The effectiveness of self-healing on depression and social anxiety in women with bulimia nervosa.
Design
A controlled clinical trial, with parallel groups, is purposively selected and then non-randomly assigned to 60 women with bulimia nervosa who are selected to be in an experimental and control group, with no blinding.
Settings and conduct
The study will be conducted on 60 women with bulimia nervosa in Ahvaz. Participants will be randomly divided into an intervention group (self-healing therapy) and a control group (no treatment) and will be assessed before and after the intervention. Blinding will not be performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of bulimia nervosa by a psychiatrist or psychologist, willingness to participate in the study and follow self-healing techniques. Exclusion criteria: Medical conditions that may be influential, suffering from any significant psychological illness (such as personality disorder, major depression, obsessive-compulsive disorder, bipolar disorder, etc.)
Intervention groups
Self-healing: 30 women with bulimia nervosa received a self-healing intervention that refers to mental and physical processes through which a person can enhance their recovery. This process may include various techniques such as meditation, breathing exercises, positive thinking, and changing negative behavioral patterns. There will be 3 sessions per week (each session is 1 hour) for 8 weeks.
Meditation is a mental technique used to achieve relaxation and focus.
Breathing exercises that are performed with controlled breathing to reduce stress and increase relaxation. Positive thinking in which a person helps improve their mental state by focusing on positive thoughts and avoiding negative thoughts.
30 people for the control group, in which no intervention method is used.
Main outcome variables
Depression and social anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250826067004N1
Registration date:2025-09-28, 1404/07/06
Registration timing:registered_while_recruiting
Last update:2025-09-28, 1404/07/06
Update count:0
Registration date
2025-09-28, 1404/07/06
Registrant information
Name
Yasaman Haghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4254 0431
Email address
yasaman.haghani@iau.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-11, 1404/06/20
Expected recruitment end date
2025-11-11, 1404/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of self-healing on depression and social anxiety in women with bulimia nervosa
Public title
The effectiveness of self-healing on the bodies of women with bulimia nervosa
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of bulimia nervosa by a psychiatrist or psychologist
Willingness to participate in the study and follow self-healing techniques
Exclusion criteria:
Having any significant psychological illness (such as personality disorder, major depression, obsessive-compulsive disorder, bipolar disorder, etc.)
Medical conditions that may affect
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Islamic Azad University, Ahvaz Branch
Street address
Ahvaz Branch, Islamic Azad University, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Approval date
2025-07-23, 1404/05/01
Ethics committee reference number
IR.IAU.AHVAZ.REC.1404.226
Health conditions studied
1
Description of health condition studied
Women with bulimia nervosa
ICD-10 code
F50.2
ICD-10 code description
Bulimia nervosa
Primary outcomes
1
Description
Depression
Timepoint
In the initial study (before the start of the intervention) and about three months after the start of the intervention, i.e. after the end of the intervention
Method of measurement
The Beck Depression Inventory is a standardized assessment tool used to assess the severity of depression in individuals. The questionnaire consists of 21 questions that assess symptoms of depression.
2
Description
Social anxiety
Timepoint
At the beginning of the study (before the intervention) and about three months after the intervention, i.e. after the intervention was completed.
Method of measurement
The Leibowitz Social Anxiety Inventory is a standardized assessment tool used to assess the severity of social anxiety in individuals. The questionnaire consists of 24 questions that assess social fears and avoidance.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Self-healing: 30 women with bulimia nervosa will receive an intervention that refers to mental and physical processes through which an individual can enhance their recovery. This process may include various techniques, including meditation, breathing exercises, positive thinking, and changing negative behavioral patterns. Meditation involves focusing on breathing and is a mental technique used to achieve relaxation and focus. This technique usually involves focusing on breathing and mental exercises that help reduce stress and increase awareness. Breathing exercises are techniques that are performed by controlling breathing to reduce stress and increase relaxation. These exercises usually involve deep, relaxing breathing. Positive thinking refers to the process in which an individual helps improve their mental state by focusing on positive thoughts and avoiding negative thoughts. This technique may include positive thinking exercises and changing negative thought patterns. This intervention is carried out for 8 weeks, 3 sessions per week (each session is 1 hour).
Category
Behavior
2
Description
Control group: No psychological treatment will be given to the control group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Armanshahr Ahvaz Specialized Weight Loss Clinic
Full name of responsible person
Yasaman Haghani
Street address
Ariobarzen Complex, Pahlevan Gharbi, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6153646313
Phone
+98 61 3333 1741
Email
Yasamanhaghaniyh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Pejman Taghipour Birgani
Street address
Ahvaz Branch, , Islamic Azad University, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8324
Email
info@iauahvaz.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
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
Full name of responsible person
Yasaman Haghani
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 1, Ground Floor, Yas 16, Yas Block, Mehr Zibashahr Housing
City
Dezful
Province
Khouzestan
Postal code
6461830704
Phone
+98 61 4254 0431
Email
Yasamanhaghaniyh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Fariba Hafezi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ahvaz Branch, Islamic Azad University, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 4333 4238
Email
dr.haffezi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Yasaman Haghani
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 1, Ground Floor, Yas 16, Yas Block, Mehr Zibashahr Housing
City
Dezful
Province
Khouzestan
Postal code
6461830704
Phone
+98 61 4254 0431
Email
Yasamanhaghaniyh@gmail.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
Undecided - It is not yet known if there will be 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