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Survey of the Effectiveness of Acceptance and Commitment Therapy (ACT) on Quality of Life in menopause Women

Protocol summary

Study aim
The Effectiveness of Acceptance and Commitment (ACT) Therapy on the Quality of Life in menopausal Women
Design
This clinical trial has two groups of intervention and control in parallel and two-blind, blind and randomized groups. The intervention group receives counseling weekly for 6 sessions of 90 minutes. The control group will receive only the routine care of menopausal women. At the end of the treatment sessions, the post-test will be performed on both groups.
Settings and conduct
The place of research is the comprehensive health services centers of Sabzevar city. The beginning of the study was completed by filling in the demographic data and using Menopausal Quality of Life Questionnaire and WHO Quality of Life Questionnaire. The participants of each group do not aware about Existence of another group. Researcher dose not aware about randomized allocation because of closed packets. The analyzer dose not aware about the people in the group's neither.
Participants/Inclusion and exclusion criteria
Iranian nationality, reading and writing literacy, age range 45-60 years, physiological menopause, at least 12 months from the last menstruation, no alternative hormone therapy during the past 6 months, absence of specific diseases such as cancer, No drug addiction, lack of participation restrictions, willingness to participate in the study, and filling out a form of informed consent, not taking psychiatric drugs, no crisis during the last year. not attending more than two sessions, a person's unwillingness to continue to study, family crisis from the start of the study to the end of one month follow-up
Intervention groups
The control group receive routine cares, and the intervention group receive 6 sessions counseling of 90 minutes.
Main outcome variables
Effectiveness of treatment based on admission and commitment to quality of life in menopausal women

General information

Reason for update
Acronym
ACT
IRCT registration information
IRCT registration number: IRCT20190401043150N1
Registration date: 2019-05-30, 1398/03/09
Registration timing: registered_while_recruiting

Last update: 2019-05-30, 1398/03/09
Update count: 0
Registration date
2019-05-30, 1398/03/09
Registrant information
Name
Samaneh Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4465 9787
Email address
s.ghasemi3060@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-21, 1398/02/31
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of the Effectiveness of Acceptance and Commitment Therapy (ACT) on Quality of Life in menopause Women
Public title
Effectiveness of Acceptance and Commitment Therapy (ACT) on Quality of Life in menopause Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality Literacy reading and writing Age range 45-60 years Physiologic menopause At least 12 months have passed since the last menstruation Hormone replacement therapy has not been consumed within the last 6 months Not having certain diseases like cancer Do not have drug addiction No restrictions on attending meetings The desire to participate in the study and fill out the informed consent form Non-use of psychiatric drugs The lack of a crisis in the last year, like the death of one of the loved ones, and so on
Exclusion criteria:
Do not attend more than two sessions Unwillingness to continue to study Crisis in the family from the beginning of the study to the end of a one-month follow-up
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
The randomized sequences under the web and by person who out of the research team will be done. Randomized foursome block as a limited method will be used and the people in the order of arrival will stay on blocks. The researcher put each allocation in closed white packet and numbered it.Qualified people in the order of arrival will be register by researcher and receive a code and relevant questionnaire complete for theme.Then according to the codes one packet will be opened and the person will be allocated to one of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The Participants of each group do not aware about existence of another group. Researcher dose not aware about randomized allocation because of closed packets. After intervention questionnaires will complete by another person except researcher. The analyzer dose not aware about the people in the groups nether.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahrood University of Medical Sciences
Street address
7th tir square, shahrood University of Medical Sciences
City
Shahrood
Province
Semnan
Postal code
3614773947
Approval date
2019-05-08, 1398/02/18
Ethics committee reference number
IR.SHMU.REC.1398.010

Health conditions studied

1

Description of health condition studied
Quality of life in menopause
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Quality of life in menopausal women is measured using the WHO Quality of Life Questionnaire and Quality of Life questionnaire for menopausal women
Timepoint
Before the intervention, immediately after the intervention, during the follow-up one month later
Method of measurement
World Health Organization Quality of Life Questionnaire and Quality of Life Questionnaire for menopausal Women

Secondary outcomes

empty

Intervention groups

1

Description
Control group: dose not recieve any intervention
Category
Behavior

2

Description
Intervention group: this group will recieve the consultation Acceptance and Commitment Therapy (ACT). The women in the intervention group, in addition to routine menopausal care receive counseling weekly for 6 sessions of 90 minutes, with Acceptance and Commitment (ACT) Therapy and structured commitment in each session, with mind-awareness training, review of previous sessions, potential support exercises, and homework assignments In this model, counseling and treatment will be provided. The content of the sessions is based on Acceptance and Commitment (ACT) Therapy to anxiety and depression, which is based on the six process (Acceptance, Defusion , Self as a context, Contact with present moment, recognition of values and committed action). The samples are gradually being enrolled in the study, samples are collected for 10 people who have received weekly sessions, and simultaneous sampling is ongoing for both groups. The length of the consultation period is expected to be two months for each 10-member group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive Health Services Centers
Full name of responsible person
Dr Fatemeh Nowdeh
Street address
Taleghani St, Sabzevar Health Center
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617684155
Phone
+98 51 4464 5200
Email
health@medsab.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hassan Emamian
Street address
7th tir square, Shahroud University of Medical Sciences
City
shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Email
info@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Samaneh Ghasemi
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.1,Second Alley., Payam Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618913111
Phone
+98 51 4465 9787
Email
s.ghasemi3060@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Samaneh Ghasemi
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.1,Second Alley., Payam Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618913111
Phone
+98 51 4465 9787
Email
s.ghasemi3060@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Samaneh Ghasemi
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.1,Second Alley., Payam Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618913111
Phone
+98 51 4465 9787
Email
s.ghasemi3060@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is 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
puplishable data include thesis interpreted results and papers and protocol if needed
When the data will become available and for how long
Access from 2019-2020
To whom data/document is available
Data are access for all researchers in scientific institudes
Under which criteria data/document could be used
In case of Author's permission
From where data/document is obtainable
To corresponding author or executive author
What processes are involved for a request to access data/document
By contact with the departmant or send an email to authors
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