Design and implementation of the package of spiritual psychotherapy to treat clients with obsessive- compulsive disorder (OCD), and comparison of its effectiveness with cognitive behavior therapy (CBT)
The aim of this study is to design a spiritual psychotherapy package for clients with obsessive-compulsive disorder and to evaluate its validity. A randomized clinical trial was also conducted to compare the effectiveness of spiritual psychotherapy with cognitive-behavioral therapy for patients with OCD.
Design
firstly the Spiritual Psychotherapy package is designed for people with OCD, then face and content validity is also evaluated using focus group discussions with experts. 30 clients with OCD are randomly assigned to two intervention programs (spiritual psychotherapy, cognitive-behavioral therapy).
Settings and conduct
This study is performed in the Psychiatry Research Center of TUMS as a randomized clinical trial to compare the two methods of spiritual psychotherapy and cognitive-behavioral therapy for patients with OCD.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the age range of participants 18 to 60; Receiving OCD diagnosis based on diagnostic criteria of DSM-V by a psychiatrist; do not have comorbid disorders; do not have systemic disorders including cardiovascular disease; not using psychiatric medications during one month ago; not using drug or alcohol during one month ago; did not commit suicide; Being literate.
Exclusion criteria: Failure to receive a diagnosis of OCD; clients aged less than 18 or more than 60 years; having comorbid disorders; having systemic disorders; used psychiatric medications during one month ago; used drug or alcohol during one month ago; Having a history of suicide attempts; Being illiterate.
Intervention groups
The two interventions of spiritual psychotherapy and cognitive-behavioral therapy are randomly performed for 15 clients with OCD and the results are compared.
Main outcome variables
OCD symptoms; the scores of thought–action fusion; the scores of obsessive beliefs.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120225009127N4
Registration date:2020-12-14, 1399/09/24
Registration timing:prospective
Last update:2020-12-14, 1399/09/24
Update count:0
Registration date
2020-12-14, 1399/09/24
Registrant information
Name
Maryam Salmanian
Name of organization / entity
Tehran University of medical sciences, psychiatry and psychology research center
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 3540
Email address
marysal1981@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and implementation of the package of spiritual psychotherapy to treat clients with obsessive- compulsive disorder (OCD), and comparison of its effectiveness with cognitive behavior therapy (CBT)
Public title
Design of the package of spiritual psychotherapy to treat clients with obsessive- compulsive disorder (OCD), and comparison of its effectiveness with cognitive behavior therapy (CBT)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. the age range of participants between 18 to 60. 2. Receiving OCD diagnosis based on diagnostic criteria of DSM-V by a psychiatrist. 3. do not have comorbid disorders such as bipolar disorder, psychosis, pervasive developmental disorder, mental retardation, and substance abuse. 4. do not have systemic disorders including cardiovascular disease. 5. not using psychiatric medications during one month ago. 6. not using drug or alcohol during one month ago. 7. did not commit suicide. 8. Being literate.
Exclusion criteria:
1. Failure to receive a diagnosis of OCD by a psychiatrist. 2. clients aged less than 18 or more than 60 years. 3. having comorbid disorders. 4. having systemic disorders. 5. used psychiatric medications during one month ago. 6. used drug or alcohol during one month ago. 7. Having a history of suicide attempts. 8. Being illiterate
Age
From 18 years old to 60 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
In this study, a simple randomization method is performed individually using computer software. Allocation concealment is not used.
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
Ethics committee of Tehran University of Medical Sciences
Street address
Psychiatry and Psychology Research Center, Roozbeh Hospital, South Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1333715914
Approval date
2020-11-21, 1399/09/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.816
Health conditions studied
1
Description of health condition studied
obsessive- compulsive disorder (OCD)
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
obsessive–compulsive disorder (OCD) symptoms
Timepoint
before and after intervention, and 3 months after the intervention
Method of measurement
The Yale–Brown Obsessive Compulsive Scale (Y-BOCS)
2
Description
the scores of thought-moral action, thought-action-probability action for others, thought-action-probability action for self
Timepoint
before and after intervention, and 3 months after the intervention
Method of measurement
Thought–action fusion (TAF)
3
Description
the scores of sense of responsibility / overestimation of risk, perfectionism / inability to tolerate uncertainty, importance / control of thoughts
Timepoint
before and after intervention, and 3 months after the intervention
Method of measurement
Obsessive beliefs questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, firstly the Spiritual Psychotherapy package is designed for people with OCD, then face and content validity is also evaluated using focus group discussions with experts. 30 clients with obsessive-compulsive disorder are randomly assigned to two intervention programs (spiritual psychotherapy, cognitive-behavioral therapy). The spiritual psychotherapy package is presented in twelve 90-minute group sessions, two sessions per week, for 15 clients with OCD, by a familiar spiritual psychotherapist who is proficient in performing the spiritual psychotherapy package. Spiritual psychotherapy sessions include: Familiarity with the treatment framework and obsessive-compulsive disorder. Realization and analysis of obsessive beliefs. Responsibility. Flexibility and quitting habits. Targeting. Forgiveness. Love of self. Love of others, work and belongings. Belief in sacred. Spiritual awareness, belief in transformation and change of religious obsessions. Prepare for the end and prevent recurrence.
Category
Behavior
2
Description
Intervention group: 30 clients with obsessive-compulsive disorder are randomly assigned to two intervention programs (spiritual psychotherapy, cognitive-behavioral therapy). Cognitive-behavioral therapy protocol is presented for 15 clients with obsessive-compulsive disorder in the twelve 90-minute group sessions, two sessions per week, by a psychotherapist who is proficient in cognitive-behavioral therapy.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatry and Psychology Research Center, Roozbeh Hospital
Full name of responsible person
Maryam Salmanian
Street address
Psychiatry and Psychology Research Center, Roozbeh Hospital, South Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 3540
Email
marysal1981@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Vice Chancellor in Research Affairs, sixth floor, first of Ghods St, Tehran University of Medical Sciences, Keshavarz Blvd, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Web page address
https://vcr.tums.ac.ir/#
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Salmanian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Psychiatry and Psychology Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 3540
Email
m-salmanian@alumnus.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Salmanian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Psychiatry and Psychology Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 3540
Email
m-salmanian@alumnus.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Salmanian
Position
Asisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Psychiatry and Psychology Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 3540
Email
m-salmanian@alumnus.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available