Duloxetine plus collaborative care treatment versus Duloxetine alone in the treatment of concomitant pain and depressive disorder. A randomized clinical trial in primary care.

Completed

Conditions: pijnklachten
Depression
Major Depressive Dissorder
10027946

Registration Number: NL-OMON31476

Lead Sponsor: Trimbos instituut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 116

Inclusion Criteria

Patients will be selected that have presented themselves with pain at their primary care physician. 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 the BPI (brief pain inventory). In case of a cut-off score of >10 on the PHQ and a score of >= 3 on the 'average pain' item of the BPI, they will be included in the study.

Exclusion Criteria

Exclusion criteria will be: cancer; recent post traumatic pain; alcohol or drug abuse; suicidal ideation; psychotic symptoms; dementia; somatization disorder; or already being under psychiatric treatment. Also, all contraindications known by the PCP for Duloxetine will be exclusion criteria as well.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary parameter used to substantiate the primary study objective will be<br /><br>severity of pain measured by the average pain item of the BPI, this is a 0-10<br /><br>numeric rating scale.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters will be severity of depression (PHQ-9, IDS-SR), QALY as<br /><br>measured by EQ-D5 and SF-36 and costs measured by TIC-P. Also other health<br /><br>symptoms (e.g. anxiety) will be taken into account (PHQ), and another secondary<br /><br>parameter will be the severity of somatoform symptoms (WI). Changes in pain<br /><br>catastrophizing will be evaluated with the Pain Catastrophizing Scale (PCS).<br /><br>The LKV (Lichamelijke Klachten Vragenlijst) will be used to see which physical<br /><br>complaints are reported by the subjects.<br /><br>The duration of the pain symptoms and pain catastrophizing behavior will be<br /><br>taken into account as effect modifiers.<br /><br>Process measures will be compliance and adherence to treatment, the<br /><br>patient-doctor relationship as measured by the PDRQ-9, as well as assessment of<br /><br>the care provided in both experimental conditions (Contacten met dokters en<br /><br>andere behandelaars). </p><br>