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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Integrated Cognitive Behavioral Therapy (CBT) & Mindfulness Group Intervention for Adjustment to Vision Loss
BehavioralThe 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.