To investigate if E-PsEYE leads to a reduction in depression and anxiety symptoms (primary outcomes) and problems with adaptation to vision loss(secondary outcome). Conducting a process evaluation to determine adherence and patient satisfaction. To…
ID
Source
Brief title
Condition
- Other condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
- Mood disorders and disturbances NEC
Synonym
Health condition
angstsymptomen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Retinal diseases are the leading cause of vision loss in older adults. A drug
inhibiting the growth factor VEGF (vascular endothelial growth factor) that is
injected into the eye (intravitreal injection) at various intervals can have a
beneficial effect. In many cases this can prevent a deterioration of sight.
However, the effects vary strongly between patients. The process to progressive
vision loss and uncertainty surrounding the effects of the anti-VEGF injections
can greatly affect the psychosocial wellbeing of patients. Previous research
shows that about one in three patients experience symptoms of depression and/or
anxiety. These symptoms can have a negative influence on quality of life and
may deteriorate the visual and physical condition of people. To guide people in
dealing with these symptoms, a self-help course based on cognitive behavioral
therapy (called E-PsEYE) is offered via the Internet. This intervention
requires relatively little effort from professionals, it stimulates patient
empowerment and may result in cost savings. The purpose of this study is to
pilot-test (n=30) this intervention.
Study objective
To investigate if E-PsEYE leads to a reduction in depression and anxiety
symptoms (primary outcomes) and problems with adaptation to vision
loss(secondary outcome). Conducting a process evaluation to determine adherence
and patient satisfaction. To examine the feasibility of the pilot study as a
prelude to a randomized controlled trial (RCT) in a larger group of patients to
determine the effectiveness of the E-PsEYE intervention. Data from the pilot
study can be used to optimize the intervention (increase feasibility), to get
an impression of the effect, and to be able to perform a proper sample size
calculation.
Study design
Based on a pilot study (n=30), the feasibility of performing an RCT on the
cost-effectiveness of E-PsEYE is determined. All outcomes are measured at
baseline and after 3 months.
Intervention
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 adaptation to vision loss. The
programme consists of a welcome module, in which the patient is informed about
his disease and the effects of the anti-VEGF injections and the content of the
intervention. Also, information on follow-up care is provided, such as care
from low vision rehabilitation organisations. After the welcome module,
depression, anxiety and adaptation to vision loss will be determined with a
"mood thermometer". If patients have symptoms, 8 follow-up modules will be
provided, supported online by a social worker from Royal Dutch Visio ( low
vision rehabilitation organisation). The 8 modules are based on the previously
developed and effective self-help course for visually impaired elderly *Blik op
je Dip* are aimed at: 1) dealing with retinal diseases and uncertainty
surrounding anti-VEGF injections; 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.
Study burden and risks
Participating in this study is with minimally exceeding negligible risk. We
expect that the burden of E-PsEYE will be acceptable. The focus is on helping
patients with symptoms of depression, anxiety, and difficulty in adaptation to
vision loss. However, it is possible that the intervention will cause 'adverse
effects', causing the symptoms to worsen. In that case the general practitioner
is immediately contacted. Moreover, participation is voluntary and participants
may drop-out at any time.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
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 are: (A) patients are cognitively impaired, which is assessed by telephone with the six-item Mini Mental State Examination (score <3); and (B) patients have severe depression (score of 20 or higher on the Patient Health Questionnaire (PHQ)-9).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58660.029.16 |