| 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
|
|
|
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
|
|
|
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. |