The primary aim of the study is to test the effectiveness of a collaborative care model for major depressive disorder for patients with DM, CVD, COPD, and HIV in the general hospital outpatient setting. Secondary aim is to estimate the cost-…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is remission of depressive symptoms (i.e. reduction of
DSM-IV criteria below threshold for a depressive disorder diagnosis) as
measured by the Dutch version of the depression subscale of the *Patient Health
Questionnaire* (PHQ-9). The PHQ-9 is a brief but valid instrument that scores
each DSM-IV criterion of a major depressive disorder.
Secondary outcome
As secondary outcome measure, the cost-utility of collaborative care compared
to CAU is assessed in this study. Therefore, an estimation of the direct
medical costs and the costs due to production losses (productivity costs) is
made. To estimate the costs, the *Trimbos/iMTA questionnaire for Costs
associated with Psychiatric Illness* (TiC-P) is used. Quality of life is
assessed by the the *EuroQol* (EQ-5D) and the *Medical Outcomes Study Short
Form Health Survey - 36* (SF-36).
Additional outcome measures and effect modifiers:
-Physical illness is measured by the CBS-list, a questionnaire by the Central
Bureau for Statistics (CBS) in the Netherlands. The CBS-list contains 28
chronic conditions ranging from diabetes type II to multiple sclerosis.
-Disability caused by disorder is evaluated with the *World Health
Organization-Disability Assessment Survey-II* (WHO-DAS-II). The WHO-DAS-II is
developed to assess the limitations in activity and participation restrictions
actually experienced by an individual irrespective of diagnosis and contains
six major domains: understanding and communicating, getting around, self-care,
getting along with people, life activities, and participation in society.
-Depressive symptoms is measured by the Inventory for Depressive
Symptomatology-Self Report (IDS-SR).
-Patient and provider adherence is assessed by a qualitative questionnaire.
-Adverse effects of medication are measured with the 'Discontinuation Emergent
Signs and Symptoms' checklist (DESS).
-Preferences of the patient (PST and/or antidepressant medication) are assessed
by the choices of patients within the intervention group.
-Attitude of the medical specialists and nurses towards the treatment of
depressive disorder is measured with the 'Depression Attitude Questionnaire'
(DAQ).
-Somatisation is assessed as the number and intensity of functional somatic
complaints a patient experiences by using the *Lichamelijke Klachten
Vragenlijst* (LKV; Bodily Complaints Questionnaire).
-Hypochondria is measured by the *Whitley Index*.
-Health anxiety and illness behaviour is measured with the Illness Attitude
Scale (IAS).
-Comorbid somatoform disorder is measured by the SOMS-7.
-The working relationship between the patient and the care manager is measured
by the *Helping Alliance Questionnaire* (HAQ-II) as the care manager will
provide PST.
-Treatment in the CAU group is assessed in patients, general practitioners, and
other treating physicians with the *Scale assessing medical utilization of
health services*. Given that this trial is considered an effectiveness trial,
the content of usual care is not known yet. It is expected however, that a lot
of variation will be seen concerning treatment of the usual care group.
-Life-events are assessed by the *Social Readjustment Rating Scale* to indicate
the amount of change in daily life, which form the *Life Change Unit* (LCU).
These can be used to quantify the stress of life-events irrespective of the
desirability of those events.
-Pain is measured by the *McGill Pain Questionnaire - Dutch Language
Version* (MPQ-DLV).
-Fatigue is assessed by the Dutch version of the *Multidimensional Fatigue
Inventory* (*Multidimensionele Vermoeidheids Index*).
-Personality traits are measured by two scales of the *NEO Five-Factor
Inventory* (NEO-FFI), the abbreviated version of the NEO personality inventory
which measures the big five personality traits: extraversion, openness,
agreeableness, conscientiousness, and neuroticism. In this study, only
neuroticism and extraversion scales are used.
- The 'Preceived need for care' will be used to assess the perceived need for
care of diabetes patients in the OLVG.
-
Background summary
Depressive disorder is one of the two most common disorders and is even more
prevalent in chronic medically ill patients. The presence of comorbid
depression has a negative influence on quality of life, costs, morbidity, and
mortality of chronic medically ill patients. However, early diagnosis with
subsequent well-organized treatments of depression showed to have a positive
influence on these aspects. Evidence-based treatments of depressive disorder
are already available, but are used insufficiently and with less result than
possible. In the general hospital setting, recognition and treatment remains
unsatisfactory. Prior research in the US has shown good results regarding the
treatment of depressive disorder using a collaborative care approach and an
antidepressant algorithm. In the UK *Problem Solving Treatment* has proved to
be feasible to use. However, in the general hospital setting, this approach has
not yet been evaluated. These treatment strategies may also be effective in the
Netherlands even though the health care systems differ.
Study objective
The primary aim of the study is to test the effectiveness of a collaborative
care model for major depressive disorder for patients with DM, CVD, COPD, and
HIV in the general hospital outpatient setting. Secondary aim is to estimate
the cost-effectiveness of each treatment involved.
Study design
The study consists of a two-armed randomized clinical trial, with randomization
between patients. The aim of the trial is an evaluation of the treatment of
depressive disorder in the general hospital setting in the Netherlands by means
of a collaborative care model including contracting, PST, an antidepressant
algorithm, een zelfhulp werkboek voor depressie bij chronisch zieke patienten,
and compliance and adherence improving strategies. 126 outpatients will be
randomised between the intervention group and control group. Patients are
included who are diagnosed with moderate to severe depression based on DSM-IV
criteria and measured by the M.I.N.I. The intervention group receives treatment
based on the collaborative care approach; the control group receives *Care As
Usual* (CAU). Baseline measures and follow up measures (after 3, 6, 9, and 12
months) are done by means of questionnaires.
Primary outcome measure is the severity of depressive symptoms as measured with
the PHQ-9. Secondary outcome measure is the cost-utility as measured with the
TiQ-P, the EQ-5D and the SF-36. Further outcome measures are remission of
depressive symptoms, pain, patient and provider adherence, (possible)
preferences of the patient, fatigue, somatisation, hypochondrias, effects of
life events, patient satisfaction, and the working relationship between the
care manager and the patient.
Intervention
A treatment of depression fit in the collaborative care model with problem
solving treatment, an antidepressant algorithm, contracting, care management,
and a manual guided self-help depression for chronically ill patients.
Study burden and risks
The expected risk are very little. No physiological parameters will be
assessed. The control group receives care as usual. The intervention group
receives only evidence-based treatment techniques. We expect that these are a
supplement to care as usual. Furthermore, good results are found using the
collaborative care model abroad.
AJ Ernststraat 887
1081 HL Amsterdam
NL
AJ Ernststraat 887
1081 HL Amsterdam
NL
Listed location countries
Age
Inclusion criteria
All patients of the OLVG visiting the participating outpatient clinics (diabetes, cardiology, HIV, and part of lung medicine [patients with chronic obstructive pulmonary disease (COPD)]) and who already have a diagnosis specified in their file. Patients are included in the study if a cut off score of 15 (moderate to severe depressive disorder) is reached on the PHQ-9. The symptoms have to be present for at least six weeks or have to cause marked dysfunctioning (e.g. problems at work, housekeeping).
Exclusion criteria
-Suicidal (in case of a high risk for suicide, patients will be referred.);(Concerning the following criteria a suggestion is given to the patients concerning a different kind of help:)
-Psychotic
-Suffering from dementia or delirium
-Insufficient knowledge of the Dutch language to fill in questionnaires
-Serious mental impairment
-Alcohol or drug addiction
-Already receiving psychiatric treatment
-Pregnancy
-Bipolar disorder;Concerning HIV patients:
-Organic psychosyndrome
-Personality change
-In terminal phase
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 |
|---|---|
| ISRCTN | ISRCTN95575369 |
| CCMO | NL13965.067.06 |