Optimizing Low Vision Rehabilitation in Emotionally Distressed Patients With Inherited Retinal Diseases

University of Michigan

Status: Enrolling

Conditions: Inherited Retinal Diseases

Treatments: Behavioral: Emotion Regulation Therapy (ERT); Behavioral: Low Vision Rehabilitation (LVR)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06651736

HUM00246479

1R01EY035016-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 3 patient groups

Arm 1 - Low Vision Rehabilitation LVR

Active Comparator group

Description:

Participants (N \~ 60) without vision-related anxiety will be designated to Arm 1 and receive LVR. This group is intended to be a comparison for the higher vision-related anxiety groups. For this reason, these patients may be placed on a waitlist (meaning participants low-vision rehabilitation may be delayed), until the study team can match with someone in one of the other groups.

Treatment:

Behavioral: Low Vision Rehabilitation (LVR)

Arm 2 - ERT (after randomization) and then concurrent with LVR

Experimental group

Description:

Participants with vision-related anxiety (must meet this per protocol by self-reports) randomized to this arm will receive immediate ERT. The LVR therapy will start approximately during 4-6 sessions of ERT.

Treatment:

Behavioral: Low Vision Rehabilitation (LVR)

Behavioral: Emotion Regulation Therapy (ERT)

Arm 3- LVR with delayed ERT

Experimental group

Description:

Participants with vision-related anxiety (must meet this per protocol by self-reports) randomized to this arm will receive LVR with delayed ERT.

Treatment:

Behavioral: Low Vision Rehabilitation (LVR)

Behavioral: Emotion Regulation Therapy (ERT)