← Back to Search

Low Vision Rehabilitation + Emotion Regulation Therapy for Visual Impairment

N/A

Waitlist Available

Led By K. Thiran Jayasundera, MD, MS

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with vision impairment with IRD etiology

Be older than 18 years old

Must not have

Current mental health therapy

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if combining Low Vision Rehabilitation (LVR) with Emotional Regulation Therapy (ERT) can help individuals with inherited retinal diseases (IRDs) who are emotionally distressed due to their

Who is the study for?

This trial is for individuals with inherited retinal diseases who are experiencing emotional distress due to vision loss. Participants should be emotionally distressed specifically because of their visual impairment.

What is being tested?

The study aims to determine if Low Vision Rehabilitation (LVR) combined with Emotion Regulation Therapy (ERT) can improve the well-being of patients with inherited retinal diseases and related emotional distress.

What are the potential side effects?

Since LVR and ERT are non-invasive therapies focusing on rehabilitation and psychological support, significant physical side effects are not expected. Emotional discomfort during therapy is possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with vision loss due to an inherited retinal disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently receiving treatment for a mental health condition.

Select...

My mental health medication dose has been stable for at least a month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine if LVR improves vision-related disabilities and distress measures by the Michigan Retinal Degeneration Questionnaire (MRDQ)

Determine if LVR improves vision-related disabilities and distress measures by the Michigan Vision-related Anxiety Questionnaire (MVAQ)

Determine if LVR measures are different between low-distress and high-distress groups accessed at month-6 by MRDQ

+3 more

Secondary study objectives

Determine if LVR improves vision-related disabilities and distress measures by the Short Form Survey (SF-36)

Determine if adjunctive ERT treatment improves LVR treatment adherence greater than LVR alone measured by the Daughty Device Compliance Questionnaire (DDCQ)

Determine if adjunctive ERT treatment improves LVR treatment adherence greater than LVR alone measured by the Psychosocial Impact of Assistive Devices Scale (PIADS)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm 3- LVR with delayed ERTExperimental Treatment2 Interventions

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

Group II: Arm 2 - ERT (after randomization) and then concurrent with LVRExperimental Treatment2 Interventions

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.

Group III: Arm 1 - Low Vision Rehabilitation LVRActive Control1 Intervention

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.

0 / 3Eligibility criteria met