Effects of a stepped-care intervention programme among older subjects who screened positive for depressive symptoms in general practice: the PROMODE randomised controlled trial

IntroductionIt has been suggested that palliative care integrated into standard cancer treatment from the early phase of the disease can improve the quality of life of patients with cancer. In this paper, we present the protocol for a multicentre randomised controlled trial to examine the effectiveness of a nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer.Methods and analysisA total of 206 patients will be randomised (1:1) to the intervention group or the control group (usual care). The intervention, triggered with a brief self-administered screening tool, comprises comprehensive need assessments, counselling and service coordination by advanced-level nurses. The primary outcome is the Trial Outcome Index of the Functional Assessment of Cancer Therapy (FACT) at 12 weeks. The secondary outcomes include participants’ quality of life (FACT-Lung), depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), illness perception (Prognosis and Treatment Perceptions Questionnaire), medical service use and survival. A mixed-method approach is expected to provide an insight about how this intervention works.Ethics and disseminationThis study has been approved by the Institutional Review Board of the National Cancer Center Japan (approval number: 2016-235). The findings will be disseminated through peer-reviewed publications and conference presentations and will be reflected on to the national healthcare policy.Trial registration numberUMIN000025491.

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A stepped care intervention for non-specialist health workers' management of depression in the Mental Health in Primary Care (MeHPriC) project, Lagos, Nigeria: A cluster randomised controlled trial

General Hospital Psychiatry ◽

10.1016/j.genhosppsych.2019.07.012 ◽

2019 ◽

Vol 60 ◽

pp. 76-82 ◽

Cited By ~ 1

Author(s):

Abiodun O. Adewuya ◽

Bolanle A. Ola ◽

Olurotimi Coker ◽

Olayinka Atilola ◽

Adedolapo Fasawe ◽

...

Keyword(s):

Mental Health ◽

Primary Care ◽

Randomised Controlled Trial ◽

Health Workers ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Stepped Care ◽

Cluster Randomised ◽

Care Intervention ◽

Randomised Controlled

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Improving Depressive Symptoms through Personalised Exercise and Activation (IDEA): Study Protocol for a Randomised Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18126306 ◽

2021 ◽

Vol 18 (12) ◽

pp. 6306

Author(s):

Aitana García-Estela ◽

Natalia Angarita-Osorio ◽

Sandra Alonso ◽

Maria Polo ◽

Maria Roldán-Berengué ◽

...

Keyword(s):

Physical Activity ◽

Depressive Symptoms ◽

Randomised Controlled Trial ◽

Physical Health ◽

Controlled Trial ◽

Exercise Group ◽

Global Functioning ◽

Motivational Messages ◽

Randomised Controlled ◽

Group Programme

Individuals who suffer from depressive symptoms experience a substantial impact on psychosocial functioning, physical health, mortality, and quality of life. In the search for therapeutic strategies, exercise has been found to play a relevant part in its treatment. However, the promotion of exercise entails adherence difficulties that arose out of the tendency towards sedentarism led by symptomatology. Personalised exercise plans on top of usual care have the potential to enhance behavioural changes and mental health. The present study aims at evaluating the changes in functioning deriving from a blended intervention merging a psychological intervention with a personalised exercise programme based on medical assessment. We will conduct a three-arm randomised controlled trial in which 172 participants suffering from mild–moderate depressive symptoms will be allocated to Intervention A (personalised exercise group programme + app with motivational messages), B (personalised exercise group programme + app with no motivational messages) or control group (app with no motivational messages). Data regarding global functioning, well-being, symptoms, physical activity, and exercise capacity will be collected at baseline, 4, 12, and 36 weeks. The results of this trial will provide information about whether this physical activity support programme may be efficient for improving mental and physical health outcomes. Trial registration: ClinicalTrials.gov NCT04857944 (accessed on 15 April 2021). Registered April 2021.

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