Developing Evidence-Based Cognitive Approaches to Improve Adjustment to Vision Loss

NCT07073521 | Recruiting

• 1 other identifier: WSHF - 2025
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to develop and pilot test a therapeutic strategy combining cognitive behavioral therapy (CBT) with mindfulness practices tailored for individuals adjusting to vision loss. The study will begin with focus groups to inform the design of the intervention. Participants will complete brief surveys on their background and experiences with vision loss prior to attending a focus group, and some may be invited to a second session to provide additional feedback before preliminary testing begins. In the pilot phase, participants will attend weekly group therapy sessions using the developed intervention and complete assessments before and after the program, including questions about vision status, demographics, and experiences with vision loss.

Conditions

Depression, Anxiety; Visual Impairment; Adjustment; Adjustment Disorder With Anxious Mood; Adjustment Disorder With Depressed Mood; Blindness, Acquired; Blindness and Low Vision; Vision Loss

Keywords

Visually impaired; Blind; Vision loss; mental health; CBT; Cognitive-behavioral therapy (CBT); mindfulness; adjustment to vision loss; focus group; pilot test; group therapy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Mean Adaption to Vision Loss (AVL) Scale Score

  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.

  Assessed at baseline and following the 8-week intervention period

Secondary Outcomes (2)

• Change from Baseline in Mean Patient Health Questionnaire (PHQ-9) Score

  Assessed at baseline and following the 8-week intervention period

• Change from Baseline in Mean Generalized Anxiety Disorder (GAD-7) Score

  Assessed at baseline and following the 8-week intervention period

Study Arms (1)

Pilot Testing - Assessing Feasibility and Acceptability

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.

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

Interventions

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

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.

Pilot Testing - Assessing Feasibility and Acceptability

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Chicago Lighthouse: lead

Study Sites (1)

The Chicago Lighthouse

Chicago, Illinois, 60608, United States

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders; Vision Disorders; Blindness; Vision, Low; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction

Study Officials

• Chief Research Officer

  The Chicago Lighthouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Senior Research Associate

CONTACT

(312) 447-3254; Research@chicagolighthouse.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Research Officer

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 18, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 13, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)