Adjustment, Adjustment Disorder With Anxious Mood, Adjustment Disorder With Depressed Mood, Blindness, Acquired, Blindness and Low Vision, Depression, Anxiety, Vision Loss, Visual Impairment
Conditions
Keywords
Visually impaired, Blind, Vision loss, mental health, CBT, Cognitive-behavioral therapy (CBT), mindfulness, adjustment to vision loss, focus group, pilot test, group therapy
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.
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
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Mean Adaption to Vision Loss (AVL) Scale Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Mean Generalized Anxiety Disorder (GAD-7) Score | 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. |
| Change from Baseline in Mean Patient Health Questionnaire (PHQ-9) Score | 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. |
Countries
United States