Transmural Collaborative Care: Integrated antidepressant and psychotherapeutic treatment of concomitant pain and depressive disorder.|
|- candidate number||2808|
|- NTR Number||NTR1089|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-okt-2007|
|- Secondary IDs||WC 2007-069 |
|- Public Title||Transmural Collaborative Care: Integrated antidepressant and psychotherapeutic treatment of concomitant pain and depressive disorder.|
|- Scientific Title||Effectiveness and Cost-effectiveness of Transmural Collaborative care with Consultation Letter (TCCCL) and Duloxetine for major depressive disorder (MDD) and (sub)chronic pain in collaboration with primary care: A randomized placebo-controlled Multi-Centre trial. TCC:PAINDIP.|
|- hypothesis||Combined treatment (collaborative care + duloxetine) is more effective than mono-treatment (duloxetine or collaborative care + placebo) in depressive symptom reduction on the PHQ as main outcome for patients with MDD and (sub)chronic pain.|
|- Healt Condition(s) or Problem(s) studied||Depressive disorders, Chronic pain|
|- 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||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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2007|
|- planned closingdate||1-feb-2013|
|- Target number of participants||219|
|- 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; Problem Solving Treatment; 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 integrated care as mentioned above. |
|- Primary outcome||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||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.
|- Timepoints||Assessments: T0 at baseline; T1 at 3 months, T2 at 6 months, T3 at 9 months and T4 at 12 months.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. C.M. Feltz-Cornelis, van der|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. C.M. Feltz-Cornelis, van der|
|- Sponsor/Initiator ||Trimbos-institute - Netherlands Institute of Mental Health and Addiction, NIMHA,|
(Source(s) of Monetary or Material Support)
|Eli Lilly Nederland B.V., GGZ Breburg, Arkin, GGZ Ingeest, VU University Medical Center|
|- Publications||Facts on depression. DVD. Trimbos Instituut 2006.|
|- Brief summary||The burden of pain and depression is high for patients in terms of disability, wellbeing, and use of medical care. Patients with major and minor depression often present themselves with pain to a general practitioner and recognition of depression is low. Also, physical symptoms, including pain, in major depressive disorder, predict a poorer response to treatment. A multi-faceted, patient-tailored treatment programme, such as collaborative care, is needed. However, treatment of chronic pain conditions in depressive patients has, so far, not received much attention. Also, cost effectiveness of an integrated approach of pain in depressed patients has not been studied yet.
This article describes the aims and design of a study that is currently underway. The aim of this study is to evaluate effects and costs of collaborative care with Duloxetine for patients with pain symptoms and a depressive disorder, compared to mono-treatment (collaborative care with placebo, Duloxetine alone).
This study is a placebo controlled double blind, three armed randomized Multi Centre trial with a factorial design. Patients with (sub) chronic pain and a depressive disorder will be included. They will be randomized to either collaborative care with Duloxetine, collaborative care with placebo, or Duloxetine alone. In the collaborative care conditions, the care-manager will provide Problem Solving Treatment and guidance with a self-help manual. The care-manager is also responsible for monitoring of depressive and pain symptoms. Also, patients are referred to a physiotherapist. Here, they will receive treatment according to a 'Graded Activity' protocol. The psychiatrist is responsible for the medication. According to an antidepressant algorithm, the psychiatrist prescribes an antidepressant (Duloxetine or placebo). For the pain medication, a pain medication algorithm will be followed. The psychiatrist will also monitor progress of pain and depressive symptoms. After 12 weeks, the patient will be referred back to the general practitioner with a Consultation Letter. This letter contains information for further treatment of the patient. 189 completers are needed to attain sufficient power to show a clinically significant effect of 0.6 SD on the primary outcome measures. Data on depression, anxiety, mental and physical health, medication adherence, quality of life, patient-doctor relationship, coping, health resource use and productivity will be collected at baseline and after three, six, nine and twelve months.|
|- Main changes (audit trail)||15-okt-2009: Title changed, old title: Collaborative care: integrated antidepressant and psychotherapeutic treatment of concomitant pain and depressive disorder in primary care.
SCIENTIFIC TITLE CHANGED, old title: Duloxetine plus collaborative care treatment versus Duloxetine alone in the treatment of concomitant pain and depressive disorder. A randomized clinical trial in primary care.
Old hypothese: Treatment of concomitant pain and depressive disorder in a collaborative care model, that is an integrated intervention including a training program, a short behavioral intervention and treatment with duloxetine 60 mg daily is more cost effective than duloxetine 60 mg daily alone.
Old inclusion: Patients will be selected that present themselves with pain that remains medically unexplained. They will be approached for the study and asked informed consent. If they consent, they will be screened with the PHQ for depressive disorder. In case of a cut-off score of >10, they will be included in the study.
Changed mec approval to yes.
Changed multicenter trial to YES.
Changed blinding from single to double.
Changed start date from 1-dec-2007 to 1-sept-2007.
Changed closingdate from 1-dec-2011 to 1-feb-2013.
Target number of participants changed from 104 to 219.
Old intervention: Experimental intervention will be integrated care including psycho education with DVD developed specifically on Depression and pain; self-management with training and relaxation techniques by patient, monitored by PCP; and Duloxetine 60 mg daily. Control group will be treated with Duloxetine 60 mg alone.
Old primary outcome: Primary parameter used to substantiate the primary study objective will be severity of pain according to a VAS and Brief Pain Inventory (BPI).
Old secondary outcome: Secondary parameters will be severity of pain (VAS, BPI) and depression (PHQ, IDS-SR), QALY as measured by EQ-D5 and SF-36 and costs measured by TIC-P. Process measures will be compliance and adherence to treatment, the patient-doctor relationship as measured by the PDRQ-9, as well as assessment of the care provided in both experimental conditions.
all changed at 15-okt-2009- Jurre
14-Jun-2011: Public title change. Old title: Collaborative care: integrated antidepressant and psychotherapeutic treatment of concomitant pain and depressive disorder in primary care. NM
19-Jul-2011: Several changes - NM
Old scientific title: Efficacy of a transmural Collaborative care intervention and Duloxetine for major depressive disorder and (sub)chronic pain in primary care: a randomized placebo-controlled Multi-Centre trial.
Old inclusion criteria: Patients will be selected that present themselves with pain that remains medically unexplained. They will be approached for the study and asked informed consent. If they consent, they 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, they will receive a MINI interview. If patients have a positive MINI depression score and suffers from (sub)chronic pain, they will be included in the study.
Old exlusion criteria: 1. concomitant medical illness; 2. alcohol or drug abuse; 3. suicidal ideation; 4. psychotic symptoms; 5. dementia; 6. already being under psychiatric treatment; 7. all contraindications for Duloxetine will be exclusion criteria as well, namely allergy for duloxetine, simultaneous treatment with non selective, irreversible Monoamine-Oxidase Inhibitors (MAO-inhibitors), fluvoxamine, ciprofloxacine or enoxacine, liver disease as indicated by elevated transaminase levels, renal insufficience with creatinine clearance < 30 ml/min, and uncontrolled hypertension.
Old intervention: Experimental intervention will be integrated care including psycho education with DVD developed specifically on Depression and pain; self-management with training and relaxation techniques by patient, and a pain medication protocol, in a transmural collaborative care model resulting in a CL letter to PCP, combined with Duloxetine 60 mg daily. Control group will be treated with Duloxetine 60 mg alone. The third group will receive placebo plus integrated care as mentioned above.
09-May-2012: Primary and Secundary outcomes have changed - NM
Old primary outcome: Primary outcome will be to establish the effectiveness on severity of depression (measured by PHQ-9), of the intervention collaborative care + duloxetine in primary care for concomitant pain and depression compared to duloxetine alone.
Old secundary outcome: Secondary outcome will be to establish effectiveness in terms of PHQ-9 of collaborative care plus placebo as compared to collaborative care + duloxetine. To establish cost effectiveness and to establish improvement on pain in terms of BPI three interventions will be compared namely: dulxetine versus duloxetine + collaborative care versus placebo + collaborative care. Another secondary outcome will be to train primary care practitioners to perform an integrated depression and pain treatment.
|- RECORD||15-okt-2007 - 9-mei-2012|
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