General purpose: The general purpose of this research is to compare the effectiveness of resilience-based therapy and mindfulness-based therapy in improving family relationships and reducing substance abuse relapse.
Design
Clinical trial with control group, two intervention groups, in 45 patients. People will be randomly divided into three groups.
Settings and conduct
After giving written consent to participate in the research, people will be randomly divided into two experimental groups and one control group. First, all people enter the test and complete the research questionnaire. Then two test groups will be treated with treatment protocol. Meetings are held at Mohrhari Hospital in Shiraz. After the treatment, the research questionnaires will be completed again by all three groups and then analyzed using spss software.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include being over 18 years old and not suffering from an incurable disease. Exclusion criteria include taking neuropsychiatric drugs and suffering from chronic psychological diseases.
Intervention groups
Resilience Intervention Group: This Pennsylvania Resilience Program was designed based on the cognitive-behavioral model by Gillham et al. (1990) at the University of Pennsylvania. In the study of Khanjani et al. (2014), the content validity of the Pennsylvania Resilience Program was confirmed. The participants of the current research are given this training in 12 sessions.
Mindfulness intervention group: The participants in this group are subjected to a relapse prevention treatment protocol based on mindfulness for 8 sessions and weekly. The content of this intervention is taken from the therapeutic protocol of Boen et al. (2011).
Control group: no intervention is done for this group.
Main outcome variables
improving family relationships; Reducing substance abuse relapse
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240420061537N1
Registration date:2024-05-04, 1403/02/15
Registration timing:prospective
Last update:2024-05-04, 1403/02/15
Update count:0
Registration date
2024-05-04, 1403/02/15
Registrant information
Name
amene zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3650 0291
Email address
amene1365z@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-07, 1403/02/18
Expected recruitment end date
2024-05-24, 1403/03/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of resilience and mindfulness therapy in improving family relationships and reducing substance abuse relapse
Public title
Comparing the effectiveness of resilience and mindfulness therapy in substance abuse relapse
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Not suffering from incurable physical diseases
Over 18 years old
Exclusion criteria:
Use of neuroleptics
The presence of other chronic psychological disorders in the participants
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
The people participating in this research will be selected by available sampling method and will be randomly divided into three groups (two experimental groups and one 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 Islamic Azad University, Arsanjan branch
Street address
Islamic Azad University, Arsanjan branch, Educational complex, University blvd
City
Arsenjan
Province
Fars
Postal code
7376153161
Approval date
2024-04-09, 1403/01/21
Ethics committee reference number
IR.IAU.A.REC.1403.005
Health conditions studied
1
Description of health condition studied
substance abuse
ICD-10 code
F19.1
ICD-10 code description
Other psychoactive substance abuse
Primary outcomes
1
Description
Substance abuse relapse score in Wright et al.'s questionnaire
Timepoint
Measuring the reduction of substance use relapse before and after the implementation of the intervention
Method of measurement
Wright et al.'s substance use relapse prediction scale (1993)
2
Description
The improvement score of family relationships in Ritchie and Fitzpatrick questionnaire
Timepoint
Measuring the improvement of family relationships before and after the implementation of the intervention
Method of measurement
Ritchie and Fitzpatrick family communication patterns scale (1990)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pennsylvania Resilience Program Protocol
Ostad Moharari Hospital for Neurology and Psychiatry
Full name of responsible person
Mojtaba Naqshvarian
Street address
Ostad Mohrhari Neurological and Psychiatric Hospital, in front of Niayesh settlement, Kilometer 13 of the Shiraz-Marvdast highway
City
Shiraz
Province
Fars
Postal code
7144113331
Phone
+98 71 3627 7501
Fax
+98 71 3260 5702
Email
moharrerihosp@sums.ac.ir
Web page address
https://asabravan.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Arsanjan branch
Full name of responsible person
Mohammad Rostampour
Street address
Arsanjan branch, educational complex of Islamic Azad University, university boulevard, Arsanjan, Fars
City
Arsanjan
Province
Fars
Postal code
Phone
+98 71 4352 3908
Fax
+98 71 4352 2483
Email
mojtabamiraki1361@gmail.com
Web page address
https://arsanjan.iau.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Project student named Amene Zare
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University, Arsanjan branch
Full name of responsible person
Amene Zare
Position
freelance job
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Javid Street, Afarinesh Boulevard, Goldasht Hafez
City
Shiraz
Province
Fars
Postal code
7186955972
Phone
+98 71 4352 3907
Email
amene1365z@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Arsanjan branch
Full name of responsible person
Amene zare
Position
freelance job
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Javid Street, Afarinesh Boulevard, Goldasht Hafez
City
Shiraz
Province
Fars
Postal code
7186955972
Phone
+98 71 4352 3907
Email
amene1365z@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Arsanjan branch
Full name of responsible person
Amene Zare
Position
freelance job
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Javid Street, Afarinesh Boulevard, Goldasht Hafez
City
Shiraz
Province
Fars
Postal code
7186955972
Phone
+98 71 4352 3907
Email
amene1365z@gmail.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
reducing substance abuse relapse, improving family relationships. All potential data can be shared after de-identifying individuals.
When the data will become available and for how long
The access period starts 5 months after the results are published
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
The descriptive statistics data and the data obtained from the analysis of variance test can be used to provide the background of the research in the future researches of other researchers.
From where data/document is obtainable
Refer to the Islamic Azad University, Arsanjan branch, and the project manager, Mrs. Amene Zare.
What processes are involved for a request to access data/document
E-mail and call the academic unit and project manager