To evaluate whether the e-mental health intervention E-PsEYE is cost-effective in comparison with usual care from a healthcare and societal perspective in reducing depression and anxiety in patients with retinal exudative diseases. In addition, a…
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
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 outcome
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.
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 mild 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 is offered via the Internet. This intervention requires
relatively little effort from professionals, it stimulates patient empowerment
and may result in cost savings.
Study objective
To evaluate whether the e-mental health intervention E-PsEYE is cost-effective
in comparison with usual care from a healthcare and societal perspective in
reducing depression and anxiety in patients with retinal exudative diseases. In
addition, a problem analysis for the implementation of E-PsEYE will be
performed.
Study design
Single-blinded multicentre randomised controlled trial (n=174) in two parallel
groups.
In addition, a qualitative study based on semi structured interviews will be
performed with patients (n*8, of whom half also participates in the RCT) who
received the E-PsEYE intervention and professionals (n*24) to determine
barriers and facilitators of implementation.
Intervention
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 three steps: (1) offering the first
module, i.e., providing information about anti-VEGF treatment and
psycho-education, (2) only offering the 8 follow-up modules when symptoms of
depression/anxiety persist after the first module, and 3) referring patients
to their general practitioner when symptoms still persist after step 2. E-PsEYE
will be delivered on top of usual care.
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 De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117 De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
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 for patients are: (A) patients are cognitively impaired, which is assessed by telephone with the six-item Mini Mental State Examination (score <3); (B) patients have severe depression (score of 20 or higher on the PHQ-9); (C) patients are suicidal; and (D) patients are heavy drinkers (score of 8 or higher on the Alcohol Use Disorders Identification Test questionnaire (AUDIT)).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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In other registers
| Register | ID |
|---|---|
| CCMO | NL59656.029.16 |