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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45657
Enrollment
202
Registered
2017-02-17
Start date
2017-08-08
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

angstsymptomen diabetic retinopathy down (depression) fear fright (anxiety) low spirits macular degeneration retinal diseases

Interventions

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

Sponsors

Oogheelkunde
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for patients are: (A) patients should have at least mild symptoms of depression and/or anxiety (score of 5 or higher on the Patient Health Questionnaire (PHQ)-9, and/or score of 3 or higher on the Hospital Anxiety and Depression Scale * Anxiety (HADS-A)); (B) patients should be able to speak the Dutch language adequately; and (C) patients should have access to the Internet.;For the problem analysis of the implementation study, social workers who are currently working at low vision rehabilitation organisations (n*8), managers/directors from these organisations (n*2), ophthalmologists (n*4), nurses and desk assistants (n*4), managers/department heads from the Ophthalmology department of Dutch academic and general hospitals (n*3) and health insurers (n*3) will be included. The aim is to involve a diverse group of these professionals (with different backgrounds and demographic characteristics) in order to obtain the best possible picture of barriers and facilitators for the implementation of E-PsEYE.

Exclusion criteria

Exclusion criteria: Exclusion criteria for patients are: (A) patients are cognitively impaired, which is assessed by telephone with the six-item Mini Mental State Examination (score

Design outcomes

Primary

MeasureTime frame
Main outcome measures are: depression (measured with the Patient Health Questionnaire-9), and anxiety (measured with the Hospital Anxiety and Depression Scale * Anxiety). Quality-adjusted life-years are determined with the Health Utility Index-3 and the EuroQol-5 Dimensions..

Secondary

MeasureTime frame
Secondary clinical outcomes: adaptation to vision loss (measured with the Adaptation to Vision Loss scale), illness-cognitions related to helplessness, acceptation and disease benefits (measured with the Illness Cognition Questionnaire), vision-related quality of life (measured with the Low Vision Quality of Life questionnaire), mastery (measured with the Pearlin Mastery Scale) and cognitive therapy skills (measured with the Competencies of Cognitive Therapy Scale-Self Report). Cost-evaluation outcomes: the iMTA Medical Consumption Questionnaire is used to measure health care utilisation and the iMTA Productivity Cost Questionnaire to measure and value absence and presenteeism from paid and unpaid work. Process evaluation outcomes: compliance (measured with one question on a 10-point scale), patients are asked to keep a diary on how often and for how long they used the intervention, recall of the previous module (measured with one question on a 10-point scale) and patient satisfaction (measured with the Dutch Mental Healthcare thermometer of satisfaction). A topic list for the semi-structured interviews will be used based on the framework of Fleuren et al. 2004.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)