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Evaluation of the effectiveness of online group acceptance and commitment-based shame therapy on depression, experience of shame, quality of life and marital adjustment in depressed infertile women

Protocol summary

Study aim
To investigate the effectiveness of online group therapy with the approach of shame-based acceptance and commitment therapy on reducing depression among infertile women
Design
A clinical trial with a control group, with parallel groups, without blinding and randomized using a table of random numbers
Settings and conduct
Infertile women in Tehran, who refer to Dr. Zareian's clinic, enter the process of selection, evaluation and placement in intervention and control groups according to the inclusion and exclusion criteria. Sampling will be done purposefully. Evaluation, treatment and allocation to groups are done randomly using a table of random numbers. Shame-based acceptance and commitment treatment protocol has 11 sessions, before the intervention and after the intervention, thresholds are measured in both groups. Also, online intervention on the Google Meet platform will be held weekly for a 2-hour session.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Symptoms of depression, Experience shame , The length of infertility is more than one year, Age range from 20 to 40 years, Education at least diploma. Exclusion criteria: Psychotic disorders, personality disorders, Having a childbirth
Intervention groups
The first group includes shame-based acceptance and commitment group therapy online and 2-hour sessions once a week with an 11-session protocol. In this intervention, exposure and self-compassion exercises are used in order to create cognitive changes. The second group is a group in which the people are defined as the waiting group and no intervention is done for them in order to control the test error.
Main outcome variables
Beck Depression Inventory Score, Young Shame and Defect Schema Questionnaire Score, Quality Of Life Questionnaire Score, Marital Adjustment Questionnaire Score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230502058049N1
Registration date: 2023-09-16, 1402/06/25
Registration timing: retrospective

Last update: 2023-09-16, 1402/06/25
Update count: 0
Registration date
2023-09-16, 1402/06/25
Registrant information
Name
Najmeh Amiri
Name of organization / entity
Shiraz university
Country
Iran (Islamic Republic of)
Phone
+98 21 4448 5228
Email address
n-amiri@shirazu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-01, 1402/04/10
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of online group acceptance and commitment-based shame therapy on depression, experience of shame, quality of life and marital adjustment in depressed infertile women
Public title
Effect of online group therapy of shame in depressed infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women with symptoms of depression Infertile women who experience shame The length of waiting (infertility) is more than one year The duration of marriage is more than 2 years Age range from 20 to 40 years Education at least diploma
Exclusion criteria:
Specific disorders such as psychotic and personality disorders Substance dependence disorder Suicidal thoughts or attempts during the current period of depression Having a history of a previous pregnancy or childbirth Women who are currently undergoing medication or psychotherapy due to depression and anxiety disorders or were undergoing psychotherapy in the last 3 months.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is a simple randomization that the participants will be placed in two treatment and control groups in a simple and individual way using a Random number 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
Ethics Committee of Faculty of Educational Sciences and Psychology of Shiraz University
Street address
Ground floor, Faculty of Educational Sciences and Psychology, Eram Campus, Eram Dormitory, Eram Square
City
Shiraz
Province
Fars
Postal code
7194684759
Approval date
2023-04-18, 1402/01/29
Ethics committee reference number
IR.US.PSYEDU.REC.1402.006

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

2

Description of health condition studied
Major Depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode

Primary outcomes

1

Description
Beck Depression Inventory Score
Timepoint
Before starting the treatment (Pre-test) and After treatment (Post-test)
Method of measurement
Beck Depression Inventory

2

Description
Young Shame and Defect Schema Questionnaire Score
Timepoint
Before starting the treatment (Pre-test) and After treatment (Post-test)
Method of measurement
Young Shame and Defect Schema Questionnaire

Secondary outcomes

1

Description
Quality Of Life Questionnaire Score
Timepoint
Before starting the treatment (Pre-test) and After treatment (Post-test)
Method of measurement
Quality Of Life Questionnaire

2

Description
Marital Adjustment Questionnaire Score
Timepoint
Before starting the treatment (Pre-test) and After treatment (Post-test)
Method of measurement
Marital Adjustment Questionnaire

Intervention groups

1

Description
Intervention group: Shame-based acceptance and commitment treatment plan is designed in 11 sessions. Also, meetings are held online once a week and each meeting lasts for two hours. The first 3 sessions of this protocol include the assessment of shame and defect schemas, clinical symptoms such as depression, and shame-based coping behaviors. In the fourth session, practical training on changing the direction from avoidance to commitment is provided. In the fifth, sixth, and seventh session, the practice of seeing thirty seconds, defining and clarifying values, and dissociative techniques are discussed, respectively. Next, confrontation and self-compassion exercises form the content of the eighth to tenth sessions. Finally, the 11th session deals with relapse prevention training and terminating the treatment. It should be noted that before the intervention and after the intervention, the baseline assessment is done.
Category
Treatment - Other

2

Description
Control group: It is a group in which the people are defined as the waiting group and no intervention is done for them in order to control the test error.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Zahra Zareian Clinic
Full name of responsible person
Mahdi Imani
Street address
No. 41, Noorani St., Farahzadi St., Qods Town
City
Tehran
Province
Fars
Postal code
1468963143
Phone
+98 21 2238 6106
Email
zzareian@gmail.com
Web page address
https://drzahrazareian.com/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University
Full name of responsible person
MohammadHadi Sadeghi
Street address
5th Floor, Management Area, Shiraz University, Islamic Republic Blvd.
City
Shiraz
Province
Fars
Postal code
7194684759
Phone
+98 71 3613 4000
Email
Sadeghi@Shirazu.ac.ir
Web page address
https://law.shirazu.ac.ir/fa/~sadeghi
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University
Full name of responsible person
Mahdi Imani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No.14, First Floor, Shiraz University,Islamic Republic Boulevard
City
Shiraz
Province
Fars
Postal code
7194684759
Phone
+98 21 4448 5228
Email
dr.mahdiimani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz university
Full name of responsible person
Najmeh Amiri
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit13, No. 21, Shahid Islamian Street, Ashrafi Esfahani Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1469619884
Phone
+98 21 4448 5228
Fax
Email
n-amiri@shirazu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz university
Full name of responsible person
Najmeh Amiri
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit13, No. 21, Shahid Islamian Street, Ashrafi Esfahani Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1469619884
Phone
+98 21 4448 5228
Fax
Email
n-amiri@shirazu.ac.ir

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
Due to compliance with ethical standards
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Sharing the protocol and data from the intervention
When the data will become available and for how long
The access period will start 6 months after the official publication of the article.
To whom data/document is available
Access is allowed only for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
It can be used after official publication in reputable scientific journals.
From where data/document is obtainable
Just send their request via email 1- n-amiri@shirazu.ac.ir 2- najmehamiri.psy@gmail.com
What processes are involved for a request to access data/document
After the official publication of the article, the applicant can obtain the protocol and treatment results (about one or two years later)
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