Investigating the Effectiveness of Online Counseling with a Therapeutic Approach Based on Acceptance and Commitment on Health-promoting Behaviors in Middle-aged Women
Determining the effect of online counseling with a therapeutic approach based on acceptance and commitment on health-promoting behaviors in middle-aged women
Design
This interventional research will be conducted as a parallel clinical trial in two intervention and control groups, with a one-month follow-up and without blinding. 68 samples will be selected based on the study's entry and exit criteria and will be assigned to two control and intervention groups using a randomization site.
Settings and conduct
The place of study is Haji Maghsoudi Comprehensive Health Center of Shahid Sadougi University of Medical Sciences, Yazd. The population studied is middle-aged menopausal women covered by this center and blinding is not done, but random allocation is done by a person who is not aware of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Iranian middle-aged women aged 40-60 years;
Having a desire to participate in the study and giving an informed consent;
Having a smart mobile phone and the ability to use it for virtual classes;
Having an authorized virtual network;
Having a minimum education degree.
Exclusion criteria:
Recent unfortunate events such as death of first-degree relatives, divorce from spouse, etc.;
Consumption of cigarettes, alcohol, drugs and psychotropic drugs;
Previous participation in lifestyle promotion counseling classes;
Suffering from acute physical and mental illnesses under treatment
Intervention groups
For the intervention group, 8 weekly 45-minute online counseling sessions will be held in Sky Room. The control group will receive the health promotion behavior training booklet.
Main outcome variables
Average score of health promoting behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230302057588N1
Registration date:2023-04-20, 1402/01/31
Registration timing:prospective
Last update:2023-04-20, 1402/01/31
Update count:0
Registration date
2023-04-20, 1402/01/31
Registrant information
Name
Zahra Rezvani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4662 2210
Email address
z.rezvani@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effectiveness of Online Counseling with a Therapeutic Approach Based on Acceptance and Commitment on Health-promoting Behaviors in Middle-aged Women
Public title
The effect of counseling based on acceptance and commitment on health-promoting behaviors of middle-aged women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian middle-aged women aged 40-60 years
Having a desire to participate in the study and informed consent
Having a smart mobile phone and the ability to use it for virtual classes
Having an authorized virtual network
Having a minimum education degree
Exclusion criteria:
Recent unfortunate events such as death of first-degree relatives, divorce from spouse, etc.
Consumption of cigarettes, alcohol and drugs and psychotropic drugs
Previous participation in lifestyle promotion counseling classes
Suffering from acute physical and mental illnesses under treatment
Concurrent participation in another similar study
Self-reported drug use due to psychological illnesses
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
A number of middle-aged people are selected after checking the information of the applicants' files. 68 middle-aged people who meet the study entry criteria and informed consent are selected as samples. Each person is given a number and randomly divided into control and intervention groups using the RANDOM.ORG - Sequence Generator site.
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
Research Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Bahonar Square، Yazd
City
Yazd
Province
Yazd
Postal code
8916189165
Approval date
2023-03-01, 1401/12/10
Ethics committee reference number
IR.SSU.REC.1401.104
Health conditions studied
1
Description of health condition studied
Health promoting behaviors
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Average score of health-promoting behaviors in middle-aged women
Timepoint
In the baseline, the completion of the intervention in week 8 and the follow-up period in week 12 in two groups
Method of measurement
Health Promotion Lifestyle Questionnaire (Walker et al.)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group receives health-promoting behavior counseling based on an acceptance and commitment approach by a trained student under the supervision of a supervisor and a fellow psychologist during 8 sessions of 45-minute once a week online on the Sky room platform. For the intervention group in the authorized virtual network, before the start of counseling sessions, the link of online sessions and training on how to use this space will be provided to them. In each session, the contents of the previous sessions will be reviewed and assignments will be reviewed. The content of the sessions includes the introduction of therapy and education, mindfulness, constructive frustration, clarification of values, fault and its techniques, self-observation, acceptance and committed action. At the end of each session, people's questions are answered.
Category
Behavior
2
Description
Control group: They will receive the training booklet on health-promoting behaviors and they will complete the relevant questionnaire in all three times before, immediately after and one month after the end of the intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Haji Maghsoudi Comprehensive Health Center
Full name of responsible person
Behnaz Enjezab
Street address
Javad Al-Aameh
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3838 0920
Email
enjezabbehnaz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Amir Hoshang Mehrparvar
Street address
Central Organization of Shahid Sadoughi University of Medical Sciences, Dr. Bahnar Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Fax
+98 35 3726 3732
Email
ah.mehrparvar@gmail.com
Grant name
Grant code / Reference number
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
Behnaz Enjezab
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Jahad Blvd, Safaiyah
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
enjezabbehnaz@yahoo.com
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
Jihad Blvd, Safaiyah
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
Behnaz Enjezab
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Jahad Blvd, Safaiyah
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
enjezabbehnaz@yahoo.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
All personal data of study participants can be shared after de-identification.
When the data will become available and for how long
After results publication
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Scientific use
From where data/document is obtainable
enjezabbehnaz@yahoo.com
What processes are involved for a request to access data/document