General purpose: to determine the comparison of the effectiveness of acceptance and commitment therapy (ACT) and matrix in preventing relapse in patients with substance abuse.
Design
Clinical trial with control group, with parallel groups, pseudo-randomized, 45 participants
Settings and conduct
First, all people entered the test and completed the research questionnaires. Then two experimental groups were treated with treatment protocol. The sessions were held twice a week and each session lasted for 90 minutes at Moharari Hospital in Shiraz. After completing the treatment, the research questionnaires were completed again by all three groups and then statistically analyzed.
Participants/Inclusion and exclusion criteria
The criteria for entering the study included having informed consent to the study and not regularly taking neuropsychiatric drugs, and the criteria for exiting the study included suffering from incurable physical diseases and chronic psychological diseases under the approval of a psychologist or psychiatrist.
Intervention groups
The participants were divided into three groups (two experimental groups and one control group):
A- Matrix therapy sessions
The matrix therapy method was invented in 1980 by an American institute. Matrix therapy sessions in this research are held in 8 sessions, 2 sessions a week in groups and each session lasts 90 minutes for the participants of the experimental group.
B_ Acceptance and Commitment Therapy (ACT)
These therapy sessions are based on the intervention of Hayes and Wilson (2014). In the present study, the patients of the second experimental group participate in eight group sessions during two months. There are two sessions every week and each session lasts 90 minutes.
C- The control group on which no treatment is performed.
Main outcome variables
The main outcome in the present study is substance relapse.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231120060114N1
Registration date:2023-12-25, 1402/10/04
Registration timing:registered_while_recruiting
Last update:2023-12-25, 1402/10/04
Update count:0
Registration date
2023-12-25, 1402/10/04
Registrant information
Name
Farzaneh Zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3650 1371
Email address
fzare980@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-07, 1402/09/16
Expected recruitment end date
2024-02-13, 1402/11/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of Acceptance and Commitment Therapy (ACT) and Matrix in preventing relapse in patients with substance abuse
Public title
Investigating the effect of acceptance and commitment and matrix therapy in addiction prevention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent for the study
Lack of regular use of neuropsychiatric drugs
Exclusion criteria:
Having incurable physical diseases
Suffering from chronic psychological diseases under the approval of a psychologist or psychiatrist
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Not randomized
Randomization description
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, Marvdasht branch
Street address
Islamic Azad University of Marvdasht ,Killometer three of Takht Jamshid Blvd , Marvdasht
City
Shiraz
Province
Fars
Postal code
7371113119
Approval date
2023-12-05, 1402/09/14
Ethics committee reference number
IR.IAU.M.REC.1402.099
Health conditions studied
1
Description of health condition studied
Substance use disorders
ICD-10 code
F11.18
ICD-10 code description
Opioid abuse with other opioid-induced disorder
Primary outcomes
1
Description
Drug relapse prevention score in Wright questionnaire
Timepoint
Before the therapeutic interventions of Act and Matrix and after the completion of the interventions
Method of measurement
Wright addiction relapse prediction questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In this group, treatment intervention is not performed
Category
N/A
2
Description
The first intervention group: therapeutic intervention based on acceptance and commitment (ACT): these therapeutic sessions are organized based on the intervention of Hayes and Wilson (2014). In the present study, the patients of the first intervention group participate in eight group sessions during two months. There are two sessions every week and each session lasts 90 minutes. The content of the sessions is as follows: First session: getting to know the members, stating the topic and goals of the treatment and the number of sessions, conducting the pre-test. The second session: general familiarity with acceptance and commitment therapy and its role in regulating emotions and how it affects reducing drug use. The third session: explaining the treatment components and using the necessary metaphors in Inford, giving homework. Session 4: Reviewing homework, examining ineffective strategies and abandoning them, practicing techniques. The fifth session: Reviewing homework, explaining the effect of exercises and reviewing members' assignments and practicing the sequence of techniques. Session 6: Homework review, self-acceptance and self-belief, creating a sense of superiority in oneself (along with parables). Session 7: Making a commitment to valuable actions and practicing relapse prevention (with examples). The eighth session: review of all sessions and presentation of final strategies and post-test implementation.
Category
Prevention
3
Description
The second intervention group: Matrix therapy: Matrix therapy was invented in 1980 by an American institution with the aim of helping people quit drugs and stimulants such as cocaine and glass. In this research, the fourth edition of Matrix Incas treatment protocol (Makri, 2013) was used. Matrix therapy sessions in this research are held in 8 sessions, 2 sessions a week in groups and each session lasts 90 minutes for the participants of the experimental group. The content of these sessions is as follows: First session: scale of change (why do we leave materials?). Second session: initiators (triggers, triggers, ...), internal initiators, external initiators. The third session: the course of recovery, major problems in recovery (distrust of family and surrounding people, loss of energy). The fourth session: Temptation and the right and wrong ways to deal with it. The fifth session: Thoughts and feelings underlying consumption, activities that prevent and predispose to relapse. Session 6: work, guilt, recovery motivation. The seventh session: truthfulness, complete purity. Session 8: Addictive sexual relationships, behaviors and thoughts related to relapse and its prediction.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Moharrari Neurological and Psychiatric Hospital
Full name of responsible person
Mojtaba Naqshvarian Jahromi
Street address
Mohrhari Neurological Hospital, Next to the Faculty of Agriculture, Bajgah, km 13 of Shiraz-Marvdasht road
City
Shiraz
Province
Fars
Postal code
7186955972
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
Full name of responsible person
Masoumeh Emadi
Street address
Islamic Azad University of Morvdasht, kilometer three of Takht Jamshid Blvd., Marvdasht
City
Marvdasht
Province
Fars
Postal code
7371113119
Phone
+98 71 4331 1172
Email
admin@miau.ac.ir
Web page address
https://marvdasht.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
The Islamic Azad University of Marvdasht
Full name of responsible person
Farzaneh zare
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Islamic Azad University of Marvdasht,Kilometer three of Takht Jamshid Blvd,Marvdasht
City
Marvdasht
Province
Fars
Postal code
7371113119
Phone
+98 71 4331 1172
Email
admin@miau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Marvdasht
Full name of responsible person
Farzaneh zare
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Islamic Azad University of Marvdasht , Killometer three of Takht Jamshid Blvd , Marvdasht
City
Marvdasht
Province
Fars
Postal code
7371113119
Phone
+98 71 4331 1172
Email
admin@miau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Marvdasht
Full name of responsible person
Farzaneh zare
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Islamic Azad University of Marvdasht , Killometer three of Takht Jamshid Blvd , Marvdasht
City
Marvdasht
Province
Fars
Postal code
7371113119
Phone
+98 71 4331 1172
Email
admin@miau.ac.ir
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The main outcome data of the research and the results of the data analysis are shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in universities, psychotherapy and psychology centers
Under which criteria data/document could be used
Data and documents can be sent without mentioning the name of the participants. Necessary conditions for performing statistical analyzes are obtaining permission from the authors of the research and the ethics committee of the university.
From where data/document is obtainable
Refer to the authors of the research (student and supervisor), Islamic Azad University, Maroodasht branch and the journal in which the article related to this research will be published.
What processes are involved for a request to access data/document
Submitting an application to the Islamic Azad University of Maroodasht branch and progressing the administrative steps of the issue process in the university's research vice-chancellor