| 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
|
|
|
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
|
|
|
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. |