| CTRI Number |
CTRI/2025/03/083374 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving Cognitive Function in Substance Use Disorder with Indian Neurocognitive module |
|
Scientific Title of Study
|
To evaluate the effectiveness of the Indian Digital Neuro-Cognitive module as an intervention for cognitive remediation in substance use disorders: A Randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Simran Kaur |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Stress and Cognitive Electroimaging Lab, Department of Physiology, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
09810811594 |
| Fax |
|
| Email |
drsimrankaur@aiims.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Simran Kaur |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Stress and Cognitive Electroimaging Lab, Department of Physiology, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
09810811594 |
| Fax |
|
| Email |
drsimrankaur@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Simran Kaur |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Stress and Cognitive Electroimaging Lab, Department of Physiology, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
09810811594 |
| Fax |
|
| Email |
drsimrankaur@aiims.edu |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research
Ansari Nagar, New Delhi-110029
Email: po.epms@icmr.gov.in
Contact us:011-26589571 |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India
|
| Type of Sponsor |
Government funding agency |
|
|
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 Simran Kaur |
AIIMS, New Delhi |
Stress and Cognitive Electroimaging Lab, Room number 6010, Convergence block, Department of Physiology, AIIMS, New Delhi
South
DELHI |
9810811594
drsimrankaur@aiims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, (2) ICD-10 Condition: F112||Opioid dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control arm |
control arm shall be assessed at the base line and then at 2 weeks (/- 3 days), 4 weeks (/- 7 days) and 12 weeks (/- 7 days) . These subjects shall continue to receive the treatment as usual as decided by the clinical team. |
| Intervention |
Indian digital neurocognitive module |
Subjects shall be included in the randomized controlled trial and shall be allocated to either the intervention or the waitlist control arm using a random number table. Those in the intervention arm shall be assessed at the baseline using the study questionnaires and instruments. 1. Cognitive function tests 2. Validated cognitive battery (CANTAB) 3. Quantitative EEG based approach 1. Cognitive function tests : Attention: Posner’s task,Working memory: Sternberg working memory task, Visual approach/ avoidance task, Emotional interference task. CANTAB shall serve as a positive comparator for the tests designed by the project team. The data from the healthy subjects shall be the negative control. For each of domain, subject score and reaction time will be ascertained and compared with the standard score and percentile ranks (as per the available normative data) The content of the module shall be offered on a predetermined time schedule in the SUD patients. The intervention will be administered in two parts for 12 weeks: 1. Cognitive enhancement: • Location: It will be done at the NDDTC, Ghaziabad • Format: Digital app based supervised by a psychologist. • Frequency: 2 times a week. • Duration: 1 hour 2. Consolidation: • Location: Home based • Format: Digital app based, supervised virtually • Frequency: 4 times a week. • Duration: 1 hour Cognitive training structure: Sequential administration: Firstly, lower order cognitive domain like attention will be administered. Followed by working memory. Subsequently higher order cognitive skills like interference will be introduced in the form of visual avoidance tasks and emotional interference tasks. Hierarchical administration: Administration will be with increasing level of load i.e. through 3 levels (easy, moderate and difficult) Control: The patients with substance use disorders (alcohol, cannabis, inhalant, opioids, tobacco) seeking treatment at NDDTC shall be used as a waitlist control. This shall be offered in addition to the treatment as usual as per the decisions of the treatment team. The subjects shall be assessed at the end of 2 weeks (/- 3 days), 4 weeks (/- 7 days) and 12 weeks (/- 7 days) using the study instruments and investigations to document the change in the cognitive functions. Those allocated to the control arm shall be assessed at the base line and then at 2 weeks (/- 3 days), 4 weeks (/- 7 days) and 12 weeks (/- 7 days) . These subjects shall continue to receive the treatment as usual as decided by the clinical team. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients with SUD (alcohol, cannabis, inhalant, opioids, tobacco) seeking treatment at NDDTC, AIIMS, New Delhi
b) Aged 18 years or more
c) Willing to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
a) Patients refusing to provide written informed consent
b) Patients having active withdrawal symptoms
c)Patients with any other neuropsychiatric/ neurodegenerative disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of the study the data on feasibility and effectiveness of the neuro- cognitive module for assessment and rehabilitation of the patients with substance use disorders shall be generated. |
2 weeks, 4 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To develop biomarker based on multivariate feature selection of neurocognitive scores analysis in SUDs for cognitive remediation |
baseline, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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 3 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsimrankaur@aiims.edu].
- For how long will this data be available start date provided 30-01-2030 and end date provided 31-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Substance use disorders (SUD) are a significant public health problem, responsible for 5.5% Disability Adjusted Life Year globally. In India the burden due to the neuropsychiatric disorders has been estimated to be 6·2% of all DALYs. SUD impact various dimensions of health and wellbeing, including cognitive deficits. Various SUDs well documented to lead to deficits in various domains including attention and concentration, working memory, reaction time, executive functioning among others. The prevalence of deficits has been found to range from 30-80% in the published literature, and we found that 40-79% among alcohol and opioid use disorders exhibited cognitive deficits in working memory in our study. These cognitive deficits are detrimental, which can increase the risk of relapses, hence worsening the outcome. Also, the presence of these cognitive deficits interferes with day-to-day functioning and the rehabilitation process. Hence it is imperative to offer interventions that are targeted for cognitive remediation. Over the year effective treatment options have been developed for different use disorders. These include both pharmacological and non-pharmacological interventions. However, these interventions are aimed at motivation enhancement, withdrawal management of craving and relapse prevention. None of these interventions are targeted addressing the underlying neurocognitive deficits. Further, the existing and ongoing intervention research in the country have not focused on addressing the cognitive deficits among patients of SUDs. In fact, there are no Indian interventions areavailable for this purpose that have developed and tested for efficacy. This is a major limitation of the existing management the patients with SUD. Thus, there is an unmet need to develop a neurocognitive module which is culturally sensitive and relevant to Indian population, matching the socio-educational background. This Indian digital Neurocognitive module will ensure effectivity and applicability to the Indian populations delivered using mobile based user interface. Subsequently, after the development, the module shall be validated objectively using cognitive assessment and underlying neural mechanisms using EEG cortical source analysis. This shall be done using noninvasive, high density 128 channel Quantitative EEG, ensuring the capture of neural changes during baseline and after the neurocognitive intervention. Using multivariate machine learning algorithms, relevant features will be extracted from high-density EEG and neurocognitive datasets. Subsequently, a composite biomarker will be constructed that reflects cognitive deficits and cognitive remediation |