Treating Psychosocial Distress in Glaucoma

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Distress, Emotional; Glaucoma, Primary Open Angle
• Intervention / Treatment: Behavioral: Acceptance commitment therapy

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in psychological flexibility	Measured using the Acceptance and Action Questionnaire 7-Item Scale. The scale ranges from 0-49 with higher values indicating lower psychological flexibility.	Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
Change in disease acceptance	Measured using the Acceptance of Illness 8-Item Scale. The scale ranges from 8-40 with higher scores indicating better acceptance of illness.	Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
Change in self-efficacy	Measured using Self-efficacy for managing chronic disease 6-Item Scale. The scale ranges from 6-60 with higher values indicating higher self-efficacy.	Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
Change in mindfulness	Measured using Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) 10-Item. The scale ranges from 10-40 with higher values indicating higher mindfulness.	Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
Change in perceived social support	Measured using 8-item Medical Outcomes Study Social Support Survey. The scale ranges from 8-40 with higher values indicating higher perceived social support.	Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study feasibility	Reaching target accrual (N=25) within a 12-month study recruitment period.	Collected within a one-year period from the beginning of recruitment.
Study feasibility	<20% study attrition, defined as the percentage of participants who completed the post-intervention A2 assessment (primary end-point).	Collected at the post-intervention assessment (A2), six-weeks after the initial assessment.
Study acceptability	≥80% of participants reporting intervention satisfaction (i.e., Client Satisfaction Questionnaire mean≥3.00/4.00). The score ranges from 8 to 32, with larger numbers indicating greater satisfaction.	Collected at the post-intervention assessment (A2), six-weeks after the initial assessment.
Study acceptability	≥75% of participants reporting use of skills or ideas from the intervention.	Collected at the post-intervention assessment (A2), six-weeks after the initial assessment.

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Eye Institute (NEI)

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Actual): January 26, 2026
• Study Completion (Actual): January 26, 2026

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Eye Diseases; Ocular Hypertension; Glaucoma; Behavior; Anxiety Disorders; Depression; Glaucoma, Open-Angle; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Acceptance and Commitment Therapy
• Other Study ID Numbers: Pro00108155; R00EY033027 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Except for personal identifying data such as name, address and contact information, all raw survey and qualitative data, the data dictionary, and any statistical programs used to analyze the survey data will be preserved and shared. The rationale is to provide scientific collaborators with access to all data collected during the study while preserving participant privacy. The data will be shared through the NEI Data Commons.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No