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CTRI Number  CTRI/2024/01/061836 [Registered on: 25/01/2024] Trial Registered Prospectively
Last Modified On: 19/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Factors associated with dropout from psychiatric treatment 
Scientific Title of Study   Determinants of dropout from psychiatric outpatient treatment- a cross sectional study 
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 Shubhangi Varshney 
Designation  Junior Resident MD Psychiatry 
Affiliation  Rohilkhand Medical College 
Address  Department of Psychiatry Rohilkhand Medical College and Hospital Gate no.3, Pilibhit Bypass road, Bareilly

Bareilly
UTTAR PRADESH
243006
India 
Phone  9045545114  
Fax    
Email  varshneyshubhangi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Col. Siddharth Dixit 
Designation  Professor and Head, Department of Psychiatry 
Affiliation  Rohilkhand Medical College 
Address  Department of Psychiatry Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly, Uttar Pradesh

Bareilly
UTTAR PRADESH
243006
India 
Phone  9650010992  
Fax    
Email  sid68sify@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhinav Kuchhal 
Designation  Associate Professor, Department of Psychiatry 
Affiliation  Rohilkhand Medical College 
Address  Department of Psychiatry Rohilkhand Medical College and Hospital, Pilibhit bypass road, Bareilly, Uttar Pradesh

Bareilly
UTTAR PRADESH
243006
India 
Phone  9560022326  
Fax    
Email  dr.abhinavkuchhal@gmail.com  
 
Source of Monetary or Material Support  
Rohilkhand Medical College and Hospital Pilibhit Bypass Road Bareilly (U.P.) 243006 INDIA 
 
Primary Sponsor  
Name  Rohilkhand Medical College and Hospital 
Address  Rohilkhand Medical College and Hospital Pilibhit Bypass Road Bareilly (U.P.) 243006 INDIA 
Type of Sponsor  Private medical college 
 
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 
Dr Shubhangi Varshney  Rohilkhand Medical College and Hospital  Room no- 1192, Psychiatry OPD
Bareilly
UTTAR PRADESH 
09045545114

varshneyshubhangi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Rohilkhand Medical College & Hospital Bareilly  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients who fulfill the following criteria will be included:
Patients with written and informed consent.
At our setting, all patients attending the OPD are initially evaluated by a faculty member and diagnosis is made as per the International Classification of Diseases, Tenth Revision criteria
Age range : All adults above age of 18 years 
 
ExclusionCriteria 
Details  The group of patients excluded from the study includes those who have a diagnosis solely of intellectual disability, substance abuse or dependence, those who have significant cognitive impairment caused by organic brain syndromes, patients with autism and ADHD.
Patients with significant physical health conditions such as cardiovascular disease, cancer, central nervous system disorders, respiratory disorders, or gastrointestinal diseases.
Patient not diagnosed with any psychiatric disorder 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparison of level of functioning and severity of illness of the dropout group and regular attendee group using CGI-S scale  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the socio-demographic and environmental factors responsible for drop-out behaviour in patients who are attending the psychiatric outpatient services.
To assess the influence of patient related, illness related and clinician related factors on dropping out of contact with outpatient services. 
one year 
 
Target Sample Size   Total Sample Size="138"
Sample Size from India="138" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="138" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/02/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/12/2024 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

A lot of studies have focused their attention on the issue of non-adherence to psychiatric medications, but the research on non-adherence to outpatient appointments and factors associated with dropout has been much less extensive. Different studies have reported a wide range of dropout rates, on average 14% to 64%, among individuals receiving outpatient psychiatric services.1 Of all people who miss an outpatient appointment, a quarter to half of them completely disengage from the mental health services.2 This rate of dropping out of treatment vary considerably and depends on the definition and time of drop out as well as characteristics of the population sample and study design.  For the purpose of this study dropouts were defined as patients having attended atleast one session for diagnostic assessment and thereafter discontinuing the treatment process on patients own initiative for a period of 3 months.13

Factors which lead to dropout from treatment include environmental and demographic factors, patient related factors, illness factors and clinician factors.3-5 Research has identified certain demographic factors that are associated with a higher rate of dropouts, such as being younger, male, being divorced, having a low socio-economic status, being unemployed or having a low income, and a lack of formal education. Other studies found a correlation between dropping out from treatment and distance from treating facility, treatment costs, substance use, and lack of family support. Some of the environmental factors that are linked to dropping out from treatment are: the type of treatment setting; longer wait times for the initial appointment, and longer gaps between subsequent appointments.

The relationship between mental illness and dropout is somewhat less certain. Some data support the notion that the diagnosis of schizophrenia increases the likelihood of dropping out. Similarly, patients diagnosed with personality disorders have been reported to have low rates of adherence to treatment. On other hand, higher levels of adherence to outpatient therapy are seen among those with depressive disorders. According to De Panfilis and colleagues’ research, individuals who had attempted suicide in the past were more likely to stop therapy prematurely.

There appears to be a bimodal relation between attendance and severity of illness (both low and high illness severity leading to non attendance). In a study that followed 365 patients over time, it was found that those who missed their psychiatric follow-up appointments had more severe illness and poorer social functioning compared to those who attended their appointments. Several studies have reported a link between time from first contact and dropping out from treatment. Also it has been observed that adherence to outpatient treatment seems to improve when both pharmacological treatment and psychotherapy are prescribed as opposed to the prescription of  just one form of treatment. Patients with unclear or dual diagnosis have a higher dropout rate (3 times higher in dual diagnosis group as compared to single diagnosis group).

In terms of clinician related factors associated with non adherence quality of service provided, rapport between patient and clinician and a lower level of patient satisfaction are important determinants.

The rate of missed appointments is much higher in psychiatry than in other medical fields (almost twice as many), and this can have a significant impact on patients involved.3,6 People with mental health conditions like schizophrenia, schizoaffective disorder, and bipolar affective disorder are particularly vulnerable to negative consequences of missed appointments.1 In a comprehensive study, Reference Nelson et al (2000), it was found that patients who kept a follow-up appointment had a 1 in 10 chance of being rehospitalised as opposed to patients who did not keep an appointment, where the chances were 1 in 4. The Confidential Inquiry into Homicides and Suicides by Mentally Ill People (Royal College of Psychiatrists, 1996) found that 28% of mentally ill suicide victims had lost contact with mental health services. Other consequences may include increased health costs due to illness exacerbation, frequent relapses, increased potential for assault and dangerous behaviors. Thus loss of patients to follow-up is a major problem in psychiatric outpatient services and it is pertinent that factors associated with treatment dropout be identified, proactive methods be employed to improve the clinical outcomes.

There are a few studies from India which have focused on the dropout rates of patients who receive psychiatric outpatient services.7-9  Some of them have also examined the factors that contribute to treatment dropout, but there is a lack of consistency in the factors that have been identified across the studies. However all the studies lack the utilization of standardized tools to evaluate factors like medication compliance, satisfaction with treatment and the extent or intensity of the illness.

In this background, this study intents to examine the factors that are linked to discontinuation of contact with outpatient services.

 
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