1. Depressive disorder
Conditions
Interventions
Experimental intervention will be integrated care including psychoeducation with DVD developed specifically on depression and pain
a self-help manual with psycho education and exercises (i.e. relaxation techniques)
a pain medication protocol
an antidepressant protocol, consisting of an algorithm for Duloxetine
Graded Activity, provided by a physiotherapist
a Consultation Letter to the PCP. The control group will be treated with Duloxetine according to the antidepressant protocol with Duloxetine algorithm. The third group will receive a placebo plus inte
Sponsors
Trimbos Instituut / NIMHA, Utrecht, the Netherlands.
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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; 2. Psychotic symptoms or use of antipsychotic medication that may influence perception of pain; 3. Use of St. Johns worth (Hypericum Perforatum); 4. Pregnancy and breastfeeding; 5. Inability to participate in case of too severe language barrier, dementia; 6. Somatization disorder without depressive symptoms; 7. All contra-indications for Duloxetine; 8. Lastly, suicidal ideation is an exclusion criterion if this constitutes immediate danger and the need for crisis management according to the consulted psychiatrist. For this purpose, a suicide protocol is used in the study, defining degrees of suicide risk and prescribing necessary steps to be taken to advert such risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. To establish cost effectiveness in terms of QALY as measured by EuroQol-5 and SF-36 and costs measured by TIC-P; 2. To establish improvement on pain in terms of Brief Pain Inventory (BPI) of three compared interventions: 1. TCCCL + Duloxetine; 2. Versus TCCCL + placebo; 3. Versus Duloxetine alone. | — |
Contacts
Public ContactC.M. Feltz-Cornelis, van der
Trimbos-institute - Netherlands Institute of Mental Health and Addiction, Department of Diagnosis en Treatment, P.O. Box 725
Outcome results
None listed