ClinicalTrials.gg
Active, not recruitingNCT06914076Updated Apr 6, 2025

Evaluating The Effectiveness Of Structured Psychosocial Counseling On Mental Health And FI Individuals With Low Vision

An interventional study of Structured Psychosocial Counseling and Standard Care in Low Vision, sponsored by Superior University. Active, not recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-06.

Sponsored by Superior University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Vision impairments affect 2.2 billion people worldwide, including 36 million who are blind and 217 million with moderate-to-severe visual impairment. In the US, age-related vision loss is a leading cause of disability among older adults.

Read the detailed description

With increasing longevity, global blindness rates are expected to triple, and moderate-to-severe vision impairment rates to double in 30 years. The study aims to assess the effects of structured psychosocial counseling on mental health (depression, anxiety) and functional independence in individuals with low vision. Additionally, it seeks to evaluate the overall impact on quality of life (QoL) following the counseling intervention. A randomized controlled trial will be conducted at Superior University Lahore.

02

Conditions studied

  • Low Vision

Browse trials for

03

In context

Vision, Low

98 studies on the registry are indexed under Vision, Low; 23 are open to participants now.

This study's enrollment of 28 is below the median of 60 across 78 interventional studies indexed under Vision, Low.

Browse Vision, Low studies →

Lead sponsor

Superior University is the lead sponsor of 253 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals aged 18 to 80 years.
  • Both male and female
  • Individuals diagnosed with low vision, defined as a visual acuity of less than 6/18 but equal to or better than 3/60 in the better eye with best correction.
  • Individuals having visual acuity 6/60, Counting fingers or light perception.
  • Individuals experiencing symptoms of depression or anxiety as assessed through a validated screening tool.
  • Individuals reporting reduced functional independence in daily activities due to low vision.

Exclusion criteria

Exclusion Criteria:

  • Unable to provide .
  • Diagnosed with severe psychiatric disorders such as schizophrenia, bipolar disorder, or severe post-traumatic stress disorder.
  • Existing involvement in similar counseling programs.
  • Presence of medical conditions or disabilities.
  • Pregnant individuals if pregnancy-related complications or responsibilities could interfere with participation in the intervention.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Structured Psychosocial Counseling

    Combination Product: Structured Psychosocial Counseling

  • Active comparator
    Standard Care

    Diagnostic Test: Standard Care

Interventions

  • Combination productStructured Psychosocial Counseling

    "Group A (Experimental Group): Participants in the Experimental group will be divided into groups with the persons having visual acuity 6/60, counting fingers and light perception will receive low vision aids etc and structured psychosocial counseling tailored for individuals with low vision. Counseling will be delivered over a 12-week period, consisting of weekly 60-minute sessions conducted by trained counselors. The program will focus on the following: Coping mechanisms for depression and anxiety. Strategies to improve functional independence and daily living skills. Social integration techniques to enhance participation in community activities. Low visions aids under supervision of low vision specialist."

  • Diagnostic testStandard Care

    Group B (Control Group): The control group will continue receiving standard care, including referrals and informational support.

06

What researchers measure

Primary outcomes

  1. DASS 21

    The DASS-21 uses the following categories to interpret scores: Normal: 0-9 (Depression), 0-7 (Anxiety), 0-14 (Stress) Mild: 10-13 (Depression), 8-9 (Anxiety), 15-18 (Stress) Moderate: 14-20 (Depression), 10-14 (Anxiety), 19-25 (Stress) Severe: 21-27 (Depression), 15-19 (Anxiety), 26-33 (Stress) Extremely Severe: 28+ (Depression), 20+ (Anxiety), 34+ (Stress)

    Time frame: 12 Months

  2. LVQoL Questionare

    Total Score Interpretation: * 25-50: Good quality of life * 51-75: Moderate quality of life * 76-100: Poor quality of life * 101-125: Very poor quality of life

    Time frame: 12 Months

07

Study locations

1 site
  • Dial hospital, Qadirabad road Ali pur chattah
    Gujrānwāla, Punjab, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06914076
Responsible party
Muhammad Naveed Babur (Principal Investigator, Superior University) — Principal investigator
First posted
Apr 6, 2025
Start date
Mar 20, 2025
Primary completion
Jun 20, 2025 (estimated)
Completion
Feb 20, 2026 (estimated)
Last update
Apr 6, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion