Treating Psychosocial Distress in Glaucoma

Study Overview
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Brief Summary
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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.

Official Title
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Treating Psychosocial Distress in Glaucoma

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

Intervention / Treatment
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* Behavioral: Acceptance commitment therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be diagnosed with primary open-angle glaucoma, be scheduled for a glaucoma clinic encounter to the Duke Eye Center main or satellite site in the succeeding two months, have a previous encounter to a Duke glaucoma clinic and at least one-year of follow-up, be at least 18 years of age, be able to understand, speak, and read English, and be able to provide informed consent. Exclusion Criteria: a glaucoma surgery (e.g., trabeculectomy) within the past 6-months, reported or suspected cognitive impairment indicated by provider or chart review, presence of untreated serious mental illness (e.g., schizophrenia) indicated by provider or chart review, and legal blindness as indicated by provider or chart review.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acceptance commitment therapy via a mobile-application<br>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. The intervention will be developed and refined using qualitative feedback from glaucoma patients and healthcare stakeholders. | Behavioral: Acceptance commitment therapy<br>* 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.<br>|

What is the study measuring?
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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 0-21 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 distress thermometer (DT). 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) 25. 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 16-item McGill Quality of Life Questionnaire. The scale ranges from 0-160 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). |