| CTRI Number |
CTRI/2024/05/067807 [Registered on: 22/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Group Counselling to Reduce Stigma Against Opioid Use Disorder |
|
Scientific Title of Study
|
Adaptation and Validation of a Social-contact-based Intervention for Stigma Against Opioid Use Disorder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arshia Sood |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Post Graduate Institute of Medical Education and Research, Nehru Hospital, 3rd floor, Cobalt Block, Department of Psychiatry, Sector 12, Pin 160012, Chandigarh
Chandigarh
CHANDIGARH
160036
India |
| Phone |
07508661051 |
| Fax |
|
| Email |
arshiasood3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhishek Ghosh |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Post Graduate Institute of Medical Education and Research, Department of Psychiatry, Drug Deaddiction and Treatment Centre, 1st floor, Sector 12, Pin 160012, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09815890436 |
| Fax |
|
| Email |
ghoshabhishek12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek Ghosh |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Post Graduate Institute of Medical Education and Research, Department of Psychiatry, Drug Deaddiction and Treatment Centre, 1st floor, Sector 12, Pin 160012, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09815890436 |
| Fax |
|
| Email |
ghoshabhishek12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Sector 12, Pin 160012, Chandigarh, India |
|
|
Primary Sponsor
|
| Name |
Post Graduate Insitute of Medical Education and Research (PGIMER) |
| Address |
Sector 12, PIN 160012, Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhishek Ghosh |
Post Graduate Institute of Medical Education and Research (PGIMER) |
Department of Psychiatry, Drug Deaddiction and Treatment Centre, 1st floor, Conference Hall, Sector 12, Pincode 160012, Chandigarh
Chandigarh
CHANDIGARH |
09815890436
ghoshabhishek12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Medical Education and Research, Institutional Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Social-contact-based Intervention for Stigma Against Opioid Use Disorder |
This study aims to determine a social contact-based interventions feasibility and acceptability to reduce public stigma in opioid use disorder. In the first phase of the study, the content of the social-contact-based intervention will be adapted and then validated by the Delphi consensus method. A set of slides and a one-page information booklet aimed at improving participants’ knowledge and potentially changing attitudes towards people who use drugs and alcohol will be made. The second phase of the study will be an open-label study. Thirty participants will be recruited, who will receive information and in-person social contact from a person with lived experience. The format of delivery will be group-based, and the content will be delivered in a single session. Baseline assessment will include the administration of a questionnaire for the assessment of public stigma. This assessment will be repeated post- intervention (within 48 hours of receiving the intervention) and after approximately 12 weeks of the intervention. We will assess direct and indirect acceptability/feasibility outcomes. A questionnaire will assess direct outcomes comprising eight questions regarding the intervention- overall experience, effort required, understandability, if it is worth their time, if it matches their value system, if it will change their beliefs and attitudes, and if they will recommend it to family and friends. Indirect outcome measures will be based on trial phases, i.e., recruitment, participation, and completion rates. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Has never lived in the same household (for more than 1 year) as a family member who has been diagnosed with opioid use disorder as per DSM-5
Able to read Hindi/English
Able to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
Those unwilling to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To adapt and validate an information-dissemination and social contact-based intervention to reduce public stigma in opioid use disorder.
2. To test the acceptability and feasibility of this intervention.
|
48 hours and 12 ± 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To measure the change in stigma score after the intervention. |
48 hours and 12 ± 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Opioids are one of
the world’s largest used substances, just behind alcohol and cannabis. In
India, approximately 2.1% of individuals (three times the global average) are
known to be suffering from an opioid use disorder (OUD), and 0.7% are known to
be “problem users†(using opioids in a harmful or dependent pattern). Stigma is
defined by a mark of disgrace connected to a quality of an individual, which
often leads to social exclusion and adversely impacts mental and physical
health. Stigma not only affects the individual but also families, communities,
and societies. The literature describes four types of stigmas: self-stigma,
affiliate stigma, public stigma, and structural stigma. Historically, substance
use disorders (SUDs) are stigmatized more than other mental illnesses. This
study aims to determine a social contact-based intervention’s feasibility and acceptability
to reduce public stigma in OUD. In the first phase of the study, the content of the
social-contact-based intervention will be adapted and then validated by the
Delphi consensus method. A set of slides and a one-page information booklet
aimed at improving participants’ knowledge and potentially changing attitudes
towards people who use drugs and alcohol will be made. The second phase of the
study will be an open-label study. Thirty participants will be recruited, who will
receive information and in-person social contact from a person with lived
experience (PWLE). The format of delivery will be group based, and the content
will be delivered in a single session. Baseline assessment will include the administration
of a questionnaire for the assessment of public stigma.
This assessment will be repeated post- intervention (within 48 hours of
receiving the intervention) and after 12 ± 2 weeks of the intervention. We will
assess direct and indirect acceptability/feasibility outcomes. A questionnaire
will assess direct outcomes comprising eight questions regarding the
intervention- overall experience, effort required, understandability, if it is
worth their time, if it matches their value system, if it will change their
beliefs and attitudes, and if they will recommend it to family and friends.
Indirect outcome measures will be based on trial phases, i.e., recruitment,
participation, and completion rates. |