| CTRI Number |
CTRI/2025/02/080405 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A study to evaluate whether nurse-led counseling and support are effective in improving the symptoms, quality of life, daily functioning, and confidence in managing their condition for people with obsessive-compulsive disorder. |
|
Scientific Title of Study
|
The effectiveness of a Nurse-led psychosocial intervention package on the treatment outcome, functional impairment, health-related quality of life, and self-efficacy among patients with obsessive-compulsive disorder (OCD) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAKESH V R |
| Designation |
Tutor |
| Affiliation |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
College of Nursing
All India institute of Medical Sciences Bhubaneswar
Sijua
Dumduma Post
Bhubaneswar
Dumduma Post
Khordha
ORISSA
751019
India |
| Phone |
8147910907 |
| Fax |
|
| Email |
rakeshvrpkd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Udit Kumar Panda |
| Designation |
Assistant Professor |
| Affiliation |
Kalinga Institute of Medical Sciences (KIMS), KIIT University, Bhubaneswar |
| Address |
Department of Psychiatry
Kalinga Institute of Medical Sciences (KIMS), KIIT University, Bhubaneswar 751024
Odisha
Khordha
ORISSA
751024
India |
| Phone |
7978961817 |
| Fax |
|
| Email |
uditkumar.panda@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Udit Kumar Panda |
| Designation |
Assistant Professor |
| Affiliation |
Kalinga Institute of Medical Sciences (KIMS), KIIT University, Bhubaneswar |
| Address |
Department of Psychiatry
Kalinga Institute of Medical Sciences (KIMS), KIIT University, Bhubaneswar 751024
Odisha
ORISSA
751024
India |
| Phone |
7978961817 |
| Fax |
|
| Email |
uditkumar.panda@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Sciences (KIMS) Bhubaneswar,
KIIT Road, Patia, Bhubaneswar, Odisha
PIN 751024
India |
|
|
Primary Sponsor
|
| Name |
RAKESH V R |
| Address |
Tutor
College of Nursing
All India Institute of Medical Sciences Bhubaneswar
Sijua
Dumduma Post
Odisha 751019 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Udit Kumar Panda |
KIMS Bhubaneswar |
Department of Psychiatry
Kalinga institute of medical Sciences
KIIT University
Bhubaneswar
Bhubaneswar
Khordha
ORISSA |
7978961817
uditkumar.panda@kims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS Institutional Ethics Committe |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F422||Mixed obsessional thoughts and acts, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse-led Psychosocial interventions |
Standard of Care + The psychosocial interventions include the following components
a) Psychoeducation for 30 minutes, on days 1 and 2
b) Motivational Intervention for 20 minutes, on days 1 and 2
c) Relaxation Training for 30 minutes, on days 1 and 2
d) Supportive Booster intervention for 10 minutes, on days 4 and 8 |
| Comparator Agent |
Standard of care or No other Treatment |
Standard of care only (Medications and psychotherapy) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients With a diagnosis of OCD seeking follow-up treatment from the psychiatric department
2. Aged between 18 to 60 years
3. Receiving treatment and follow-up for OCD for at least the last 6 months
4. Having a moderate to good level of insight about the illness.
5. Able to read and understand Hindi, Odia, or English
6. Able to communicate with the researcher
7. Well-versed in using mobile phone
|
|
| ExclusionCriteria |
| Details |
Patients who were;
1. Not willing to participate in the study/intervention
2. With comorbid psychiatric disorders and substance use disorders except for depression and anxiety
3. On any nurse led structured psychosocial intervention along with treatment as usual.
4. With compromised cognitive functions
5. With severe visual or hearing defects or any other sensory or motor problems that may inhibit the completion of nurse-led intervention
6. with an acute risk of suicide
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Severity of illness |
Baseline, 6th week, 12th week |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Functional impairment, health related quality of life, self efficacy |
Baseline, 6th week, 12th week |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
24/02/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This is a nonrandomized parallel group controlled study to assess the efficacy of add-on nurse-led psychosocial interventions on the illness severity, functional impairment, health-related quality of life, and self-efficacy among patients with obsessive-compulsive disorder. The primary outcomes are illness severity, functional impairment, health related quality of life, and self efficacy among patients with obsessive compulsive disorder. The outcomes will be ascertained at baseline as well as at the 6th week and 12th week after the nurse led psychosocial intervention.
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