Treating Psychosocial Distress in Glaucoma

NCT06053307 | Completed

• 2 other identifiers: Pro00108155R00EY033027
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma, Primary Open Angle; Distress, Emotional; Anxiety; Depression

Outcome Measures

Primary Outcomes (4)

• Change in psychosocial distress

  Measured using the Hospital Anxiety and Depression Scale (HADS). The scale ranges from 0-42 with higher values indicating higher distress.

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

• Change in psychosocial distress

  Measured using the Subjective Unit of Distress (SUDS) scale. The scale ranges from 0-10 with higher values indicating higher distress.

  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)

  Measured using the National Eye Institute (NEI)- Visual Functioning Questionnaire (VFQ) 9. The scale ranges from 0-100 with higher values indicating higher vision-related QoL.

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

• Change in health-related QoL

  Measured using the CDC Health-Related Quality-of-Life 4-Item Scale. For our outcome we will use the self-rated scale from Poor to Excellent, which has a scale from 1-5, with higher values indicating higher QoL.

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

Secondary Outcomes (5)

• Change in psychological flexibility

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

• Change in disease acceptance

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

• Change in self-efficacy

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

• Change in mindfulness

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

• Change in perceived social support

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

Other Outcomes (4)

• Study feasibility

  Collected within a one-year period from the beginning of recruitment.

• Study feasibility

  Collected at the post-intervention assessment (A2), six-weeks after the initial assessment.

• Study acceptability

  Collected at the post-intervention assessment (A2), six-weeks after the initial assessment.

Study Arms (1)

VISION-ACT: Acceptance commitment therapy via a mobile-application

EXPERIMENTAL

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

Interventions

Acceptance commitment therapy BEHAVIORAL

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.

VISION-ACT: Acceptance commitment therapy via a mobile-application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),
• years old,
• able to understand, speak, and read English, and
• be able to provide informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Duke University Eye Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Anxiety Disorders; Depression

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: April 1, 2025
• Primary Completion: January 26, 2026
• Study Completion: January 26, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE

Locations

US (1)