Primary objectives:*To evaluate the effects on labour supply (work loss days, work cut back days with lower productivity) and work productivity/functioning of psychiatric outpatient treatment (treatment as usual; TAU) vs. psychiatric outpatient…
ID
Source
Brief title
Condition
- Psychiatric disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary parameters:
- work absenteism (work loss days, work cut back days)
- work productivity
- work functioning
Secondary outcome
Secondary parameters:
- psychopathology: depressive symptoms
- health related quality of life
- costs
- neurocognitive functies (concentration, memory deficits)
Background summary
Depression or Major Depressive Disorder is a mental disorder with a year
prevalence of 3-5 percent and a life time prevalence of 20-30 percent for women
and 15 to 20 percent for men. Depression reduces the likelihood that affected
individuals will be able to participate in the labour market, either by lower
workplace performance (work cut back days) or by time absent from work (work
loss days). Although the effects of depression on labour market participation
have been described in many ways, there are only a few studies that examined
labour supply effects of interventions for major depressive disorder. During
the past few years we executed a small randomized controlled trial. We studied
a homogeneous sample of 62 patients with major depression who had been off from
work because of depression. These patients were randomized to care as usual or
care as usual plus an occupational therapy done by occupational therapist. This
study showed that the addition of occupational therapy to care as usual reduced
work loss days significantly. The cost effectiveness analysis indicated that
occupational therapy was cost effective. The study described in this protocol
will be an improved version of the pilot project. We will improve the number of
cases to increase power of the effectiveness of the occupational therapy
program.
Study objective
Primary objectives:
*To evaluate the effects on labour supply (work loss days, work cut back days
with lower productivity) and work productivity/functioning of psychiatric
outpatient treatment (treatment as usual; TAU) vs. psychiatric outpatient
treatment +occupational therapy (TAU+OT) for patients with work related
depression.
*To evaluate the differential effectiveness of two types of occupational
interventions (TAU+OTshort and TAU+OTlong) on work related outcome measures.
Study design
The study is a randomized controlled trial with random allocation to three
conditions:
- psychiatric outpatient treatment (TAU) (n=40)
- psychiatric outpatient treatment + occupational therapy: 3 month version (TAU
+OTshort) (n=60)
- psychiatric outpatient treatment + occupational therapy: 6 month version (TAU
+OTlong) (n=60)
Intervention
Psychiatric outpatient treatment (TAU): patients will be treated by psychiatric
residents in the outpatient department of the Mood Disorder Program according
to a treatment as usual protocol.
The 6 month version (24 weeks) of OT will include 12 individual sessions, 24
group sessions and 3 follow-up sessions. The intervention focuses on coping
with work related problems, mastery of work related situations, improved work
functioning and the development of a work reintegration plan. The patient is
directed to start working during the intervention.
The 3 month version of OT (12 weeks) will include 6 individual sessions, 8
group sessions and a work place visit. The intervention focuses on coping with
work related problems, mastery of work related situations, improved work
functioning and the development of a work reintegration plan. The patient may
start to work during the intervention.
Study burden and risks
The burden will consist of:
- telephone screening by physician
- 2 intake sessions by physician
- 4 neuropsychological sessions and filling out of questionnaires at researcher
- about 9 sessions for TAU
- short occupational intervention: 6 individual sessions and 8 groupsessions +
workvisit
-long occupational intervention: 12 individual sessions, 24 group sessions, 3
follow-up sessions
There are no specific risks for the patient.
Tafelbergweg 25
1105 BC
Nederland
Tafelbergweg 25
1105 BC
Nederland
Listed location countries
Age
Inclusion criteria
- age: 18-65 years
- diagnosis: depressive and/or dysthymic disorder (DSM IV) ;- labour effect: absenteeism or partial absenteeism (minimum of 25% absenteeism)
- duration absenteeism more than 8 weeks OR duration DSMIV diagnosis depression more than 3 months
- reintegration: possibility to return to own or new job
- relation between depressive disorder and work:
o work is one of the determinants of depressive disorder and contributes substantially (>25%) or
o depressive symptoms reduces productivity or hinders the return to work
- occupational therapy is an acceptable intervention for the patient
Exclusion criteria
- bipolar disorder
- psychotic disorder or depression with psychotic characteristics
- severe alcohol or drug misuse/alcohol or drug dependence
- severe physical problems that make participation to the study impossible
- inpatient treatment at the clinic is indicated for patient
- current participation in depression or occupational therapy cannot be discontinued
- current participation in research study that enables participation in the DO IT study
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 | NL15357.018.06 |