Acceptance Commitment Therapy for Glaucoma

Overseen By Samuel Berchuck, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: Pressure lowering eye drops

Disqualifiers: Borderline glaucoma, Glaucoma surgery, Major medical conditions, Psychiatric conditions, Cognitive impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage stress and anxiety in people with glaucoma using Acceptance and Commitment Therapy (ACT). ACT, a type of behavioral therapy, helps individuals accept their thoughts and feelings while committing to personal values. Delivered through a mobile app, the therapy aims to improve the mental well-being of those with glaucoma. This trial may suit individuals with glaucoma who experience stress or anxiety and use eye drop medication. Participants will refine the treatment by sharing their experiences, potentially leading to a larger study in the future. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance mental health support for glaucoma patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on a behavioral intervention, so you may not need to change your medication routine, but it's best to confirm with the trial coordinators.

What prior data suggests that this behavioral intervention is safe for glaucoma patients?

Studies have shown that Acceptance and Commitment Therapy (ACT) can help improve mental health. Researchers have tested it in many situations, and it is generally well-tolerated. Research indicates that ACT assists in managing emotions and enhancing self-care without causing major side effects.

The therapy encourages awareness and acceptance of thoughts and feelings, rather than resisting them. This method is both effective and safe for most people. While researchers are adapting ACT for use with glaucoma patients through a mobile app, it has a strong record of safety and effectiveness. So far, similar settings have reported no significant negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for glaucoma, which typically focus on reducing intraocular pressure with eye drops, oral medications, or surgery, acceptance commitment therapy (ACT) addresses the psychosocial distress that patients experience. Researchers are excited about this treatment because it uses a mobile application, VISION-ACT, to deliver behavioral therapy, making it accessible and convenient for patients to use in their daily lives. This innovative approach targets the mental and emotional well-being of glaucoma patients, potentially improving their overall quality of life alongside their physical health.

What evidence suggests that Acceptance Commitment Therapy might be an effective treatment for psychosocial distress in glaucoma?

Research has shown that Acceptance and Commitment Therapy (ACT) can reduce psychological distress. One study found that ACT outperformed other treatments, showing a noticeable positive impact. Although specific data for glaucoma is not yet available, ACT's success in managing stress and mental health suggests potential benefits. In this trial, ACT will be delivered through a mobile app designed for glaucoma patients, called VISION-ACT, to enhance accessibility. Early signs are promising, indicating it could improve the mental well-being of people with glaucoma. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with primary open-angle glaucoma who speak English and are scheduled for a clinic visit at Duke Eye Center. They must have had previous appointments there and be able to consent. It's not specified who can't join.

Inclusion Criteria

I have been diagnosed with primary open-angle glaucoma.

I can understand, speak, and read English.

I have an upcoming appointment at the Duke Eye Center for glaucoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development of a baseline intervention using Acceptance and Commitment Therapy (ACT) delivered via a mobile application

4-8 weeks

Intervention Refinement

Refinement of the baseline intervention using qualitative interviews with glaucoma patients and health professionals

4-8 weeks

Pilot Study

Measurement of acceptability and feasibility of the refined intervention through a single-armed pilot study

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acceptance commitment therapy

Trial Overview The study tests a mobile app delivering Acceptance Commitment Therapy (ACT) to manage distress in glaucoma patients. It involves developing the app, refining it through interviews with patients and health pros, then testing its acceptability in a pilot study.

How Is the Trial Designed?

Group I: VISION-ACT: Acceptance commitment therapy via a mobile-application Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06053307

NCT06053307 | Treating Psychosocial Distress in Glaucoma The arm will pilot a behavioral intervention to treat psychosocial distress in patients with glaucoma using acceptance commitment therapy (ACT) delivered via a ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00314158?intr=AZOPT&aggFilters=studyType:int&viewType=Table&rank=3

A Study of a Glaucoma Therapy to Treat Open-Angle ... The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.

3. dovepress.com dovepress.com/article/download/95396

A Cross-Sectional Study The aim of the study was to examine the impact of sociodemographic and psychological factors on adherence to glaucoma therapy. Materials and ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25547522/

A meta-analysis of the efficacy of acceptance and ... Results: ACT outperformed control conditions (Hedges' g = 0.57) at posttreatment and follow-up assessments in completer and intent-to-treat analyses for primary ...

5. glaucomatoday.com glaucomatoday.com/articles/2023-july-aug/patient-experience-data-collection

Patient Experience Data Collection Patient experience data can be utilized to inform clinical development, contextualize the impact of a treatment, support regulatory submissions, and more.

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05089474

Study Details | NCT05089474 | A First in Human ... A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE SURGICAL SYSTEM in Patients With Open-Angle Glaucoma. ClinicalTrials.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12346411/

Effectiveness of Acceptance and Commitment Therapy ... Results: The reviewed studies suggest that ACT may promote psychological flexibility, emotion regulation, and self-care behaviors in patients ...

8. aao.org aao.org/eyenet/article/landmark-glaucoma-studies-key-findings-treatment-l

Landmark Glaucoma Studies: Key Findings and Treatment ... The 10-year incidence of glaucoma was roughly linear, with treatment reducing it by about 50 percent in all three levels of risk, said Dr. Kass.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT07206628

NCT07206628 | Real-world Study to Assess Adherence ... Real-world Study to Assess Adherence to IOP Lowering Therapy in Glaucoma Patients Using CONNECTDROP®: the GRANITE Study (Glaucoma tReatment ...

10. contextualscience.org contextualscience.org/act_randomized_controlled_trials_1986_to_present

ACT Randomized Controlled Trials (1986 to present) This list is to add all randomized controlled trials of Acceptance and Commitment Therapy and its components that have appeared in the scientific literature.