Anxiety & Depression Association of America

Treating Psychosocial Distress in Glaucoma

Purpose

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.

Conditions

Glaucoma, Primary Open Angle
Distress, Emotional
Anxiety
Depression

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Other
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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.	Behavioral: Acceptance commitment therapy The baseline intervention will use ACT, a psychological intervention based on modern behavioral psychology, including relational frame theory, that uses acceptance and mindfulness strategies, along with commitment and behavior-change strategies to increase psychological flexibility. The proposed intervention will be delivered over a 6-week period, with each week including content related to one of the six tenets of ACT: cognitive defusion, acceptance, contact with the present moment, the observing self, values, and committed action. Each week will include educational material, skills work, and homework. The intervention will be delivered via a mobile application.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Duke University

Study Contact

Samuel Berchuck, PhD
(919) 613-4975
sib2@duke.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.