Visual Impairment and depression Mental and Behavioural Disorders Depressive episode, unspecified
Conditions
Interventions
This trial includes three interventions:
1. Waiting list control
The control arm of this trial will be a follow up low vision assessment 6 weeks after the initial visit
Sponsors
Cardiff University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (aged at least 18 years) 2. Score of at least 6 on the GDS-15 (administered as part of the routine pre assessment questionnaire)
Exclusion criteria
Exclusion criteria: 1. Those who have already had a low vision assessment within the previous 12 months 2. Those who are referred to the clinic in error (i.e. so visually impaired that low vision care and follow up are inappropriate or, so visually able (e.g. following refraction) that there are no low vision needs) 3. Those already being treated for depression including psychotherapeutic and psychopharmacological treatments 4. Inability to understand English 5. Inability to use the telephone e.g. caused by very poor hearing 6. Severe medical illness that would preclude participation in a 6 month study 7. A score of 2 or 3 on the BDI-II question about suicidal ideation. All people in this group will be urgently referred to their GP (See Appendix N for referral protocol) 8. Those screening positive for significant cognitive / memory problems will be excluded (see Appendix I for cognitive screening instrument / scoring key)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trial outcomes will be assessed by telephone at the baseline interview, immediately before randomisation, and then again at 3 and 6 months after randomisation. 1. At 3 months, participants in all arms of the study will be interviewed using five outcome measures: 1.1. The Beck Depression Inventory (BDI-II) 1.2. The 7 item Visual Function Questionnaire (7 item NEI-VFQ) 1.3. Near vision subscale of the VFQ-48 1.4. The EQ-5D 1.5. ICECAP capability measures 2. At 6 months the same outcome measures will be used again along with: 2.1. GDS-15 2.2. Client Services Receipt Inventory (CSRI) In order to minimise 'loss to follow up', interviews will be based on a standard script and will remind participants of their valuable contribution and the need to complete the study. 3. In the exploratory randomised trial the primary outcome measure will be the change in depressive symptoms at 3 and 6 months (before randomisation - 3 & 6 months after randomisation) as measured by the BDI-II. These time intervals were chosen to: 3.1. Examine the short and longer term effects of the interventions 3.2. Coincide with those used in previous studies (Rovner, Casten et al, 2007) 3.3. Minimise the chance that a subsequent depressive episode might impact on outcomes | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in visual disability between baseline telephone interview and, 3 and 6 months as measured with the 7 item NEI VFQ (Ryan et al, 2008). We have recently used the 7 item NEI VFQ to evaluate functional ability outcomes in hospital and community based low vision services and it has shown itself to be a sensitive outcome measure (Court et al, 2010). Change in visual disability will also be evaluated using the near vision subscale of the VFQ-48 as used by Stelmack et al, (2008) in the LOVIT trial. 2. Change in 'generic health related quality-of-life' at 3 and 6 months as measured by the EQ-5D which assesses 5 health related dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression. NICE recommend the use of the EQ-5D, which can be used to calculate 'utility', as a standardised outcome measure. 3. The proportion of people still screening positive for depression as measured with the GDS-15 at 6 months. At the end of the trial (6 months): 1. Participants will be asked about any treatments for depression they have received during the trial period (specifically, whether they received regular review and support by their GP, referral to a community mental health team, supportive psychotherapy, counselling, problem-solving therapy, cognitive-behavioural therapy or antidepressant therapy). They will also be asked about the acceptability of this intervention. 2. Participants in the PST arm will be asked about the acceptability of this intervention. 3. Participants in the waiting list control group who still screen positive for depression (GDS-15, 6+) will be referred to their GP. And, 3 months later asked about any treatment for depression received as a result of the referral (as per 1 above). | — |
Countries
United Kingdom
Outcome results
None listed