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

Completed

Conditions: angstsymptomen
diabetic retinopathy
macular degeneration
retinal diseases
10027946
down (depression)
10047060
fear
fright (anxiety)
low spirits

Registration Number: NL-OMON43082

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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