Optimizing Low Vision Rehabilitation in Emotionally Distressed Patients With Inherited Retinal Diseases
This study is looking at whether combining Low Vision Rehabilitation (LVR) with Emotion Regulation Therapy (ERT) can help people with inherited retinal diseases (IRDs) who are experiencing emotional distress related to their vision loss. LVR involves working with a specialist to find devices and techniques to improve your vision and mobility. ERT is a type of talk therapy that helps you manage your emotions. The study aims to see if LVR improves vision-related difficulties and distress, and if ERT further enhances these benefits, especially for those with higher anxiety. You may be able to join if you are 18 or older, have a vision impairment due to an IRD, and meet certain vision criteria. The study plans to enroll 180 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 180 participants.
- What's involved
- You will have an initial session with an LVR specialist and ten weekly, 1-hour sessions of Emotion Regulation Therapy. Your vision and distress levels will be measured at the beginning and at 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be followed for 6 months after starting the interventions.
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Optimizing Low Vision Rehabilitation in Emotionally Distressed Patients With Inherited Retinal Diseases
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- K. Thiran Jayasundera, MD, MS · PRINCIPAL_INVESTIGATOR · University of Michigan
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Determine if LVR improves vision-related disabilities and distress measures by the Michigan Vision-related Anxiety Questionnaire (MVAQ)Baseline to 6 month
The Michigan Vision-related Anxiety Questionnaire is a 14 -item questionnaire designed to assess anxiety/distress related to vision impairments. Responses can range between: Never, Sometimes, Frequently, Always, N/A for Non-Vision Reasons. The questionnaire provides 2 scores (one for anxiety about rod function and one for anxiety about cone function). Both of those scores fall between -3 and 3 (an increasing score indicates higher levels of anxiety).
- Determine if LVR improves vision-related disabilities and distress measures by the Michigan Retinal Degeneration Questionnaire (MRDQ)Baseline to 6 month
The Michigan Retinal Degeneration Questionnaire is a 59-item questionnaire aimed to assess vision-related functional impairment. Responses can range between: None, A little difficulty, Moderate difficulty, Extreme difficulty, My vision is too poor to do this, N/A for non-vision reasons. The questionnaire provides 7 scores (for 7 different domains of vision) and also range from -3 to 3 (0 is centered at the mean trait level of the population and extreme values for theta (i.e., -3, +3) are indicative of low or high visual dysfunction based on item responses).
- Determine if LVR measures are different between low-distress and high-distress groups accessed at month-6 by MVAQBaseline, 6 months
Comparison between low-distress arm and high-distress arm prior to ERT treatment at month-6. The Michigan Vision-related Anxiety Questionnaire is a 14 -item questionnaire designed to assess anxiety/distress related to vision impairments. The Michigan Vision-related Anxiety Questionnaire is a 14 -item questionnaire designed to assess anxiety/distress related to vision impairments. Responses can range between: Never, Sometimes, Frequently, Always, N/A for Non-Vision Reasons. The questionnaire provides 2 scores (one for anxiety about rod function and one for anxiety about cone function). Both of those scores fall between -3 and 3 (an increasing score indicates higher levels of anxiety).
- Determine if LVR measures are different between low-distress and high-distress groups accessed at month-6 by MRDQBaseline, 6 months
Comparison between low-distress arm and high-distress arm prior to ERT treatment at month-6. The Michigan Retinal Degeneration Questionnaire is a 59-item questionnaire aimed to assess vision-related functional impairment. Responses can range between: None, A little difficulty, Moderate difficulty, Extreme difficulty, My vision is too poor to do this, N/A for non-vision reasons. The questionnaire provides 7 scores (for 7 different domains of vision) and also range from -3 to 3 (0 is centered at the mean trait level of the population and extreme values for theta (i.e., -3, +3) are indicative of low or high visual dysfunction based on item responses).
- Determine if adjunctive ERT treatment in the high-distress arms improves vision-related disabilities and vision-related distress measures greater than LVR alone measured by MVAQBaseline, 6 months
The Michigan Vision-related Anxiety Questionnaire is a 14 -item questionnaire designed to assess anxiety/distress related to vision impairments. Responses can range between: Never, Sometimes, Frequently, Always, N/A for Non-Vision Reasons. The questionnaire provides 2 scores (one for anxiety about rod function and one for anxiety about cone function). Both of those scores fall between -3 and 3 (an increasing score indicates higher levels of anxiety).
- Determine if adjunctive ERT treatment in the high-distress arms improves vision-related disabilities and vision-related distress measures greater than LVR alone measured by the MRDQBaseline, 6 months
The Michigan Retinal Degeneration Questionnaire is a 59-item questionnaire aimed to assess vision-related functional impairment. Responses can range between: None, A little difficulty, Moderate difficulty, Extreme difficulty, My vision is too poor to do this, N/A for non-vision reasons. The questionnaire provides 7 scores (for 7 different domains of vision) and also range from -3 to 3 (0 is centered at the mean trait level of the population and extreme values for theta (i.e., -3, +3) are indicative of low or high visual dysfunction based on item responses).