Determining the efficacy of Change Following a Resilience Intervention on Stress-Related Growth in Women with Addicted Spouses
Design
The clinical trial has a control group with parallel groups, random assignment to two groups of intervention and control on 40 people (20 people in each group). Simple cluster randomization is used.
Settings and conduct
After obtaining a license from the ethics committee of the university of social welfare and rehabilitation sciences, a letter of introduction will be referred to the welfare organization of Qom city, and then the license to do research in the city will be received. According to the inclusion criteria, 40 individuals will be selected to participate in the study and will be randomly classified into the control and intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Minimum education, At least one year has passed since the beginning of their married life, High perceived stress, Conscious consent to participate in research. Exclusion criteria: Using drugs, Existence of psychotic and suicidal symptoms, Receiving other simultaneous psychotherapy
Intervention groups
Type of intervention: Change Following a Resilience Intervention program for 1 month, in four weekly sessions, the intervention group is asked to work on transforming Stress Into Resilience, responsibility, focus on empowering interpretations and make meaningful connections.The control group don't get any treatment.
Main outcome variables
Stress-Related Growth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220227054135N1
Registration date:2022-04-12, 1401/01/23
Registration timing:registered_while_recruiting
Last update:2022-04-12, 1401/01/23
Update count:1
Registration date
2022-04-12, 1401/01/23
Registrant information
Name
Akram Ahmadzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3665 3909
Email address
ak.ahmadzadeh@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Change Following a Resilience Intervention on Stress-Related Growth in Women with Addicted Spouses compared with control group
Public title
Change Following a Resilience Intervention on Stress-Related Growth
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum cycle education
At least one year has passed since the beginning of their married life.
High perceived stress
Conscious consent to participate in research
Exclusion criteria:
Using drugs
Existence of psychotic and suicidal symptoms
Receiving other simultaneous psychotherapy
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is simple and clustered. A code is assigned to each of the sampling centers and then the codes are selected randomly. The codes are placed in a lottery container. Finally, among them, numbers are selected and registered. The Lottery will be continued to reach certain numbers.
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 University of social welfare and rehabilitation sciences
Finding of other drugs of addictive potential in blood
Primary outcomes
1
Description
Stress-related growth
Timepoint
Before the intervention, the last meeting of the intervention and 3 month after the end of intervention
Method of measurement
Post-traumatic growth questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Change Following a Resilience Intervention program for 1 month, in four weekly sessions, the intervention group is asked to work on transforming Stress Into Resilience, responsibility, focus on empowering interpretations and make meaningful connections.
Category
Lifestyle
2
Description
Control group: control group don't get any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Welfare Administration
Full name of responsible person
Zohreh Bookaei
Street address
Ta`avon Blvd.
City
Qom
Province
Ghoum
Postal code
۱۱۳۶۵/۴۱۸۷
Phone
+98 919 350 1377
Email
zohreh.bookaei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Elham Faraji
Street address
The end of the sixth Alley, Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2819
Email
rd@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
1
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
University of social welfare and rehabilitation sciences
Full name of responsible person
Akram Ahmadzadeh
Position
student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Velenjak, the end of the sixth Alley
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
098 21 22180083
Email
ahmadzadeh.a68@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohammad Saeed Khanjani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
the end of the sixth Alley, Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
098 21 22180061
Email
saeedkh76@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Akram Ahmadzadeh
Position
student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
the end of the sixth Alley, Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
098 25 36653909
Email
ahmadzadeh.a68@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
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