Treating Psychosocial Distress in Glaucoma

Not Applicable

Recruiting

• Conditions: Depression; Glaucoma, Primary Open Angle; Distress, Emotional; Anxiety
• Interventions: Behavioral: Acceptance commitment therapy

• Registration Number: NCT06053307
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-22
• Study First Posted: 2023-09-25
• Study Start: 2025-04-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acceptance commitment therapy via a mobile-application	Acceptance commitment therapy	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.

Primary Outcome Measures

Name	Time	Method
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 Subjective Unit of Distress (SUDS) scale. 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) 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.
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 Subjective Unit of Distress (SUDS) scale. 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) 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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Duke University Eye Center; 🇺🇸 Durham, North Carolina, United States