Treating Psychosocial Distress in Glaucoma

March 17, 2026 updated by: Duke University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Samuel Berchuck, PhD
  • Phone Number: (919) 613-4975
  • Email: sib2@duke.edu

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in psychosocial distress
Time Frame: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
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
Time Frame: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
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)
Time Frame: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
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
Time Frame: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in psychological flexibility
Time Frame: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
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
Time Frame: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
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
Time Frame: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
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
Time Frame: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
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
Time Frame: Measures will be administered at baseline (A1), immediately post-intervention (A2), and 1-month post treatment assessment (A3).
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Study feasibility
Time Frame: Collected within a one-year period from the beginning of recruitment.
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
Time Frame: Collected at the post-intervention assessment (A2), six-weeks after the initial assessment.
<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
Time Frame: Collected at the post-intervention assessment (A2), six-weeks after the initial assessment.
≥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
Time Frame: Collected at the post-intervention assessment (A2), six-weeks after the initial assessment.
≥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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Eye Institute (NEI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 26, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 26, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings