Transmural Collaborative Care: Integrated antidepressant and psychotherapeutic treatment of concomitant pain and depressive disorder.
- Conditions
- 1. Depressive disorder<br />2. pain<br /> 3. collaborative care<br />4. primary care<br />5. cost effectiveness<br />6. RCT.
- Registration Number
- NL-OMON26763
- Lead Sponsor
- Trimbos Instituut / NIMHA, Utrecht, the Netherlands.
- Brief Summary
Facts on depression. DVD. Trimbos Instituut 2006.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 219
The patients are referred to a mental health centre and at this point they have the possibility to participate in this study. At the mental health centre, the patients will be screened with the PHQ for depressive disorder and with the BPI measuring for pain. In case of a cut-off score of >10 on the PHQ-9 and a numerical score of more than 3 on the 'average pain' item and after informed consent, the patient will be included in the study.
Patients with pain for which by diagnostic medical assessment a structural and continuing physical cause has been found in terms of tissue damage, illness or otherwise, that requires treatment, such as pain due to cancer or recent post traumatic pain, are excluded from the study and advised to seek such treatment Other exclusion criteria are:
1. Alcohol use >3 units a day or drug abuse or dependence in the last 6 months, defined as current use of any hard drugs or cannabis;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish effectiveness on severity of depression (measured by PHQ-9), of a closely monitored integrated intervention (TCCCL + duloxetine) for concomitant (sub)chronic pain and depression compared to TCCCL + placebo and compared to Duloxetine alone.
- Secondary Outcome Measures
Name Time Method 1. To establish cost effectiveness in terms of QALY as measured by EuroQol-5 and SF-36 and costs measured by TIC-P;<br /><br>2. To establish improvement on pain in terms of Brief Pain Inventory (BPI) of three compared interventions:<br /><br>1. TCCCL + Duloxetine;<br /><br>2. Versus TCCCL + placebo;<br /><br>3. Versus Duloxetine alone.