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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Change from Baseline in Mean Adaption to Vision Loss (AVL) Scale Score [Срок оценки: Assessed at baseline and following the 8-week intervention period]

Вторичные конечные точки (2)

• Change from Baseline in Mean Patient Health Questionnaire (PHQ-9) Score [Срок оценки: Assessed at baseline and following the 8-week intervention period]
• Change from Baseline in Mean Generalized Anxiety Disorder (GAD-7) Score [Срок оценки: Assessed at baseline and following the 8-week intervention period]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The Chicago Lighthouse — Chicago

Идентификаторы

NCT: NCT07073521 · WSHF - 2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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