Skip to main content
OpenTrials
Completed

NCT Number: NCT06053307

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glaucoma, Primary Open Angle Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Distress, Emotional Eye Diseases Glaucoma Glaucoma, Open-Angle Mental Disorders Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Eye Center

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.