This study aims to test the efficiency and cost-effectiveness of a brief collaborative care intervention (primary objective). Assessment of patient wellbeing and (social) functioning are the secondary objectives.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Trial 1: proportion of participants who successfully discontinue their
long-term antidepressants drug use, defined as having no antidepressant drug
use within the last 6 months of the follow-up and the absence of a mood- or
anxiety disorder during one-year follow-up. Trial 2: proportion of participants
in which the mood or anxiety disorders present at baseline, has remitted at
one-year follow-up.
Secondary outcome
Assessment of dimensional measures of psychopathology and in addition direct
and indirect costs.
- the Symptom Checklist 90-item version (SCL-90) for measuring psychological
distress and global psychopathology
- the Centre for Epidemiological Studies Depression Scale (CES-D) for
measuring depressive symptoms
- the Penn State Worry Questionnaire (PSWQ) for assessing the frequency and
severity of symptoms of worrying
- the Panic and Agoraphobic Scale (PAS) for measuring the severity of illness
in patients with panic disorder
- the Fear of Negative Evaluation Scale (FNES) for assessing expectations and
distress associated with negative evaluations by others
- the EuroQol-5D (EQ-5D) will be included as a utility instrument enabling the
economic analyses. The EQ-5D has previously been validated and has been applied
successfully in studies of mood- and anxiety disorder;
- Costs will be measured by the Trimbos/iMTA questionnaire for Costs associated
with Psychiatric Illness (TiC-P)
- and the DESS scale will be used to assess the prevalence of the AD
discontinuation syndrome.
- Demographic variables (including ethnic origin) and the use of psycho-active
substances (nicotine, alcohol, drugs) will be recorded at the baseline
interview.
- Personality characteristics and the patient-physician relationship will be
examined by administration of the NEO-Five Factor Inventory (NEO-FFI) and the
Patient-centeredness questionnaire, respectively.
- The number of comorbid chronic somatic disorders will be assessed at baseline
using the EMD of the GP.
Background summary
Inappropriate prescription of antidepressants is worrisome for reasons of
patient safety and costs in case of overtreatment (continuation in the absence
of a clinical indication) and, in case of undertreatment (continuation in the
absence of therapeutic efficacy), because of disorder-related burden, i.e. lack
of wellbeing and associated costs. Both scenarios are highly prevalent
according to a recent Dutch report, and applicable to approximately half of all
long term AD users (50-60 long-term users of antidepressants per average Dutch
general practice).
Study objective
This study aims to test the efficiency and cost-effectiveness of a brief
collaborative care intervention (primary objective). Assessment of patient
wellbeing and (social) functioning are the secondary objectives.
Study design
Two randomised, controlled parallel-group trials will be conducted in tandem.
The choice for two trials is inherent to the aim of the study, i.e. reduction
of inappropriate antidepressant usage, which could be based on the absence of a
clinical indication (trial 1) and on the absence of therapeutic efficacy (trial
2), respectively. Cluster randomization will be used at the level of general
practices (intervention arm in trial 1 and 2 vs usual care in trial 1 and 2).
Intervention
Based on a structured psychiatric interview the GPs will receive a tailor made
treatment proposal based on the Dutch multidisciplinary guideline on mood- and
anxiety disorders. Patients receiving antidepressants outside a valid clinical
indication will be randomised to receive a discontinuation intervention or
treatment as usual (trial 1, equivalence trial). Patients receiving
antidepressants but still suffer from a psychiatric disorder will be randomised
to receive a patient-tailored treatment proposal based on current
multidisciplinary guidelines for the treatment of depressive or anxiety
disorders or treatment as usual (trial 2, superiority trial). This advice is a
patient-tailored treatment given to the GP in case of a psychiatric disorder
despite long-term antidepressant usage.
Study burden and risks
The control conditions for both trials consist of usual care and do not impose
restrictions on GPs to deliver care or to refer to specialised mental health
care, including the continuation or discontinuation of psychotropic drugs.
Therefore the control patients do not pose any risks. The intervention is
according to Dutch guidelines, thus no risk is to be expected.
Laan van Nieuw Oost Indië 334
2509 AE Den Haag
NL
Laan van Nieuw Oost Indië 334
2509 AE Den Haag
NL
Listed location countries
Age
Inclusion criteria
9 or more months of using antidepressants
Exclusion criteria
a) current treatment in a psychiatric setting;
b) history of psychosis, bipolar disorder, or obsessive compulsive disorder;
c) addiction;
d) recurrent depression with 3 or more episodes;
e) recurrent disorders with at least two relapses after antidepressant-discontinuation.
Design
Recruitment
Medical products/devices used
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 | NL29718.091.09 |