Protocol summary

Study aim
Developing and effectiveness of behavioral, emotional and spiritual therapy protocol on obsessive-compulsive symptoms, scrupulosity, fusion of thought and action and rumination
Design
In this study, 40 people who refer to Qom counseling centers who volunteer for obsessive-compulsive disorder will be selected by available sampling.. Also, the sample size in similar studies is 30 people who are randomly placed and matched in two experimental and control groups. Of course, 40 people are selected to increase the credibility of the study and considering the possibility of falling. The two experimental and control groups will be matched based on the variables of age, marriage, education and history of obsession.
Settings and conduct
Qomaz Counseling Centers The clients of Qom city counseling centers who meet the criteria for entering the research, 40 participants are selected and invited to participate in the research. Participants complete the questionnaires one week before starting treatment. The assessment will be performed by psychometricians who are unaware of the research hypotheses. Participants are then divided into experimental and control groups. The control group is on the waiting list.
Participants/Inclusion and exclusion criteria
Male gender 2- The person has obsessive-compulsive disorder (obsessive-compulsive disorder and compulsive behavior ‌ has both) 4- The person has a history of obsession for at least six months and a maximum of 5 years Top
Intervention groups
behavioral, emotional and spiritual therapy protocol on obsessive-compulsive symptoms
Main outcome variables
obsessive-compulsive symptoms, scrupulosity, fusion of thought and action and rumination in patients with OCD

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211120053117N1
Registration date: 2022-02-16, 1400/11/27
Registration timing: retrospective

Last update: 2022-02-16, 1400/11/27
Update count: 0
Registration date
2022-02-16, 1400/11/27
Registrant information
Name
Mohammad Farhoush
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3778 0659
Email address
farhoush.mohammad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-01, 1400/09/10
Expected recruitment end date
2021-12-31, 1400/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Developing and effectiveness of behavioral, emotional and spiritual therapy protocol on obsessive-compulsive symptoms, scrupulosity, fusion of thought and action and rumination in patients with OCD.
Public title
effectiveness of behavioral, emotional and spiritual therapy protocol on obsessive-compulsive symptoms
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
gender Man Diagnosis of obsessive-compulsive disorder based on a structured clinical interview based on the DSM-5 conducted by a specialist psychologist and also a person with a score of more than 10 on the Yale Brown Obsessive Questionnaire. The person has obsessive-compulsive disorder (obsessive-compulsive disorder and compulsive behavior ‌ have both) The person has a history of obsession for at least six months and a maximum of 5 years The age of the person is 18 to 40 years Diploma level higher Be prepared and satisfied to attend all treatment sessions. Complete all research questionnaires. Volunteer to treat obsessive-compulsive disorder. Has not received treatment for obsessive-compulsive disorder in the last trimester.
Exclusion criteria:
Mental Retardation, Psychotic Disorders, Type 1 Bipolar Disorder, Severe Personality Disorder, Severe Depressive Disorder, Substance Abuse Disorder Receive concurrent psychological interventions. Receive medication intervention simultaneously.
Age
From 18 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, 40 people who meet the inclusion criteria are selected. They are then sorted by age and education and will be divided into experimental and control groups. Finally, it is assessed that the two groups are peer based on the variables of age, marriage, education.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are not aware that they are in the experimental or control group. The therapist also does not know. So the two heads are blind. But the researcher who collects and analyzes the data knows.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Semnan University of Medical Sciences and Health services
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran.
City
semnan
Province
Semnan
Postal code
35147-99442
Approval date
2021-07-27, 1400/05/05
Ethics committee reference number
IR.SEMUMS.REC.1400.101

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-compulsive symptoms
Timepoint
Before the intervention and after the intervention
Method of measurement
Yale Brown Questionnaire

Secondary outcomes

1

Description
rumination
Timepoint
Before and after the intervention
Method of measurement
rumination questionnaire

2

Description
scrupulosity
Timepoint
Before and after the intervention
Method of measurement
peen inventory of scrupulosity

3

Description
obsessive beliefs
Timepoint
Before and after the intervention
Method of measurement
obsessive beliefs questionnarie

4

Description
fusion of thought and action
Timepoint
Before and after the intervention
Method of measurement
thought fusion instrument

Intervention groups

1

Description
Intervention group: behavioral, emotional and spiritual therapy The total treatment plan is 15 sessions of 90 minutes, the first 8 sessions are held in four weeks and the next 7 sessions are held once a week. The objectives of the sessions are: 1) Establishing a therapeutic relationship and explaining the disease cycle and the logic of treatment 2) Positive secondary spiritual evaluation of negative thoughts 3) Review and completion of positive secondary spiritual evaluation of negative thoughts 4) Accepting doubts 5) Self-relaxation training 6) Reducing thought fusion and Action 7) Mindfulness skills about negative thoughts and feelings 8) Facing and refraining from responding 9) Accepting doubts and managing behavior in practical obsession 10) Regulating emotion to reduce vulnerability 11) Mindfulness skills mixed with spirituality 12) Removing barriers In the hierarchy of exposure and inhibition of response 13) removal of barriers to exposure and inhibition of response 14) increase in quality of life 15) prevention of recurrence and lifestyle modification. In order to achieve these goals, behavioral therapy techniques and mindfulness, acceptance and commitment therapy techniques are used.
Category
Treatment - Other

2

Description
Control group: During the intervention in the experimental group, they do not receive treatment and wait in line, and after the intervention in the experimental group, they receive the treatment due to the research ethics.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Qom Seminary Counseling Center
Full name of responsible person
Jalal Erfani
Street address
safaeeie
City
Qom
Province
Ghoum
Postal code
3719159697
Phone
+98 25 3783 8081
Email
ahmaderfani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
parviz kokhaei
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran.
City
semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3345 2199
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
mohammad farhoush
Position
phd student of psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 27, Aftab Complex, Alley 5, Shahid Ghodoosi St., 75 meters Amaryasar, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3719159697
Phone
+98 25 3778 0659
Email
farhoush.mohammad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
mohammad farhoush
Position
phd student of psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 27, Aftab Complex, Alley, Shahid Ghodoosi St.,75 meters Amaryasar, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3719159697
Phone
+98 25 3778 0659
Email
farhoush.mohammad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
mohammad farhoush
Position
phd student of psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 27, Aftab Complex, Alley 5, Shahid Ghodoosi St., 75 meters Amaryasar, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3719159697
Phone
+98 25 3778 0659
Email
farhoush.mohammad@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All participants' information is shared by deleting their names.
When the data will become available and for how long
Access period starts one year after the results are published
To whom data/document is available
Only faculty members in the field of psychology
Under which criteria data/document could be used
Meta-analysis is allowed
From where data/document is obtainable
Email farhoush.mohammad@gmail.com and request
What processes are involved for a request to access data/document
Finally, the data will be sent one week after the request
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