| CTRI Number |
CTRI/2024/08/072474 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Self-Harm: Tool and Intervention development for adolescents and young adults |
|
Scientific Title of Study
|
Self-Harm in Transitional Age Youth (TAY): Development and Validation of an Assessment Tool and Randomised Feasibility Trial of a Trauma-Focused CBT Intervention Module |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akanksha Yadav |
| Designation |
Ph.D. Scholar |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi |
| Address |
4082 A, Department of Psychiatry, Teaching Block, All India Institute of Medical Sciences (AIIMS), New Delhi
Central
DELHI
110029
India |
| Phone |
9971664922 |
| Fax |
|
| Email |
akankshay41295@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sujata Satapathy |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi |
| Address |
4082 A, Department of Psychiatry, Teaching Block, All India Institute of Medical Sciences (AIIMS), New Delhi
Central
DELHI
110029
India |
| Phone |
9999267141 |
| Fax |
|
| Email |
sujatasatapathy2022@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akanksha Yadav |
| Designation |
Ph.D. Scholar |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), New Delhi |
| Address |
4082 A, Department of Psychiatry, Teaching Block, All India Institute of Medical Sciences (AIIMS), New Delhi
Central
DELHI
110029
India |
| Phone |
9971664922 |
| Fax |
|
| Email |
akankshay41295@gmail.com |
|
|
Source of Monetary or Material Support
|
| University Grants Commission, Bahadur Shah Zafar Marg, New Delhi, 110002 |
|
|
Primary Sponsor
|
| Name |
University Grants Commission |
| Address |
University Grants Commission, Bahadur Shah Zafar Marg, New Delhi, 110002 |
| Type of Sponsor |
Government funding agency |
|
|
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 Bichitra Nanda Patra |
All India Institute of Medical Sciences (AIIMS) |
Room no. 129, Psychiatry OPD (1st Floor), New RAK OPD, All India Institute of Medical Sciences (AIIMS), New Delhi
Central
DELHI |
9717880196
patrab.aiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F99||Mental disorder, not otherwise specified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Psycho-education |
single session psychoeducation module |
| Intervention |
Trauma Focussed Cognitive Behavioral Therapy |
A therapist-facilitated, CBT-based brief trauma and self-harm focused psychological intervention with individual sessions.
Number of sessions- 6-8
Frequency: weekly |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed case of specific mental illness including EUPD, Depression, Anxiety, PTSD, Adjustment disorder
2. History of experience of at least one trauma incident
3. History of self-harm- 5 incidents within last one year
4. Psychotherapy naïve
5. On/Off medication |
|
| ExclusionCriteria |
| Details |
1. Known case of physical, neurological, or mental disability
2. Diagnosed case of severe mental illness including BPAD, OCD, Psychosis, MBD due to substance use in dependent pattern, neurodevelopmental disorders (ID, ASD, ADHD)
3. History of suicide attempt or para-suicide attempt in past one year
4. Unable to understand Hindi or English
5. Not consenting |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Frequency and severity of self harm |
Baseline and post intervention (6-8 weeks after baseline assessment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Impulsivity, emotional regulation, depression, anxiety, stress, childhood trauma, resilience, peer relationships, emotional intelligence, family functioning |
baseline & post intervention (6-8 weeks after baseline assessment) |
|
|
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 Enrollment (India)
|
26/08/2024 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM:
The aim of the study is to develop and validate a self-harm assessment tool and
test feasibility of a Trauma-Focused CBT intervention module for Transitional
Age Youth (TAY).
OBJECTIVES:
Objective
1: To develop and validate a new self-harm assessment tool for TAY.
Objective
2: To modify Trauma-Focused CBT intervention module for TAY.
Objective
3: To assess the feasibility of the modified Trauma-Focused CBT intervention
module in TAY.
Objective
4: To compare the experimental and the control group on outcome variables
immediately after intervention.
RATIONALE
FOR STUDY:
Self-harm
is a transdiagnostic problem that is prevalent in late adolescents and young
adults. Late adolescence to young adulthood or transitional age youth (TAY) is
a period of transition from a child to an adult. This time period has a
significant impact on the individual. Problems during this time period
increases the risk of psychopathology later in life like depression, anxiety,
relationship problems, and occupational difficulties. Self-harm has strong
links to trauma as evidenced by theory. The lack of research in India as well
as Asia pertaining to self-harm makes it crucial to address this global health
crisis. Majority of the tools for assessment have limited evidence for
psychometric properties and are not based on the DSM-5 criteria. No tool has
been developed or validated in India or translated to Hindi.
SAMPLING:
Purposive
sampling will be used for samples for scale development and validation. A list
of potential patients will be prepared and a systematic random sampling will be
done to recruit patients for the intervention. The sample will be taken from Psychiatry
OPD, AIIMS, New Delhi.
|