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Effectiveness of Human Givens Therapy on forgiveness, distress tolerance, psychological well-being and meaning of life in students with romantic breakdown

Protocol summary

Study aim
The purpose of this study is to investigate the effectiveness of Human Givens Therapy on improving students' emotional breakdown in order to promote designing and developing educational and support programs in the future.
Design
Clinical trial including experimental and control groups, single-blind, randomized on 40 patients, rand function of Excel software was used for randomization
Settings and conduct
The present study is in the field of clinical psychology interventions. The interventions will be implemented in the form of 70-minute group sessions at the Neyshabour University Counseling Center. Blinding is one-way and participants are aware of their participation in the study but are not informed whether they are in the experimental or control group.
Participants/Inclusion and exclusion criteria
Age range between 20 and 30 years, studying in Bachelor's degree, minimum relationship duration of 6 months, minimum 1 month and maximum 6 months have passed since the relationship ended, obtaining a minimum score of 16 on the Rosse Love Trauma Questionnaire, Filling out questionnaires completely, and written and informed consent to participate in the research.
Intervention groups
After assigning participants into experimental and control groups, the experimental group will receive the main intervention (7-session weekly 70-minute Human Givens Therapy protocol), and the control group will have sessions without active intervention to control for the effects of attention and positive expectations.
Main outcome variables
Improving the components of forgiveness, distress tolerance, psychological well-being, and meaning of life in students Improving love trauma syndrome in students with romantic breakdown

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250323065145N1
Registration date: 2025-05-04, 1404/02/14
Registration timing: retrospective

Last update: 2025-05-04, 1404/02/14
Update count: 0
Registration date
2025-05-04, 1404/02/14
Registrant information
Name
Amirhossein Ghodsi
Name of organization / entity
The University of Semnan
Country
Iran (Islamic Republic of)
Phone
+98 51 4322 1931
Email address
amir.h_ghodsi@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-09, 1404/01/20
Expected recruitment end date
2025-04-14, 1404/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Human Givens Therapy on forgiveness, distress tolerance, psychological well-being and meaning of life in students with romantic breakdown
Public title
Effectiveness of Human Givens Therapy on romantic breakdown in students
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age range between 20 and 30 years Studying in Bachelor's degree Minimum relationship duration 6 months At least 1 month and a maximum of 6 months have passed since the relationship ended. Obtaining a minimum score of 16 on the Rosse Love Trauma Questionnaire Filling out questionnaires completely Written and informed consent to participate in the research
Exclusion criteria:
Substance use and psychiatric medications Attending other psychotherapy sessions simultaneously
Age
From 20 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random, individual units, using software and in the form of a drawing without replacement
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants are aware of their participation in the study but are not informed whether they are in the experimental or control group.
Placebo
Used
Assignment
Parallel
Other design features
After assigning participants into experimental and control groups, the experimental group will receive the main intervention, and the control group will have sessions without active intervention in order to control attention and positive expectations effects

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Headquarters of the University of Medical Sciences and Health Services, Basij Blvd.
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2025-03-10, 1403/12/20
Ethics committee reference number
IR.SEMUMS.REC.1404.005

Health conditions studied

1

Description of health condition studied
Romantic Breakdown
ICD-10 code
F99
ICD-10 code description
Mental disorder, not otherwise specified

Primary outcomes

1

Description
Forgiveness score on the Heartland Forgiveness Questionnaire
Timepoint
Before the start of the intervention, after the end of the intervention and 1 month after the end of the intervention
Method of measurement
Heartland forgiveness scale

2

Description
Distress tolerance score on the Simons and Gaher Distress Tolerance Questionnaire
Timepoint
Before the start of the intervention, after the end of the intervention and 1 month after the end of the intervention
Method of measurement
Simons and Gaher Distress Tolerance Scale

3

Description
Psychological well-being score on the Ryff Psychological Well-being Questionnaire
Timepoint
Before the start of the intervention, after the end of the intervention and 1 month after the end of the intervention
Method of measurement
Ryff Psychological Well-Being Scale

4

Description
Meaning of life score on the Steger Meaning of Life Questionnaire
Timepoint
Before the start of the intervention, after the end of the intervention and 1 month after the end of the intervention
Method of measurement
Steger Meaning of Life Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group will have weekly, group, 70-minute sessions of the Griffin and Tyrrell (2007, 2006) Human Givens Treatment Protocol.
Category
Treatment - Other

2

Description
Control group: The control group will have weekly, 70-minute group sessions to express their feelings and experiences.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Neyshabour university
Full name of responsible person
Amirhossein Ghodsi
Street address
End of Janbazan Blvd., End of west Adib Bivd., Nizam-ol-Molk Blvd.
City
Neyshabour
Province
Razavi Khorasan
Postal code
9319774446
Phone
+98 51 4330 5000
Fax
+98 51 4330 5234
Email
info@neyshabur.ac.ir
Web page address
https://neyshabur.ac.ir/fa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abbasali Vafaei
Street address
Imam Reza Highway, opposite Sookan Park
City
Semnan
Province
Semnan
Postal code
19111-35131
Phone
+98 23 3153 0000
Fax
+98 23 3153 9555
Email
pr@semnan.ac.ir
Web page address
https://semnan.ac.ir/
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
Parviz Sabahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Imam Reza Highway, opposite Sookan Park
City
Semnan
Province
Semnan
Postal code
19111-35131
Phone
+98 23 3153 0000
Fax
+98 23 3153 9555
Email
p_sabahi@semnan.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Sabahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Imam Reza Highway, opposite Sookan Park
City
سمنان
Province
Semnan
Postal code
19111-35131
Phone
+98 23 3153 0000
Email
p_sabahi@semnan.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Amirhossein Ghodsi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 2, Niloufar Ave., Emam Khomeini 34 Blvd., Neyshabour Town
City
Neyshabour
Province
Razavi Khorasan
Postal code
9313966654
Phone
+98 51 4322 1931
Email
amir.ghodsi919@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
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
Group information related to the main outcomes such as frequency, mean, standard deviation, and analysis results will be published.
When the data will become available and for how long
Access period starts 6 months after results are published.
To whom data/document is available
researchers and Students working in academic and scientific institutions
Under which criteria data/document could be used
Citing the research results by citing the source
From where data/document is obtainable
Semnan University Library website Published article magazine E-mail of the author of the article; amir.ghodsi919@gmail.com
What processes are involved for a request to access data/document
After sending the request via email, publishable data will be made available within a maximum of 3 days.
Comments
Research data, such as information on the main outcomes as well as the treatment protocol, with a description of the content of the sessions, will be available after the results are published.
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