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

Evaluating The Effectiveness Of Structured Psychosocial Counseling On Mental Health And Functional Independence In Individuals With Low Vision

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Low Vision
• Intervention / Treatment: Combination product: Structured Psychosocial Counseling; Diagnostic test: Standard Care

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care	Diagnostic test: Standard Care; Group B (Control Group): The control group will continue receiving standard care, including referrals and informational support.
Experimental: Structured Psychosocial Counseling	Combination product: Structured 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."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 Months
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	12 Months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Estimated): June 20, 2025
• Study Completion (Estimated): February 20, 2026

Study Registration Dates

• First Submitted: March 29, 2025
• First Submitted That Met QC Criteria: March 29, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: March 29, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Vision Disorders; Sensation Disorders; Vision, Low
• Other Study ID Numbers: MSRSW/Batch-Fall23/814

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No