| CTRI Number |
CTRI/2023/04/052041 [Registered on: 27/04/2023] Trial Registered Prospectively |
| Last Modified On: |
25/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The Relationship between Dermatology Life Quality and Depression, Anxiety and Stress and the effect of Psychological Capital on this relationship among patients with Psoriasis |
|
Scientific Title of Study
|
Impact of Psychological Capital on The Relationship Between Dermatology Life Quality and Depression Anxiety and Stress Among Patients with Psoriasis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ammu G Thampi |
| 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, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8547551123 |
| Fax |
|
| Email |
ammu.thampi1@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Rai |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986516581 |
| Fax |
|
| Email |
rai.shweta@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Rai |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9986516581 |
| Fax |
|
| Email |
rai.shweta@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal, Udupi, Karnataka, 576104 |
|
|
Primary Sponsor
|
| Name |
Ammu G Thampi |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal |
| 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 Shweta Rai |
Kasturba Hospital |
Department of Dermatology, Venereology and Leprosy, Manipal
Udupi
KARNATAKA |
9986516581
rai.shweta@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with a diagnosis of psoriasis for 1 year or more
Above the age of 18
Belonging to either male or female gender
Can read Kannada, Malayalam or English. |
|
| ExclusionCriteria |
| Details |
Individuals diagnosed with psychiatric illness prior to onset of psoriasis |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The scores of Psychological Capital, Dermatology Life Quality and Depression, Anxiety and Stress |
Baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2023 |
| Date of Study Completion (India) |
31/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a cross-sectional observational study investigating the role of psychological capital in the
relationship between Dermatology Life Quality Index (DLQI) and depression,
anxiety, stress among 110 individuals diagnosed with psoriasis. The
participants will be recruited from the OP and IP patient from Department of
Dermatology, Venereology and Leprosy of KMC Manipal according to the proposed
inclusion and exclusion criteria, after which the informed consent will be
taken from each participant. The primary outcome measures are Psychological
Capital Scores, which is continuous variable and the scores range from 24 – 144;
DLQI Scores which is also a continuous variable with scores ranging from 0 – 30
and interpreted as higher the score higher the impairment and finally DASS
Scores, also a continuous variable with 3 scores for Depression, Anxiety and
Stress and scores for each ranging from 0-21 and higher the score higher the
intensity of symptoms. |