Treating Psychosocial Distress in Glaucoma

Depression Clinical Trial

Official title:

Treating Psychosocial Distress in Glaucoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06053307
• Other study ID #: Pro00108155
• Secondary ID: 1K99EY033027-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2023
• Source: Duke University
• Contact: Samuel Berchuck, PhD
• Phone: (919) 613-4975
• Email: sib2[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Distress, Emotional
• Glaucoma
• Glaucoma, Open-Angle
• Glaucoma, Primary Open Angle

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Eye Institute (NEI)

Outcome

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).