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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Chicago Lighthouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Pilot Testing - Assessing Feasibility and AcceptabilityExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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

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.

Time frame
Assessed at baseline and following the 8-week intervention period
2

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

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.

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

Other outcomes

Sponsors and contacts

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