| CTRI Number |
CTRI/2024/08/072033 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluating Inhibitory Control Training to Reduce Aggression in Individuals with Co-occuring Substance Use and Gambling Disorders |
|
Scientific Title of Study
|
A Randomized Controlled Trial to Evaluate the Efficacy of Inhibitory Control Training for Aggressive Behaviours among Individuals with Co-occurring Substance Use Disorder and Gambling Behaviour |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yashita Ahluwalia |
| Designation |
Ph.D. Scholar |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi |
| Address |
Room No. 4080, 4th Floor, Teaching Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, Delhi
South West
DELHI
110027
India |
| Phone |
01126593236 |
| Fax |
|
| Email |
yashitaahluwalia4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yatan Pal Singh Balhara |
| Designation |
Professor of Psychiatry |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi |
| Address |
Room No. 4080, 4th Floor, Teaching Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, Delhi
South West
DELHI
110029
India |
| Phone |
01126593236 |
| Fax |
|
| Email |
ypsbalhara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yashita Ahluwalia |
| Designation |
Ph.D. Scholar |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi |
| Address |
Room No. 4080, 4th Floor, Teaching Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, Delhi
South West
DELHI
110029
India |
| Phone |
01126593236 |
| Fax |
|
| Email |
yashitaahluwalia4@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, Delhi, 110029 |
| National Drug Dependence Treatment Centre, Sector-19, CGO Complex, Bsr Road, Kamla Nehru Nagar, Ghaziabad, Uttar Pradesh 201002 |
|
|
Primary Sponsor
|
| Name |
Yashita Ahluwalia |
| Address |
Room No. 4080, 4th Floor, Teaching Block, All India Institute of Medical Sciences (AIIMS), Ansari Nagar East, New Delhi, Delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 Yatan Pal Singh Balhara |
National Drug Dependence Treatment Centre (NDDTC) |
National Drug Dependence Treatment Centre, Sector-19, CGO Complex, Bsr Road, Kamla Nehru Nagar, Ghaziabad, Uttar Pradesh 201002
Ghaziabad
UTTAR PRADESH |
01126593236
ypsbalhara@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences |
Approved |
| Institute Ethics Committee, All India Institute of Medical Sciences (AIIMS), New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F10-F19||Mental and behavioral disorders due to psychoactive substance use, (2) ICD-10 Condition: F630||Pathological gambling, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inhibitory Control Training |
It is a computerized behavioural intervention aimed to reduce aggressive behaviours by indirectly associating aggression-related stimuli with no-go tendencies. It employs an Associative Go/No Go Paradigm with a 100% contingency, meaning that participants are consistently instructed to respond or withhold response based on the format of presented pictures in a virtual format on a digital device. During the intervention, pictures contained in circles prompt participants to respond (by pressing the space bar), while pictures contained in squares cue participants to withhold response.
By consistently pairing non-aggressive stimuli with the ‘go’ response (pictures in circles) and aggressive stimuli with the ‘no-go’ response (pictures in squares), the intervention aims to create habitual implicit links that reduce aggressive behaviors over time.
The training program will be structured into 6 sessions, spanning 3 consecutive days, with 2 15-minute sessions conducted each day. These sessions will progressively increase in complexity, in terms of reducing probability of ‘No-Go’ stimuli and decreasing stimulus response duration. The participants will be receiving feedback on correct and incorrect responses during the practice sessions.
Each session will consist of 5 blocks, and each block will comprise 50 trials. This structure will result in a total of 1500 trials throughout the training program.
The training program will consist of six sessions, each with a duration of 15 minutes, conducted over a period of three consecutive days. Two sessions will be administered each day, culminating in a total training duration of 1.5 hours. |
| Comparator Agent |
Sham Training |
The sham version of inhibitory control training will employ an Associative Go/ No Go Paradigm with 50% contingency. Sham training is matched with the inhibitory control training in both stimulus exposure and response requirements, with the contingency factor being the only difference.
The go cues and no-go cues will be inconsistently paired with non-aggressive and aggressive stimuli, maintaining 50% contingency. During the practice sessions, participants will not receive feedback on correct and incorrect responses. The training sessions will not be scored.
These sessions will not progressively increase in complexity - In terms of probability, go and no-go cues will be equally divided between aggressive and non-aggressive stimuli in all training sessions. All stimuli will consistently be presented at 3000 ms.
The training program will be structured into 6 sessions, spanning 3 consecutive days, with 2 15-minute sessions conducted each day. Each session will consist of 5 blocks, and each block will comprise 50 trials. This structure will result in a total of 1500 trials throughout the training program.
The training program will consist of six sessions, each with a duration of 15 minutes, conducted over a period of three consecutive days. Two sessions will be administered each day, culminating in a total training duration of 1.5 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1.Patients seeking treatment from the Inpatient Department (IPD) at NDDTC, AIIMS.
2.Male Patients.
3.Patients diagnosed with substance use disorder in accordance with DSM-5, as per clinical history.
4.Patients qualifying the criteria of problem or pathological gambling in accordance with the score on South Oaks Gambling Screen (SOGS). A score of 1 to 4 suggests problem gambling while score of more than 4 indicates probable pathological gambling.
5.Patients must be willing to participate in the study. 6.Patients willing to attend follow-ups.
|
|
| ExclusionCriteria |
| Details |
1.Patients with severe medical/ psychiatric illnesses that preclude their participation in the study, as per clinical history.
2.Patients with a lifetime history of a neurological illness, neurodevelopmental disorder, or traumatic head injury as per clinical history.
3.Patients not willing to participate or provide informed consent for the study.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Score on the Overt Aggression Scale – Modified (OAS-M). |
At 1 Month Follow Up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Score on the Overt Aggression Scale – Modified (OAS-M) |
At 3 Months Follow Up |
| Score on the Timeline Follow Back Scale for each substance used |
At 1 Month Follow Up and 3 Months Follow Up |
| Score on the South Oaks Gambling Scale (Item – 1) for each type of gambling behaviour engaged in |
At 1 Month Follow Up and 3 Months Follow Up |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
This study is a randomized controlled trial (RCT) investigating the efficacy of Inhibitory Control Training compared to Sham Training in reducing aggression among individuals with co-occurring substance use disorder and gambling behavior. The trial employs a two-group, parallel design and evaluates participants at four time points: pre-intervention, post-intervention (1 day, 1 month, and 3 months). The primary outcome measure is the frequency and intensity of aggressive behaviors reported one month after the intervention, assessed using the Overt Aggression Scale – Modified. Secondary outcomes include scores on the Overt Aggression Scale at the three-month follow-up, substance use assessed by the Timeline Follow Back Scale, and gambling behavior measured by the South Oaks Gambling Scale, both at 1-Month Follow Up and 3-Month Follow up. |