| CTRI Number |
CTRI/2023/08/056414 [Registered on: 11/08/2023] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Brief CBT for psychological distress in the elderly after orthopaedic surgery
|
|
Scientific Title of Study
|
The effectiveness of brief cognitive behavioural therapy on psychological distress among the elderly population undergoing orthopaedic surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vivek Prasanna R |
| Designation |
Principal Investigator |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No.1 Ramachandra nagar, Sri Ramachandra Institute of Higher Education And Research , Porur
Faculty of Allied Health Sciences
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9003264820 |
| Fax |
|
| Email |
vivekprasannar@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrTR Ashok |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No 1, Ramachandra nagar, Porur
Department of Orthopaedics.
G-Block fourth floor
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9940525045 |
| Fax |
|
| Email |
ashok.tr@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vivek Prasanna R |
| Designation |
Principal Investigator |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No.1 Ramachandra nagar, Sri Ramachandra Institute of Higher Education And Research , Porur
Faculty of Allied health sciences
G-Block 4th Floor
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9003264820 |
| Fax |
|
| Email |
vivekprasannar@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Founder Chancellor Shri NPV Ramasamy Udayar Research Fellowship SRIHER |
|
|
Primary Sponsor
|
| Name |
Founder Chancellor Shri NPV Ramasamy Udayar Research Fellowship SRIHER |
| Address |
Sri Ramachandra Institute of Higher Education and Research (DU),No.1, Ramachandra nagar, Porur, Chennai, Tamil Nadu, India 600116 |
| 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 |
| Vivek Prasanna |
Sri Ramachandra Instititute of Higher Education and Researhc |
No. 1, Ramachandra Nagar, Porur, Chennai - 600116
Kancheepuram
TAMIL NADU |
9003264820
vivekprasannar@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brief Cognitive Behavioural Therapy |
Brief CBT is the compression of CBT material and reduction of the average 12-20 sessions into four to eight sessions. In brief CBT the concentration is on specific treatments for a limited number of the patients problems. Specificity of the treatment is required because of the limited number of sessions |
| Comparator Agent |
Standard Care |
The participants in this group will receive follow up visits with surgeons, medication adjustment, and occupational or
physical therapy
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Elderly population aged 60 years and above.
Closed musculoskeletal trauma
Obtain a score of 20 in Depression, 14 in Anxiety and 25 in Stress in the DASS 21 scale and a score of 26 above in the MoCA scale.
Able to read and write Tamil or English.
Willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Congenital absence of limb(s)
Birth defects
Open and pathological fractures Musculoskeletal and neuromuscular disorders Presence of cerebrovascular accident
Having neurological deficits such as dementia, Alzheimer’s disease, Parkinson’s disease etc Presence of schizophrenia or other psychotic disorder based on medical record or patient self report. Already undergoing another form of psychotherapy
Those who have difficulty maintaining follow up ( E.g living far away from the hospital, transportation issues etc.)
Poly trauma with head injury. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The anticipated outcome from this study would be to see a reduction of the intensity of Depression, Anxiety & Stress through the use of B-CBT that was caused by Psychological distress through surgery.
To report the treatment effectiveness of B-CBT for elderly participants with PD.
To report an increase in the Barthels index score in the experimental group as a result of B-CBT.
 |
the scales will be administered once within 24-48 hours of admission & then at the end of 7 weeks in the seventh outcome assessor session. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To report an increase in the Barthels index score in the experimental group as a result of B-CBT.
 |
This will be measured at the end of 7th session. |
|
|
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)
|
18/08/2023 |
| 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="0"
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 - NO
|
Brief Summary
Modification(s)
|
the research is focused on the elderly who are above the age of 55 and are admitted for orthopaedic surgery at sri ramachandra hospital will be admitted to the study. the admission process will happen within 24-48 hours of the patient arriving at the hospital. the researcher will utilise questionnaires such as Montreal cognitive assessment and DASS 21 on the patient. the MoCA is a test of cognitive function and a score of 26 and above is preferred, the DASS 21 is a test of current levels of depression, anxiety and stress in the patient in which a score of 10 in Depression OR 8 in Anxiety OR 15 in Stress and above is preferred, MoCA will be administered once to determine eligibility in the study, DASS21 will be utilised twice during the course of the study, once at the beginning and once at the end of 7 sessions, Barthel’s index is a test of performance of daily living. this is done to measure mobility levels post surgery in both the groups to see which group scores highest. |