Protocol summary

Study aim
The purpose of this study is to compare the effectiveness of approach CBT and ACT on sexual function and sexual schemas in postmenopausal women.
Design
The research method is semi-experimental and the research design is three groups with pre-test, post-test, and follow-up 3 months later.
Settings and conduct
The statistical population of study consist of postmenopausal women that have menopause in 5 past year and have sexual problems and are attending in the health center in zanjan in 2020. The sample consist of 45 individuals who will randomly assign to three groups of 15. In the implementation of the research, the control group will not receive any intervention, while the other two groups are the experimental ones, one of which will receiv cognitive behavioral therapy and the other group will receiv acceptance and commitment treatment for 8 sessions.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Married women; Menopausal women that have menopause in 5 past year; Sexual performance score below 28; Completed Secondary education level; monogamy. Exclusion Criteria: Having known physical and mental illness according; Consumption of drugs affecting sexual relationships; Addiction; Participate in other similar studies; Occurrence of unpleasant event.
Intervention groups
Intervention Group 1: CBT - (Cognitive-Behavioral Therapy): Treatment sessions are performed in 8 sessions (each session approximately 2 hours per week ) according to the protocol (Kaplan, 1974; Kennedy, 2012). Intervention Group 2: (ACT - Acceptance and Commitment-Based Therapy): Treatment sessions are performed in 8 sessions (each session approximately 2 hours per week) according to the protocol (Kaplan 1974; Foreman and Herbert 2008). Control group: No intervention is performed and is only for comparison with the intervention groups.
Main outcome variables
sexual function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200428047230N1
Registration date: 2020-05-05, 1399/02/16
Registration timing: registered_while_recruiting

Last update: 2020-05-05, 1399/02/16
Update count: 0
Registration date
2020-05-05, 1399/02/16
Registrant information
Name
Fatemeh Rostamkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3377 6533
Email address
frostamkhani47@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-02, 1398/10/12
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effectiveness of approach CBT and ACT on sexual function and sexual schemas in postmenopausal women
Public title
The comparison of the effectiveness of approach CBT and ACT on sexual function and sexual schemas in postmenopausal women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
-Married women -Menopausal women that have menopause in 5 past year -Sexual performance score below 28 with FSFI questionnaire -Completed Secondary education level -Have willingness to participate in the study -Being monogamy
Exclusion criteria:
-Having known physical and mental illness according to self-reported -Consumption of drugs affecting sexual relationships -Addiction -Participate in other similar studies -Occurrence of unpleasant event
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher randomly selected 3 centers out of 18 health centers in Zanjan by writing numbers on paper by drawing lots, then by referring to the mentioned health center, 45 of them were selected by available sampling method and coded from 1-45. Using randomly assigned block allocation methods, they were divided into 3 groups of 15 people (2 intervention groups and one control group). How to do it: First we encode the groups based on the Latin letters as follows: A = cognitive-behavioral therapy, B = acceptance and commitment treatment and C = control group In this study with three groups A, B and C, the following six groups were created: And we assign the numbers 1 to 6 to each: ABC-ACB-BAC-BCA-CAB-CBA Then we contract using a table of random numbers, whenever the numbers 1, 2, 3, 4, 5, and 6, respectively. It appeared that one of these blocks would be selected, and if another number appeared, we assumed it to be null and void and moved on to the next selection. In fact, we get a random sequence of numbers with a table of random numbers, which we consider the order of the assigned allocation for each number. In this way, the number of people in the groups is almost equal.
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 zanjan University of Medical Sciences
Street address
Azadi Square, Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
45156-13191
Approval date
2019-10-15, 1398/07/23
Ethics committee reference number
IR.ZUMS.REC.1398.328

Health conditions studied

1

Description of health condition studied
Sexual Function
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Menopausal women who receive sexual performance scores less than 28 with FSFI Questionnaire
Timepoint
Pre-test, post _test and follow up
Method of measurement
FSFI Questionnaire

Secondary outcomes

1

Description
sexual schemas
Timepoint
Pre-test, Post-test and follow up
Method of measurement
Women’s sexual self-schema Questionnaire

Intervention groups

1

Description
Intervention group: Intervention Group 1 CBT - (Cognitive-Behavioral Therapy), Treatment sessions are performed in 8 sessions (each session approximately 2 hours per week for 2 months) according to the protocol (Kaplan, 1974; Kennedy, 2012). Measurements are taken with pre-test, post-test and follow-up 3 months later.
Category
Treatment - Other

2

Description
Intervention group: Intervention Group 2: ACT - ( Acceptance and Commitment-Based Therapy), Treatment sessions are performed in 8 sessions (each session approximately 2 hours per week for 2 months) according to the protocol (Kaplan 1974; Foreman and Herbert 2008). Measurements are taken with pre-test, post-test and follow-up 3 months later.
Category
Treatment - Other

3

Description
Control group: Control group: A 15-member control group, on which no intervention is performed and is only for comparison with the intervention groups. Measurements are taken with pre-test, post-test and follow-up 3 months later.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
The health center in zanjan
Full name of responsible person
Fatema Rostamkhani
Street address
Unit 4, No 4, Kowsar 7 st, Niksazan, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515996746
Phone
+98 24 3377 6533
Email
frostamkhani47@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Rahnema
Street address
Student Square, Zanjan Branch, Islamic Azad University
City
Zanjan
Province
Zanjan
Postal code
4515996746
Phone
+98 24 3377 6533
Email
frostamkhani47@gmail.com
Grant name
Vice Chancellor for Research, Islamic Azad University of Zanjan
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
Private
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
Fatemeh Rostamkhani
Position
Abhar Branch, Islamic Azad University, Faculty of Humanities, Counseling ph.D candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Transit Road Km 4 Abhar- Khorram Dareh
City
Abhar
Province
Zanjan
Postal code
4561934367
Phone
+98 24 3522 6080
Email
frostamkhani47@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Rostamkhani
Position
MS of Midwifery, Academic member of Nursing and Midwifery Faculty, Zanjan Azad University
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Student Square, Zanjan Branch, Islamic Azad University
City
Zanjan
Province
Zanjan
Postal code
45156-58145
Phone
+98 24 3346 5007
Email
frostamkhani47@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Rostamkhani
Position
MS of Midwifery, Academic member of Nursing and Midwifery Faculty, Zanjan Branch, Islamic Azad Unive
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Unit 4, No 4, Kowsar 7 st, Niksazan, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515996746
Phone
+98 24 3377 6533
Email
frostamkhani47@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Loading...