|- candidate number||6621|
|- NTR Number||NTR2057|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-okt-2009|
|- Secondary IDs||06/285 MEC|
|- Public Title||Effect of occupational therapy on absenteeism, work resumption and work productivity in patients with work-related depression.|
|- Scientific Title||Depression and Occupation Intervention Trial: Evaluation of the effects of psychiatric outpatient treatment and adjuvant occupational therapy on absenteeism, work resumption and work productivity in patients with work related depression.
|- Healt Condition(s) or Problem(s) studied||Depressive Disorder , Workers|
|- Inclusion criteria||1. Age: 18-65 years; |
2. Diagnosis: Major Depressive Disorder (DSM IV);
3. Absenteeism or partial absenteeism (minimum of 25% absenteeism);
4. Duration absenteeism > 8 weeks OR duration DSM-IV diagnosis depression > 3 months;
5. Reintegration: possibility to return to own or new job;
6. Relation between depressive disorder and work:
A. Work is one of the determinants of
depressive disorder and contributes
substantially (>25%), or;
B. Depressive symptoms reduces
productivity or hinders the return to work.
7. Occupational therapy is an acceptable intervention for the patient.
|- Exclusion criteria||1. Bipolar disorder;|
2. Psychotic disorder or depression with psychotic characteristics;
3. Severe alcohol or drug misuse/alcohol or drug dependence;
4. Severe physical problems that make participation to the study impossible;
5. Severe suicidality;
6. Inpatient treatment at the clinic is indicated for patient;
7. Current or recent (during their current depressive episode) therapy by a psychotherapist, psychologist or occupational therapist which content resembles the content of our occupational therapy;
8. Current treatment at a family practitioner or psychiatrist which does not resemble our treatment as usual or which cannot be taken over by the psychiatrist of our research study (good communication is a must);
9. Current participation in research study that disables participation in the DO IT study.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2007|
|- planned closingdate||1-jan-2012|
|- Target number of participants||120|
|- Interventions||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 (author: V. Rohak/A. Schene). Visits will include pharmacological treatment and clinical management, including psychoeducation, supportive therapy and cognitive behavioural interventions. Therapies will be supervised by an experienced psychiatrist. Pharmacotherapy will be done according to an antidepressant algorithm. If patients are deteriorating and outpatient therapy is not adequate any longer, patient can start day treatment or inpatient treatment. If the physician wants to treat in a different way than the TAU-protocol prescribes, he/she needs to contact the research group.
Psychiatric outpatient treatment + occupational therapy (TAU+OT): Patients will get the same protocollized outpatient treatment as the TAU patients with pharmacological treatment in combination with occupational treatment by an occupational therapist of the AMC. The adjuvant occupational therapy will include a four week analysis phase, 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. In this way, patients can learn to have more control over their functioning in the work situation, which can increase their work satisfaction, for example because there is more contact with colleagues, or it can imply that they manage stressful situations better.
In addition, the patient will be adviced to return to a work situation, which can be the old or a new work situation.
|- Primary outcome||1. Work absenteeism/work resumption;|
2. Work productivity and work functioning.
|- Secondary outcome||1. Depressive symptoms;|
2. Neuropsychological functioning;
3. Work related coping;
4. Health-related quality of life;
5. Total costs.
|- Timepoints||Baseline, 3 months, 6 months, 12 months, and 18 months after start of intervention.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||M.Sc. H.L. Hees|
|- CONTACT for SCIENTIFIC QUERIES||M.Sc. H.L. Hees|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|UWV Amsterdam, Fonds Psychische Gezondheid, Utrecht|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||19-okt-2009 - 26-okt-2009|