Clinical trial NCT06053307: Treating Psychosocial Distress in Glaucoma
Official title: Treating Psychosocial Distress in Glaucoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma, Primary Open Angle
Distress, Emotional
Anxiety
Depression
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2023-09-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 criteria: 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.

Primary outcomes:
measure: Change in psychosocial distress
timeFrame: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
measure: Change in psychosocial distress
timeFrame: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
measure: 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).
measure: Change in health-related QoL
timeFrame: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
Secondary outcomes:
measure: Change in psychological flexibility
timeFrame: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
measure: Change in disease acceptance
timeFrame: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
measure: Change in self-efficacy
timeFrame: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
measure: Change in mindfulness
timeFrame: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
measure: Change in perceived social support
timeFrame: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
Other outcomes:
measure: Study feasibility
timeFrame: Collected within a one-year period from the beginning of recruitment.
measure: Study feasibility
timeFrame: Collected at the post-intervention assessment (A2), six-weeks after the initial assessment.
measure: Study acceptability
timeFrame: Collected at the post-intervention assessment (A2), six-weeks after the initial assessment.
measure: Study acceptability
timeFrame: Collected at the post-intervention assessment (A2), six-weeks after the initial assessment.
Locations:
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
Study officials:
References: