| CTRI Number |
CTRI/2024/11/077389 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [EXPLORATORY STUDY WITH THERAPEUTIC INTERVENTION] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
NON-SUICIDAL SELF INJURY (NSSI): Exploration and Intervention |
|
Scientific Title of Study
|
The correlation between emotional dysregulation, adult attachment, aggression orientation, and trauma symptoms with the occurrence of NSSI was explored. An intervention was applied to selective individuals engaging in NSSI. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANWESHA BHATTACHARYYA |
| Designation |
Ph.D Scholar |
| Affiliation |
Department of Applied Psychology, UNIVERSITY OF CALCUTTA |
| Address |
Department of Applied Psychology,
2nd floor,
Rajabazar Science College (UCST),
92 Acharya Prafulla Chandra Road,
Rajabazar,
Kolkata-700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
9073426405 |
| Fax |
|
| Email |
anwesha.bhattacharyya2019@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ushri Banerjee |
| Designation |
Assistant Professor |
| Affiliation |
Department of Applied Psychology, UNIVERSITY OF CALCUTTA |
| Address |
Department of Applied Psychology,
Rajabazar Science College (UCST),
Rajabazar
92 Acharya Prafulla Chandra Road,
Rajabazar,
Kolkata-700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
9831244000 |
| Fax |
|
| Email |
ushribanerjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ushri Banerjee |
| Designation |
Assistant Professor |
| Affiliation |
Department of Applied Psychology, UNIVERSITY OF CALCUTTA |
| Address |
Department of Applied Psychology,
2nd Floor,
Rajabazar Science College (UCST),
Rajabazar
92 Acharya Prafulla Chandra Road,
Rajabazar,
Kolkata-700009
Kolkata
WEST BENGAL
700019
India |
| Phone |
9831244000 |
| Fax |
|
| Email |
ushribanerjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF APPLIED PSYCHOLOGY,
SECOND FLOOR,
RAJABAZAR SCIENCE COLLEGE(UCST),
RAJABAZAR,
KOLKATA
PIN-700009 |
|
|
Primary Sponsor
|
| Name |
ANWESHA BHATTACHARYYA |
| Address |
DEPARTMENT OF APPLIED PSYCHOLOGY
SECOND FLOOR
RAJABAZAR SCIENCE COLLEGE (UCST)
RAJABAZAR
KOLKATA
PIN-700009 |
| Type of Sponsor |
Research institution |
|
|
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 USHRI BANERJEE |
DEPARTMENT OF APPLIED PSYCHOLOGY, RAJABAZAR SCIENCE COLLEGE |
UNIVERSITY COLLEGE OF SCIENCE AND TECHNOLOGY,
RAJABAZAR,
KOLKATA-700009
Kolkata
WEST BENGAL |
9831244000
ushribanerjee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE FOR BIO MEDICAL AND HEALTH RESEARCH INVOLVING HUMAN PARTICIPANTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R458||Other symptoms and signs involvingemotional state, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Trauma-Focused Cognitive Behavior Therapy |
Trauma-focused cognitive behavioral therapy (TF-CBT)will address the associative cues for traumatic memory, facilitating exposure to these cues, and modifying the narrative of the traumatic experiences. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
The individuals within age range of 18-24 years, Regular students studying in colleges and universities with English as the medium of instruction and communication,
Students belonging to the middle socioeconomic status in Kolkata
|
|
| ExclusionCriteria |
| Details |
Chronic physical condition like fibromyalgia, Crohn’s disease, severe diabetes or any terminal illness, traumatic brain injury or any neuropsychological injury or condition
Any recent episode of any accident, sudden death of a loved one or any other source of acute psychological trauma
Active suicidal ideation or intent or recent history of suicide attempt (within a month of the data collection procedure) needing emergency intervention
Individuals belonging to broken homes or separated families.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
NSSI occurrence, frequency and outcome were measured by FASM
Depression and Anxiety symptoms were measured by BDI and BAI respectively
Trauma Symptoms were measured by TSC-40 |
Baseline measure was done.
Intermediate measure at 6-8 weeks.
Post-intervention measure at 12-16 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The alleviation of symptoms of depression as per BDI (at least below moderate level),and the alleviation of symptoms of anxiety as per BAI (at least below moderate level) |
3-6 months |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/12/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
For Phase I of the data collection procedure, the authority of the respective educational institutions from each of the five zones mentioned in Kolkata was approached, and permission will be sought. Prevalence studies conducted worldwide reveal that the prevalence of NSSI among the community or student population is roughly 30-31%. Of the 920 participants, the ones detected with the presence of NSSI were selected based on the information schedule, FASM questionnaire, and BPRS (to screen out individuals with psychotic symptoms). On these selected students engaging in NSSI, the scales for the other respective variables were administered to explore the association between NSSI and these variables. Suggested statistical analyses for this phase were descriptive statistics like frequencies, percentages, means and standard deviation, and inferential statistics like Chi-square, t-test, ANOVA, MANOVA, and predictive statistics like binomial regression. For Phase 2, firstly the participants who significantly engage in NSSI and also have significant symptoms of psychological trauma were randomly allocated to either of the two treatment arms. One clinical group consisted of intervention by trauma-focused CBT (TF-CBT), whereas the other treatment group comprised only supportive therapy and basic emotional regulation training. The participants in the clinical treatment group were provided with a brief report and were also informed about the expected outcome of TF-CBT in the alleviation of the symptoms. An additional consent form was provided to the young adult students who engaged in NSSI and also scored significantly higher in the TSC-40 and volunteered for this intervention program. These individuals were intervened by application of TF-CBT, spanning over an average number of 12-18 sessions across a span of 3-6 months, in contrast to the supportive therapy treatment group. The statistical analyses for the pre-intermediate-post measures were done with non-parametric statistics based on pre-post measures of TSC-40, BDI, BAI and FASM.
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