| CTRI Number |
CTRI/2024/11/076860 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Acceptance and commitment therapy for caregivers of stroke |
|
Scientific Title of Study
|
Acceptance and commitment therapy for caregivers of stroke survivors for reducing caregivers burden and stress :Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shweta Parikh |
| Designation |
Associate Professor |
| Affiliation |
K M Patel Institute of Physiotherapy |
| Address |
152,Physiotherapy department, K M Patel Institute of Physiotherapy, Shree
Krishna Hospital, Karamsad, Anand, GUJARAT, 388325
India
Anand
GUJARAT
388325
India |
| Phone |
9427083406 |
| Fax |
|
| Email |
shwetap@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shreya Patel |
| Designation |
P G Resident |
| Affiliation |
K M Patel Institute of Physiotherapy |
| Address |
152,Physiotherapy department, K M Patel Institute of Physiotherapy, Shree
Krishna Hospital, Karamsad, Anand, GUJARAT, 388325
India
Anand
GUJARAT
388325
India |
| Phone |
9687681851 |
| Fax |
|
| Email |
shreya16491999@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanvi Dalvi |
| Designation |
Assistant Professor |
| Affiliation |
K M Patel Institute of Physiotherapy |
| Address |
152,Physiotherapy department, K M Patel Institute of Physiotherapy, Shree
Krishna Hospital, Karamsad, Anand, GUJARAT, 388325
India
Anand
GUJARAT
388325
India |
| Phone |
7567788035 |
| Fax |
|
| Email |
tanvipd@charutarhealth.org |
|
|
Source of Monetary or Material Support
|
| 152,Physiotherapy department, K M Patel Institute of Physiotherapy, Shree
Krishna Hospital, Karamsad, Anand, GUJARAT, 388325
India |
|
|
Primary Sponsor
|
| Name |
Dr Shweta Parikh KM Patel Institute of physiotherapy |
| Address |
152,Physiotherapy department, K M Patel Institute of Physiotherapy, Shree
Krishna Hospital, Karamsad, Anand, GUJARAT, 388325
India |
| Type of Sponsor |
Private medical college |
|
|
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 Shweta Parikh |
K.M. Patel institute of Physiotherapy |
152,Physiotherapy department, K M Patel Institute of Physiotherapy, Shree
Krishna Hospital, Karamsad, Anand, GUJARAT, 388325
India
Anand
GUJARAT |
9427083406
shwetap@charutarhealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee-2, Bhaikaka University, Karamsad, Anand, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers of stroke survivors |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acceptance and Commitment Therapy (ACT) |
Group 1 will receive Acceptance and Commitment Therapy (ACT) along with routine counselling for 5 sessions for 5 days. |
| Comparator Agent |
Routine counselling |
Group 2 will receive only routine counselling by nursing staff for 5 sessions for 5 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Caregivers of stroke patients who are admitted in ICU and ward
Caregivers who are close family members
Both female and male caregivers of age 18 & above
Caregivers who will Not being diagnosed with severe mental disorder (eg. Psychotic
disorders)
In Depression, Anxiety and Stress Scale-21(DASS-21) caregivers fall in above
10(Depression), 8(Anxiety), 15(stress)
In Caregiver Burden Self Assessment Scale caregivers fall in above 20 |
|
| ExclusionCriteria |
| Details |
Stroke with any other long standing illness in patient
In Caregiver Burden Self Assessment Scale caregivers fall in 0 to 20 (Little or no burden)
In Depression, Anxiety and Stress Scale-21(DASS-21) caregivers fall in 0-9(Depression), 0-
7(Anxiety), 0-14(stress)
Any known neurological and psychological disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Caregiver Burden Self Assessment Scale (Zarit Burden Interview) |
Pre treatment and post treatment(After 5 sessions) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Depression Anxiety Stress Scale (DASS 21) |
Pre treatment and post treatment(After 5 sessions) |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
18/11/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
Modification(s)
|
The study is going to be conducted on caregivers of stroke survivors. As being an experimental study, 2 different intervention will be given to the caregivers, forming two group for the same: Where group 1 will receive Acceptance and Commitment Therapy (ACT) along with routine counselling while another group 2 will receive only routine counselling. The patients will be randomly allocated into two group by using computer generated scheme. Prior to the intervention, outcome measures will be taken in form of Caregiver Burden Self Assessment Scale and Depression Anxiety Stress Scale (DASS 21).Caregiver will be blinded as they will not be knowing about the intervention to be given. After 5 sessions of intervention same outcome measures will be taken again. The total duration of the intervention will be 5 days. |