Protocol summary
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Study aim
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Determining the efficacy of Change Following a Resilience Intervention on Post-Traumatic Growth in Women with Addicted Spouses
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Design
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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 randomization is used.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Post-Traumatic Growth
General information
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Reason for update
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Completion of information
The addition of secondary consequences
Methodological change
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220227054135N1
Registration date:
2022-04-12, 1401/01/23
Registration timing:
registered_while_recruiting
Last update:
2023-03-04, 1401/12/13
Update count:
1
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Registration date
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2022-04-12, 1401/01/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-03-21, 1401/01/01
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Expected recruitment end date
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2023-03-21, 1402/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Efficacy of Change Following a Resilience Intervention on Post-Traumatic Growth in Women with Addicted Spouses compared with control group
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Public title
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Change Following a Resilience Intervention on Post-Traumatic Growth
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 50 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is simple . A code is assigned to each of the eligible persons 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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The participants in the intervention and control groups did not know which group they were in.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-11-17, 1400/08/26
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Ethics committee reference number
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IR.USWR.REC.1400.202
Health conditions studied
1
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Description of health condition studied
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Addiction
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ICD-10 code
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R78.4
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ICD-10 code description
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Finding of other drugs of addictive potential in blood
Primary outcomes
1
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Description
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Post-Traumatic growth
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Timepoint
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Before the intervention, the last meeting of the intervention and 3 month after the end of intervention
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Method of measurement
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Post-traumatic growth questionnaire
Secondary outcomes
1
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Description
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Perceived Stress
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Timepoint
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Before the intervention, the last meeting of the intervention and 3 month after the end of intervention
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Method of measurement
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Perceived Stress Scale
2
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Description
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Resilience
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Timepoint
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Before the intervention, the last meeting of the intervention and 3 month after the end of intervention
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Method of measurement
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Conner-Davidson Resilience Scale
3
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Description
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Coping Skills
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Timepoint
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Before the intervention, the last meeting of the intervention and 3 month after the end of intervention
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Method of measurement
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Coping Skills Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Lifestyle
2
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Description
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Control group: control group don't get any intervention.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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University of social welfare and rehabilitation sciences
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Proportion provided by this source
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1
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable