Acceptance Commitment Therapy for Glaucoma

Overseen By Samuel Berchuck, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: Pressure lowering eye drops

Disqualifiers: Borderline glaucoma, Glaucoma surgery, Major medical conditions, Psychiatric conditions, Cognitive impairment

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

Compensation: Varies

Number of Visits: Unknown

45 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for adults over 18 with primary open-angle glaucoma who speak English and are scheduled for a clinic visit at Duke Eye Center. They must have had previous appointments there and be able to consent. It's not specified who can't join.

Inclusion Criteria

I have been diagnosed with primary open-angle glaucoma.

I can understand, speak, and read English.

I have an upcoming appointment at the Duke Eye Center for glaucoma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development of a baseline intervention using Acceptance and Commitment Therapy (ACT) delivered via a mobile application

4-8 weeks

Intervention Refinement

Refinement of the baseline intervention using qualitative interviews with glaucoma patients and health professionals

4-8 weeks

Pilot Study

Measurement of acceptability and feasibility of the refined intervention through a single-armed pilot study

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Acceptance commitment therapy

Trial Overview The study tests a mobile app delivering Acceptance Commitment Therapy (ACT) to manage distress in glaucoma patients. It involves developing the app, refining it through interviews with patients and health pros, then testing its acceptability in a pilot study.

Participant Groups

Group I: VISION-ACT: Acceptance commitment therapy via a mobile-application Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+