Protocol summary

Study aim
Developing and validating a combination of attachment-based therapy and compassion-based therapy and its effectiveness on emotion regulation, shame and fear of intimacy in adults with insecure attachment
Design
Two groups of 15 people: intervention and control Purposive sampling followed by random assignment
Settings and conduct
Nayeri Psychological Counseling and Services Clinic
Participants/Inclusion and exclusion criteria
Mashhad City Theater students Having an insecure attachment style Age 20 to 35 years
Intervention groups
The effectiveness of a combined package of attachment-based therapy and compassion-based therapy The control group receives the intervention after the follow-up phase
Main outcome variables
Emotion regulation, Shame, Fear of intimacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240930063208N1
Registration date: 2024-11-30, 1403/09/10
Registration timing: registered_while_recruiting

Last update: 2024-11-30, 1403/09/10
Update count: 0
Registration date
2024-11-30, 1403/09/10
Registrant information
Name
Hamid Nejat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3847 3761
Email address
dr.nejat54@iau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-27, 1403/09/07
Expected recruitment end date
2024-12-04, 1403/09/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Developing and validating a combination of attachment-based therapy and compassion-based therapy and its effectiveness on emotion regulation, shame and fear of intimacy in adults with insecure attachment
Public title
Developing and validating a combination of attachment-based therapy and compassion-based therapy and its effectiveness on emotion regulation, shame and fear of intimacy in adults with insecure attachment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mashhad City Theater students Having an insecure attachment style
Exclusion criteria:
Age
From 20 years old to 35 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
First, 30 people will be selected from the target population through purposive sampling based on the inclusion criteria, and then the random matching method will be used, in which the subjects will be converted into a list of pairs of subjects based on the attachment style obtained from the attachment style questionnaire and gender (which will include men and women in equal numbers in the initial sampling). Then, by simple random drawing, one of the two paired elements will be assigned to the intervention group and the other to the control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees Of Mashhad Medical Science Islamic Azad University
Street address
No. 213, Seyed Rezi 37, Seyed Rezi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9188758680
Approval date
2024-08-07, 1403/05/17
Ethics committee reference number
IR.IAU.MSHD.REC.1403.067

Health conditions studied

1

Description of health condition studied
Emotion regulation, shame and fear of intimacy in adults with insecure attachment
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Attachment styles
Timepoint
Beginning of the study
Method of measurement
Hazan & Shaver attachment style questionnaire

Secondary outcomes

1

Description
Emotion regulation, shame and fear of intimacy
Timepoint
Pre-test, post-test and follow-up
Method of measurement
Gross and John's Emotion regulation, Tangney and Dearing's automatic emotion, Descutner and Thelen's Fear of intimacy

Intervention groups

1

Description
Intervention group: Integrated package of attachment-based therapy and compassion-based therapy
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad Independent Theater Campus
Full name of responsible person
Mashhad Independent Theater Campus
Street address
No. 78, between Hafez and Saremi Squares, Saremi Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
R1N155G5F100J0
Phone
+98 51 3890 5567
Email
info@pardistheater.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Nejat
Street address
2nd floor,No. 6,20 Hakim Nizami St,Kohsangi St
City
Mashhad
Province
Razavi Khorasan
Postal code
9188758680
Phone
+98 51 3847 3761
Email
Dr.nejat54@iau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Nejat
Position
Assisstan professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
2nd floor,No. 6,20 Hakim Nizami St,Kohsangi St
City
Mashhad
Province
Razavi Khorasan
Postal code
9188758680
Phone
+98 51 3847 3761
Fax
Email
Dr.nejat54@iau.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Nejat
Position
Assisstan professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
2nd floor,No. 6,20 Hakim Nizami St,Kohsangi St
City
Mashhad
Province
Razavi Khorasan
Postal code
9188758680
Phone
+98 51 3847 3761
Fax
Email
Dr.nejat54@iau.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Nejat
Position
Assisstan professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
2nd floor,No. 6,20 Hakim Nizami St,Kohsangi St
City
Mashhad
Province
Razavi Khorasan
Postal code
9188758680
Phone
+98 51 3847 3761
Fax
Email
Dr.nejat54@iau.ir

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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Developed protocol and its validation Pre-test, post-test, and follow-up data files
When the data will become available and for how long
After completion of the follow-up phase (3 months after the intervention)
To whom data/document is available
Academic institutions and scientific journals
Under which criteria data/document could be used
Maintaining confidentiality regarding research data Cite the source if new analyses need to be performed
From where data/document is obtainable
dr.nejat54@iau.ac.ir
What processes are involved for a request to access data/document
Send an email with the details and after checking the file details, the email will be sent. Send an email with the details and after checking the file details, the email will be sent
Comments
Loading...