The primary aim of the study is to evaluate the cost-effectiveness of a collaborative care model for major depressive disorder in the occupational health setting.
ID
Source
Brief title
Condition
- Psychiatric disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure in this study is time to return to work, as is measured
by inquiry with the patient and which refers to the duration of sickness
absence until return to work. Tertiairy outcome measure is the
cost-effectiveness of collaborative care compared to CAU. 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 EQ-5D and the SF-36.
Secondary outcome
Secondary outcome measure is reduction of symptoms as measured by 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.
Additional outcome measures are as follows:
Somatoform presentation will be assessed by: (a) the Physical Complaints List
(LKV), which measures the number and intensity of functional somatic complaints
that a patient is experiencing 75, (b) the Whitely Index, measuring somatic
amplification 76; 77, (c) the SOMS-7, measuring co-morbid somatoform disorders
78, and (d) the Illness Attitude Scale (IAS), which measures health anxiety and
illness behaviour. 77
In addition to the PHQ-9, symptoms will also be assessed with: (e) the
Inventory for Depressive Symptomatology Self Report (IDS-SR), measuring the
severity of the symptoms of MDD as well as remission 79, and (f) the
Four-Dimensional Symptom Questionnaire (4DSQ), which measures distress,
depression, anxiety and somatisation, and has been developed to distinguish
non-specific general distress from depression, anxiety and somatisation. 80
Concomitant symptoms of co-morbid chronic illness will be measured with: (g)
the World Health Organization Disability Assessment Survey II (WHO-DAS II) 81,
measuring the extent to which the patient is handicapped by MDD, and (h) the
CBS list, a questionnaire developed by the Dutch Central Department of
Statistics, measuring co-morbid chronic medical illness. Pain will be measured
according to: (i) a Visual Analogue Scale and (j) the SF-36 Pain scale.
Patient preference will also be measured on the basis of the choices made by
patients in the intervention group. Patient adherence will be assessed by means
of a qualitative questionnaire in the intervention group and compared to the
CAU group. 48 The treatment received in the CAU group, assessed in patients,
will be measured according to the Scale Assessing Contacts between patients and
practitioners. 48
The working relationship between patient and occupational physician will be
assessed by means of the Patient-Doctor Relationship Questionnaire (PDRQ-9) 65
and the attitude of the occupational physician towards the treatment of MDD in
general will be assessed by means of the Depression Attitude Questionnaire
(DAQ). 66; 67 Work characteristics will be measured by the Job Content
Questionnaire. ref Information concerning previous history of absenteeism will
be acquired from the files of the occupational health service.
Background summary
Nowadays, depressive disorder is a common mental health problem, which burdens
individual patients as well as society. It affects many facets of patients
life, among which work. Not only is major depressive disorder (MDD) associated
with absenteeism from work, absence caused by mental disorders is of longer
duration on average than absence caused by physical illness. Although
evidence-based treatments for MDD are available, these are applied
insufficiently. Also, in most treatments occupational functioning is not a
focus. Lack of coordination of care and ineffective disability management for
sick listed patients may lead to long-term absenteeism and permanent disability
with unnecessarily high costs. In the occupational health setting, there is a
need for more efficient screening and management of MDD, with a focus on
occupational functioning. The multidisciplinary collaborative care approach
coordinated by a case manager has proven to be an effective model in the
treatment of MDD, as appears from prior research in primary care in the USA.
Hallmark of collaborative care are activated patients who take responsibility
for their treatment, which could make collaborative care an effective way to
deal with MDD in the occupational health setting
Study objective
The primary aim of the study is to evaluate the cost-effectiveness of a
collaborative care model for major depressive disorder in the occupational
health setting.
Study design
CC: DOC (Collaborative Care: Depression initiative in Occupational Care) is a
randomised controlled trial in which the treatment of MDD in the occupational
health setting will be evaluated in the Netherlands. The cost-effectiveness of
a collaborative care model, containing adherence enhancing techniques,
contracting, Problem Solving Treatment (PST), a workplace intervention,
antidepressant medication, and manual guided self-help will be compared with
care as usual (CAU). Patients on sick leave between 6 and 52 weeks who are
diagnosed with MDD are included in the study. Patients allocated to the
intervention group will receive multidisciplinary treatment based on the
collaborative care framework and patients allocated to the control group will
receive CAU. Care in the intervention group will be provided within a
multidisciplinary team of the psychiatrist and a trained OP-care manager. The
treatment is strictly and clearly separated from the sickness certification and
sickness guidance, and both will be performed by different OPs. Data will be
collected by means of questionnaires at baseline and at 3, 6, 9 and 12 months
after baseline. Primary outcome measure is time to return to work, secondary
outcome measure is reduction of symptoms. A cost effectiveness and cost-utility
analysis is conducted alongside the RCT.
Intervention
A treatment of major depressive disorder according to the collaborative care
model, containing a. problem solving treatment, b. an antidepressant protocol,
c. contracting, d. casemanagement, e. a self-help and lifestyle manual, f. a
workplace intervention
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.
Sparrenheuvel 16 / Postbus 304
3700 AH Zeist
NL
Sparrenheuvel 16 / Postbus 304
3700 AH Zeist
NL
Listed location countries
Age
Inclusion criteria
A score of 15 or higher on the PHQ9, a short questionnaire that screens for Major Depressive Episode. The patient has to resume work for 6 to 52 weeks and has no prospect yet for work resumption.
Exclusion criteria
Patients who are suicidal, psychotic or demented, according to the company OP, will be excluded from the study (they are however referred to a doctor in case of high suicidal risk or a suggestion is given for another form of help), and also patients who are addicted to drugs or alcohol, as assessed by the MINI interview, and patients who do not have sufficient command of the Dutch language to fill in the questionnaires. Also patients who are in conflict with their employer will be excluded from the study as well as patients who are already receiving disablement insurance benefit due to MDD and patients who are pregnant. Patients with a lawsuit against their employer e.g. due to a conflict at work, will be excluded. Patients who are already receiving psychiatric treatment can be included in the study, if there is mutual agreement with their care-giver.
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 | ISRCTN78462860 |
| CCMO | NL13830.029.06 |