The project aims to establish whether CBASP can be a good addition to the current range of treatments for chronic depressive patients in second-line mental healthcare services. This group of patients is amply represented within institutions for…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
OUTCOME:
All measures of outcomes are widely used internationally, are reliable and
valid, also for usage in the Netherlands. Measurements take place at 0 weeks
(pre-test) and after 12 weeks (post-test). In addition a half-year follow-up
will take place after 26 weeks. The inclusion period will extend over a period
of a year. The primary measure of outcomes is the IDS-C, with which the
reduction in the seriousness of the depression can be measured. Patients with a
complaint reduction of 50%, measured on the IDS-C, can be seen as responder.
Secondary outcome
Secondary measures of outcomes are the EUROquol, which measures the degree of
limitation and quality of life (Dolan, 1997); the CSQ-8 which measures patient
satisfaction with the interventions (de Brey, 1983); TIC-P, which tracks both
absenteeism levels and the utilization of care services
(www.imta.nl/publications/0261.pdf;) and health care consumption will be kept
up with a diary.
The measurements will be performed by research nursing staff who are blind to
the treatment condition of the included patients.
Background summary
The proposed research project fits in well with the 'Early evaluation of
medical innovation' sub-programme of the Efficacy Study. For it concerns the
application of a new intervention that has proved its value elsewhere (in the
USA) but is not yet applied anywhere in the Netherlands. It focuses on the
effectiveness of an innovative intervention that is relevant for the treatment
of patients affected by a chronic mood disorder. Chronic depression is a big
health problem, both from a patient perspective and from a social perspective.
Patients with chronic depression are amply represented within mental health
populations and healthcare professionals experience the treatment of these
patients as difficult and often unsatisfactory because the existing treatment
protocols fall short of these patients' needs.
Most intervention research with this specific group of patients relates to
medicinal treatments. These were shown to be effective if optimally carried
out, though the remission percentages remained low (Keller et al., 1998).
However, an optimal approach is rarely achieved in practice. The willingness to
accept and comply with medicinal treatment is often low: an estimated fifty per
cent of the patients fail to follow the recommended therapy (Spijker et al.,
1998). This supports the idea that, both from a care and patient perspective,
there is a need for effective psychotherapeutic treatment for chronic
depression. Though little is known about the (cost-)effectiveness of different
forms of psychotherapy with chronic depression, CBASP has been shown to offer
clear added value in the treatment of this group of patients.
Research into the (cost-)effectiveness of CBASP can make an important
contribution to the improvement of care for chronic depressive patients in the
Netherlands. According to the American research results (Keller et al., 2000),
73% of these patients can be effectively treated if CBASP is combined with
medicinal treatment. CBASP can also be an alternative for patients who are not
motivated for or refractory to medicinal treatment. The application of CBASP is
innovative for the Dutch situation as this form of therapy is not yet applied
here.
One unique feature of CBASP is that this treatment is 'designed' for chronic
depressive patients (McCullough, 2000). The complaints and behavioural pattern
that are characteristic for chronic depressive patients are explained on the
basis of an explanatory model that was specifically designed for these
patients. The central notion is that patients with chronic depression are
extremely self-absorbed and withdraw from social interactions. Partly for this
reason they are not receptive to the usual cognitive-behaviour and
interpersonal therapies, which consequently tend to produce unsatisfactory
results with these patients. Both the patients and the therapists feel
powerless as they are unable to break the cycle of hopelessness. With the
treatment model of CBASP the therapist is taught specific techniques to break
through the pattern of social withdrawal. The therapist's first step is to
build a relationship with the patient. This patient-therapist relationship is
pivotal to the treatment. The intensive bond that is built up with the patient
gives the therapist a basis for adopting an actively confrontational stance. In
this way the therapist offers the patient insight into the characteristics of
chronic depression and the accompanying behaviour, as also occurs in the
therapy sessions, and teaches the patient to change dysfunctional interaction
patterns. In addition, CBASP makes extensive use of normal
cognitive-behavioural therapeutic and interpersonal techniques, but only after
a basis for growth has been created through the intensive patient-therapist
relationship.
The results of this study will make it clear whether CBASP may also lead to
more (cost-)effective care in the Netherlands for chronic depressive patients.
Insofar as we know, no other study into CBASP is currently being conducted in
the Netherlands
Study objective
The project aims to establish whether CBASP can be a good addition to the
current range of treatments for chronic depressive patients in second-line
mental healthcare services. This group of patients is amply represented within
institutions for outpatient mental healthcare and the normal range of
healthcare services often falls short of their needs.
A randomized clinical trial alongside an economic evaluation is planned,
addressing the following research questions:
1. Is CBASP CAU more effective than CAU regarding disability, quality of life
and healthcare utilization?
2. Is CBASP more cost-effective than CAU alone?
Study design
STUDY DESIGN:
The (cost-)effectiveness of CBASP will be studied in a randomized clinical
trial, where CBASP is compared with the normal second-line care for patients
with chronic depression.
Intervention
INTERVENTIONS:
After the screening, all patients will be allocated at random to CBASP or to
normal care. CBASP consists of 16-20 sessions spread over 12 weeks; two
sessions per week in the first 4 weeks followed, in principle, by one session
per week through to week 12. If establishing the therapeutic relationship
proves particularly difficult, the two-weekly sessions can be continued longer.
The work will be performed on the basis of the CBASP protocol. The exercise
book for therapists will be translated into Dutch (McCullough, 2001). All
participating therapists will be trained by McCullough. In the CBASP condition
the existing use of anti-depressants will be continued. Within the control
condition, the existing treatment will be continued.
Study burden and risks
The burden of participation for the patients will be five hours of extra work.
These five hours consist of five measure moments, where the patient has to fill
in questionnaires.
A.J. Ernststraat 887
1081 HL Amsterdam
NL
A.J. Ernststraat 887
1081 HL Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients (aged 18-65) can take part if they meet the DSM-IV criteria for: a) a chronic (i.e. existing for longer than 2 years) depressive disorder or b) depressive disorder superimposed on a previus dysthymic disorder or c) a recurring depressive disorder which, in the past 2 years, never went into full remission between several episodes.
Exclusion criteria
Psychotic disorder, bipolar disorder, organic psychosyndrome, dependence on drugs or alcohol, and serious personality disorder (schizotypical, antisocial, borderline).
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 | NL13765.029.06 |