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CTRI Number  CTRI/2021/03/032247 [Registered on: 23/03/2021] Trial Registered Prospectively
Last Modified On: 26/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Nursing interventions for improving ego resilience and quality of life among people with depression. 
Scientific Title of Study   A study to assess the efficacy of specific nursing intervention on ego resilience and quality of life among people with depression in selected mental health unit. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  K Jayakrishnan 
Designation  Nursing Tutor 
Affiliation  All India Institute of Medical Sciences Patna 
Address  Room No. 24, 2nd Floor, College of Nursing Building, AIIMS PATNA Campus, Phulwarishariff

Patna
BIHAR
801507
India 
Phone  09348310322  
Fax    
Email  jk.snc007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arunjyoti Baruah 
Designation  Professor and Guide 
Affiliation  Lokopriya Gopinath Bordoloi Regional Institute of Mental Health 
Address  Department of Psychiatric Nursing, LGBRIMH, Tezpur P.O

Sonitpur
ASSAM
784001
India 
Phone  9435380045  
Fax    
Email  arunjyotibaruah@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Pankaj Kumar 
Designation  Additional Professor and Co-Guide 
Affiliation  All India Institute of Medical Sciences, Patna 
Address  Room No. 2, Department of Psychiatry, 1st Floor, Left wing, OPD Building, AIIMS Patna Hospital, Phulwarishariff

Patna
BIHAR
801507
India 
Phone  9868226571  
Fax    
Email  cppankajkumar13@gmail.com  
 
Source of Monetary or Material Support  
Mr. K Jayakrishnan, Room No. 24, 2nd Floor, College of Nursing Building, AIIMS PATNA Campus, Phulwarishariff, Patna, Bihar 
 
Primary Sponsor  
Name  K Jayakrishnan 
Address  Room No. 24, 2nd Floor, College of Nursing Building, AIIMS PATNA Campus, Phulwarishariff 
Type of Sponsor  Other [Self] 
 
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 
K Jayakrishnan  All India Institute of Medical Sciences Patna  Psychiatric IPD, 1st Floor, C Block, IPD Building, AIIMS Patna Hospital, Phulwarishariff
Patna
BIHAR 		 9348310322

jk.snc007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee, AIIMS Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F313||Bipolar disorder, current episodedepressed, mild or moderate severity, (2) ICD-10 Condition: F314||Bipolar disorder, current episodedepressed, severe, without psychotic features, (3) ICD-10 Condition: F315||Bipolar disorder, current episodedepressed, severe, with psychotic features, (4) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, (5) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, (6) ICD-10 Condition: F323||Major depressive disorder, singleepisode, severe with psychotic features, (7) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, (8) ICD-10 Condition: F328||Other depressive episodes, (9) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified, (10) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, (11) ICD-10 Condition: F333||Major depressive disorder, recurrent, severe with psychotic symptoms, (12) ICD-10 Condition: F338||Other recurrent depressive disorders, (13) ICD-10 Condition: F339||Major depressive disorder, recurrent, unspecified, (14) ICD-10 Condition: F39||Unspecified mood [affective] disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Specific Nursing Interventions  The intervention involves four different nurse led interventions, provided to the participants for a period of two weeks. The interventions are Physical Exercise (provided every day), Psychoeducation (Provided every alternate day), Counselling (provided every other alternate day) and Cognitively oriented Group Therapy (Four Sessions in any of the two weeks) 
Comparator Agent  Treatment as usual  The control arm will not be provided with any intervention from the investigator. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) Clinical diagnosis of Bipolar/Unipolar depression

2)Known diagnosis for more than 6 months

3)Individuals with moderate, severe and extreme depression

4)Aged more than 18 years of age

5) Individuals who read, write and understand English or Hindi language.

6)Individuals admitted in selected mental health centres as inpatients.

7) Hamilton Depression Rating Scale (HAM-D) score more than 14
 
 
ExclusionCriteria 
Details  1)With primary diagnosis of any neurotic, organic or substance related disorders.

2) Unwilling to participate in the study.

3) Participation in any other trials.

4) Current use of complementary and alternative therapies.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quality of Life  Baseline, 45 days, 90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Ego Resilience  Baseline, 45 days, 90 days 
Severity of Depression  Baseline, 45 days, 90 days 
 
Target Sample Size   Total Sample Size="53"
Sample Size from India="53" 
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)   05/04/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The project that has been undertaken as a part of completing the PhD in Nursing coarse, and is aimed at improving the ego resilience and quality of life of people with depression. The study is conducted at a central government based tertiary level medical college in Patna, Bihar. The study is attempting to assess the efficacy of four nursing interventions, bundled to be provided as a intensive intervention for a period of two weeks. The interventions would include, Physical Exercise, Psycho-education, Counselling and Cognitively oriented group therapy. The variables would be assessed by WHO Quality of life - Bref scale for Quality of life, Ego Resilience Scale - 14 by Kremen and Block for Ego Resilience and Hamilton Depression Rating scale for severity of Depression. The Trial is expected to be over within an year.  
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