Determining the role of acceptance and commitment therapy on reducing internal stigma in drug users
Design
Double-blind non randomized clinical trial with parallel group is performed on 80 patients.Computer software is used for randomization
Settings and conduct
The sample consists of all people who refer to Ostad Moharrari Hospital of Shiraz during two months to quit addiction.First, demographic conditions and perceived stigma are measured, then the volunteers are assigned to two groups that are matched in terms of demographic conditions and perceived stigma.The therapist and the patient are blind to what group they are in and the division is done by the secretary of the department.For one group, ACT treatment is performed by a psychologist and placebo group therapy is performed for the other group.The subjects receive a total of 12 hours of treatment for three weeks.Then the questionnaires will be completed again and the results will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria:-Age 18-50year-Diagnosis of substance use disorder-informed consent
Exclusion criteria:-medical disease-cognitive problems-psychiatric disorders
Intervention groups
In the intervention group, there are four subgroups of 10 persons who receive admission and commitment therapy for three weeks including 12 hours in total.The sessions are based on 5 issues including willingness and values and committed action and efficiency of transfer and two non-specific objectives including stigma and shame.
In the control group, placebo group therapy is performed with the same duration.
Main outcome variables
The effect of acceptance and commitment therapy on internalized stigma in drug users
The effect of acceptance and commitment therapy on quality of life in drug users
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211118053093N1
Registration date:2021-12-04, 1400/09/13
Registration timing:prospective
Last update:2021-12-04, 1400/09/13
Update count:0
Registration date
2021-12-04, 1400/09/13
Registrant information
Name
Kimia Sahraian
Name of organization / entity
Eghlid Higher Education Center
Country
Iran (Islamic Republic of)
Phone
+98 71 3630 3886
Email address
leilarazeghian1366@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-15, 1400/09/24
Expected recruitment end date
2022-03-15, 1400/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the role of acceptance and commitment therapy on reducing internalized stigma in patients with substance use disorder
Public title
Investigating the role of acceptance and commitment therapy in patients with substance use disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-50 year
Diagnosis of substance use disorder
Informed consent
Exclusion criteria:
Medical disease
Cognitive problems
Psychiatric disorders
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants do not know which group they are in.
The data analyser does not know which group it is analysing.
The number of people in the intervention and treatment groups is the same (we have 10 patients in each group for the treatment group). The duration for both intervention and control groups is 12 hours for three weeks.The number of sessions is equal, so the patient is blind to the type of treatment.Data analysis is given only data and does not know what treatment was done for either group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
13 km shiraz-isfahan highway, Ostad Mehrari Hospital
City
Shiraz
Province
Fars
Postal code
71441-13331
Approval date
2021-11-09, 1400/08/18
Ethics committee reference number
IR.SUMS.MED.REC.1400.432
Health conditions studied
1
Description of health condition studied
Substance use disorder
ICD-10 code
F19.1
ICD-10 code description
Other psychoactive substance abuse
Primary outcomes
1
Description
Internalized stigma score
Timepoint
Before the study and one week after the intervention
Method of measurement
Internalized Stigma Questionnaire that includes 28 Likert questions
Secondary outcomes
1
Description
Quality of life score.
Timepoint
Before the intervention and one week after the intervention
Method of measurement
World Health Organization Quality of Life Questionnaire
Intervention groups
1
Description
Intervention group: It consists of four groups of ten. Subjects receive their treatment in groups for three weeks including 12 hours in total (two two-hour sessions a week) and after one week after the end of the treatment, they will be asked again. ACT sessions consist of 5 cases including willingness and values and committed action and efficiency and two non-specific objectives including stigma and shame.How to run meetings is as follows:Session 1 achieves the basic goals of the patient and familiarizes himself with his past efforts to accomplish the goal. Session 2: Logic training of behavioral activation and initial regulation of functional behavioral goal. Session 3 Continue extracting the patient's experience to strengthen the cognition of "controlling a problem" and introducing desire as an alternative and introducing the concept of depressive thoughts.Session 4 The 4th session is to know your mind is not your friend and identifying the simple behavioral goal.Session 5 assesses the patient's ability to pass on depressing thoughts and feelings.Session 6 introduces self-conceptualized distinction against the observer himself.Session 7 showing the importance of values and understanding the references and continuing the practice of mindfulness.Session 8 is a help for the patient who continuously recognizes the areas of life that do not conform to one's values.Session 9The finding the relationship between goals, activities.Session 10 Continues to emphasize the components that are related to the clients' issues.Session 11 Training to the patient to be a therapist himself.Session 12show the progress achieved and the continuous goals of the patient.
Category
Treatment - Other
2
Description
Control group: The subjects receive their treatment in groups for three weeks including 12 hours in total (two two-hour sessions a week) and after one week after the end of the treatment, they are asked again to complete the internalized stigma questionnaire and quality of life questionnaire.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ostad Mohrari Hospital
Full name of responsible person
Leila Razeghian Jahromi
Street address
13 km Shiraz-Isfahan, Ostad Mehrari Hospital
City
Shiraz
Province
Fars
Postal code
71441-13331
Phone
+98 71 3260 5701
Email
leilarazeghian1366@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Razeghian Jahromi
Street address
13 km Shiraz-Isfahan, Ostad Mehrari Hospital
City
Shiraz
Province
Fars
Postal code
71441-13331
Phone
+98 71 3260 5701
Email
leilarazeghian1366@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Leila Razeghian Jahromi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
13th Km Shiraz-Isfahan, Ostad Mehrari Hospital
City
Shiraz
Province
Fars
Postal code
71441-13331÷
Phone
+98 71 3226 5702
Email
leilarazeghian1366@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Razeghian Jahromi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
13th Km Shiraz-Isfahan, Ostad Mehrari Hospital
City
Shiraz
Province
Fars
Postal code
71441-13331
Phone
+98 71 3260 5702
Email
leilarazeghian1366@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Razeghian Jahromi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
13th Km Shiraz-Isfahan, Ostad Mehrari Hospital
City
Shiraz
Province
Fars
Postal code
71441-13331
Phone
0098713205702
Email
leilarazeghian1366@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