1. Home
  2. Approved trials
  3. » فارسی

Efficacy of Change Following a Resilience Intervention on Post-Traumatic Growth in Women with Addicted Spouses compared with control group

View the latest revision

History
# Registration date Revision Id
2 2023-03-01, 1401/12/10 257866
1 2022-04-12, 1401/01/23 222428
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Protocol summary

    Determining the efficacy of Change Following a Resilience Intervention on Stress-Related Growth in Women with Addicted Spouses
    Determining the efficacy of Change Following a Resilience Intervention on Post-Traumatic Growth in Women with Addicted Spouses
    تعيين اثربخشي مداخله تغيير از طريق تاب آوري بر رشد مرتبط با استرس در زنان داراي همسر معتاد
    تعيين اثربخشي مداخله تغيير از طريق تاب آوري بر رشد پس از سانحه در زنان داراي همسر معتاد
    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.
    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.
    كارآزمايي باليني داراي گروه كنترل، با گروههاي موازي، اختصاص تصادفي به دو گروه مداخله و كنترل بر روي 40 نفر (هرگروه 20 نفر) ميباشد. از تصادفي سازي ساده و خوشه اي استفاده ميگردد.
    كارآزمايي باليني داراي گروه كنترل، با گروههاي موازي، اختصاص تصادفي به دو گروه مداخله و كنترل بر روي 40 نفر (هرگروه 20 نفر) ميباشد. از تصادفي سازي ساده استفاده ميگردد.
    Stress-Related Growth
    Post-Traumatic Growth
    رشد مرتبط با استرس
    رشد پس از سانحه

  • General information

    Not blinded
    Single blinded
    1
    empty
    Completion of information The addition of secondary consequences Methodological change
    empty
    تكميل اطلاعات اضافه شدن پيامدهاي ثانويه تغيير روش شناختي
    Change Following a Resilience Intervention on Stress-Related Growth
    Change Following a Resilience Intervention on Post-Traumatic Growth
    اثر مداخله تغيير از طريق تاب آوري بر رشد مرتبط با استرس
    اثر مداخله تغيير از طريق تاب آوري بر رشد پس از سانحه
    Efficacy of Change Following a Resilience Intervention on Stress-Related Growth in Women with Addicted Spouses compared with control group
    Efficacy of Change Following a Resilience Intervention on Post-Traumatic Growth in Women with Addicted Spouses compared with control group
    بررسي اثربخشي مداخله تغيير از طريق تاب آوري بر رشد مرتبط با استرس در زنان داراي همسر معتاد در مقایسه با افراد گروه کنترل
    بررسي اثربخشي مداخله تغيير از طريق تاب آوري بر رشد پس از سانحه در زنان داراي همسر معتاد در مقایسه با افراد گروه کنترل
    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.
    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.
    تصادفي سازي ساده و به صورت خوشه اي انجام ميگيرد. به هريك از مراكز نمونه گيري كد تعلق ميگيرد و سپس به صورت تصادفي كدها انتخاب ميگردد. كدها در ظرف قرعه­‌کشی قرار می­گیرند. در نهایت از بین آن­ها، شماره­‌ها انتخاب و ثبت ميشود. قرعه­‌کشی تا رسیدن به تعداد مورد نیاز ادامه­ می­یابد
    تصادفي سازي ساده انجام ميگيرد. به هريك از افراد واجد شرايط كد تعلق ميگيرد و سپس به صورت تصادفي كدها انتخاب ميگردد. كدها در ظرف قرعه­‌کشی قرار می­گیرند. در نهایت از بین آن­ها، شماره­‌ها انتخاب و ثبت ميشود. قرعه­‌کشی تا رسیدن به تعداد مورد نیاز ادامه­ می­یابد
    The participants in the intervention and control groups did not know which group they were in.
    افراد شركت كننده در دو گروه مداخله و كنترل، نميدانستند در كدام گروه قرار دارند.

  • Primary outcomes

    #1
    Stress-related growth
    Post-Traumatic growth
    رشد مرتبط با استرس
    رشد پس از سانحه

  • Secondary outcomes

    #1
    empty
    Perceived Stress
    empty
    استرس ادراك شده
    empty
    Before the intervention, the last meeting of the intervention and 3 month after the end of intervention
    empty
    قبل از مداخله، آخرین جلسه مداخله و 3 ماه پس از پایان مداخله
    empty
    Perceived Stress Scale
    empty
    پرسشنامه استرس ادراك شده
    #2
    empty
    Resilience
    empty
    تاب آوري
    empty
    Before the intervention, the last meeting of the intervention and 3 month after the end of intervention
    empty
    قبل از مداخله، آخرین جلسه مداخله و 3 ماه پس از پایان مداخله
    empty
    Conner-Davidson Resilience Scale
    empty
    مقياس تاب آوري كانر-ديويدسون
    #3
    empty
    Coping Skills
    empty
    مهارتهاي مقابله اي
    empty
    Before the intervention, the last meeting of the intervention and 3 month after the end of intervention
    empty
    قبل از مداخله، آخرین جلسه مداخله و 3 ماه پس از پایان مداخله
    empty
    Coping Skills Questionnaire
    empty
    پرسشنامه مهارتهاي مقابله اي

Protocol summary

Study aim
Determining the efficacy of Change Following a Resilience Intervention on Post-Traumatic 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 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
Post-Traumatic Growth

General information

Reason for update
Completion of information The addition of secondary consequences Methodological change
Acronym
IRCT registration information
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
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 Post-Traumatic Growth in Women with Addicted Spouses compared with control group
Public title
Change Following a Resilience Intervention on Post-Traumatic 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
  • Participant
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants in the intervention and control groups did not know which group they were in.
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
Street address
No. 1, Shahid Kolahdooz Alley 2, Ansar Al-Hussein Ave
City
Qom
Province
Ghoum
Postal code
3719868791
Approval date
2021-11-17, 1400/08/26
Ethics committee reference number
IR.USWR.REC.1400.202

Health conditions studied

1

Description of health condition studied
Addiction
ICD-10 code
R78.4
ICD-10 code description
Finding of other drugs of addictive potential in blood

Primary outcomes

1

Description
Post-Traumatic 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

1

Description
Perceived Stress
Timepoint
Before the intervention, the last meeting of the intervention and 3 month after the end of intervention
Method of measurement
Perceived Stress Scale

2

Description
Resilience
Timepoint
Before the intervention, the last meeting of the intervention and 3 month after the end of intervention
Method of measurement
Conner-Davidson Resilience Scale

3

Description
Coping Skills
Timepoint
Before the intervention, the last meeting of the intervention and 3 month after the end of intervention
Method of measurement
Coping Skills Questionnaire

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
Data Dictionary
Not applicable
Loading...