|- candidate number||8682|
|- NTR Number||NTR2626|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-nov-2010|
|- Secondary IDs||NL3363.008.10 CCMO|
|- Public Title||Disease management of depression and anxiety in primary care patients with diabetes, asthma and/or COPD.|
|- Scientific Title||Disease management of depression and anxiety (DiMaCoDeA) in primary care patients with diabetes mellitus, asthma and/or COPD.|
|- hypothesis||A disease management approach to depression and anxiety in primary care patients with diabetes mellitus, asthma and/or COPD will result in reduced symptoms of depression and/or anxiety, better quality of life, less disease specific distress, better self-management and lower health care costs compared to care as usual.|
|- Healt Condition(s) or Problem(s) studied||Depression, Chronic Obstructive Pulmonary Disease (COPD), Anxiety, Asthma, Diabetes Mellitus|
|- Inclusion criteria||1. Having diabetes, asthma and/or COPD in primary care;|
2. Depressive symptoms or anxiety symptoms;
3. 18 years or older.
|- Exclusion criteria||1. Current treatment for depression and/or anxiety;|
2. Major psychiatric problems (e.g. schizophrenia, suicidality, bipolar disorder);
3. Not being able to read or speak Dutch sufficiently;
4. Being younger than 18 years old.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2011|
|- planned closingdate||1-dec-2013|
|- Target number of participants||320|
|- Interventions||The current study is a randomized control trial, with an intervention of one year and an additional one year follow up. Randomization will be at patient level. All eligible primary care patients with diabetes, asthma and/or COPD will be invited for participation. They will receive a set of questionnaires assessing depression (PHQ-9) and anxiety (GAD-7). Those who score above a cutoff point on the depression (PHQ-9 > 10) or anxiety scale (GAD-7 > 8) and signed informed consent, will be included in the study.|
The study has two conditions:
1) Intervention for depression and anxiety (disease management);
2) Care as usual.
Intervention group: Disease management for depression and anxiety.
The patients in the disease management arm will receive stepped care program for depression and anxiety. After each step, patients' symptoms will be evaluated. In case of worsening of symptoms or in case of non-response, the patient will step up to the next treatment. If a significant worsening of symptoms occurs during treatment, the patient can step up to the next treatment even if the current treatment has not been finished yet. In case of treatment response, the patient will enter the monitoring phase.
The stepped care intervention consists of three steps:
Step 1: Four sessions of psycho education. Improved (PHQ-9 <10 & GAD-7 <8) --> monitoring. Not improved --> step 2;
Step 2: Coping with depression / anxiety course. The course takes approximately 10 weeks to complete and is given individually. Improved (PHQ-9 <10 & GAD-7 <8) --> monitoring. Not improved --> step 3;
Step 3: Extension of the course with an option for additional drug treatment.
Monitoring phase: Each three months the patients are monitored using the PHQ-9 and GAD-7. If worsening of symptoms occur, the patient will receive treatment again.
Control group: Care as usual.
The control group receives care as usual and will be monitored.
The intervention (stepped care and monitoring) will last for 1 year.
|- Primary outcome||1. Depressive symptoms (PHQ-9);|
2. Anxiety symptoms (GAD-7).
|- Secondary outcome||1. Quality of life (SF-12, ADDQoL, CCQ);|
2. Disease specific distress (PAID);
3. Health care costs (TiC-P, EuroQoL);
4. Self-management and life style behaviours (SDSCA, SQUASH, medication adherence);
5. Satisfaction (PEQD).
|- Timepoints||0, 3, 6, 9, 12, 18, 24 months.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc. C.H. Stoop|
|- CONTACT for SCIENTIFIC QUERIES||Dr. F. Pouwer|
|- Sponsor/Initiator ||University of Tilburg |
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||The aim of the DiMaCoDeA study is to test the effectiveness of a disease management approach for anxiety and depression in primary care patients with diabetes mellitus, asthma or COPD. The intervention is a disease management approach for depression and anxiety. In the intervention group, patients with symptoms of depression or anxiety will be offered a stepwise treatment of depression and anxiety and monitoring of the symptoms. This approach will be compared to care as usual.|
|- Main changes (audit trail)|
|- RECORD||18-nov-2010 - 11-dec-2010|