NCT06053307Completed
Treating Psychosocial Distress in Glaucoma
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 18 Sept 2023
- Start date
- 1 Apr 2025
- Primary completion date
- 26 Jan 2026
- Lead sponsor
- Duke University
- Diseases
- Glaucoma
- NCT number
- NCT06053307
What you commit to
- Study type: Interventional
- Participants enrolled: 28
- From 1 Apr 2025 to the primary completion date, 26 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- had a glaucoma surgery in past month (e.g., trabeculectomy, glaucoma drainage device/tube),
Other illness
- 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.
Other
- diagnosed with borderline glaucoma or as a glaucoma suspect,
- visual acuity of worse than 20/70 in the better seeing eye,
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Eye Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.