An interventional study of Integrated Cognitive Behavioral Therapy (CBT) & Mindfulness Group Intervention for Adjustment to Vision Loss in Depression, Anxiety, Visual Impairment and Adjustment, sponsored by The Chicago Lighthouse. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by The Chicago Lighthouse · Not applicable, Interventional, and Treatment
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.
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 45 is below the median of 81 across 7,063 interventional studies indexed under Depression.
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Exclusion Criteria:
Participants will be testing an 8-week therapeutic strategy combining cognitive behavioral therapy (CBT) with mindfulness practices tailored for people adjusting to vision loss in a group therapy setting and complete assessments before and after completing the program.
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.
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
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
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
Plan to share: No
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