| CTRI Number |
CTRI/2026/03/105344 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
04/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Psychoeducation] |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of an Awareness Program for the Mental Well-being of Young Adults with Low Vision |
|
Scientific Title of Study
|
Impact of Psychoeducation-based Intervention on the Mental Well-being of Young Adults with Macular Dystrophies Attending a Tertiary Ophthalmic Centre in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Astha Sharma |
| Designation |
PhD Scholar, Department of Mental Health Education |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Mental Health Education, Dr MV Govindaswamy Centre, National Institute of Mental Health and Neuro Sciences, Hosur Rd, Hombegowda Nagar, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9986335194 |
| Fax |
|
| Email |
sharma1996astha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Latha K |
| Designation |
Associate Professor, Department of Mental Health Education |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Mental Health Education,Dr MV Govindaswamy Centre, National Institute of Mental Health and Neuro Sciences, Hosur Rd, Hombegowda Nagar, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9611732837 |
| Fax |
|
| Email |
latha12k@gmmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Astha Sharma |
| Designation |
PhD Scholar, Department of Mental Health Education |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Mental Health Education,Dr MV Govindaswamy Centre, National Institute of Mental Health and Neuro Sciences, Hosur Rd, Hombegowda Nagar, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9986335194 |
| Fax |
|
| Email |
sharma1996astha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Ms Astha Sharma |
Narayana Nethralaya |
121/C, Chord Rd, 1st R Block, Rajajinagar, Bengaluru, Karnataka 560010
Bangalore
KARNATAKA |
9986335194
sharma1996astha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee (Behavioural Science Division), NIMHANS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H353||Degeneration of macula and posterior pole, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Psycho-education based Intervention |
60-to 90-minute-long psychoeducation-based intervention sessions addressing mental well-being will be conducted in Hindi and English weekly for 7 weeks using a free, accessible online video conferencing platform.
The sessions will use a ‘blended learning’ method, i.e., participants will have access to selected material used in the intervention session so they can refer to it at their own pace before the session.
Pre- and Post-intervention data will be collected using standardized scales. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
1) Young adults (ages 18-24 years)
2) All genders
3) Diagnosed with Macular Dystrophy in the last 3 years
4) Having Low Vision (BCVA less than or equal to 20/60 but grater than 3/60)
5) Registered at Narayana Nethralaya
6) Speaking English or Hindi |
|
| ExclusionCriteria |
| Details |
1) Any other retinopathy
2) Any other visual impairment
3) Having intellectual disability
4) Deaf-blindness
5) Pregnant individuals
6) Having a score of 30 or higher on the K10 Scale
7) Screening positive on the K10 Scale for suicidal ideation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The psychoeducation-based intervention is intended to improve coping, self-efficacy, and quality-of-life, and reduce psychological distress among young adults diagnosed with macular dystrophies. This will be assessed using standardized scales before and after the intervention. |
Baseline - Before the Intervention
Endline - 4 weeks after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The developed psychoeducation-based intervention will be useful in developing an interdisciplinary patient-care module that is holistic in nature. |
Endline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/04/2026 |
| 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="5"
Months="0"
Days="0" |
|
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
|
This Mixed-Methods,
Quasi-Experimental Study (without a Control Group) aims to examine the impact of a psychoeducation-based
intervention on the mental well-being of young adults diagnosed with Macular Dystrophies. The study will last for three years, with participant recruitment and data collection taking place at Narayana Nethralaya, Rajajinagar, Bangalore.The study will take part in three phases: 1) Needs assessment - In-depth
interviews will be conducted with participants, caregivers, and
healthcare experts to identify the mental well-being-related felt needs of the
study participants 3) Intervention - Data
will be collected in-person using a socio-demographic data sheet and
standardized scales to record pre-intervention scores of psychological
distress, coping, self-efficacy, and quality of life in the participants, followed by the intervention and post-intervention
data collection, 4 weeks after the intervention using a
repeat administration of the standardized scales |