Protocol summary

Study aim
Comparison of the Effectiveness of Cognitive-Behavioral Therapy and Acceptance and Commitment Therapy on Reducing the symptoms of coronary anxiety and obsessive-compulsive disorder (a case study of housewives)
Design
Clinical trial with two control groups and one control group, with parallel groups, simple randomization, on 60 patients. A computer was used for randomization.
Settings and conduct
The research population will include all clients to counseling and psychotherapy centers in Central Province in 1401. Sampling method will be available as sampling. Announcements of participating in educational groups will be reproduced in counseling centers and 60 volunteers will be selected as a sample, taking into account the criteria for entering and exiting the research. Then, based on the list collected in a simple random manner, 20 people were placed in the control group, 20 people in the cognitive-behavioral test group, and 20 people in the acceptance and commitment test group. In this way, the subjects will be randomly placed in different groups. . The research tools will be completed by the members of the experimental and control groups before the intervention.
Participants/Inclusion and exclusion criteria
Entry criteria: having a minimum education, not suffering from acute medical and psychiatric problems, willingness to participate in the study Exclusion criteria: non-satisfaction with cooperation, incomplete questionnaires, and people with severe psychological problems such as major depression and psychosis.
Intervention groups
Cognitive behavioral therapy intervention test was performed on one group and acceptance and commitment based therapy intervention test was performed on the other group. On the control group, the intervention was not implemented and pre-test and post-test were taken.
Main outcome variables
Corona Disease Anxiety; Obsessions Compulsive Disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220702055344N1
Registration date: 2022-07-06, 1401/04/15
Registration timing: registered_while_recruiting

Last update: 2022-07-06, 1401/04/15
Update count: 0
Registration date
2022-07-06, 1401/04/15
Registrant information
Name
Shima Chehrei
Name of organization / entity
Islamic Azad University, Arak Branch
Country
Iran (Islamic Republic of)
Phone
+98 918 363 4903
Email address
sh-chehreii@iau-arak.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Cognitive-Behavioral Therapy and Acceptance and Commitment Therapy on Reducing the symptoms of coronary anxiety and obsessive-compulsive disorder (a case study of housewives)
Public title
Comparison of the Effectiveness of Cognitive-Behavioral Therapy and Acceptance and Commitment Therapy on Reducing the symptoms of coronary anxiety and obsessive-compulsive disorder (a case study of housewives)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a minimum cycle education Absence of acute medical and psychiatric problems Willingness to participate in the study
Exclusion criteria:
Unwillingness to cooperate Incompleteness of questionnaires People with severe psychological problems such as major depression and psychosis
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Clinical trial with two control groups and one control group, with parallel groups, simple randomization, on 60 patients. In this study, a simple random allocation method is used with the help of rand function of Excel software. In this method, a list of numbers from 1 to 60 is prepared. This list of numbers is randomly divided and based on the created list, the participants are divided into two experimental groups (treatment based on cognitive behavioral exposure and treatment based on parenting and commitment) and group Control (the group that does not receive intervention) are assigned.
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
Research Ethics Committees of Islamic Azad University- Arak Branch
Street address
Vice Chancellor for Research and Technology, Islamic Azad University of Arak, Amirkabir Town, 3 km of Khomeini Road University, Imam Khomeini Boulevard, Imam Khomeini Square, Arak
City
Arak
Province
Markazi
Postal code
3836119131
Approval date
2022-05-31, 1401/03/10
Ethics committee reference number
IR.IAU.ARAK.REC.1401.053

Health conditions studied

1

Description of health condition studied
Obsessions Compulsive Disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder

2

Description of health condition studied
Corona Disease Anxiety
ICD-10 code
B97.2
ICD-10 code description
Coronavirus as the cause of diseases classified elsewhere

Primary outcomes

1

Description
Corona Disease Anxiety
Timepoint
Before the intervention and 1 month after the intervention
Method of measurement
Corona Disease Anxiety Scale (Alipour, et al., 2020)

2

Description
Obsessive - compulsive disorder
Timepoint
Before the intervention and 1 month after the intervention
Method of measurement
Maudsley obsessive compulsive inventory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The first experimental group will be trained with cognitive behavioral approach (CBT) by the researcher in 8 one-hour sessions. The content of the training sessions will be based on the cognitive behavioral intervention protocol developed by Wright et al. (2017). Meetings will be held regularly and twice a week. The content of the training sessions is as follows: First session: introduction and explanation of cognitive behavioral therapy; The second session: increasing the conceptual framework about the participant; Third session: Target selection and determination of treatment goals with the help of Yimar and activity planning; The fourth session: identifying and recognizing spontaneous thoughts, practicing recording thoughts and assigning them to the patient as homework; The fifth session: changing and correcting spontaneous thoughts, teaching techniques for replacing logical thoughts; Sixth session: recognition of cognitive errors; The seventh session: designing graded assignments, using visual confrontation techniques; Eighth session: Homework review, answering patient's questions and summarizing.
Category
Treatment - Other

2

Description
Intervention group: The training sessions of the second experimental group will be held by the researcher in 8 two-hour sessions with the approach of acceptance and commitment. Meetings will be held regularly and twice a week. The content of the training sessions is as follows: the first session: introducing and familiarizing the members with each other and introducing the treatment; Second session: receiving feedback from clients and discussing their experiences and evaluation; The third session: identifying and defining effective and ineffective coping strategies; The fourth session: duty and behavioral commitment and introduction and understanding of self-conceptualized integration; Session 5: Showing separation to self and inner experiences; Sixth session: identifying the values ​​of patients' lives, using mindfulness techniques with emphasis on the present; Seventh session: Examining the values ​​of each person and deepening previous concepts, goals and common mistakes in choosing values ​​and possible internal and external obstacles in following values; Eighth session: Understanding the nature of desire and commitment and identifying behavioral plans in accordance with values ​​and making a commitment to act on them.
Category
Treatment - Other

3

Description
Control group: does not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Counseling and psychotherapy centers of Markazi province
Full name of responsible person
Shima Chehrei
Street address
Arak
City
Arak
Province
Markazi
Postal code
3836119131
Phone
+98 918 363 4903
Email
Sh-chehreii@iau-arak.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Arak Branch
Full name of responsible person
Ali Hasani Joshaghani
Street address
Vice Chancellor for Research and Technology, Islamic Azad University of Arak, Amirkabir Town, 3 km of Khomeini Road University, Imam Khomeini Boulevard, Imam Khomeini Square, Arak
City
Arak
Province
Markazi
Postal code
3836119131
Phone
+98 86 3341 2101
Email
Ahj_ir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Arak Branch
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
Islamic Azad University, Arak Branch
Full name of responsible person
Mahta Sadeghi
Position
M.A. student in Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Islamic Azad University of Arak, Amirkabir Town, 3 km of Khomeini Road University, Imam Khomeini Boulevard, Imam Khomeini Square, Arak
City
Arak
Province
Markazi
Postal code
3836119131
Phone
+98 918 361 9858
Email
mahtasadeghi361@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Arak Branch
Full name of responsible person
Shima Chehrei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Islamic Azad University of Arak, Amirkabir Town, 3 km of Khomeini Road University, Imam Khomeini Boulevard, Imam Khomeini Square, Arak
City
Arak
Province
Markazi
Postal code
3836119131
Phone
+98 918 363 4903
Email
sh-chehreii@iau-arak.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Arak Branch
Full name of responsible person
Mahta Sadeghi
Position
M.A. student in Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Islamic Azad University of Arak, Amirkabir Town, 3 km of Khomeini Road University, Imam Khomeini Boulevard, Imam Khomeini Square, Arak
City
Arak
Province
Markazi
Postal code
3836119131
Phone
+98 918 361 9858
Email
mahtasadeghi361@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
Because of moral issues
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
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
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