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NCT Number: NCT07073521

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chicago Lighthouse

Chicago, Illinois, 60608, United States

Location status: Recruiting

Location contact

Chief Research Officer

PRINCIPAL_INVESTIGATOR

Licensed Clinical Professional Counselor

SUB_INVESTIGATOR

Senior Research Associate

CONTACT

[email protected]

312-447-3254

CONTACT

312-447-3234

About this study

The goal of this study is to develop and pilot test an 8-week cognitive behavioral therapy (CBT) & mindfulness curriculum tailored for people adjusting to vision loss. Development of the curriculum during the initial phase of this research will include a thorough review of the literature, input from participant groups, and insights from an expert panel. An initial draft of the curriculum will be developed based on the findings from the literature review. 30-40 Participants will have the opportunity to attend up to two focus group sessions to provide feedback and input on content relevance, feasibility, and acceptability of the curriculum. In the pilot testing phase, 15-20 participants will attend eight weekly group therapy sessions held either in-person or virtually using the developed curriculum and will complete assessments before and after the program. These assessments will include questions about your vision, demographics, and experiences with vision loss, as well as collecting baseline and post-intervention measures prior to undergoing the 8-week pilot testing.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Assessed at baseline and following the 8-week intervention period

    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 outcomes

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

    Time frame: Assessed at baseline and following the 8-week intervention period

    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.

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

    Time frame: Assessed at baseline and following the 8-week intervention period

    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 contacts

Contact information is provided by the study sponsor or research team.

Senior Research Associate

CONTACT

[email protected]

(312) 447-3254

Sponsors and collaborators

Lead sponsor

The Chicago Lighthouse

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 18, 2025
Registry last updated
Jul 30, 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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