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CTRI Number  CTRI/2023/05/052309 [Registered on: 04/05/2023] Trial Registered Prospectively
Last Modified On: 03/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To assess the medication adherence and symptom severity after nurse led psycho education. 
Scientific Title of Study   “A randomised control trial to assess the effectiveness of nurse led psycho education on medication adherence and symptom severity among patients with depression attending psychiatric OPD, AIIMS, New Delhi.”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anysha N 
Designation  M.Sc. n student 
Affiliation  AIIMS 
Address  RZD3/210 GALI NO 9 FIRST FLOOR MAHAVIR ENCLAVE NEW DELHI
ANSARI NAGAR, NEW DELHI
New Delhi
DELHI
110045
India 
Phone  9818362679  
Fax    
Email  anyshan720@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrShashi Mawar 
Designation  associate professor 
Affiliation  AIIMS 
Address  room no 2,porta cabin, college of nursing,AIIMS,New Delhi
ANSARI NAGAR, NEW DELHI
New Delhi
DELHI
110029
India 
Phone  8800228317  
Fax    
Email  drshashimawar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anysha N 
Designation  M.Sc. n student 
Affiliation  AIIMS 
Address  RZD3/210 GALI NO 9 FIRST FLOOR MAHAVIR ENCLAVE NEW DELHI
ANSARI NAGAR, NEW DELHI

DELHI
110045
India 
Phone  9818362679  
Fax    
Email  anyshan720@gmail.com  
 
Source of Monetary or Material Support  
investigator 
 
Primary Sponsor  
Name  AIIMSNEW DELHI 
Address  CON,AIIMS,NEW DELHI, 110029  
Type of Sponsor  Research institution and hospital 
 
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 
ANYSHA N  All India institute of medical sciences   ROOM NO 117, psychiatry OPD,FIRST FLOOR RAK OPD, AIIMS. NEW DELHI
New Delhi
DELHI 		 9818362679

anyshan720@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICAL COMMITTEE FOR POST GRADUATE RESEARCH,AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F325||Major depressive disorder, singleepisode, in full remission,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  control group  treatment as usual 
Intervention  psycho education  individual psycho education is given for 30 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Patients who are willing to participate in the study, including willingness/ability to follow up after around a month.

2 Patients with the age group of 18-65 who have a diagnosis of depression (as per ICD-10 F 32 and F 33)- currently depressed (as per HAM-D and CUDOS)

3 Patients who have been on prescribed medications for at least one month or more, before recruiting into the study.

 
 
ExclusionCriteria 
Details  1 Patients with co-occurring psychiatric disorders.
2 Patients who are not able to read Hindi/English, unconscious and with severe depression.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the medication adherence after psychoeducation using medication adherence rating scale  4 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the severity of symptoms after psychoeducation using HAM-D and CUDOS.  4 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/08/2023 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   published after the study. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Depression is one of the most common mental disorders with more than 300 million people across all ages affected globally (WHO, 2018)

According to WHO, depression is the leading cause of disease burden globally, and it is on the rise (WHO, 2018). According to the National Mental Health Survey (NIMHANS report, 2016), overall weighted prevalence of depressive disorders was 2.7%for current experience and 5.3% for lifetime experience. According to a report in the year 2022, the prevalence rate of depression in India is 4.50% and the cases stand at 56,675,969.

Medication adherence is a common issue influenced by various factors among patients with depression worldwide. Depressive patients have more chances to change the medication, to change the dosage or to stop medication suddenly which can lead to severity of symptoms. To maintain treatment effectiveness and to reduce the severity of symptoms, it is important for patients with depressive disorder to keep taking their medications continuously over the long term.

 

Psychoeducational intervention has proved to be effective in reducing depression symptoms. It enhances the knowledge about illness, importance of medication adherence and general strategies to decrease the severity of symptoms. So there is a need of psycho education for depressive patients on regular basis.

 

So a nurse led psychoeducation can make a significant impact to improve medication adherence and reducing  the symptom severity among patients with depression. This study will develop an evidence in effectiveness of nurse led psychoeducation program among depression patients.

 

 

 

 
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