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Effect of Group Counseling Based on Commitment and Acceptance Therapy on Body Image and Self-esteem in Patient with Poly Cystic Ovary Syndrome

 View older revisions Content changed at 2020-10-12, 1399/07/21

Protocol summary

Study aim
Determining the effect of group counseling based on acceptance and commitment treatment on body image and self-esteem in poly cystic ovary syndrome patients
Design
A randomized clinical trial with two groups of test and control (waiting), with 48 subjects as sample size, a purpose-based sampling method and dividing subjects into two groups of test and control (waiting)
Settings and conduct
The site of the study is the diabetes research center in Yazd city.
Participants/Inclusion and exclusion criteria
The inclusion criteria for this research will be:  Women with poly cystic ovarian syndrome according to Rotterdam criteria and specialist's diagnosis  Iranian and resident of Yazd city  At the age of 45-20 years The exclude criteria for this research will be:  Patients with known psychological problems such as depression who are under the care of a mental health specialist  Individuals who have had whole-body laser hair removal  Current enrollment in other counseling programs effective on the mind
Intervention groups
After doing a pre-test in persons entered into the study, a group counseling session based on the acceptance and commitment therapy will be held weekly and each session for 90 minutes for the test group. The control group (waiting) will not receive any intervention. After the consultation sessions based on acceptance and commitment treatment, the post-test will be performed again for the subjects in the two groups. After a month after the end of treatment and counseling sessions in the test group, follow-up tests will be performed again for the subjects in the two groups.
Main outcome variables
Acceptance and commitment therapy can be used to improve the body image and self-esteem of patients with PCOS in gynecologic clinics.

General information

Reason for update
Acronym
PCOS
IRCT registration information
IRCT registration number: IRCT20180509039590N1
Registration date: 2018-06-24, 1397/04/03
Registration timing: registered_while_recruiting

Last update: 2020-10-12, 1399/07/21
Update count: 1
Registration date
2018-06-24, 1397/04/03
Registrant information
Name
Fatemeh Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3775 0863
Email address
f.moradi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Group Counseling Based on Commitment and Acceptance Therapy on Body Image and Self-esteem in Patient with Poly Cystic Ovary Syndrome
Public title
Effect of Group Counseling Based on Commitment and Acceptance Therapy on Body Image and Self-esteem in Patient with Poly Cystic Ovary Syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women with poly cystic ovarian syndrome according to Rotterdam criteria and specialist's diagnosis Iranian and resident of Yazd city At the age of 45-20 years
Exclusion criteria:
Patients with known psychological problems such as depression who are under the care of a mental health specialist Individuals who have had whole body laser hair removal Current enrollment in other counseling programs effective on the mind
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with PCOS who have inclusion criteria and tend to participate in this study will be entered to study, then the samples will be randomly assigned to the test and control (Waiting) groups.
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 Shahid Sadoughi University of Medical Sciences
Street address
Central building of Shahid Sadoughi University of Medical Sciences of Yazd, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916189165
Approval date
2018-04-25, 1397/02/05
Ethics committee reference number
IR.SSU.REC.1397.004

Health conditions studied

1

Description of health condition studied
polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
The Mean of Body Image Score in Body Image Concern Inventory
Timepoint
The measurement of mean of the body image before the intervention, immediately after the intervention and one month after the end of the intervention.
Method of measurement
Body Image Concern Inventory

2

Description
Mean Score of Self-Esteem in Rosenberg Self-Esteem Questionnaire
Timepoint
The measurement of mean of the self-esteem before the intervention, immediately after the intervention and one month after the end of the intervention.
Method of measurement
Rosenberg Self-Esteem Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The test group will receive 8 sessions of group counseling based on acceptance and commitment treatment weekly and each session for 90 minutes.
Category
Treatment - Other

2

Description
Control group: The control group will not receive any intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes reserch center
Full name of responsible person
Fatemeh Moradi
Street address
Shahid Sadoughi Blvd, Ba honar Square
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
f.moradi@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Central building of Shahid Sadoughi University of Medical Sciences of Yazd, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916189165
Phone
+98 35 3726 3733
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
5870
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Moradi
Position
A graduate student in Counseling in Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, Buali Alley, Timsar Falahi Ave, Safayeh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
f.moradi@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behnaz Enjezab
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing & Midwifery, Buali Alley, Timsar Falahi Ave, Safayeh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
enjezabbehnaz@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Moradi
Position
A graduate student in Counseling in Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, Buali Alley, Timsar Falahi Ave, Safayeh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
f.moradi@ssu.ac.ir

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

Trial results

Please tick if results have been published
Yes
Summary result posting date
2020-10-12, 1399/07/21
Table of baseline comparison

Baseline characteristics of subjects in the intervention and control groups

Variables               Control group Intervention group P-value*
Education level  Diploma and under diploma 7 (26.9) 10 (38.5) 0.47
Academic education 19 (73.1) 16 (61.5)
Occupational status Employed 13 (50) 8 (30.8) 0.15
Housewife 13 (50) 18 (69.2)
Marital status  Married 16 (61.5) 21 (80.8) 0.12
Single 10 (38.5) 5 (19.2)
Spouse’s education level Diploma and under diploma 5 (31.2) 9 (42.9) 0.20
Academic education 11 (68.8) 12 (57.1)
Infertility history Yes 6 (37.5) 6 (28.6) 0.56
No 10 (62.5) 15 (71.4)
Obesity Yes 16 (61.5) 21 (80.8) 0.12
No 10 (38.5) 5 (19.2)
Irregular menstruation cycles Yes 21 (80.8) 21 (80.8) 1.0
No 5 (19.2) 5 (19.2)
Hirsute face Yes 19 (73.1) 18 (69.2) 0.76
No 7 (26.9) 8 (30.8)
Hirsute body Yes 10 (38.5) 11 (42.3) 0.77
No 16 (61.5) 15 (57.7)
Acne Yes 9 (34.6) 7 (26.9) 0.54
No 17 (65.4) 19 (73.1)
Hair loss   Yes 15 (57.7) 16 (61.5) 0.77
No 11 (42.3) 10 (38.5)

Data presented as frequency (%); *Chi-Square

Participant flow diagram

 

                                                                          Assessed for eligibility (n = 118)

                                                                                Excluded (n = 66)

                                                                Not meeting inclusion criteria (n = 11)

                                                                Other reasons (55)

                                                                   Completing the informed consent form

                                                                               Randomized (n = 52)

Intervention (n = 26)                                                    Allocation                                        Control (n = 26)

Allocated to ACT Intervention (n = 26)                                                                     Allocated to control group (n = 26)

Completed pretest questionnaires and onset of ACT sessions (n = 26)                   Completed pretest questionnaires (n = 26)

Discontinued Intervention (n = 3)                                                                           Completed post-test questionnaires (n = 26)

Completed post-test questionnaires (n = 23)                                                            Completed follow-up questionnaires (n = 23)

Completed follow-up questionnaires (n = 22)

                                                                                                           

                                                                                      Follow-up

Lost to follow-up (n = 1)                                                                                            Lost to follow-up (n = 3)

Follow-up (n = 22)                                                                                                    Follow-up (n = 23)

                                                                                       Analysis

Analyzed questionnaires (n = 22)                                                                               Analyzed questionnaires (n = 23)

 

Participant’s flow diagram

Table of variable outcomes' results

Comparison of mean scores of body image concern and self-esteem and its changes before the intervention, after the intervention, and follow-up in two groups

Variables Intervention group Control group P-value*
Body image concern Before intervention  40.13 ± 84.50  44.9 ± 07.71 0.32*
After intervention 37.12 ± 04.69 44.10 ± 46.68 0.03*
Follow-up 36.12 ± 22.28 43.10 ± 60.91 0.03*
P-value** 0.001** 0.105**
Self-esteem Before intervention 28.5 ± 34.69 29.3 ± 11.37 0.55*
After intervention 31.4 ± 82.96 29.3 ± 42.36 0.05*
Follow-up 30.5 ± 59.40 30.4 ± 73.30 0.92*
P-value** ≤ 0.001** 0.006**

Data presented as Mean ± SD; *Independent t-test; **Test of within-subject contrasts of repeated measures

Table of adverse events

There were no adverse events. 

First publication date
2020-04-04, 1399/01/16
Abstract of published paper
Abstract Background: Polycystic ovary syndrome (PCOS) is one of the most common endocrine and metabolic disorders known with irregular menstruation, hirsutism, alopecia, obesity, infertility, and acne. These symptoms cause a negative effect on the satisfaction of body image, self-esteem, and quality of life in such patients. Recent studies emphasize the need to consider the psychological problems in these women and also the need for appropriate interventions. Objective: The aim of this study was to determine the effectiveness of group counseling based on acceptance and commitment therapy (ACT) on body image and self-esteem in patients with PCOS. Materials and Methods: In this randomized controlled trial, 52 women with PCOS were randomly allocated to intervention and control groups (n = 26/each) using the table of random numbers. Group counseling based on the ACT was held in eight sessions of 90 min once a week for the intervention group. The demographic questionnaire, Littleton development of the body image concern inventory and Rosenberg self-esteem scale were completed in both groups before, immediately after, and one month after the intervention. Results: The mean scores of body image concern (p = 0.001) and self-esteem (p ≤ 0.001) in the intervention group after the intervention and follow-up were significantly different from the control group. Conclusions: Based on the findings of this study, use of cognitive-behavioral therapies in health care centers is recommended as a complementary method. Key words: Acceptance and commitment therapy, Body image, Self-esteem, Polycystic ovary syndrome, Cognitive behavior therapies.
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