@gmail.com
Web page address
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
Because if the original data is released, the principle of privacy will be violated.
Study Protocol
No - There is not 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
Yes - There is 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
The study will be reported as an article. And will be published in a credible journal
When the data will become available and for how long
It is not clear yet
To whom data/document is available
This issue depends on the rules of the magazine.
Under which criteria data/document could be used
In order to study and refer in later studies
From where data/document is obtainable
Related sites
What processes are involved for a request to access data/document
No need to request. And you can get a report by referring to the relevant journal.