| CTRI Number |
CTRI/2022/01/039455 [Registered on: 14/01/2022] Trial Registered Prospectively |
| Last Modified On: |
29/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Resilience training for long term effect of childhood trauma] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effectiveness of resilience training on depression, anxiety, fear of happiness and Dysfunctional belief among nursing students with history of childhood trauma |
|
Scientific Title of Study
|
Effectiveness of Resilience Training on depression, anxiety, fear of happiness and dysfunctional attitude among nursing students with history of childhood trauma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EC/NEW/INST/2021/531/56 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neeta Austin Singha |
| Designation |
Associate Professor |
| Affiliation |
College of Nursing, Christian Medical College, Ludhiana, Punjab, India |
| Address |
132 Model House
PO Model Town
Ludhiana
PUNJAB
141002
India |
| Phone |
9872873148 |
| Fax |
|
| Email |
neeta1005.phd19@chitkara.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Neeta Austin Singha |
| Designation |
Associate Professor |
| Affiliation |
College of Nursing, Christian Medical College, Ludhiana, Punjab, India |
| Address |
132 Model House
PO Model Town
Ludhiana
PUNJAB
141002
India |
| Phone |
9872873148 |
| Fax |
|
| Email |
neeta1005.phd19@chitkara.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Neeta Austin Singha |
| Designation |
Associate Professor |
| Affiliation |
College of Nursing, Christian Medical College, Ludhiana, Punjab, India |
| Address |
132 Model House
PO Model Town
Ludhiana
PUNJAB
141002
India |
| Phone |
9872873148 |
| Fax |
|
| Email |
neeta1005.phd19@chitkara.edu.in |
|
|
Source of Monetary or Material Support
|
| Chitkara School of Health Sciences-PhD Programme Chandigarh-Patiala National Highway (NH-64) Village Jansla, Rajpura, Punjab, 140401 |
|
|
Primary Sponsor
|
| Name |
Neeta Austin Singha |
| Address |
Chitkara School of Health Sciences-PhD Programme Chandigarh-Patiala National Highway (NH-64) Village Jansla, Rajpura, Punjab, 140401 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Vinay Kumari |
Chitkara School of Health Sciences- PhD Programme |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Usha Singh |
College of Nursing, CMC & Hospital, Ludhiana |
College of Nursing, CMC & Hospital, Ludhiana
Ludhiana
PUNJAB |
9814529275
drushasingh275@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics committee Chitkara Univeersity, Punjab |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preventive or Screening Intervention |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Resilience Training |
Refers to 6 sessions of training to improve the resilience behavior of the individual with history of childhood trauma, (each session will be of 60 to 90 minutes) and will comprise of
1.Overview of the training, meaning and importance of resilience to deal with stressful situations
2.Cognitive perspective to Resilience: Techniques to Improve Optimism and Resilient Thinking
3.Dealing with Anxiety and working on Positive Emotions
4.Imposing Character Strengths and Strengthening Relationships
|
| Comparator Agent |
Resilience training |
Refers to 6 sessions of training to improve the resilience behavior of the individual with history of childhood trauma, (each session will be of 60 to 90 minutes) and will comprise of 1.Overview of the training, meaning and importance of resilience to deal with stressful situations 2. Cognitive perspective to Resilience: Techniques to Improve Optimism and Resilient Thinking 3. Dealing with Anxiety and working on Positive Emotions 4. Imposing Character Strengths and Strengthening Relationships
These sessions will be given to the wait listed control arm after completion of experimental group with the all sessions of resilience training. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Nursing students with history of childhood trauma i.e., CTQ score is greater than 46.
2.Nursing students who will give consent to participate
|
|
| ExclusionCriteria |
| Details |
1. Nursing The nursing students who will be on any psychological intervention and / or on any psychotropic medication.
2.Students attending less than 50% of the sessions from Resilience training
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Resilience |
at 7th day after resilience training and at 30th day after resilience training |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in depression, anxiety, fear of happiness and dysfunctional Attitude |
after 7days of resilience training and after 30 days of resilience training |
|
|
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)
|
17/01/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Childhood trauma is a major etiological predecessor for the occurrence of abnormal psychology later in life. however, not all individuals who encounter childhood adversities develop psychopathology during their maturity, and may be regarded as own resilience traits that protect them from developing psychopathology. the motive of this study is to bring about evidence for the generality of childhood trauma and essentially to determine the long term influences of childhood trauma on mental health including depression, anxiety, fear of happiness and dysfunctional attitude among nursing students. this study will help to test the efficacy of Resilience Training on depression, anxiety, fear of happiness and Dysfunctional attitude. |