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Clinical Trial Details (PDF Generation Date :- Sun, 26 Sep 2021 17:30:56 GMT)

CTRI Number CTRI/2016/08/007154 [Registered on: 05/08/2016] - Trial Registered Prospectively Last Modified On 05/08/2016 Post Graduate Thesis No Type of Trial Interventional Type of Study Behavioral Study Design Randomized, Parallel Group Trial Public Title of Study A study to evaluate psycho social intervention module for rural women with major depression Scientific Title of A Randomized Controlled Study of brief psychosocial intervention for rural women with major Study depressive disorder Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Satheesh Rao Trial Coordinator (multi-center study) Designation Professor & Head Department of Psychiatry Affiliation K S Hegde Medical Academy Address Department of Psychiatry K S Hegde Medical Academy Nitte University Deralakatte Mangaluru Taluk District Dr Satheesh Rao 31 Valerie Manor Britto Lane Falnir Mangaluru 575001 Dakshina Kannada KARNATAKA 575018 India Phone 9845085561 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Satheesh Rao Query) Designation Professor & Head Department of Psychiatry Affiliation K S Hegde Medical Academy Address Department of Psychiatry K S Hegde Medical Academy Nitte University Deralakatte Mangaluru Taluk Dakshina Kannada District Karnataka Dr Satheesh Rao 31 Valerie Manor Britto Lane Falnir Mangaluru 575001 Dakshina Kannada KARNATAKA 575018 India Phone 9845085561 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Satheesh Rao Designation Professor & Head Department of Psychiatry Affiliation K S Hegde Medical Academy Address Department of Psychiatry K S Hegde Medical Academy Nitte University Deralakatte Mangaluru Taluk Dakshina Kannada District Karnataka Dr Satheesh Rao 31 Valerie Manor Britto Lane Falnir Mangaluru 575001

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Dakshina Kannada KARNATAKA 575018 India Phone 9845085561 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > K.S.Hegde Medical Academy Primary Sponsor Primary Sponsor Details Name K S Hegde Medical Academy Address Nitte University Deralakatte 575018 taluk Dakshina Kannada District Type of Sponsor Private medical college Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator DrSatheesh Rao K.S.Hegde Hospital Room No:16 Psychiatry 9845085561 Out Patient Department,K.S.Hegde dr_satheeshrao@yahoo Hospital Deralakatte .com Mangalore 575018 Dakshina Kannada KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Central Ethics Approved 12/02/2015 No Committee Nitte University Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients primarily diagnosed with major depression Intervention / Type Name Details Comparator Agent Intervention Psycho social intervention psycho social intervention which has been delivered to intervention group includes the components from Cognitive Behavior Therapy,problem solving therapy,interpersonal psychotherapy,behavioral activation and psycho education. Comparator Agent usual treatment usual treatment includes the treatment available in the department like medication and counselling etc. Inclusion Criteria Inclusion Criteria

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Age From 18.00 Year(s) Age To 45.00 Year(s) Gender Female Details Individuals fulfilling primary diagnosis of Major Depressive Disorder according to DSM IV
Individuals who give consent to participate Exclusion Criteria Exclusion Criteria Details Patients with any other comorbid Psychiatric diagnosis Patients with organic mental disorder and psychotic disorders secondary to general medical conditions Patients inability to give informed consent Method of Generating Computer generated randomization Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment Blinding/Masking Outcome Assessor Blinded Primary Outcome Outcome Timepoints symptom severity baseline assessment quality of life 6 weeks 16 weeks Secondary Outcome Outcome Timepoints disability 6 weeks individual and social functioning 16 weeks Target Sample Size Total Sample Size=70 Sample Size from India=70 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 09/08/2016 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=3 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details none yet Brief Summary Background Major depression is leading cause of burden in women in Low Income Countries (WHO, 2014 :Patel V,Lancet 2010,). Burden of Depression is 50% higher in females (WHO 2008).Depression now 4th leading Contributor for Global Burden of disease.Epidemiological studies conducted in South India shows high prevalence of Depression in women, especially in rural women.Brief form of psychotherapies are effective and best suited to primary care,for those willing to engage in short term.( Meta Analysis by Cape et al:2003 and Nieuwsma et al:2012). There is strong evidence for equal effectiveness of Brief Psycho social Interventions and Antidepressants in developed countries. Brief Psycho social interventions along with anti depressants are most effective for major depression in developing countries ( Patel et al : Lancet 2003).Psychological treatment s can successfully applied in low and middle income countries (Guijpers et al : 2008).Majority of women attending primary care recieves only pharmacotherapy and effectiveness which depends on treatment adherence in developing countries (WHO: 2003).

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Need for the Study:

High vulnerability of rural women to Major Depressive Disorder - gender specific risk factors,poverty ,illiteracy,absence of mental health services ,stigma attached to mental health ,high prevalence ,increasing suicide rate etc. are indicators of high vulnerability.

Scarcity of Literature on efficacy of Brief Psycho social Interventions specific to rural women.No availability of culturally feasible ,acceptable,adaptable Brief Psycho social intervention manual for rural women.

Study aim:

To examine whether the brief psycho social Intervention is more effective than treatment as usual in improving the outcome of major depressive disorder among rural women in Psychiatry setting.

Specific Objectives:To develop a brief Psycho social Intervention program for rural women with Major Depressive Disorder.To evaluate the impact of Brief Psycho social Intervention program for the rural women with Major Depressive Disorder.To conceptualize and develop a Psycho social intervention manual for rural women with Major Depressive Disorder.

Hypothesis :

1.The rural women in the experimental group have better outcome at 6 weeks and 16 weeks follow up than other women in the control group

2.The rural women in the experimental group will have improved social and individual functioning than other women in the control group

3.The rural women in the experimental group will have improved treatment adherence than other women in the control group.

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