Low VisionNCT06914076
Evaluating The Effectiveness Of Structured Psychosocial Counseling On Mental Health And FI Individuals With Low Vision
A study testing Structured Psychosocial Counseling in people with Low Vision, run by Superior University at 1 site in Pakistan.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Vision
- What is being tested?
- Structured Psychosocial Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dial hospital, Qadirabad road Ali pur chattah
Chak One Hundred Seventy-five Nine Left, Punjab Province
About this study
Official title: 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.
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.
- Conditions
- Low Vision
- Being tested
- Structured Psychosocial Counseling, Standard Care
- Medical subject headings
- Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Psychosocial CounselingCombination 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 CareDiagnostic test
Group B (Control Group): The control group will continue receiving standard care, including referrals and informational support.
| Study group | Role | What they receive |
|---|---|---|
| Structured Psychosocial Counseling | Experimental | Not described Receives: Combination Product: Structured Psychosocial Counseling |
| Standard Care | Active comparator | Not described Receives: Diagnostic Test: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start20 Mar 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low VisionStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914076
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/814
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating The Effectiveness Of Structured Psychosocial Counseling On Mental Health And Functional Independence In Individuals With Low Vision
- ClinicalTrials.gov ID
- NCT06914076
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/814
- Conditions
- Low Vision
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Psychosocial Counseling | Experimental | Combination Product: Structured Psychosocial Counseling |
| Standard Care | Active comparator | Diagnostic Test: Standard Care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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." | Combination product | Structured Psychosocial Counseling |
| Standard CareGroup B (Control Group): The control group will continue receiving standard care, including referrals and informational support. | Diagnostic test | Standard Care |
Primary outcome
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Psychosocial Counseling in people with Low Vision, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DASS 21 (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.