Rajiv Gandhi University of Health Sciences



PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

BANGALORE

|1 |NAME OF THE CANDIDATE AND ADDRESS | |

| |(In block letters) | |

| | |DR. AMRTAVARSHINI. R. |

| | |POSTGRADUATE IN PSYCHIATRY, |

| | |BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, |

| | |BANGALORE. |

| | | |

|2 |NAME OF THE INSTITUTION | |

| | | |

| | |BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BANGALORE |

| | | |

|3 |COURSE OF STUDY AND SUBJECT | |

| | | |

| | |M.D. PSYCHIATRY. |

| | | |

| | | |

|4 |DATE OF ADMISSION TO THE COURSE | |

| | | |

| | |31-05-2013 |

| | | |

| | | |

|5 |TITLE OF THE TOPIC | |

| | | |

| | |“PREVALENCE AND RISK FACTORS FOR POST STROKE DEPRESSION-IN A TERTIARY |

| | |CARE SET UP”. |

| | | |

| | | |

6. BRIEF RESUME OF INTENDED WORK

6.1 NEED FOR STUDY

Stroke is a global health problem. It is the second commonest cause of death and fourth leading cause of disability worldwide. Depression is a common complication post-stroke affecting approximately one-third of patients.

Global Stroke estimates range from prevalence of 400-800 strokes per 100,000 with 5.7 million deaths per year and 28,500,000 DALYs (disability adjusted life-year) (WHO 2004) [1].

Stroke Morbidity and Mortality data in India show a prevalence of 90-222 per 100,000,102- 620 million deaths per year and 6,398,000 DALYs (disability adjusted life-year) (WHO 2009) [1].

The prevalence of depression following stroke worldwide varies between 20% and 40% [2, 3], depending on the population studied, the assessment measures and the definition of depression applied, with similar estimates in India (36.98% - Neelanjana Paul et.al) [2]

Early detection of post stroke depression (PSD) is important as this has been negatively associated with survival, cost of medical care, compliance with therapy including rehabilitation, functional outcome, resumption of social activities and quality of life [3-5].

Though the exact pathophysiology of PSD remains elusive, several risk factors have been implicated including female sex, stroke severity, lesion location, past history of depression or psychiatric illness, functional limitations, and cognitive impairment [6, 7].

The present study shall be undertaken for identification of these various risk factors for PSD in the Indian scenario as there is a paucity of studies in the area. Moreover, risk factors such as cognitive impairment, medical & psychiatric co morbidities associated with post stroke depression have seldom been studied, which are included in this study.

Identification of these factors is important and helpful for early diagnosis, adequate treatment and improvement in quality of life, both for patients and caregivers.

6.2 REVIEW OF LITERATURE

Stroke is “the rapid development of clinical signs and symptoms of a focal neurological disturbance lasting more than 24 hours or leading to death with no apparent cause other than vascular origin’’(WHO 2005) [8].

Paolucci et al. (2005) reported that, of 1064 patients included in the DESTRO study, 36% developed depression. Eighty percent of these became depressed within the first three months of the stroke event (Paolucci et al 2005). In that study, dysthymia (mild depression) was the most common form of depression, occurring in 80.7% of cases, whereas major depression was diagnosed in only 2.9% [4].

A Systematic review by Hackett and Anderson (2005) included data from a total of 21 studies. Of the many different variables assessed, physical disability, stroke severity and cognitive impairment were most consistently associated with depression [9].

Farner et al. (2010) reported persistent depression in more than half (55%) of the individuals identified as depressed during inpatient rehabilitation post stroke. Significant predictors of persistent depression included lower levels of pre-stroke social activity, greater severity of stroke and lower levels of function at baseline [5].

A prospective study on the prevalence and risk factors of post stroke depression by A. De Ryck et.al (2013) showed that risk of developing PSD is increased in patients with more functional and cognitive impairment greater dependency with regard to ADL (activities of daily living) functions and with occurrence of speech and language dysfunctions and apraxia [7].

There remains a wide diversity of findings in studies looking at the relationships between stroke location and depression. Not all studies have confirmed this relationship and meta-analyses have failed to establish a definitive relationship between the site of the brain lesion and depression [3].

An Indian study on Post-stroke depression which assessed prevalence and relationship with disability in chronic stroke survivors by Abhishek Srivastava et.al showed prevalence of 35.29%. Most important determinants of depression were demographic variables like male gender, marital status, and living situation [6].

6.3 OBJECTIVES OF STUDY:

• Estimation of prevalence of depression after stroke.

• Assessment of medical & psychiatric co morbidities predisposing to post stroke depression.

• Assessment of cognitive & physical disabilities associated with post stroke depression.

7. MATERIALS AND METHODS:

7.1 SOURCE OF DATA:

The study is to be carried out in Departments of Psychiatry and Neurology, Bangalore Medical College and Research Institute.

7.2 METHODS OF COLLECTION OF DATA:

A.STUDY DESIGN:

Cross sectional Study.

B.STUDY PERIOD:

November 2013 to Oct 2015.

C.PLACE OF STUDY:

Department of Psychiatry & Neurology, Bangalore Medical College and Research Institute, Bangalore.

D.SAMPLE SIZE: 100

E. INCLUSION CRITERIA

• Persons above 18 years of age

• Patients diagnosed for stroke, 1 month after the acute stroke, within the past year.

• Persons giving written informed consent to participate in the study.

F. EXCLUSION CRITERIA

• Exclusive episode/s of TIA.

• Patients with severe medical & psychiatric illnesses.

• Patients with dementia.

G. METHODOLOGY

After obtaining clearance and approval from the institutional ethical committee, participants fulfilling the above criteria will be included in the study with informed consent prior to study. [Annexure –I]

Detailed socio demographic profile & other data including risk factors, location, type & extent of brain lesion shall be collected by interviewing patients / relatives, from previous medical records and neuroimaging reports using a semi-structured proforma [Annexure –II]

Severity of stroke shall be assessed using NIH-Stroke Scale [Annexure –III],a composite scale derived from the Toronto Stroke Scale, the Oxbury Initial Severity Scale, the Cincinnati Stroke Scale and the Edinburgh-2 Coma Scale. It is a 15-item scale, Items are graded on a 3 or 4 point ordinal scale; Stroke severity may be stratified on the basis of NIHSS scores as follows (Brott et al, 1989):Very Severe:  >25 .Severe: 15 – 24, Mild to Moderately Severe: 5 – 14 & Mild: 1 – 5.

Cognitive assessment shall be carried out using Mini Mental Status Examination (MMSE) to rule out Major cognitive impairment (Dementia) [Annexure –IV] which tests a total of 5 domains with a maximum scoring of thirty with a score of less than 20 indicating severe dementia.

Physical & cognitive disability due to stroke shall be assessed using Functional Independence Measure (FIM) [Annexure –V]. This scale includes 18 items, of which 13 items are physical domains based on the Barthel Index and 5 items are cognition items. Each item is scored from 1 to 7 based on level of independence, where 1 represents total dependence and 7 indicates complete independence. Possible scores range from 18 to 126, with higher scores indicating more independence.

Each case shall be screened for depression using depression screening in M.I.N.I (Mini International Neuropsychiatric Interview) (version 5).For those who are positive for depression, the scale shall be completed. [Annexure –VI]. It is structured interview design for the major axis I psychiatric disorders in DSM-IV and ICD-10. The M.I.N.I is divided into modules identified by letters, each corresponding to a diagnostic category, at the beginning of each of which are screening questions corresponding to the main criteria of the disorder which is used as a screener tool in this study for co-morbid psychiatric conditions .It features questions on rule outs, disorder sub typing and chronology.

The severity of depression shall be further assessed by HAM-D scale [Annexure –VII]. It consists of 21 items, the scoring is based on the first 17. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Sum the scores from the first 17 items.0-7 = Normal, 8-13 = Mild Depression, 14-18 = Moderate Depression, 19-22 = Severe Depression, ≥ 23 = Very Severe Depression.

STUDY TOOLS

• Consent form [Annexure –I]

• Study proforma [Annexure –II]

• NIH Stroke Scale [Annexure –III]

• The Mini-Mental State Exam (MMSE) [Annexure –IV]

• Functional Independence Measure (FIM) [Annexure –V]

• M.I.N.I (Mini International Neuropsychiatric Interview) [Annexure –VI]

• HAM-D scale (Hamilton rating scale for depression) [Annexure –VII]

H. STATISTICAL METHODS INVOLVED:

The Statistical data analysis will be done using SPSS data editor Version 17.5.

3. DOES STUDY REQUIRE ANY INVESTIGATIONS TO BE CONDUCTED ON PATIENTS AND ANIMALS? SPECIFY.

No.

4. HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3?

Will be submitted for approval. The study shall be conducted after obtaining informed consent from each subject. Confidentiality shall be maintained. No invasive procedure is planned.

8. LIST OF REFERENCES:

1. Stroke in India factsheet (updated 2012) Fiona c Taylor, Suresh Kumar ,south Asia network for chronic disease, IIPH Hyderabad, public health foundation of India

2. Depression Among Stroke Survivors: A Community-based, Prospective Study from Kolkata, India. Paul, Das S, Hazra A, Ghosal MK, Ray BK, Banerjee TK, Chaudhuri A, Sanyal D, Basu A, Das SK, Am J Geriatr Psychiatry. 2013 Sep; 21(9):821-31.

3. Post stroke Depression: A Review, Robert G. Robinson, MD and Gianfranco Spalletta, MD, PhD Can J Psychiatry. 2010 June; 55(6): 341–349.

4. Paolucci S, Gandolfo C, Provinciali L, Torta R, Toso V. The Italian multicenter observational study on post-stroke depression (DESTRO). J Neurol Neurosurg Psychiatry2006; 253:556-56.

5. Farner L, Wagle J, Engedal K, Flekkoy KM, Wyller TB, Fure B. Depressive symptoms in stroke patients: a 13 month follow-up study of patients referred to a rehabilitation unit. J Affect Disord 2010; 127(1-3):211-218.

6. Post-stroke depression: Prevalence and relationship with disability in chronic stroke survivor Abhishek Srivastava, Arun B. Taly, [...], and Thyloth Murali, Ann Indian Acad Neurol. 2010 Apr-Jun; 13(2): 123–127.

7. De Ryck et al.: A Prospective Study on the Prevalence and Risk Factors of PoststrokeDepression Cerebrovasc Dis Extra 2013;3:1–13.

8. WHO MONICA Project Investigators. The World Health Organization MONICA Project (Monitoring trends and determinants in cardiovascular disease). J Clin Epidemiol 41, 105-114. 1988.

9. Hackett ML, Anderson CS. Frequency, management, and predictors of abnormal mood after stroke: the Auckland Regional Communitya Stroke (ARCOS) study, 2002 to 2003. Stroke 2006;37:2123-2128.

ANNEXURE I

Title of the study: Prevalence of depression among stroke survivors and predisposing factors for the same

Investigator: Dr. Amrtavarshini R, Postgraduate Student in Psychiatry, BMC&RI

Guide: Dr. Chandrashekar H, Professor & Head. Dept. of Psychiatry, BMC&RI

Co-Guide: Dr. J B Agadi, Professor & Head. Dept. of Neurology, BMC&RI

University: Rajiv Gandhi Institute of Health Sciences, Bangalore

Information and purpose of the study:

• This study titled as “Prevalence of depression among stroke survivors and predisposing factors for the same” is a study conducted on patients diagnosed for stroke within the past year. This study is conducted as a part of curriculum to pursue ‘Doctor of Medicine’ postgraduate degree in Psychiatry from Rajiv Gandhi Institute of Health Sciences. This study aims at assessment of medical, psychiatric co morbidities and cognitive, physical disabilities predisposing to post stroke depression, which plays an important role in rehabilitation of stroke survivors. This study is optional. Any patient fulfilling inclusion criteria can participate in it. The study involves 5 questionnaires to interview participants and collecting information regarding various aspects. Some of the information may be needed to be collected from attendants of patients. However privacy policy ensures that no personal information involving identity of patient will be disclosed. This is a non-profitable, unsponsored and non-funded study in which participants are not paid in monetary terms or discounted from hospital charges for the participation. Participant is free to opt out of the study at any point of the time if he/she wishes so. Participation in this study, in no way interferes with the course of treatment received by or bears extra cost on part of the patient.

7.5 Written informed consent for the participation in study

I Mr. /Mrs. /Ms. _________________________ aged / Father/Mother/Guardian of have been explained in my own understandable language about the study, its purpose, policies, terms and condition and have understood the same. I hereby give my voluntary consent for the participation in the study and thereby agree for the interview and collection of data with the above mentioned questionnaires.

Signature of the participant Surrogate’s Signature

Place:

Date:

ANNEXURE II

STUDY PROFORMA

1. Sociodemographic Profile

Date –

OPD Number-

Name: _______________________________________________ Age: _______Years

Gender: 1- Male 2-Female

Marital status: 1-Single, 2-Married, 3-Separated, 4-Divorced, 5- Widowed, 6-Cohabiting

Duration of marital status: ____ Years

Number of children: _____

Family composition: 1-Nuclear, 2- Joint, 3- Extended Joint

Educational Status: 1-Illiterate, 2-Literate/able to sign but no formal education, 3- Primary school, 4-secondary school, 5-high school, 6- Pre-university/Diploma, 7-Graduate, 8- Postgraduate and above, 9- Professional, 10-others

Current Occupational Status:

1-Unemployed, 2-Farmer, 3-Unskilled, 4-Semiskilled, 5-Skilled, 6-Student, 7-Clerical, 8-Professional, 9-Business, 10-Others (Specify) ______________________

Total Monthly Family Income: Rs_____________

Socioeconomic status: ____________

Personal and family history

H/o Psychiatric illness: 1- No, 2- Yes If Yes, specify______________

H/o Medical illness: 1- No, 2- Yes If Yes, specify______________

H/o HTN/DM/Obesity/IHD/others (specify) ____________________

Family H/o Psychiatric illness: 1- No, 2- Yes If Yes, specify___________

Lesion characteristics: As per CT MRI

Location: Right Left

Vascular territory: ACA MCA PCA

Type: Infarct hemorrhage

Extent; Dimension _______________

Other assessments used:

1. NIHSS Score_______

2. MMSE Score_______

3. FIM Score_________

4. HAM-D Score______

ANNEXURE III

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ANNEXURE IV

[pic]

ANNEXURE V

[pic]

MINI

M.I.N.I. 5.0.0

A. MAJOR DEPRESSIVE EPISODE

A1 a Have you ever been consistently depressed or down, most of the day, nearly every day, for at least two weeks? No Yes

IF A1a = YES:

b Have you been consistently depressed or down, most of the day, nearly every day, for the past 2 weeks? No Yes

A2 a Have you ever been much less interested in most things or much less able to enjoy the things you used to enjoy most of the time over at least 2 weeks?

No Yes

IF A2a = YES:

b In the past 2 weeks, have you been much less interested in most things or much less able to enjoy the things you used to enjoy most of the time.

No Yes

=>

IS A1a OR A2a CODED YES? No Yes

[pic]

|9 |SIGNATURE OF THE CANDIDATE | |

|10 |REMARKS OF THE GUIDE |Depression among stroke patients is common, study is relevant and required. |

|11 |1 |NAME AND DESIGNATION OF THE GUIDE |DR.CHANDRASHEKHAR. H |

| | |(In block letters) |PROFESSOR AND HEAD |

| | | |DEPARTMENT OF PSYCHIATRY, |

| | | |BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE. |

| |2 |SIGNATURE | |

| |3 |NAME AND DESIGNATION OF THE CO-GUIDE |DR. J B AGADI |

| | |(In block letters) |PROFESSOR AND HEAD |

| | | |DEPARTMENT OF NEUROLOGY, |

| | | |BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE. |

| |4 |SIGNATURE | |

| |5 |HEAD OF THE DEPARTMENT |DR. CHANDRASHEKHAR. H |

| | | |PROFESSOR AND HEAD |

| | | |DEPARTMENT OF PSYCHIATRY, |

| | | |BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |

| |6 |SIGNATURE | |

|12 |1 |REMARKS OF THE CHAIRMAN AND PRINCIPAL | |

| |2 |SIGNATURE | |

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ANNEXURE V

M.I.N.I PLUS

ANNEXURE VII

ANNEXURE VI

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