Skip to content

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

Economic evaluation of an e-mental health intervention for patients with retinal exudative diseases (E-PsEYE) who receive intra-ocular anti-VEGF injections: RCT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON19919
Enrollment
174
Registered
2017-04-13
Start date
2017-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E-mental health Depression Anxiety Eye diseases Economic evaluation

Interventions

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
(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,

Sponsors

VU University Medical Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, patients must meet all of the following criteria: (1) they should be 50 years or older; (2) they should be diagnosed with a retinal disease (i.e. macular degeneration, diabetes retinopathy and/or macula oedema); (3) they should be treated with anti-VEGF injections for their retinal disease; (4) they should have at least mild symptoms of depression and/or anxiety (score of 5 or higher on the Patient Health Questionnaire-9, and/or score of 3 or higher on the Hospital Anxiety and Depression Scale – Anxiety); (5) they should be able to speak the Dutch language adequately; (6) they should have access to the Internet.

Exclusion criteria

Exclusion criteria: Patients are excluded from participation in this study when: (1) they are cognitively impaired, which is assessed by telephone with a score < 3 on the six-item Mini Mental State Examination; (2) have a score of 20 or higher on the Patient Health Questionnaire-9, indicating severe symptoms of depression; (3) indicate to be suicidal; (4) are heavy drinkers (score of 8 or higher on the Alcohol Use Disorders Identification Test).

Design outcomes

Primary

MeasureTime frame
Main outcome measures are: (1) depression (Patient Health Questionnaire-9); (2) anxiety (Hospital Anxiety and Depression Scale – Anxiety) (3) quality-adjusted life-years (determined with the Health Utility Index-3 and the Euroqol 5-Dimensions).

Secondary

MeasureTime frame
Secondary clinical outcomes are: (1) adaptation to vision loss (Adaptation to Vision Loss scale); (2) illness-cognitions (Illness Cognition Questionnaire); (3) vision-related quality of life (Low Vision Quality of Life questionnaire); (4) mastery (Pearlin Mastery Scale); (5) cognitive therapy skills (Competencies of Cognitive Therapy Scale-Self Report). Cost-evaluation outcomes are: (1) health care utilisation (iMTA Medical Consumption Questionnaire); (2) absence and presenteeism from work (iMTA Productivity Cost Questionnaire). Process evaluation outcomes are: (1) compliance; (2) recall; (3) patient satisfaction (Dutch Mental Healthcare thermometer); (4) therapist satisfaction. During the trial, a qualitative problem analysis study on barriers and facilitators for implementation will be conducted to identify and target barriers for nationwide implementation.

Contacts

Public ContactH.P.A. Aa, van der

De Boelelaan 1117

h.vanderaa@vumc.nl+31 (0)20 4445064

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)