| CTRI Number |
CTRI/2024/09/073384 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A trial to study the effect of a psychotherapy treatment for PTSD resulting from childhood trauma
|
|
Scientific Title of Study
|
Imagery Rescripting for Childhood Trauma related PTSD: A Multiple baseline 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 |
Anju S Nair |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Dept of Clinical Psychology, National Institute of Mental Health and Neurosciences, Hosur Rd, near Bangalore Milk Dairy, Hombegowda Nagar, Bengaluru, Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
8281558398 |
| Fax |
|
| Email |
anjusnairresearch2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anju S Nair |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Dept of Clinical Psychology, National Institute of Mental Health and Neurosciences, Hosur Rd, near Bangalore Milk Dairy, Hombegowda Nagar, Bengaluru, Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
8281558398 |
| Fax |
|
| Email |
anjusnairresearch2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anju S Nair |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Dept of Clinical Psychology, National Institute of Mental Health and Neurosciences, Hosur Rd, near Bangalore Milk Dairy, Hombegowda Nagar, Bengaluru, Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
8281558398 |
| Fax |
|
| Email |
anjusnairresearch2@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences, Hosur Rd, near Bangalore Milk Dairy, Hombegowda Nagar, Bengaluru, Karnataka, 560029 |
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health and Neurosciences |
| Address |
National Institute of Mental Health and Neurosciences, Hosur Road, Near Bangalore Milk Dairy, Bengaluru, Karnataka, 560029. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Manjula M |
National Institute of Mental Health and Neurosciences |
Department of Clinical Psychology, National Institute of Mental Health and Neurosciences Hosur Rd near Bangalore Milk Dairy Hombegowda Nagar Bengaluru Karnataka 560029
Bangalore
KARNATAKA |
9632603597
drmanjula71@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Ethics Committee (Behavioural Sciences Division) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F431||Post-traumatic stress disorder (PTSD), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Imagery Rescripting |
Imagery Rescripting involves the individual imagining traumatic experiences with alternate outcomes, thus attempting to fulfill the core unmet needs. This process facilitates a change in the meaning that was earlier attributed to the trauma memory, thus leading to a change in their core beliefs, emotions and behaviors. We are offering 12 to 16 sessions of twice a week Imagery Rescripting for the patients in this trial |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with a primary diagnosis of PTSD (according to DSM-5 criteria) as assessed by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and those who obtain a score of 33 and above on Post Traumatic Stress Disorder Checklist (PCL-5) or Individuals with a primary diagnosis of CPTSD (according to ICD 11 criteria)
Individuals having experienced the worst traumatic event (defined according to the DSM-5) before the age of 16 and agree that this trauma will be the focus of treatment.
Individuals belonging to the age group of 18-60 years
Individuals who have undergone psychological interventions for PTSD but continue
to fulfill the criteria for the diagnosis of PTSD (Score of 33 and above on PCL-5)
Individuals who can read and write English. |
|
| ExclusionCriteria |
| Details |
Individuals with schizophrenia, bipolar disorder with current episode mania/ severe depression, current substance use/substance dependence/harmful use not in remission for at least 3 months except nicotine use
Individuals with an organic brain disorder, neurodevelopmental disorders, or intelligence below the average category
Individuals with severe symptoms of axis I disorders that might interfere with their engagement in therapy
Individuals with acute suicidal risk or self-harm
Individuals with ongoing trauma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PTSD Symptom severity as assessed by PCL-5 |
5 timepoints- Before baseline, After Baseline, before treatment, after treatment, at follow up which is 3 months after the treatment phase. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PTSD related cognitions |
5 timepoints- Before baseline, After Baseline, before treatment, after treatment, at follow up which is 3 months after the treatment phase. |
| Emotional regulation |
5 timepoints- Before baseline, After Baseline, before treatment, after treatment, at follow up which is 3 months after the treatment phase. |
| Anger |
5 timepoints- Before baseline, After Baseline, before treatment, after treatment, at follow up which is 3 months after the treatment phase. |
| Guilt |
5 timepoints- Before baseline, After Baseline, before treatment, after treatment, at follow up which is 3 months after the treatment phase. |
| Shame |
5 timepoints- Before baseline, After Baseline, before treatment, after treatment, at follow up which is 3 months after the treatment phase. |
| Anxiety |
5 timepoints- Before baseline, After Baseline, before treatment, after treatment, at follow up which is 3 months after the treatment phase. |
| Depression |
5 timepoints- Before baseline, After Baseline, before treatment, after treatment, at follow up which is 3 months after the treatment phase. |
| Well-being |
5 timepoints- Before baseline, After Baseline, before treatment, after treatment, at follow up which is 3 months after the treatment phase. |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
23/09/2024 |
| 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 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
|
The protocol aims to study the efficacy of Imagery Rescripting as a standalone treatment for individuals with PTSD with a history of childhood trauma. Participants will be recruited after screening based on inclusion-exclusion criteria, screening tools, and those who consent to participate in the study. The study follows a multiple baseline design so they will be randomly assigned to any of the 4 baseline periods; 5 weeks, 6 weeks, 7 weeks, and 8 weeks. Upon completion of the respective baselines, participants will enter the exploration phase, which will consist of 5 weekly sessions and then the intervention phase which will consist of 12-16 twice-a-week sessions. The protocol by Arntz (2019) will be used in the intervention phase. The assessments for all primary and secondary outcomes will occur at 5 time points- before baseline, after baseline, before exploration, before intervention, after intervention, and at 3 months follow-up. Assessments using PCL-5 and VAS will take place weekly. |