Determining the effect of acceptance and commitment therapy on stigma and family functioning of patients with mental disorders
Design
The present study is a randomized clinical trial without blinding.
Settings and conduct
The present study is a randomized clinical trial without blinding. 60 family members of patients with mental disorders will participate in this study. The location of the study will be the psychiatric department of Vali Asr Hospital affiliated to Fasa University of Medical Sciences.
Participants/Inclusion and exclusion criteria
In present study 60 family members of patients with mental disorders will participate in this study. Inclusion criteria include: Willingness to participate in the study and having at least one year of experience in caring for patients with mental disorders, and exclusion criteria include the absence of family members for more than two sessions in training sessions and unwillingness to continue participating in the study for any reason.
Intervention groups
For the intervention test group, the educational program will be implemented in the form of 6 sessions of 60 minutes each session and two days a week for 3 weeks. Lectures, group discussions, questions and answers, and brainstorming methods are used in the training sessions by a psychologist who has already completed the training course. In this research, the general treatment guide based on acceptance and commitment will be used. Acceptance and commitment therapy is a psychotherapy technique that promotes acceptance of negative thoughts, feelings, and events. In fact, this psychotherapy technique encourages a person to consciously participate in activities.
The control group will not receive the training intervention, but they will be given the training package.
Main outcome variables
stigma and family functioning of patients with mental disorders
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190917044802N10
Registration date:2023-09-14, 1402/06/23
Registration timing:registered_while_recruiting
Last update:2023-09-14, 1402/06/23
Update count:0
Registration date
2023-09-14, 1402/06/23
Registrant information
Name
Mostafa Bijani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5331 5012
Email address
bizhani_mostafa@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-11, 1402/06/20
Expected recruitment end date
2023-12-11, 1402/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of acceptance and commitment therapy on stigma and family functioning of patients with mental disorders
Public title
Investigating the effect of acceptance and commitment therapy on stigma and family functioning of patients with mental disorders
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Having at least one year of experience caring for patients with mental disorders
Exclusion criteria:
Absence of family members for more than two sessions in training sessions
Unwillingness to continue participating in the study for any reason
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
60 cards are placed in a sealed envelope. 30 cards will be labeled A (intervention group) and 30 cards will be labeled B (control group). Then, the members of the families participating in the study are asked to take one of the cards. People who take card A will be in the intervention group and people who take card B will be in the control group.
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 Fasa University of Medical Sciences
Street address
Fars province, Fasa city, Ibn Sina square. Fasa University of Medical Sciences. Fasa Iran
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2023-07-30, 1402/05/08
Ethics committee reference number
IR.FUMS.REC.1402.061
Health conditions studied
1
Description of health condition studied
Mental disorders
ICD-10 code
F99
ICD-10 code description
Unspecified mental disorder
Primary outcomes
1
Description
stigma
Timepoint
Before, immediately and one month after the educational intervention
Method of measurement
Shamsaei et al.'s stigma questionnaire
2
Description
Family functioning
Timepoint
Before, immediately and one month after the educational intervention
Method of measurement
Epstein et al.'s family function assessment questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:For the intervention test group, the educational program will be implemented in the form of 6 sessions of 60 minutes each session and two days a week for 3 weeks. Lectures, group discussions, questions and answers, and brainstorming methods are used in the training sessions by a psychologist who has already completed the training course. In this research, the general treatment guide based on acceptance and commitment will be used. Acceptance and commitment therapy is a psychotherapy technique that promotes acceptance of negative thoughts, feelings, and events. In fact, this psychotherapy technique encourages a person to consciously participate in activities. The training sessions include the first session of familiarization and training regarding treatment based on acceptance and commitment, the second session of creating flexible patterns of behavior through value-oriented encounter, the third session of moving towards a valuable life with an accepting and observant self, the fourth session of ways to respond to thoughts Disturbing and stressful, the fifth session is self-awareness and self-control behaviors, the sixth session is setting goals based on values and taking effective measures to achieve those goals and stay on the path of values.
Category
Behavior
2
Description
Control group: The control group will not receive the training intervention, but they will be given the training package
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr Fasa Hospital
Full name of responsible person
Mostafa Bijani
Street address
Fars province, Fasa city, Ibn Sina square. Fasa University of Medical Sciences. Fasa Iran .
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 917 330 8451
Email
bizhani_mostafa@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Akbar Farjad Far
Street address
Fars province, Fasa city, Ibn Sina square. Fasa University of Medical Sciences. Fasa Iran
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 912 176 9752
Email
farhad_2020@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fars province, Fasa city, Ibn Sina square. Fasa University of Medical Sciences. Fasa Iran .
City
Fasa
Province
Fars
Postal code
7461686688
Phone
071-53350994-6
Email
bizhani_mostafa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fars province, Fasa city, Ibn Sina square. Fasa University of Medical Sciences. Fasa Iran .
City
Fasa
Province
Fars
Postal code
7461686688
Phone
071-53350994-6
Email
bizhani_mostafa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Fars province, Fasa city, Ibn Sina square. Fasa University of Medical Sciences. Fasa Iran .
City
Fasa
Province
Fars
Postal code
7461686688
Phone
071-53350994-6
Email
bizhani_mostafa@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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After completing the study and publishing the results, researchers can send their request to the responsible author to use the results of this study
When the data will become available and for how long
After completing the study and publishing the results
To whom data/document is available
After completing the study and publishing the results, researchers can send their request to the responsible author to use the results of this study
Under which criteria data/document could be used
After completing the study and publishing the results, researchers can send their request to the responsible author to use the results of this study
From where data/document is obtainable
corresponding author: Mostafa Bijani
What processes are involved for a request to access data/document
After completing the study and publishing the results, researchers can send their request to the responsible author to use the results of this study