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CTRI Number  CTRI/2025/12/099817 [Registered on: 24/12/2025] Trial Registered Prospectively
Last Modified On: 24/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [occupational therapy study]  
Study Design  Other 
Public Title of Study   A pilot study to evaluate the effect of cognitive behavioral therapy based occupational therapy program on reducing suicidal ideation in adults with history of self harm. 
Scientific Title of Study   Effect of cognitive behavioral therapy based occupational therapy program to reduce severity of suicidal ideation in patients with history of self-harm: a pilot 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 SUSHANT SARANG 
Designation  ASSOCIATE PROFESSOR 
Affiliation  OCCUPATIONAL THERAPY TRAINING SCHOOL AND CENTRE,SETH G.S. MEDICAL COLLEGE AND KEM HOSPITAL 
Address  1st Floor KEM Orthopaedic centre Dr Ernest Borges Rd opposite TATA MEMORIAL HOSPITAL Parel East Parel Mumbai Maharashtra Seth GSMC and KEMH Occupational Therapy School and Centre Mumbai
1st Floor KEM Orthopaedic centre Dr Ernest Borges Rd opposite TATA MEMORIAL HOSPITAL Parel East Parel Mumbai Maharashtra Seth GSMC and KEMH Occupational Therapy School and Centre Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  9819722846  
Fax    
Email  drssushant@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DIPTI MISKIN  
Designation  PG Student  
Affiliation  OCCUPATIONAL THERAPY TRAINING SCHOOL AND CENTRE,SETH G.S. MEDICAL COLLEGE AND KEM HOSPITAL 
Address  1st Floor KEM Orthopaedic centre Dr Ernest Borges Rd opposite TATA MEMORIAL HOSPITAL Parel East Parel Mumbai Maharashtra Seth GSMC and KEMH Occupational Therapy School and Centre Mumbai
1st Floor KEM Orthopaedic centre Dr Ernest Borges Rd opposite TATA MEMORIAL HOSPITAL Parel East Parel Mumbai Maharashtra Seth GSMC and KEMH Occupational Therapy School and Centre Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  9763459850  
Fax    
Email  moth240010@kem.edu  
 
Details of Contact Person
Public Query
 
Name  DR SUSHANT SARANG 
Designation  ASSOCIATE PROFESSOR 
Affiliation  OCCUPATIONAL THERAPY TRAINING SCHOOL AND CENTRE,SETH G.S. MEDICAL COLLEGE AND KEM HOSPITAL 
Address  1st Floor KEM Orthopaedic centre Dr Ernest Borges Rd opposite TATA MEMORIAL HOSPITAL Parel East Parel Mumbai Maharashtra Seth GSMC and KEMH Occupational Therapy School and Centre Mumbai
1st Floor KEM Orthopaedic centre Dr Ernest Borges Rd opposite TATA MEMORIAL HOSPITAL Parel East Parel Mumbai Maharashtra Seth GSMC and KEMH Occupational Therapy School and Centre Mumbai
Mumbai
MAHARASHTRA
400012
India 
Phone  9819722846  
Fax    
Email  drssushant@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Seth GS medical college and KEM hospital 
Address  1st Floor KEM Orthopaedic centre Dr Ernest Borges Rd opposite TATA MEMORIAL HOSPITAL Parel East Parel Mumbai Maharashtra Seth GSMC and KEMH Occupational Therapy School and Centre Mumbai  
Type of Sponsor  Other [NA] 
 
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 Sushant Sarang  Seth G.S Medical College and KEM Hospital   1st Floor KEM Orthopaedic centre Dr Ernest Borges Rd opposite TATA MEMORIAL HOSPITAL Parel East Parel Mumbai Maharashtra Seth GSMC and KEMH Occupational Therapy Training School and Centre
Mumbai
MAHARASHTRA 
9819722846

drssushant@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE- II,Relating to Biomedical and Health Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G||Mental Health,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  cognitive behavioral therapy based occupational therapy program   a) Therapeutic use of self b) Activity engagement c) Environmental modification The total duration of intervention will be 6 weeks (2 session/week). 
Comparator Agent  Modified scale of Suicidal Ideation (MSSI)  • Modified scale of Suicidal Ideation (MSSI) will be administered to assess severity of suicidal ideation. Score will be recorded pre and post intervention assessment  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients referred from psychiatry department with history of self-harm or suicidal ideation
Patients with MMSE score more than 23.
 
 
ExclusionCriteria 
Details  Patients with schizophrenia
Dementia
Head injury Cerebrovascular accidents
Intellectual disability
Autism
Postpartum psychosis
Terminal illness patients
Patient under hospice care
Patients with cognitive impairment
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To implement cognitive behavioral therapy based occupational therapy program tailored to individual need.  6 weeks [twice in a week] 
 
Secondary Outcome  
Outcome  TimePoints 
To measure pre and post intervention suicidal ideation by using modified scale of suicidal ideation.  18 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   30/01/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drssushant@gmail.com].

  6. For how long will this data be available start date provided 01-08-2027 and end date provided 01-08-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Title  
Effect of cognitive behavioral therapy based occupational therapy program to reduce 
severity of suicidal ideation in patients with history of self-harm: a pilot study. 
Aim To reduce severity of suicidal ideation in patients attempting suicide. 
Objectives  
To measure pre and post intervention suicidal ideation by using modified scale of 
suicidal ideation.  
To implement CBT based OT program tailored to individual need. 
Study Design:   
Pre-test-post-test single group pilot study  
Sampling technique: Convenience sampling 
Sample size 20 
Study setting The study will be conducted in Occupational therapy sections of psychiatry 
KEMH in Mumbai. 
Inclusion criteria: 
Age  18years-60 years 
Gender-Male and female 
Patients referred from psychiatry department with history of self-harm or suicidal 
ideation 
Patients with MMSE score more than 23. 
Exclusion criteria:  
Patients with schizophrenia 
Dementia 
Head injury 
Cerebrovascular accidents 
ID 
Autism 
Postpartum psychosis 
Terminal illness patients 
Patient under hospice care  
Patients with cognitive impairment. 
Methodology  
Approval will be taken from Institutional ethics committee (IEC). 
Patients with history of self-harm or suicidal ideation referred from psychiatric 
department will be enrolled in the study.  
20 subjects /patients need to be recruited in the present study. 
Patient will be explain about purpose and nature of study. Consent will be taken from 
participant. 
Screening for the cognitive functioning of the participant will be carried out by 
administering Mini Mental State Examination more than 24 as per inclusion criteria 
they would be included in the study. 
Information about participant including demographics and MMSE score will be noted 
on record form. 
Modified scale of Suicidal Ideation (MSSI) will be administered to assess severity of 
suicidal ideation. Score will be recorded pre and post intervention assessment on case 
record form. 
Participant will receive individualized CBT based OT intervention program for to 
reducing the severity of suicidal ideation. 
Duration –Cognitive behavioral therapy based occupational therapy program will be 
given through 12 sessions in 6 weeks. The total days of therapy given will be 12 days 
in a period of 6 weeks. 
Sessions will be conducted twice in a week, with a 2 to 3 day interval between consecutive 
therapy sessions. 
Initial phase –It includes session 1 2 and 3 conducted per day on 3 different days over a 
period of 1.5 weeks. 
Middle phase –It includes session 4 5 6 7 8 and 9 conducted per day on 6 different days 
over a period of 3 weeks. 
Termination phase-It includes session 10 11 and 12 conducted per day on 3 different 
days over a period of 1.5 weeks. 
Each therapy session will last for 45 min.  
Participant will be re-evaluated on MSSI after 6 weeks of intervention protocol. 
Scores of both pre and post intervention assessment will be compared after completion 
of intervention duration. Data collected, statistical analysis would be done using 
appropriate statistical test and result will be derived. 
If the participant undergoes ECT therapy on a scheduled CBT based OT session day, 
the program session will be rescheduled for the next day. 
If any situation arises during the study that requires psychiatric attention, the participant 
will be immediately referred to a psychiatric department for appropriate management. 
Study protocol: 
Occupational therapy intervention would be tailored made for each patient using CBT based 
OT program. 
Occupational therapy intervention is based on 3 variables: 
a) Therapeutic use of self 
b) Activity engagement 
c) Environmental modification. 
Intervention consist of 3 phases: 1. Initial phase 2. Middle phase 3. Termination phase Initial phase [session 1-3] –includes 5 components a) Chain analysis b) Psychoeducation c) Safety planning d) Developing reason for living and hope e) Case conceptualization Middle phase [session 4-9] Individual (includes behavioral activation and increasing pleasurable activities mood monitoring, emotion regulation and distress tolerance techniques, cognitive restructuring, problem solving, goal setting, mobilizing social support, and assertiveness skills) Family (include family behavioral activation, family emotion regulation, family problem solving, family communication, and family cognitive restructuring) skills training modules. The termination phase [session 10-12]-includes five steps (a) Preparation (b) Review of the indexed attempt or suicidal crisis (c) Review of the attempt or suicidal crisis using skills (d) Review of a future high risk scenario (e) Debriefing and follow-up. Statistical analysis Demographic data will be summarized using descriptive statistics. Continuous data will be represented as mean (Standard deviation) or Median (IQR). Categorical data will be summarized using frequency and percentage. McNemar test will be used to analyze paired categorical data. A 2-tailed P < 0.05 will be considered to be statistically significant. Statistical analysis will be performed by appropriate statistical tests using IBM SPSS v26 (statistical package for social sciences) software. Study tools: a) Mini Mental Status Examination -MMSE b) Modified scale of Suicidal ideation-MSSI
 
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