| CTRI Number |
CTRI/2024/09/074135 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
17/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The relationship between coping and mental health aspects in patients who had stroke. |
|
Scientific Title of Study
|
The Relationship between Assimilation Accommodation Coping and Mental Health Aspects in Stroke Survivors |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Noor Fareeda |
| Designation |
MPhil Clinical Psychology Trainee |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Eshwar Nagar, Manipal, Udupi, Karnataka, Pin 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8281463661 |
| Fax |
|
| Email |
noor.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishalee S |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9488615322 |
| Fax |
|
| Email |
vaishalee.s@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ms Samyukta Vaidyanathan |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
08939372782 |
| Fax |
|
| Email |
samyukta.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Infrastructure Support - Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, Pin 576104 |
|
|
Primary Sponsor
|
| Name |
Ms. Noor Fareeda |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, MAHE, Manipal-576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Vaishalee S |
Kasturba Hospital |
Department of Clinical Psychology, Kasturba Hospital, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Udupi PIN:576104
Udupi
KARNATAKA |
9488615322
vaishalee.s@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kastura Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I63||Cerebral infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who were diagnosed with stroke at least one month before the study would be included.
2. Patients who have functional fluency in English, Hindi, or Kannada would be included in the study.
3. Patients with Montreal Cognitive Assessment(MoCA) score above 24 would be administered in the study. |
|
| ExclusionCriteria |
| Details |
1.Patients with history of a recurrent stroke or a transient ischemic attack (TIA) would be excluded from the study.
2. Patients with previous history of psychiatric conditions such as psychosis, mood disorders
substance use disorders etc. would be excluded from the study.
3.Patients with poor pre stroke functional ability would be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assimilation- accommodation coping is measured using Assimilation Accommodation Coping Scale.
Mental health aspects will be assessed using 2 scales. Stroke specific quality of life will be assessed
using Stroke Specific Quality of Life Scale.
Core mental health aspects will be assessed using Depression Anxiety Stress Scale-21. |
single time point |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
01/10/2024 |
| 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="25"
Months="5"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Title of the project: The Relationship between Assimilation, Accommodation Coping and Mental Health Aspects in Stroke Survivors Stroke is a prevalent cause of mortality in India. Psychiatric disorders are common comorbidities after stroke which is also followed by low quality of life, increased caregiving burden, and unfavorable functional status. Indian studies focused on life quality and clinical aspects of post stroke patients. There is a clear dearth in Indian studies which focus on the psychological aspects of stroke survivors. Rehabilitation of stroke survivors requires addressing multiple domains of their life. Research on the association between coping skills and mental health will help in understanding the significance of coping skills on mental health aspects of stroke survivors. The current study aims to examine the relationship between assimilation, accommodation coping and mental health aspects in stroke survivors. The study design is cross sectional design and the study participants are sub acute and chronic stroke survivors visiting Kasturba Hospital. The expected sample size is 85. Assimilation- accommodation coping is measured using Assimilation Accommodation Coping Scale. Mental health aspects will be assessed using 2 scales. Stroke specific quality of life will be assessed using Stroke Specific Quality of Life Scale. Core mental health aspects like depression, anxiety and stress will be assessed using Depression Anxiety Stress Scale-21. Ethical considerations · The study will be initiated after the Institute Ethics Committee review and approval. · Written informed consent will be sought from all the participants. · No monetary or other incentive will be offered for participation in research. · Participants will be assured of confidentiality in the storage and disposal of research data. · Appropriate referrals to psychological services will be provided to participants who report distress.
|