E-mental health treatment for patients with eye diseases (E-PsEYE): RCT

Objective: To evaluate whether E-PsEYE is cost-effective in comparison with usual care from a healthcare and societal perspective in reducing depression and anxiety in patients with retinal exudative diseases.

Hypothesis: E-PsEYE in comparison with usual care is cost-effective.

Study design: Single-blinded multicentre randomised controlled trial in two parallel groups.

Study Population: Patients aged 50 years or older with retinal exudative diseases, and (at least) mild symptoms of depression and/or anxiety, who receive intra-ocular anti-VEGF injections at one of five participating hospitals.

Intervention: E-PsEYE is a cognitive behavioural therapy-based e-mental health intervention containing 9 modules aimed at reducing depression and anxiety. A stepped-care service delivery model is used containing three steps: (1) offering the first module, i.e., providing information and psycho-education, (2) only offering the 8 follow-up modules when symptoms of depression/anxiety persist after the first module, and (3) referring patients to their general practitioner when symptoms still persist after step 2. E-PsEYE will be delivered on top of usual care.
Usual care: Usual care includes care provided by the ophthalmology departments of the five participating hospitals and other healthcare providers.

Outcome measures: Main outcome measures are: depression (measured with the Patient Health Questionnaire-9), anxiety (measured with the Hospital Anxiety and Depression Scale – Anxiety) and quality-adjusted life-years, which is determined with the Health Utility Index-3 and the Eurqol 5-Dimensions.
Sample size: A total of 174 participants will be included in the trial.

Dat analysis: Cost-effectiveness will be based on intention to treat and will be performed from a healthcare and societal perspective. Guidelines by the ISPOR Task Force will be used for the BIA.

Sensitivity analyses will be performed based on different scenarios from the perspective of decision makers.

E-PsEYE in comparison with usual care is cost-effective.

Five measurements take place: at baseline, after 3, 6, 9, and 12 months.

E-PsEYE is a patient-centered, cognitive behavioral therapy (CBT)-based e-mental health intervention, offered via the Internet with digital and telephone guidance of a social worker, for patients with retinal exudative diseases who receive anti-VEGF treatment.

It contains 9 modules aimed at: (1) information and psychoeducation; (2) dealing with retinal diseases and uncertainty surrounding treatment; (3) dealing with depression and anxiety; (4) dealing with fatigue and stress; (5) participating in pleasurable activities; (6) replacing self-defeating thoughts with healthier thoughts; (7) identifying and replacing negative thought patterns; (8) identifying and replacing negative communication styles; and (9) setting goals for the future.

A stepped-care model with three steps will be used to deliver the intervention: (1) offering the first module, i.e. providing information and psycho-education, (2) only offering the follow-up modules when symptoms of depression/anxiety persist after the first module, and (3) referring patients to their general practitioner when symptoms still persist after step two.

If required, an ICT-trainer will provide a computer training before participants start using the intervention.