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Recruiting NCT07073521

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

No phase Interventional Depression, Anxiety Visual Impairment Adjustment Adjustment Disorder With Anxious Mood

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Integrated Cognitive Behavioral Therapy (CBT) & Mindfulness Group Intervention for Adjustment to Vision Loss.
Who it may be relevant to
Registry conditions: Depression, Anxiety, Visual Impairment, Adjustment, Adjustment Disorder With Anxious Mood. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

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

  • Change from Baseline in Mean Adaption to Vision Loss (AVL) Scale Score [Time frame: Assessed at baseline and following the 8-week intervention period]
Secondary outcome measures (2)
  • Change from Baseline in Mean Patient Health Questionnaire (PHQ-9) Score [Time frame: Assessed at baseline and following the 8-week intervention period]
  • Change from Baseline in Mean Generalized Anxiety Disorder (GAD-7) Score [Time frame: Assessed at baseline and following the 8-week intervention period]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • The Chicago Lighthouse — Chicago

Identifiers

NCT: NCT07073521 · WSHF - 2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗