Recruiting

Cognitive Behavioral Therapy and Mindfulness for Vision Loss Adjustment

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What is being tested

Integrated Cognitive Behavioral Therapy (CBT) & Mindfulness Group Intervention for Adjustment to Vision Loss

Behavioral
Who is being recruted

Trauma and Stressor Related Disorders
+7

+ Adjustment Disorders
+ Mental Disorders
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorThe Chicago Lighthouse
Study ContactSenior Research Associate
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: July 14, 2025Actual date on which the first participant was enrolled.

This study aims to create and test a new program to help people who are adjusting to losing their vision. The program combines cognitive behavioral therapy (CBT) and mindfulness techniques, specifically designed for individuals experiencing vision loss. It is important because adjusting to vision loss can be challenging, and this program could offer new ways to help people cope better. Initially, the program's development involves reviewing existing research, gathering feedback from participants, and consulting with experts. The goal is to create a curriculum that is relevant and useful for those dealing with vision loss. In this study, participants will take part in focus groups to provide their opinions on the new program's content and whether it meets their needs. Later, a smaller group will participate in an 8-week course using this curriculum, which can be attended in-person or online. During the sessions, participants will be asked to answer questions about their vision and experiences before and after the program to measure its effectiveness. These assessments will help determine if the program improves their ability to manage vision loss and adjust to changes in their lives.

Official TitleDeveloping Evidence-Based Cognitive Approaches to Improve Adjustment to Vision Loss 
NCT07073521
Principal SponsorThe Chicago Lighthouse
Study ContactSenior Research Associate
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
45 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Trauma and Stressor Related Disorders
Adjustment Disorders
Mental Disorders
Blindness
Eye Diseases
Nervous System Diseases
Neurologic Manifestations
Sensation Disorders
Vision Disorders
Vision, Low
Criteria

Inclusion Criteria: * Adults who are at least 18 years old * Experiencing varying degrees of vision loss (e.g. mild, moderate, severe) * Willingness to participate in the focus group or pilot testing and provide feedback Exclusion Criteria: * Individuals with severe cognitive impairment affecting participation * Congenital blindness * Recent or current participation in another clinical trial study or medical intervention that may interfere with study results * Documented or self-reported health condition that may interfere with the outcomes of this study. * Deemed unfit to participate in the study by the site investigator * Unwilling and/or unable to participate or provide consent

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Participants will be testing an 8-week therapeutic strategy combining cognitive behavioral therapy (CBT) with mindfulness practices tailored for people adjusting to vision loss in a group therapy setting and complete assessments before and after completing the program.

The intervention will be an 8-week integrated group therapy curriculum combining cognitive behavioral therapy (CBT) with mindfulness practices designed for individuals adjusting to vision loss.
Study Objectives
Primary Objectives

The AVL is a 24-item self-report questionnaire rated on a 5-point Likert scale. Items assess emotional and psychosocial adjustment to vision loss. Scores range from 1 to 5, with higher scores indicating better adaptation. Some items are reverse-scored.
Secondary Objectives

The Patient Health Questionnaire (PHQ-9) measures average changes in depressive symptoms among participants. PHQ-9 scores range from 0 to 27, with higher scores indicating more severe depression.

The Generalized Anxiety Disorder 7-item (GAD-7) scale is used to assess the severity of anxiety symptoms. Scores range from 0 to 21, with higher scores indicating more severe anxiety. Each item is scored on a 0-3 Likert scale.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
The Chicago LighthouseChicago, United StatesSee the location
Recruiting
One Study Center
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