Treating Psychosocial Distress in Glaucoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Acceptance commitment therapy via a mobile-application 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
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.
|
Outcome Measures
Primary Outcome Measures
- 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 0-21 with higher values indicating higher distress.
- 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 distress thermometer (DT). The scale ranges from 0-10 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) 25. 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 16-item McGill Quality of Life Questionnaire. The scale ranges from 0-160 with higher values indicating higher QoL.
Secondary Outcome Measures
- 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.
Other Outcome Measures
- Study feasibility [Collected within a one-year period from the beginning of recruitment.]
Reaching target accrual (N=25) within a 12-month study recruitment period.
- Study feasibility [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).
- Study acceptability [Collected during the study exit interview at the one-month post treatment assessment (A3).]
≥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.
- Study acceptability [Collected during the study exit interview at the one-month post treatment assessment (A3).]
≥75% of participants reporting use of skills or ideas from the intervention.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Duke University
- National Eye Institute (NEI)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00108155
- 1K99EY033027-01