Depression Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 45 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Duke University | National Eye Institute (NEI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | |
Other | Study feasibility | <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. | |
Other | 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 during the study exit interview at the one-month post treatment assessment (A3). | |
Other | Study acceptability | =75% of participants reporting use of skills or ideas from the intervention. | Collected during the study exit interview at the one-month post treatment assessment (A3). | |
Primary | 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). | |
Primary | 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). | |
Primary | 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). | |
Primary | 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 | 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). | |
Secondary | 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). | |
Secondary | 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). |
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