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| ID | Type | Description | Link |
|---|---|---|---|
| R00EY033027 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VISION-ACT: Acceptance commitment therapy via a mobile-application | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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). |
| 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). |
| 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). |
Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Eye Center | Durham | North Carolina | 27705 | United States |
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.
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| 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). |
| 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. |
| D001526 |
| Behavioral Symptoms |
| D001519 | Behavior |