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

Conditions

• Inherited Retinal Diseases

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Low Vision Rehabilitation (LVR) — BEHAVIORAL
  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.
• Emotion Regulation Therapy (ERT) — BEHAVIORAL
  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.

Study Details

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.

Key Dates

Start date

Jan 13, 2025

Status verified

Mar 2026

Primary completion

Nov 24, 2028

Completion

Nov 24, 2028

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm 1 - Low Vision Rehabilitation LVR
  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.
• Experimental: Arm 2 - ERT (after randomization) and then concurrent with LVR
  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.
• Experimental: Arm 3- LVR with delayed ERT
  Participants with vision-related anxiety (must meet this per protocol by self-reports) randomized to this arm will receive LVR with delayed ERT.

Primary Outcome Measure

Determine if LVR improves vision-related disabilities and distress measures by the Michigan Vision-related Anxiety Questionnaire (MVAQ) [ Time Frame: Baseline to 6 month ]

Central Contacts

• Jessica Stout
  734-763-5590
  [email protected]

Locations (1)

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