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CTRI Number  CTRI/2024/04/065241 [Registered on: 04/04/2024] Trial Registered Prospectively
Last Modified On: 06/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Managing Type 2 Diabetes: Evaluating the impact of Cognitive Behavioral Therapy 
Scientific Title of Study   Assessment of the effectiveness of CBT related to stress in Type 2 Diabetes Mellitus. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Prasanna Deshpande 
Designation  Head of Department, Department of Clincal Pharmacy Practice 
Affiliation  Dr DY Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune, Maharashtra, India 
Address  Dr DY Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune, Maharashtra, India

Pune
MAHARASHTRA
411018
India 
Phone  9766563630  
Fax    
Email  prasanna.deshpande17@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Shambhavi Pandey 
Designation  Doctor of Pharmacy 
Affiliation  Poona College of Pharmacy, Bharati Vidyapeeth Deemed To be University, Pune, India 
Address  Poona College of Pharmacy, Bharati Vidyapeeth Deemed To be University, Pune, India

Pune
MAHARASHTRA
411038
India 
Phone  8805081544  
Fax    
Email  dr.pandeyshambhavi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Prasanna Deshpande 
Designation  Head of Department, Department of Clincal Pharmacy Practice 
Affiliation  Dr DY Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune, Maharashtra, India 
Address  Dr DY Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune, Maharashtra, India

Pune
MAHARASHTRA
411018
India 
Phone  9766563630  
Fax    
Email  prasanna.deshpande17@gmail.com  
 
Source of Monetary or Material Support  
Bharati Hospital and Research Centre, Satara Rd, Bharati Vidyapeeth Campus, Dhankawadi, Pune, Maharashtra 411043  
 
Primary Sponsor  
Name  Shambhavi Pandey 
Address  Department of Clinical Pharmacy Practice, Pune - Satara Rd, Bharati Vidyapeeth Campus, Dhankawadi, Pune, Maharashtra 411043 
Type of Sponsor  Other [Self Funded] 
 
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 
Shambhavi Pandey   Bharati Hospital and Research Centre   bha Pune - Satara Rd, Bharati Vidyapeeth Campus, Dhankawadi, Pune, Maharashtra 411043
Pune
MAHARASHTRA 
08805081544

dr.pandeyshambhavi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth ( Deemed to be) Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cognitive Behavioral Therapy   Structured Sessions - talk therapy and strategies to deal with stress. Duration- 15 days-1 month. Total duration in Hours- 260 
Comparator Agent  Non- Intervention - No Cognitive Behavioral Therapy   No sessions are given, only standard diabetes care. Duration- 15 days to 1 month. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Diagnosed with Type 2 Diabetes for more than a month- Hba1c levels - 6.5 and above. 
 
ExclusionCriteria 
Details  Any other types of Diabetes. 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Statistical significance will be determined using independent and paired t-tests. A standard deviation of less than 0.005 will be considered significant.  On Day 0 of Week 1, we will calculate PSS-10 scores. After the CBT intervention, we will calculate the scores on Day 30 of Week 4.On Day 0 of Week 1, we will calculate PSS-10 scores. After the CBT intervention, we will calculate the scores on Day 30 of Week 4. 
 
Secondary Outcome  
Outcome  TimePoints 
Scales like Generalized Anxiety and Patient Health Questionnaire will have less scores  Better health 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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/ Phase 4 
Date of First Enrollment (India)   13/04/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   The study aims to investigate the efficacy of Cognitive Behavioural Therapy (CBT) in managing stress among individuals with Type 2 Diabetes Mellitus (T2DM) in India. The primary objective is to assess the impact of CBT on perceived stress levels and glycemic control in T2DM patients.

Methodologically, we will conduct a randomized controlled trial involving T2DM patients aged 18-65 years. Participants will be randomly assigned to either the intervention group or the control group. The intervention group will receive six sessions of CBT administered by trained therapists over a period of one month, while the control group will receive standard diabetes care without CBT intervention.

Outcome measures will include perceived stress levels assessed using the Perceived Stress Scale (PSS-10), depression and anxiety symptoms measured using the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) scales, respectively, self-worth assessed using the Rosenberg Self-Esteem (RSE) scale, gratitude practices measured using the Gratitude Questionnaire-6 (GQ-6), and glycemic control evaluated through Hemoglobin A1c (HbA1c) levels.

Additionally, demographic data and information on diabetes-related factors such as duration of diagnosis, medication adherence, and lifestyle habits will be collected through structured interviews and medical records review.

The study will be conducted in a real-world clinical setting to enhance the generalizability of findings. Ethical approval is obtained, and informed consent is obtained from all participants before enrollment. Data analysis will be performed using appropriate statistical methods to compare outcomes between the intervention and control groups, with significance set at p < 0.05.

Overall, the study design and methodology ensure rigorous evaluation of the effectiveness of CBT in managing stress and improving glycemic control among T2DM patients in India, with potential implications for enhancing diabetes care globally.
 
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