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van CCT (UK)

van CCT (UK)

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

- candidate number25259
- NTR NumberNTR6082
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-sep-2016
- Secondary IDs2002829 VUmc/EMGO+ 
- Public TitleE-mental health treatment for patients with eye diseases (E-PsEYE): pilot study
- Scientific TitleE-mental health intervention for patients with retinal exudative diseases (E-PsEYE) who receive intra-ocular anti-VEGF injections: pilot study
- hypothesisIt is feasible to investigate the (cost)effectiveness of E-PsEYE in reducing depression and anxiety symptomatology in a randomized controlled trial (RCT).
- Healt Condition(s) or Problem(s) studiedE-health, Depression, Anxiety, Eye diseases
- Inclusion criteriaIn 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 criteriaPatients 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-nov-2016
- planned closingdate1-mrt-2016
- Target number of participants20
- InterventionsA 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.
- Primary outcomeDepression 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 outcomeAdaptation 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.
- TimepointsAll outcomes are measured at baseline and after 3 months by means of written questionnaires (before and after study).
- Trial web site
- statusplanned
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Soma-Psyche VU University Medical Centre, Royal Dutch Visio (low vision rehabilitation centre)
- Publications
- Brief summaryRetinal 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).
- Main changes (audit trail)
- RECORD6-sep-2016 - 25-nov-2016

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