Anxiety, Depression, Distress, Emotional, Glaucoma, Primary Open Angle
Conditions
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.
Interventions
BEHAVIORALAcceptance 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.
Sponsors
Duke University
National Eye Institute (NEI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in psychosocial distress | 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. |
| Change in vision-related quality-of-life (QoL) | 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. |
| Change in health-related QoL | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in psychological flexibility | 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. |
| Change in disease acceptance | 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. |
| Change in self-efficacy | 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. |
| Change in mindfulness | 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. |
| Change in perceived social support | 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. |
Countries
United States
Outcome results
None listed