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

Not Applicable

Active, not recruiting

• Conditions: Low Vision

• Registration Number: NCT06914076
• Lead Sponsor: Superior University

Brief 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.

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.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-20
• Study First Submitted: 2025-03-29
• Study First Submitted QC: 2025-03-29
• Last Update Submitted: 2025-03-29
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-06-20
• Study Completion: 2026-02-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 28

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

• Unable to provide informed consent.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
DASS 21	12 Months	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)
LVQoL Questionare	12 Months	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

Trial Locations

Locations (1)

Dial hospital, Qadirabad road Ali pur chattah; 🇵🇰 Gujrānwāla, Punjab, Pakistan