The goal of this study is to develop and investigate the effectiveness and cost-effectiveness of a stepped-care programme for visually impaired older adults to diminish subthreshold depression and/or anxiety symptoms and to prevent a full depressive…
ID
Source
Brief title
Condition
- Other condition
- Vision disorders
- Mood disorders and disturbances NEC
Synonym
Health condition
angststoornissen en symptomen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the cumulative incidence of DSM-IV major depressive
or anxiety disorder after 24 months as measured using the Mini International
Neuropsychiatric Interview.
Secondary outcome
Secundary dependent variables are:
- Subthreshold depression and/or anxiety symptoms.
- Vision and health-related quality of life and adaptation to vision loss.
- Process-evaluation outcomes.
- Cost measurement and valuation.
Secundary independent variables are:
- Socio-demographic and disease variables (age, gender, education, cognitive
functioning, co-morbidity, care and low vision aids received in the past half
year of the rehabilitation centres etc.).
Background summary
In our previous study we found that one out of three visually impaired older
adults experience significant depression and/or anxiety symptoms. The
percentage is in concordance with international studies (22-42%) and is at
least two times the amount found in general populations (10-15%). Health care
utilisation is elevated in populations with subclinical levels of depression
and anxiety and quality of life is seriously affected. Depressive and anxiety
symptoms may influence factors that are necessary for a successful
rehabilitation, such as the ability to learn new tasks, processing information
and being oriented towards achieving certain goals. Furthermore, these symptoms
are the most important predictors of developing a depressive or anxiety
disorder according to DSM-IV criteria. It is therefore crucial to treat these
symptoms.
Study objective
The goal of this study is to develop and investigate the effectiveness and
cost-effectiveness of a stepped-care programme for visually impaired older
adults to diminish subthreshold depression and/or anxiety symptoms and to
prevent a full depressive or anxiety disorder form occurring.
Study design
Using a multi-center international randomized controlled trial a stepped-care
programme will be developed and tested.
Intervention
The participants will be randomly assigned to a treatment (stepped-care
program) or a control group (usual care). The stepped-care programme consists
of four steps which each last 3 months. Participants will sequentially receive
a watchfull waiting approach, a cognitive behaviour therapy*based
bibliotherapy, brief cognitive behaviour therapy * based problem-solving
treatment (PST) and referral to professional treatment elsewhere, if required.
The intervention is developed and implemented in two Dutch and one Belgian
rehabilitation centre for the visually impaired.
Study burden and risks
Participation to this study is minimally exceeding negligible risk. We expect
that the burden of the stepped-care programme will be acceptable. In the
stepped-care programme the focus is on helping clients with subthreshold
depression and anxiety, which may prevent the development of psychiatric
disorders in many cases. However, it is possible that because of the treatment
so-called 'adverse effects' can occur, causing the symptoms to worsen. In that
case the general practitioner is immediately contacted. Participation is always
voluntary and participants may drop-out at any time. The control group receives
usual care by the rehabilitation centres and they are allowed to utilize any
additional care they need.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Informed consent of the participants
- Participants must be visually impaired and entered one of the three low vision rehabilitation centres.
- Participants must be 50 years or older.
- Participants must be able to speak Dutch.
- Participants must have subthreshold depression and/or anxiety, measured with a CES-D and HADS-A score.
Exclusion criteria
- Participants with severely impaired cognitive functioning will be excluded. This will be detected with the 'six-item screener' (a short version of the MMSE) at baseline.
- Participants with a DSM-IV psychiatric disorder will be excluded. This will be measured by the Mini (Mini International Neuropsychiatric Interview).
- Psychotic or suicidal participants.
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 | NL39789.029.12 |