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

Duloxetine plus collaborative care treatment versus Duloxetine alone in the treatment of concomitant pain and depressive disorder. A randomized clinical trial in primary care. - CC:PAINDIP (collaborative care: pain depression in primary healthcare)

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31476
Enrollment
116
Registered
2008-07-08
Start date
2008-04-01
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pijnklachten Depression Major Depressive Dissorder

Interventions

In the experimental arm, treatment with the antidepressant duloxetine will be combined with psycho education in the form of a DVD provided by the PCP, a self help manual containing a short (approxim

Sponsors

Trimbos instituut
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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: 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.

Design outcomes

Primary

MeasureTime frame
Primary parameter used to substantiate the primary study objective will be severity of pain measured by the *average pain* item of the BPI, this is a 0-10 numeric rating scale.—

Secondary

MeasureTime frame
Secondary parameters will be severity of depression (PHQ-9, IDS-SR), QALY as measured by EQ-D5 and SF-36 and costs measured by TIC-P. Also other health symptoms (e.g. anxiety) will be taken into account (PHQ), and another secondary parameter will be the severity of somatoform symptoms (WI). Changes in pain catastrophizing will be evaluated with the Pain Catastrophizing Scale (PCS). The LKV (Lichamelijke Klachten Vragenlijst) will be used to see which physical complaints are reported by the subjects. The duration of the pain symptoms and pain catastrophizing behavior will be taken into account as effect modifiers. 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 (*Contacten met dokters en andere behandelaars*).—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)