Low Vision Rehabilitation + Emotion Regulation Therapy for Visual Impairment

Overseen By Jessica Stout

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Mental health medications

Disqualifiers: Ocular comorbidities, Current mental therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

180 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on medication for mental health, you must be on a stable dose for at least one month to participate.

What data supports the effectiveness of the treatment Emotion Regulation Therapy (ERT) and Low Vision Rehabilitation (LVR) for visual impairment?

Research shows that emotion regulation therapy (ERT) can help improve emotional control in people with anxiety and depression, and similar therapies have been beneficial for emotional regulation in chronic diseases and cardiac rehabilitation. This suggests that ERT might also help people with visual impairment manage their emotions better. ^{1 2 3 4 5}

Is Emotion Regulation Therapy (ERT) safe for humans?

Emotion Regulation Therapy (ERT) has been studied in various contexts, including anxiety and depression, and has shown positive outcomes without significant safety concerns reported in the available research. ^{4 5 6 7 8}

How is the treatment of Low Vision Rehabilitation + Emotion Regulation Therapy for Visual Impairment different from other treatments?

This treatment is unique because it combines Low Vision Rehabilitation (LVR), which focuses on improving daily functioning for those with vision loss, with Emotion Regulation Therapy (ERT), which helps manage emotional responses. This dual approach addresses both the practical and emotional challenges of visual impairment, unlike traditional treatments that may focus solely on vision improvement. ^{9 10 11 12 13}

Research Team

K. Thiran Jayasundera, MD, MS

Principal Investigator

University of Michigan

Eligibility Criteria

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.

Inclusion Criteria

I can attend 10 weeks of sessions in Michigan.

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)

Exclusion Criteria

I am currently receiving treatment for a mental health condition.

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)

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Low Vision Rehabilitation (LVR) and Emotional Regulation Therapy (ERT) based on their randomization group

6 months

Regular sessions as per therapy protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Emotion Regulation Therapy (ERT)
• Low Vision Rehabilitation (LVR)

Trial Overview 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.

Participant Groups

Group I: Arm 3- LVR with delayed ERT Experimental Treatment 2 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 LVR Experimental Treatment 2 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 LVR Active Control 1 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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Findings from Research

In a study involving 150 adults with chronic illnesses, Mind-body and Art Therapies (MBATs) showed a slight improvement in emotional regulation skills, but the difference compared to the control group was not statistically significant.

No adverse effects were reported from the MBAT interventions, indicating they are safe for patients with chronic diseases, although the overall effectiveness in enhancing emotional regulation was only partially supported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind-body and art therapies impact on emotional regulation in patients with chronic diseases: a pragmatic mixed-methods randomized controlled trial. Le Rhun, A., Caillet, P., Lebeaupin, M., et al.[2023]

Patients with acquired brain injury (ABI) take longer and generate fewer reappraisals for regulating emotions compared to healthy controls, indicating a potential challenge in emotion regulation after brain injury.

While ABI patients can effectively decrease the intensity of negative emotions, their ability to up-regulate neutral emotions to positive is less effective, suggesting specific deficits in emotion regulation strategies that could inform neuropsychological rehabilitation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Good things better? Reappraisal and discrete emotions in acquired brain injury. Rowlands, L., Coetzer, R., Turnbull, OH.[2021]

The RENEwS intervention, aimed at improving emotion regulation in cardiac rehabilitation patients, was found to be feasible, with 57% of the 14 participants completing the program.

Participants reported positive feedback on the intervention's acceptability and implementation, suggesting it could effectively support patients in managing their emotions to improve physical activity and reduce cardiovascular risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of an Emotion Regulation Intervention for Patients in Cardiac Rehabilitation. Wierenga, KL., Fresco, DM., Alder, M., et al.[2022]

Heart rate variability biofeedback (HRV-BF) significantly improves emotional control in individuals with severe chronic acquired brain injury, as indicated by increased low frequency (LF) activity.

The study suggests that attention training can enhance the effectiveness of HRV-BF, leading to better emotional regulation outcomes, particularly when attention levels are high.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotion regulation after acquired brain injury: a study of heart rate variability, attentional control, and psychophysiology. Kim, S., Zemon, V., Lehrer, P., et al.[2020]

Emotion Regulation Therapy (ERT) showed statistically and clinically significant improvements in patients with Generalized Anxiety Disorder (GAD) and co-occurring depression, after a 20-session treatment, indicating its potential efficacy as an intervention.

Patients maintained their improvements in symptom severity, quality of life, and emotional regulation skills for up to nine months after treatment, suggesting that ERT may provide lasting benefits for individuals struggling with GAD and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AN OPEN TRIAL OF EMOTION REGULATION THERAPY FOR GENERALIZED ANXIETY DISORDER AND COOCCURRING DEPRESSION. Mennin, DS., Fresco, DM., Ritter, M., et al.[2019]

Emotion Regulation Therapy (ERT) is a new approach that combines elements of traditional cognitive behavioral therapy (CBT), mindfulness, and emotion-focused interventions to help patients with complex emotional disorders, like generalized anxiety disorder.

Preliminary evidence from open and randomized controlled trials suggests that ERT is effective in improving treatment responses by targeting motivational dysfunction and enhancing emotion regulation skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotion Regulation Therapy for Generalized Anxiety Disorder. Fresco, DM., Mennin, DS., Heimberg, RG., et al.[2020]

The Emo-regulator, a training system combining virtual reality and EEG-based neurofeedback, effectively improved emotion regulation in subjects over a two-week period, as evidenced by enhanced ability to down-regulate negative emotions.

Participants reported above-average usability of the Emo-regulator, indicating that it not only helps in emotional management but is also user-friendly, promoting the use of cognitive reappraisal techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emo-regulator: An emotion-regulation training system fusing virtual reality and EEG-based neurofeedback. Yu, M., Bai, Y., Li, Y.[2023]

A systematic review of 10 studies and a meta-analysis of 26 studies involving 84 clients showed that therapist methods for emotion regulation (ER) significantly improve patients' ability to manage their emotions, with a large effect size of 0.82 from pre- to post-treatment.

Both affect-focused methods and structured skills training are effective in enhancing emotion regulation, highlighting the importance of considering cultural backgrounds in therapy to tailor approaches for individual patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing emotion regulation. Iwakabe, S., Nakamura, K., Thoma, NC.[2023]

Patient-reported outcomes in low-vision rehabilitation (LVR) reflect the difference between a patient's visual ability and the demands of specific tasks, indicating that improving functional reserve can be achieved through medical or assistive interventions.

To accurately measure the effectiveness of LVR interventions, it is crucial to select appropriate outcome measures that align with the intervention goals and the patients' impairment levels, filtering out items that already receive high positive ratings to avoid skewing results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interpretation of low-vision rehabilitation outcome measures. Massof, RW., Stelmack, JA.[2022]

A pilot program was conducted with occupational therapists lacking experience in low vision rehabilitation, resulting in the development of a best-practice model for training in this specialty area.

After three training sessions, the participating therapists achieved entry-level competency in low vision rehabilitation, suggesting that the model could effectively prepare students during their fieldwork placements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specialty level II fieldwork in low vision rehabilitation. Nastasi, JA.[2013]

The literature review identified that older adults with age-related vision loss (ARVL) are often viewed as 'at risk' for negative outcomes like dependency and self-harm, which can influence rehabilitation practices and policies.

A dominant epidemiological approach to risk focuses on individual-level assessments and expert monitoring, neglecting the perspectives of older adults and the environmental factors that contribute to their risks, suggesting a need for more inclusive and context-aware rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Vision Rehabilitation, Age-Related Vision Loss, and Risk: A Critical Interpretive Synthesis. Laliberte Rudman, D., Egan, MY., McGrath, CE., et al.[2018]

Low vision rehabilitation (LVR) has evolved from charity-based efforts to a recognized medical discipline that significantly enhances the quality of life for visually impaired patients through various interventions.

Modern LVR incorporates advanced devices and skill retraining, ranging from simple tools like hand magnifiers to complex solutions like retinal prostheses, demonstrating the field's growth and potential for future advancements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State-of-the-art: low vision rehabilitation. Markowitz, SN.[2022]

The LOVIT II trial is a multicenter randomized controlled trial involving 330 patients with macular disease, aiming to compare the effectiveness of low vision rehabilitation (LVR) with basic low vision (LV) services.

Preliminary results show that LVR, which includes therapy sessions to teach effective use of vision aids, may lead to better improvements in visual reading ability compared to basic LV, where devices are simply dispensed without additional training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

VA LOVIT II: a protocol to compare low vision rehabilitation and basic low vision. Stelmack, JA., Tang, XC., Reda, DJ., et al.[2015]

References

1. England pubmed.ncbi.nlm.nih.gov

Mind-body and art therapies impact on emotional regulation in patients with chronic diseases: a pragmatic mixed-methods randomized controlled trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Good things better? Reappraisal and discrete emotions in acquired brain injury. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Feasibility of an Emotion Regulation Intervention for Patients in Cardiac Rehabilitation. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Emotion regulation after acquired brain injury: a study of heart rate variability, attentional control, and psychophysiology. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

AN OPEN TRIAL OF EMOTION REGULATION THERAPY FOR GENERALIZED ANXIETY DISORDER AND COOCCURRING DEPRESSION. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Emotion Regulation Therapy for Generalized Anxiety Disorder. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Emo-regulator: An emotion-regulation training system fusing virtual reality and EEG-based neurofeedback. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Enhancing emotion regulation. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Interpretation of low-vision rehabilitation outcome measures. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Specialty level II fieldwork in low vision rehabilitation. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Low Vision Rehabilitation, Age-Related Vision Loss, and Risk: A Critical Interpretive Synthesis. [2018]

12. England pubmed.ncbi.nlm.nih.gov

State-of-the-art: low vision rehabilitation. [2022]

13. England pubmed.ncbi.nlm.nih.gov

VA LOVIT II: a protocol to compare low vision rehabilitation and basic low vision. [2015]