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NCT Number: NCT06914076

Evaluating The Effectiveness Of Structured Psychosocial Counseling On Mental Health And FI 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Low Vision Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders Vision, Low

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dial hospital, Qadirabad road Ali pur chattah

Guiranwala, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Structured Psychosocial Counseling

Combination Product

"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."

Standard care

Diagnostic Test

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

Primary outcomes

  1. DASS 21

    Time frame: 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)

  2. LVQoL Questionare

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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