The Study of the Effectiveness of Acceptance and Commitment Therapy (ACT) and drug intervention on Severity of Symptom and Quality ofLife in Obsessive Compulsive Patients
Determining and Comparing the Effectiveness of Acceptance and Commitment-Based Therapy (ACT) and Medication Therapy (SSRIs) on Symptom Severity and Quality of Life in Patients with Obsessive-Compulsive Disorder
Design
The study design is a randomized controlled clinical trial with parallel groups and single-blind .
Settings and conduct
Study place is Specialty Clinic of OCD, Isfahan University of Medical Sciences.Patients are first visited by a psychiatrist to make a definitive diagnosis of obsessive-compulsive disorder, Eligible patients are randomly assigned to groups I and II by a non-therapist. Pre-test and post-test cary out by a psychologist that is unaware of the type of the groups. ACT intervention is administered by a psychologist in group 1 and drug administration by a psychiatrist in group 2. Therapists and evaluators are also unaware of the work.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of Obsessive-Compulsive Disorder based on DSM-5 criteria
2. Ages from 18 to 65 years
3. Education 9 years and up
4. Signing informed consent
Exclusion criteria:
1. Existence of Psychosis , bipolar disorder or mental retardation
2. Serious suicidal thoughts
Intervention groups
The first group receives Acceptance and Commitment Therapy (ACT) . The second group receives routine drug treatment of patients with obsessive-compulsive SSRIs according to the protocol will be Prescribed by the psychiatrist.
Main outcome variables
Decreased severity of obsessive-compulsive symptoms, increased quality of life, reduced symptoms of depression, anxiety and stress.
General information
Reason for update
Acronym
ACT
IRCT registration information
IRCT registration number:IRCT20110815007339N3
Registration date:2020-04-07, 1399/01/19
Registration timing:retrospective
Last update:2020-04-07, 1399/01/19
Update count:0
Registration date
2020-04-07, 1399/01/19
Registrant information
Name
Amrollah Ebrahimi
Name of organization / entity
Isfahan University of Medical Sciences, Isfahan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 31 3625 8818
Email address
a_ebrahimi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-31, 1398/03/10
Expected recruitment end date
2019-07-01, 1398/04/10
Actual recruitment start date
2019-06-07, 1398/03/17
Actual recruitment end date
2019-07-19, 1398/04/28
Trial completion date
2019-09-06, 1398/06/15
Scientific title
The Study of the Effectiveness of Acceptance and Commitment Therapy (ACT) and drug intervention on Severity of Symptom and Quality ofLife in Obsessive Compulsive Patients
Public title
Effectiveness of Acceptance and Commitment Therapy (ACT) in Obsessive Compulsive Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with OCD according to DSM-5 criteria,
age between 18 to 65 years
consenting to participate in research,
without underlying specific physical and other psychological treatments until 30 days before participating in the study
Exclusion criteria:
The presence of psychosis, bipolar disorder or mental retardation
Serious suicidal thoughts
Absolute illiteracy
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
30
Actual sample size reached:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is simply performed by using a random number table via someone other than the treatment team. Eligible patients will be randomly assigned to one of groups A, B, and C.
Blinding (investigator's opinion)
Single blinded
Blinding description
Evaluators and therapists are unaware of what other procedures and what patients are doing. Evaluators evaluate the treatment
several times without knowing the treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
department of Health psychology, Isfahan Univrsity of medical Sciences, Hezarjirib Avn. Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8173955174
Approval date
2015-05-24, 1394/03/03
Ethics committee reference number
IR.MUI.REC.1394.3.103
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
Quality of life, severity of obsessive-compulsive symptoms, severity of symptoms of depression, anxiety, stress
Timepoint
Study start, after study completion, and three months later (follow-up three months)
Method of measurement
By valid questionnaires: quality of life, severity of symptoms. Depression, Anxiety and Stress Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will Receive the standard protocol of Acceptance and Commitment Treatment (ACT)which developed by Steven Hayes. Treatment is offered in 8 sessions of 90 minutes and twice a week. Before, after, and after 3 months follow-up evaluation.
Category
Behavior
2
Description
Control group: This group will receive SSRIs in accordance with the standard and routine pattern prescribed for patients with obsessive-compulsive disorder. The drug is prescribed by a psychiatrist with an obsessive-compulsive research line. The dose of the drug is determined by the patient status and the physician's evaluation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Obsessive-compulsiveness clinic in Isfahan University of Medical Sciences
Full name of responsible person
َAmrollah Ebrahimi
Street address
Western Shariati Ave., Psychosomatic Research Center
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۳۹۴۸۷۶۳
Phone
+98 31 3628 9966
Fax
+98 31 3628 9966
Email
psrc@mui.ac.ir
Web page address
https://psrc.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
معاونت پژوهشی دانشگاه علوم پزشکی اصفهان
Street address
Isfahan University of Medical Sciences, Hezarjirib
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 0042
Email
research@mui.ac.ir
Grant name
research
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Amrollah Ebrahimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
West Shariati Ave, Varpashti, Niloofar Building
City
Isfahan
Province
Isfehan
Postal code
8173955174
Phone
+98 31 3625 8818
Email
a_ebrahimi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amrollah Ebrahimi
Position
associate professor of Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
West Shariati Ave, Varpashti, Niloofar Building
City
Isfahan
Province
Isfehan
Postal code
8173955174
Phone
+98 31 3625 8818
Email
a_ebrahimi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amrollah Ebrahimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
West Shariati Ave, Varpashti, Niloofar Building
City
Isfahan
Province
Isfehan
Postal code
8173955174
Phone
+98 31 3625 8818
Email
a_ebrahimi@med.mui.ac.ir
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
There is no justification for publishing raw data. The trial results are published in scientific paper
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Results will be published in the form of a Final report and a scientific paper
When the data will become available and for how long
After the publication in the Journal
To whom data/document is available
Health Researchers
Under which criteria data/document could be used
Preparation of scientific paper
From where data/document is obtainable
To the responsible author
What processes are involved for a request to access data/document