Treating Psychosocial Distress in Glaucoma

Duke University

Status: Enrolling

Conditions: Glaucoma, Primary Open Angle; Depression; Anxiety; Distress, Emotional

Treatments: Behavioral: Acceptance commitment therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06053307

R00EY033027 (U.S. NIH Grant/Contract)

Pro00108155

Details and patient eligibility

About

In this study, using three phases, the investigators will use an iterative development approach to refine a behavioral intervention for managing concomitant psychosocial distress in glaucoma. Phase 1: The investigators will begin by developing a baseline intervention using strategies from Acceptance and Commitment Therapy (ACT), and delivered using a mobile application. Phase 2: The investigators will refine the baseline intervention for glaucoma patients using qualitative interviews conducted with primary open-angle glaucoma (POAG) patients with psychosocial distress (N=20), and health professionals (N=5). Phase 3: Finally, the investigators will measure acceptability and feasibility of the refined intervention through a single-armed pilot study (N=25). The investigators hypothesize that the refined intervention will yield an acceptable and feasible intervention in a POAG patient population, setting the stage for a future efficacy study.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• diagnosed with mild, moderate, or severe chronic glaucoma (e.g., POAG),
• had a visual field within the past year at the main Duke Eye Center,
• been prescribed pressure lowering eye drop medication,
• at least mild distress (based on PHQ-4),
• 18 years old,
• able to understand, speak, and read English, and
• be able to provide informed consent.

Exclusion Criteria

• diagnosed with borderline glaucoma or as a glaucoma suspect,
• had a glaucoma surgery in past month (e.g., trabeculectomy, glaucoma drainage device/tube),
• visual acuity of worse than 20/70 in the better seeing eye,
• diagnosed with a major medical conditions (e.g., cancer, or another visual disorder, like macular degeneration),
• diagnosed with a psychiatric conditions (e.g., schizophrenia, bipolar disorder), and
• reported or suspected cognitive impairment indicated by provider or chart review.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

VISION-ACT: Acceptance commitment therapy via a mobile-application

Experimental group

Description:

The arm will pilot a behavioral intervention to treat psychosocial distress in patients with glaucoma using acceptance commitment therapy (ACT) delivered via a mobile-application, called VISION-ACT. The intervention will be developed and refined using qualitative feedback from glaucoma patients and healthcare stakeholders.

Treatment:

Behavioral: Acceptance commitment therapy