Multi-component nurse delivered intervention for major depressive disorder in patients with cancer

Completed

• Conditions: Cancer and depression; Mental and Behavioural Disorders; Reaction to severe stress and adjustment disorders

• Registration Number: ISRCTN84767225
• Lead Sponsor: niversity of Edinburgh (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-15
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Patients attending Edinburgh Cancer Centre identified through a screening process or by referral and noted to have:
1. Definite or probable major depressive disorder on Structured Clinical Interview for Depression (SCID) interview
2. SCL-20 depression score of at least 1.72
3. A diagnosis of cancer

Exclusion Criteria

Predicted survival less than 6 months; another complicating and uncontrolled medical problem or where antidepressants are contraindicated; too ill to participate in treatment due to ongoing cancer therapy; complicating major psychiatric diagnosis or an alcohol or substance misuse problem; chronic depression; under active treatment for their depression; judged to be in need of urgent psychiatric treatment; unable to communicate adequately due to language problems or cognitive impairment; unable to travel to centre for treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The principal outcome measure will be a 50% reduction in the SCL-20 depressive symptoms score from baseline.

Secondary Outcome Measures

Name	Time	Method
Secondary measures will be:<br>1. Mean depression scores from the SCL-20<br>2. Remission specified as an SCL-20 score of <0.75<br>3. The presence of major depressive disorder assessed by SCID diagnostic interview<br><br>Subsidiary outcome measures will be:<br>1. Quality of life measured on the World Health Organisation (WHO) EQ-5D<br>2. EORTC-QLQ-C30<br>3. Anxiety measured on the 10 anxiety items of the SCL-90<br>4. A measure of self-efficacy, coping and social support<br>5. An estimate of the direct health care costs measured by case note review and patient questionnaire<br><br>The outcomes will be measured at 3, 6 and 12 months