University of Michigan
Ann Arbor, Michigan, 48105, United States
Location status: Recruiting
Location contact
Jessica Stout
CONTACT
K. Thiran Jayasundera, MD, MS
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06651736
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48105, United States
Location status: Recruiting
Jessica Stout
CONTACT
K. Thiran Jayasundera, MD, MS
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The initial session will be with an LVR specialist that will recommend vision-enhancing devices and techniques to improve participant's vision and mobility functionality depending on needs. The devices will be given at no cost and include, but are not limited to: magnifiers that participants can hold or wear, glasses attachments that help filter out light to see better, or items that help with glare or seeing color. This session will be followed by at least one session with an occupational therapist, that will train participants to use the devices (take home and use) and recommend/teach ways to achieve functional goals.
Most participants will be asked to attend 2-4 visits, but additional visits may be needed depending on needs and progress toward functional goals. Additional visits if orientation and mobility training is also recommended. Participants will be asked to share experiences approximately 1-week after all visits.
There will be ten 1-hour weekly sessions of specialized psychotherapy with an ERT-trained therapist. These are typically done virtually but may be able to provide in-person sessions to those where this is needed. At the beginning of each session, the therapist will give participant's several questionnaires to learn about participant's experience with ERT. Questionnaires will also be completed after all sessions are completed.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
University of Michigan
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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