Clinical trial NCT06651736: Optimizing Low Vision Rehabilitation in Emotionally Distressed Patients With Inherited Retinal Diseases
Official title: Optimizing Low Vision Rehabilitation in Emotionally Distressed Patients With Inherited Retinal Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inherited Retinal Diseases
Keywords: Low Vision Rehabilitation
Emotional Regulation Therapy
Vision-related anxiety
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2024-10-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants with IRD will be recruited and will be allocated into one of three study arms, depending on self-reported anxiety. Participants (N \~ 60) without vision-related anxiety will be designated to Arm 1 and receive LVR. Participants (N \~ 120) with vision-related anxiety will be randomly assigned to either Arm 2 or 3, in which participants will receive LVR with adjunctive ERT.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Determine if LVR improves vision-related disabilities and distress measures by the Michigan Vision-related Anxiety Questionnaire (MVAQ)
timeFrame: Baseline to 6 month
measure: Determine if LVR improves vision-related disabilities and distress measures by the Michigan Retinal Degeneration Questionnaire (MRDQ)
timeFrame: Baseline to 6 month
measure: Determine if LVR measures are different between low-distress and high-distress groups accessed at month-6 by MVAQ
timeFrame: Baseline, 6 months
measure: Determine if LVR measures are different between low-distress and high-distress groups accessed at month-6 by MRDQ
timeFrame: Baseline, 6 months
measure: 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
timeFrame: Baseline, 6 months
measure: 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
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Determine if LVR improves vision-related disabilities and distress measures by the Short Form Survey (SF-36)
timeFrame: Baseline to 6 month
measure: Determine if adjunctive ERT treatment improves LVR treatment adherence greater than LVR alone measured by the Psychosocial Impact of Assistive Devices Scale (PIADS)
timeFrame: 6 months
measure: Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Patient Health Questionnaire (PHQ-9)
timeFrame: 6 months
measure: Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Perceived Stress Scale (PSS)
timeFrame: 6 months
measure: Determine if adjunctive ERT treatment improves LVR treatment adherence greater than LVR alone measured by the Daughty Device Compliance Questionnaire (DDCQ)
timeFrame: 6 months
measure: Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Generalized Anxiety Disorder (GAD)-7
timeFrame: 6 months
measure: Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Rumination-Reflection Questionnaire (RRQ)
timeFrame: 6 months
measure: Determine if adjunctive ERT treatment improves overall emotional distress greater than LVR alone measured by the Penn State Worry Questionnaire (PSWQ)
timeFrame: 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: K. Thiran Jayasundera, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: