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E-mental health intervention for patients with exudative retinal diseases who receive intraocular anti-VEGF injections (E-PsEYE) - pilot study

E-mental health intervention for patients with exudative retinal diseases who receive intraocular anti-VEGF injections (E-PsEYE) - pilot study - E-PsEYE pilot

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43082
Enrollment
30
Registered
2016-10-19
Start date
2016-10-30
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

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

Interventions

E-PsEYE is a cognitive behavioural therapy (CBT)-based e-mental health intervention (offered via the Internet), consisting of nine modules designed to reduce depression and anxiety and increase adap
2) dealing with depression and anxiety
3) dealing with fatigue and stress
4) participating in pleasurable activities
5) replacing self-defeating thoughts with healthier thoughts
6) identifying and replacing negative thought patterns
7) identifying and replacing negative communication styles
and 8) setting goals for the future. The duration of the intervention depend on the needs of patients, but takes a maximum of 3 months.
anxiety
depression
e-mental health
vision impairment

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria 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.

Exclusion criteria

Exclusion criteria: Exclusion criteria 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
Depression symptomatology is measured with the PHQ-9 questionnaire (containing 9 questions on a 4-point Likert scale, with total scores ranging from 0 to 27, with higher scores indicating higher symptoms of depression). Anxiety symptomatology is measured with the HADS-A questionnaire (containing 7 questions on a 4-point Likert scale, with total scores ranging from 0 to 21, with higher scores indicating more anxiety symptoms). Both questionnaires are widely used and validated in a visually impaired sample.

Secondary

MeasureTime frame
Adaptation to vision loss is measured with the Adaptation to Vision Loss (AVL) scale (with nine questions on a 4-point Likert scale, with total scores ranging from 0 to 27, with higher scores indicating better acceptance). Compliance is operationalized by patients rating their effort and social workers rating patients* compliance to the intervention, based on a 10-point scale (0=no effort/compliance to 10=full effort/compliance). Patient satisfaction is measured with the Dutch Mental Healthcare (MH) thermometer of satisfaction: a widely used 20-item questionnaire providing information on patients* satisfaction on provided information, relationship with the social worker, and results of the treatment.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)