Treating Psychosocial Distress in Glaucoma

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
North Carolina
Duke University Eye Center
RECRUITING
Durham
Contact Information
Primary
Samuel Berchuck, PhD
sib2@duke.edu
(919) 613-4975
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 45
Treatments
Experimental: VISION-ACT: Acceptance commitment therapy via a mobile-application
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.
Sponsors
Leads: Duke University
Collaborators: National Eye Institute (NEI)

This content was sourced from clinicaltrials.gov

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