Optimizing Low Vision Rehabilitation in Emotionally Distressed Patients With Inherited Retinal Diseases
- Conditions
- Inherited Retinal Diseases
- Registration Number
- NCT06651736
- Lead Sponsor
- University of Michigan
- Brief Summary
The purpose of this study is to understand if combining Low Vision Rehabilitation (LVR) with Emotional Regulation Therapy (ERT) can help people with inherited retinal diseases (IRDs) that experience emotional distress related to participants' vision loss.
The study team hypothesize that treatment with LVR will produce measurable functional gains and that these effects will be enhanced by ERT-linked improvement among the subgroup of IRD patients with elevated vision-related anxiety.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- Diagnosed with vision impairment with IRD etiology
- Must have had a clinical exam with an IRD specialist within the three months of assignment to Arm
- Have had a Goldmann visual field that was tested with III-4e isopter within the last year
- Have a disability greater than zero theta in any of the domains of Michigan Retinal Dystrophy Questionnaire (MRDQ)
- Have an indication from the IRD specialist that the ocular condition will not deteriorate over the next 1- year
- Able to participate in 10 weeks of ERT sessions while being physically located in Michigan (these will take place in the first 10 months of the study)
- Having other ocular comorbidities including those associated with an IRD such as control of cystoid macular edema (CME)
- Functional needs regarding low vision (i.e. activities of daily living) have been adequately addressed per a study low vision specialist
- Current mental health therapy
- The participant must not have an elevated suicidal intention (SI) or suicide risk based on Patient Health Questionnaire (PHQ-9) further information collected at screening (If suicidal intentions are identified, the study staff will complete the suicide protocol (per protocol)
- If the participant is using medication for mental health or psychiatry concerns, participants must be on a stable dose of the medication (1-month of taking), otherwise will be excluded
- Inability to complete study task requirements
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 MVAQ Baseline, 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 MRDQ Baseline, 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 MVAQ Baseline, 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 MRDQ Baseline, 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).
- Secondary Outcome Measures
Name Time Method Determine if adjunctive ERT treatment improves LVR treatment adherence greater than LVR alone measured by the Daughty Device Compliance Questionnaire (DDCQ) 6 months The Daughty Device Compliance Questionnaire (DDCQ) is a 5-item self-reported questionnaire designed to evaluate the adherence to and effectiveness of medical devices in daily use. It assesses factors such as user satisfaction, ease of use, and the impact on health outcomes. Completed for each device participants receive.
Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Patient Health Questionnaire (PHQ-9) 6 months The Patient Health Questionnaire is a 9-item questionnaire designed to assess depression symptoms. Participants answer questions from Not at all (0) -Nearly every day (3). The score ranges from 0 to 27, the higher scores mean more serious depression.
Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Perceived Stress Scale (PSS) 6 months The Perceived Stress Scale is a 10-item questionnaire aimed to assess participants perceived stress. Items are scored from never (0) - very often (4). Scores rage from 0-40 with higher scores indicating higher stress.
Determine if LVR improves vision-related disabilities and distress measures by the Short Form Survey (SF-36) Baseline to 6 month The survey has 36-items in which participants select responses. It measures and produces scores (0-100) for 8 domains (Physical functioning, Role limitations due to physical health, Bodily pain, General health perceptions, Vitality (energy/fatigue), Social functioning, Role limitations due to emotional problems, Mental health (emotional well-being) Scores presented on a 0-100 scale, with scores above 50 generally indicating better-than-average health-related quality of life, and scores below 50 suggesting below-average health.
Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Penn State Worry Questionnaire (PSWQ) 6 months The Penn State Worry Questionnaire is a 16-item self-report scale designed to measure the trait of worry in adults. Items are scored from not at all typical of me (1) - Very typical of me (5). The range of scores are from 16-80 with higher scores indicating higher level of worry.
Determine if adjunctive ERT treatment improves LVR treatment adherence greater than LVR alone measured by the Psychosocial Impact of Assistive Devices Scale (PIADS) 6 months The Psychosocial Impact of Assistive Devices (PIADS) is a 26-item self-reported questionnaire designed to assess the effects of an assistive device on functional independence, well-being and quality of life.
The PIADS Uses a 7-point scale for each item, ranging from -3 to +3. A score of -3 indicates the maximum negative impact, a score of 0 indicates no impact or neutral effect, and a score of +3 indicates the maximum positive impact of devices.Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Generalized Anxiety Disorder (GAD)-7 6 months The 7-item GAD-7 will measure symptoms of anxiety. Items are scored not at all (0) -Nearly every day (3), scores range from 0-21. Higher scores indicate more symptoms of anxiety.
Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Rumination-Reflection Questionnaire (RRQ) 6 months The Rumination-Reflection Questionnaire is a 24-item measure of self-reflection tendencies. Items are scored from strongly disagree (1) - Strongly agree (5). Scores range from 24 to 120; a higher score means a worse outcome.
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States