CompletedNot Applicable

Treating Psychosocial Distress in Glaucoma

United States28 participantsStarted 2025-04-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in psychosocial distress

Timeframe: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).

Change in psychosocial distress

Timeframe: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).

Change in vision-related quality-of-life (QoL)

Timeframe: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).

Change in health-related QoL

Timeframe: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).

Trial details

NCT IDNCT06053307

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-26

View on ClinicalTrials.gov More Glaucoma, Primary Open Angle trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in psychosocial distress

Timeframe: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).

Change in psychosocial distress

Timeframe: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).

Change in vision-related quality-of-life (QoL)

Timeframe: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).

Change in health-related QoL

Timeframe: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).