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CTRI Number  CTRI/2024/10/075810 [Registered on: 24/10/2024] Trial Registered Prospectively
Last Modified On: 23/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Intervention for mental disorders in diabetes 
Scientific Title of Study   Integration of screening and treatment for mental disorders in type 2 diabetes mellitus: A mixed-methods study in a health care setting of Kolar, South India 
Trial Acronym  CoMENcD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pracheth Raghuveer 
Designation  Associate Professor of Epidemiology  
Affiliation  NIMHANS  
Address  Department of Epidemiology NIMHANS Bengaluru 560029

Bangalore
KARNATAKA
560029
India 
Phone  9743289207  
Fax    
Email  prach1986@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pracheth Raghuveer 
Designation  Associate Professor of Epidemiology  
Affiliation  NIMHANS  
Address  Department of Epidemiology NIMHANS Bengaluru 560029

Bangalore
KARNATAKA
560029
India 
Phone  9743289207  
Fax    
Email  prach1986@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pracheth Raghuveer 
Designation  Associate Professor of Epidemiology  
Affiliation  NIMHANS  
Address  Department of Epidemiology NIMHANS Bengaluru 560029


KARNATAKA
560029
India 
Phone  9743289207  
Fax    
Email  prach1986@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Mental Health and Neuro Sciences Bengaluru 
Research Society for Study of Diabetes in India 
 
Primary Sponsor  
Name  Dr Pracheth R 
Address  Department of Epidemiology NIMHANS Hosur Road Bengaluru 560029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pracheth R  National Institute of Mental Health and Neuro Sciences  Room 219, Department of Epidemiology, Dr MV Govindaswamy Centre, Hosur Road Bengaluru 560029
Bangalore
KARNATAKA 		 9743289207

prach1986@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMHANS Ethics Committee Basic and Neuro Sciences Division  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brief psychological intervention  The contents of the intervention include psychoeducation, yoga with relaxation and breathing exercises, sleep hygiene, nutrition, problem-solving, motivational interview techniques, and enabling support system. This intervention will be delivered in three sessions of around 20 minutes each two weeks apart. 
Comparator Agent  Standard of care  Follow-up and simple advice will be offered for around ten minutes duration in three sessions two weeks apart 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Persons aged more than 18 years diagnosed with
type 2 diabetes mellitus seeking outpatient care at the District Hospital of Kolar will be included 
 
ExclusionCriteria 
Details  Exclusion criteria include patients with conditions like Type 1 Diabetes Mellitus, those aged less than 18 years, those unable to give informed consent and hospitalized patients who cannot communicate verbally with the investigator 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in common mental health disorders like depression, anxiety, stress and/or substance use  Baseline and eight weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Association between socio-demographic variables, morbidity profile and common mental disorders like depression, anxiety, stress, substance use (alcohol and tobacco) in both the groups (intervention and control)  Eight weeks after recruitment  
 
Target Sample Size   Total Sample Size="228"
Sample Size from India="228" 
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)   04/11/2024 
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="2"
Months="0"
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 - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [prach1986@gmail.com ].

  6. For how long will this data be available start date provided 30-10-2026 and end date provided 30-10-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Background:

The higher prevalence of mental health morbidity and substance use disorders (SUDs) among individuals with Type 2 Diabetes Mellitus (T2DM) has garnered considerable attention. There is a need to integrate screening and comprehensive care protocols to address mental health issues and SUDs in T2DM.

 

Objectives:

To integrate mental health, substance use disorder screening and low-intensity intervention for Type-2 Diabetes Mellitus; to identify operational challenges in healthcare settings and to assess the feasibility and effectiveness of a brief, low-intensity intervention to address common mental health problems and SUDs as compared to usual care in Kolar District, India.

 

Methods:

This is a sequential mixed methods study with descriptive qualitative (Key Informant Interviews - KIIs and Focused Group Discussions-FGDs) and quantitative (Randomized Controlled Trial-RCT) components. Two hundred twenty-eight persons with Type 2 Diabetes Mellitus seeking health care in District Hospital, Kolar will be recruited for the RCT, and health care providers of various cadre, persons with T2DM, will be included for the qualitative component. Block randomization will allocate the participants into intervention and control groups in a 1:1 ratio. The intervention will be delivered for 20-30 minutes with three sessions two weeks apart on-site or telephonically while the control group receives standard care.

 

Conclusion:

This is a mixed methods study focusing on integrating screening and low-intensity intervention for mental health problems and SUDs among persons with T2DM. Addressing mental health needs alongside diabetes care may enhance overall health outcomes. Implementing such integrated approaches is essential for promoting holistic healthcare delivery.

 

 
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