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

NCT ID: NCT06914076

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2026-02-20

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.

Conditions

Low Vision

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Structured Psychosocial Counseling

Group Type: EXPERIMENTAL

Structured Psychosocial Counseling

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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."

Intervention Type: COMBINATION_PRODUCT

Standard Care

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dial hospital, Qadirabad road Ali pur chattah

Chak One Hundred Seventy-five Nine Left, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

MSRSW/Batch-Fall23/814

Identifier Type: -

Identifier Source: org_study_id