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ID
Source
Brief title
Health condition
e-mental health; vision impairment; depression; anxiety
Sponsors and support
Intervention
Outcome measures
Primary outcome
Depression symptomatology is measured with the PHQ-9 questionnaire. Anxiety symptomatology is measured with the HADS-A questionnaire. Both questionnaires are widely used and validated in a visually impaired sample.
Secondary outcome
Adaptation to vision loss is measured with the Adaptation to Vision Loss (AVL)-9 scale. 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.
Background summary
Retinal exudative diseases are the leading cause of vision loss in older adults. They cause pathologically changed, and newly formed blood vessels to leak and damage the retina, reducing vision. There is no cure for these diseases, but pharmacological inhibition of the vascular endothelial growth factor (VEGF) in the eye can have a beneficial effect. Anti-VEGF drugs are injected into the eye at various intervals. In approximately one third of cases these injections lead to substantial improvement in vision. However, about one third will perceive further vision loss despite treatment, and the effects vary strongly between patients.
The uncertainty of progressive vision loss and the effectiveness of anti-VEGF injections can have a great impact on the psychological well-being of patients. Research shows that approximately one in three patients experience mild symptoms of depression and/or anxiety. These symptoms are the most important predictors of developing a DSM-V depressive or anxiety disorder and can lead to increased vision-specific disability, decreased health-related quality of life, and increased mortality.
To support patients in dealing with these symptoms, a cognitive behavioural therapy (CBT)-based e-mental health intervention was developed. This intervention is expected to be cost-effective, since it is accessible (i.e., patients can use it at home), patient empowerment is stimulated, and relatively little effort from professionals is needed.
The aim of this pilot study is to examine the feasibility of E-PsEYE in a pilot study as a prelude to performing a randomized controlled trial (RCT).
Study objective
It is feasible to investigate the (cost)effectiveness of E-PsEYE in reducing depression and anxiety symptomatology in a randomized controlled trial (RCT).
Study design
All outcomes are measured at baseline and after 3 months by means of written questionnaires (before and after study).
Intervention
A cognitive behavioural therapy-based e-mental health intervention (offered via the Internet) will be investigated, consisting of nine modules designed to reduce depression and anxiety and increase adaptation to vision loss.
H.P.A. Aa, van der
Amsterdam 1081 HZ
The Netherlands
+31 (0)20 4445064
h.vanderaa@vumc.nl
H.P.A. Aa, van der
Amsterdam 1081 HZ
The Netherlands
+31 (0)20 4445064
h.vanderaa@vumc.nl
Inclusion criteria
In order to be eligible to participate in the pilot study: (1) 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)), (2) patients should be able to speak the Dutch language adequately, (3) patients should have access to the Internet, and (4) patients should be provide written informed consent to participate.
Exclusion criteria
Patients are excluded from participation when: (1) they are cognitively impaired, which is assessed with a score <3 on the six-item Mini Mental State Examination (MMSE), (2) patients have a score of 20 or higher on PHQ-9, indicating severe symptoms of depression. These patients will be referred to their general practitioner to discuss other (more intensive) treatment options.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL5894 |
| NTR-old | NTR6082 |
| Other | : 2002829 VUmc/EMGO+ |