SMaRT oncology-2: a two arm parallel group randomised controlled trial to determine the effectiveness and cost-effectiveness of adding a complex intervention for major depressive disorder ('Depression Care for People with Cancer') to usual care, compared to usual care alone in cancer patients

IntroductionMajor depressive disorder (MDD) affects more than 264 million people worldwide and is associated with an impaired quality of life as well as a higher risk of mortality. Current routine treatments demonstrate limited effectiveness. Light therapy (LT) on its own or in combination with antidepressant treatments could be an effective treatment, but the use of conventional LT devices use is restrictive. Portable LT devices allow patients to continue with their day-to-day activities and therefore encourage better treatment compliance. They have not been evaluated in MDD.Methods and analysisThe study is a single-centre, double-blind, randomised controlled trial assessing the efficacy of LT delivered via a portable device in addition to usual care (medical care and drug treatment) for inpatients and outpatients with unipolar non-seasonal MDD. Over the course of 8 weeks, patients use the device daily for 30 min at medium intensity as soon as possible after waking up and preferably between 07:00 and 09:00. All patients continue their usual care with their referring physician. N=50 patients with MDD are included. The primary outcome measure is depressive symptom severity assessed using the Montgomery-Åsberg Depression Rating Scale between baseline and the eighth week. Secondary outcome measures are sleep quality assessed using the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale and anxiety level assessed on the Hamilton Anxiety Rating Scale, between baseline and week 8. Further parameters relating to cognitive function are measured at baseline and after the intervention. An ancillary study aims to evaluate the impact of MDD on the retina and to follow its progression. Main limitations include risk of discontinuation or non-adherence and bias in patient selection.Ethics and disseminationThe study protocol was approved by Ile de France X’s Ethics Committee (protocol number 34–2018). Findings will be published in peer-reviewed journals.Trial registration numberNCT03685942.

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CASPER plus (CollAborative care in Screen-Positive EldeRs with major depressive disorder): study protocol for a randomised controlled trial

Trials ◽

10.1186/1745-6215-15-451 ◽

2014 ◽

Vol 15 (1) ◽

Cited By ~ 7

Author(s):

Karen Overend ◽

Helen Lewis ◽

Della Bailey ◽

Kate Bosanquet ◽

Carolyn Chew-Graham ◽

...

Keyword(s):

Major Depressive Disorder ◽

Randomised Controlled Trial ◽

Depressive Disorder ◽

Study Protocol ◽

Collaborative Care ◽

Controlled Trial ◽

Major Depressive ◽

Randomised Controlled

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Acute and one-year outcome of a randomised controlled trial of brief cognitive therapy for major depressive disorder in primary care

The British Journal of Psychiatry ◽

10.1192/bjp.171.2.131 ◽

1997 ◽

Vol 171 (2) ◽

pp. 131-134 ◽

Cited By ~ 74

Author(s):

Christine Scott ◽

Mary Jane Tacchi ◽

Roger Jones ◽

Jan Scott

Keyword(s):

Primary Care ◽

Major Depressive Disorder ◽

Randomised Controlled Trial ◽

Depressive Disorder ◽

Cognitive Therapy ◽

Controlled Trial ◽

Control Group ◽

Major Depressive ◽

Treatment As Usual ◽

Randomised Controlled

BackgroundThe consensus statement on the treatment of depression (Paykel & Priest, 1992) advocates the use of cognitive therapy techniques as an adjunct to medication.MethodThis paper describes a randomised controlled trial of brief cognitive therapy (BCT) plus ‘treatment as usual’ versus treatment as usual in the management of 48 patients with major depressive disorder presenting in primary care.ResultsAt the end of the acute phase, significantly more subjects (P < 0.05) met recovery criteria in the intervention group (n=15) compared with the control group (n=8). When initial neuroticism scores were controlled for, reductions in Beck Depression Inventory and Hamilton Rating Scale for Depression scores favoured the BCT group throughout the 12 months of follow-up.ConclusionsBCT may be beneficial, but given the time constraints, therapists need to be more rather than less skilled in cognitive therapy. This, plus methodological limitations, leads us to advise caution before applying this approach more widely in primary care.

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