Protocol summary

Study aim
Determining the effectiveness of meaning therapy interventions on the dimensions of adolescents' well-being
Design
A randomized, randomized controlled clinical trial on 30 patients.
Settings and conduct
After receiving the code of ethics from the ethics committee of Tehran University of Medical Sciences, sample people are selected based on the entry and exit criteria, and then after the initial interview according to SCID and declaring their desire to participate in the meetings, explanations about the research will be given to them. will be given and written consent will be obtained from them and they will be assured that participation in the study is voluntary and the participants can leave the study at any time.
Participants/Inclusion and exclusion criteria
Age 15 to 21 years Willingness to participate in research Not suffering from severe psychiatric disorders such as bipolar spectrum disorders, psychotic spectrum disorders, and cognitive disorders
Intervention groups
Intervention group: includes all adolescents of Tehran city who receive group intervention based on meaning therapy based on the book Meaning-Centered Therapy Manual in eight 60-minute sessions (one session per week). The control group includes teenagers who do not receive any intervention.
Main outcome variables
Social Well-being, Spiritual Well-being, Psychological well-being, Physical health

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211223053494N6
Registration date: 2024-04-02, 1403/01/14
Registration timing: prospective

Last update: 2024-04-02, 1403/01/14
Update count: 0
Registration date
2024-04-02, 1403/01/14
Registrant information
Name
Jafar Sarani yaztappeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 1334 1894
Email address
sarani.jafar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-27, 1403/02/08
Expected recruitment end date
2024-12-28, 1403/10/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of group intervention based on meaning therapy on adolescent s' dimensions of well-being
Public title
Effectiveness of group intervention based on meaning therapy on adolescent s' dimensions of well-being
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 15 to 21 years Willingness to participate in research Not suffering from severe psychiatric disorders such as bipolar spectrum disorders, psychotic spectrum disorders, and cognitive disorders Absence of speech or hearing problems Not using drugs and alcohol in the last three months Not suffering from specific or underlying physical diseases,
Exclusion criteria:
receiving another similar psychological intervention at the same time as the current research, receiving psychiatric drugs at the same time as the intervention or within a month before the intervention, Lack of consent to continue the treatment during the intervention process
Age
From 15 years old to 21 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
Randomization will be simple randomization. The randomization unit is people. 30 adolescent subjects will be divided into intervention and control groups by Microsoft Excel software using Rand function. Based on this, a table of random numbers is prepared and the Randbetween function is created, and the subjects are placed in two groups of 15 people according to the rows of this table.
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
Approval date
2019-04-07, 1398/01/18
Ethics committee reference number
IR.IUMS.REC.1398.064

Health conditions studied

1

Description of health condition studied
dimensions of well-being
ICD-10 code
F54
ICD-10 code description
Psychological and behavioral factors associated with disorders or diseases classified elsewhere

Primary outcomes

1

Description
Social Well-being Score in the Keyes Questionnaire
Timepoint
At the beginning of the study (before the intervention), after the intervention and 6 months after the intervention
Method of measurement
Keyes Social Well-being Questionnaire

2

Description
Spiritual Well-being Questionnaire (SWBQ) score Paloutzian-Allison
Timepoint
At the beginning of the study (before the intervention), after the intervention and 6 months after the intervention
Method of measurement
Paloutzian-Allison Spiritual Well-being questionnaire (SWBQ)

3

Description
Psychological well-being score of Ryff and Keyes questionnaire
Timepoint
At the beginning of the study (before the intervention), after the intervention and 6 months after the intervention
Method of measurement
Ryff and Keyes Psychological Well-being Questionnaire

4

Description
Physical health score of Spence, Hemrich and Pred questionnaire
Timepoint
At the beginning of the study (before the intervention), after the intervention and 6 months after the intervention
Method of measurement
Physical Health Questionnaire Spence, Hemrich and Pred

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: includes all adolescents of Tehran city who receive group intervention based on meaning therapy based on the book Meaning-Centered Therapy Manual in eight 60-minute sessions (one session per week). This treatment is provided by Dr. Mary S. and colleagues and it was translated in Iran in the form of a book titled "Existential Psychology (Meaning Centered Therapy Guide)" by Fatemeh Vaezipour. The content of the first session: getting to know the group members and their expectations, determining the group's policy, Establishing a relationship with the members, distributing research questionnaires, briefly explaining the treatment method, and examining meaning therapy and existential analysis. The second session will be devoted to the examination and discovery of meaning and identity. The third session will focus on the ontology of the human body. , mind and soul, and the multidimensional aspects of human existence and its unique dimensions will be discussed. In the fourth session, the sources of human power and internal abilities will be explained, as well as simple techniques to reduce stress in life. In the fifth session, existential aspects will be explained. individual, and the movement from meaninglessness to a meaningful existence and the expression of the triangle of meaning therapy optimism in the face of adversity will be examined. In the sixth session, the extraction of meaning in suffering and the expression of meaning therapy as a special meaning will be discussed. The seventh session will Personal growth and development and development of abilities after the injury will be dedicated and finally the eighth session will be devoted to life in its true meaning and the sources of meaning in life and a life with meaning and purpose, summarizing the sessions, and conducting the post-test of the intervention. will be.
Category
Treatment - Other

2

Description
Control group: No Treatment
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran School of Behavioral Sciences and Mental Health
Full name of responsible person
Mohammad-Kazem Atef-Vahid
Street address
Mental Health Research Center, Department of Health Psychology, School of Behavioral Sciences and Mental Health (Tehran Institute of Psychiatry), Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 8670 3075
Email
kazemv@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
enghelab St., Ghods St., Central Headquarters of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 81631
Email
tumspr@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
Mohammad-Kazem Atef-Vahid
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Mental Health Research Center, Department of Health Psychology, School of Behavioral Sciences and Mental Health (Tehran Institute of Psychiatry), Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 8670 3075
Email
kazemv@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad-Kazem Atef-Vahid
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Mental Health Research Center, Department of Health Psychology, School of Behavioral Sciences and Mental Health (Tehran Institute of Psychiatry), Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 8670 3075
Email
kazemv@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jafar Sarani Yaztappeh
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Psychology Group, Floor4, Taleghani hospital, Erabi Ave., Yaman Ave., Chamran highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1548
Email
sarani.jafar@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The main report will publish in appropriate articles
When the data will become available and for how long
6 Months after Article Publication
To whom data/document is available
Only for Scientific and Academic Researchers
Under which criteria data/document could be used
Only for Analysis and Researches around the main topic of this study
From where data/document is obtainable
After 6 months from the publication of the article, to the responsible author (Mohammad-Kazem Atef-Vahid ) see kazemv@yahoo.com
What processes are involved for a request to access data/document
Documents will send to his email address, approximately 2 month after request
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