To evaluate the cost-effectiveness of imagery-based Interpretation Bias Modification (IBM) for patients with major depressive disorder (MDD) in the outpatient mental health care setting compared to usual care.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical evaluation: The main outcome is the change in depressive symptoms as
measured by the Beck depression Inventory.
Economic evaluation: The EQ-5D will be used to assess QALY*s and costs will be
assessed with the TiC-P.
Secondary outcome
Interpretation biases, prospective and every day use of imagery, dysfunctional
cognitions, levels of anxiety, diagnostic status, treatment expectancies and
satisfaction with treatment.
Background summary
In the Netherlands, depressive disorder affects about 800,000 people annually,
and over 160,000 depressed patients seek care at mental health services.
Current treatment options, psycho-, pharmaco-, or combination therapies, are
not always effective or acceptable for all patients. Depression-related disease
burden can also be only partially alleviated by currently available treatment
options, thus new treatment options are urgently needed. Interpretation biases
are implied in the onset and maintenance of major depressive disorder (MDD).
Experimental research shows that interpretation biases can be re-trained using
simple computer tasks through Interpretation Bias Modification (IBM). In IBM,
the aim is to modify the interpretation biases of depressed patients from
negative to positive and consequently improve their depressive symptoms levels
and achieve remission. Depressed people tend to show a deficit in generating
positive prospective imagery, which hampers positive interpretations and limits
chances to alter negative interpretation biases. Importantly, our IBM training
incorporates mental imagery: imagining oneself in the presented (positive)
scenarios in the IBM tasks. Initial promising findings justify further research
to strengthen the evidence-base and to draw robust conclusions regarding the
clinical value of IBM in the treatment of MDD. Moreover, there is currently no
information available regarding the cost-effectiveness of imagery-based IBM for
depression.
Study objective
To evaluate the cost-effectiveness of imagery-based Interpretation Bias
Modification (IBM) for patients with major depressive disorder (MDD) in the
outpatient mental health care setting compared to usual care.
Study design
A health economic evaluation alongside a single blind randomised controlled
trial, with assessments at 0, 1, 6 and 12 months.
Intervention
IBM entails 10 20-minute computer training sessions over the course of 4 weeks:
7 daily sessions during in week 1, followed by weekly sessions during the
following 3 weeks. The first session will be completed at their mental health
care location. All other sessions will be completed at home. To permit blinding
of patients and therapists the comparison group will be offered a sham-IBM
training closely matching the intervention condition.
Patients will be offered IBM before starting indicated care, of in addition to
indicated care.
Study burden and risks
IBM is a non-invasive, safe procedure that is very unlikely to produce any side
effects. It requires a minimum of time and effort from patients. Patients have
to visit their mental health care location only three times in total, as 9 of
the training sessions and all follow-up measures can be completed via the
computer at home and need no site visit. The MINI, when this interview has not
been done during the intake, will be conducted by phone. Benefits resulting
from the treatment cannot be guaranteed to patients. However, all participants
can start with their treatment (usual care) during the intervention, or receive
the intervention in addition to their treatment.
Da Costakade 45
Utrecht 3521 VS
NL
Da Costakade 45
Utrecht 3521 VS
NL
Listed location countries
Age
Inclusion criteria
- A diagnosis of major depressive disorder, first or recurrent, as assessed with the MINI (which makes use of DSM-IV-TR criteria).
- 18-65 years old.
- Waitlisted for treatment for depressive disorder or having received no more than 4 indicated psychotherapy sessions.
- Provides informed consent
Exclusion criteria
-Any psychotic disorder (current or previous)
-Current mania or hypomania or a history of bipolar disorder
-Cognitive disabilities (IQ < 80)
-Visual disabilities that interfere with a computer task
-Acute suicidal risk
-No sufficient command of Dutch language to participate in the study
-Lack of sufficient experience with the use of computers (based on subjective estimation of the patient)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL55683.091.15 |
OMON | NL-OMON27494 |