Optimizing Low Vision Rehabilitation in Emotionally Distressed Patients With Inherited Retinal Diseases
Recruiting · NCT06651736 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Michigan
View the official record on ClinicalTrials.gov →Interventions studied
Emotion Regulation Therapy (ERT)Low Vision Rehabilitation (LVR)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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)
Exclusion criteria
- 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
Where it is running
1 location listed across 1 US state.
- University of Michigan - Ann Arbor, Michigan, United States