A feasibility study and pilot study to establish methods for assessing the acceptability, and clinical and cost-effectiveness of enhanced psychological CAre in carDiac rEhabilitatioN serviCEs for patients with new onset depression compared with usual care

Not Applicable

Completed

• Conditions: Patients referred to cardiac rehabilitations services identified with depressive symptoms; Mental and Behavioural Disorders; Depression

• Registration Number: ISRCTN34701576
• Lead Sponsor: Royal Devon & Exeter NHS Foundation Trust, UK

Brief Summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26830029 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29856312

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-29
• Study Completion: 2016-07-31
• Last Update Posted: 2 July 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

A pragmatic approach will be adopted, whereby adult patients (18 years or over) referred for cardiac rehabilitation based on local clinical referral protocols of participating rehabilitation teams will be screened for eligibility by a specialist nurse. This includes patients admitted with an Acute Coronary Syndrome, i.e. ST elevation myocardial infarction or non-ST elevation myocardial infarction and unstable angina, and/or following a coronary revascularization procedure, i.e. coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). These currently constitute the majority of patients referred for rehabilitation. Within this group, eligible patients are those identified as experiencing a new episode of depression symptoms identified through nurse screening at the start of the comprehensive cardiac rehabilitation programme using the Patient Health Questionnaire-9 (PHQ-9 score of 10 or more).

Exclusion Criteria

Current exclusion criteria as of 12/11/2014:
The following patient exclusion criteria will be applied during routine cardiac rehabilitation screening by a nurse specialist. Patients who report having been actively treated for depression (psychological or drug therapy) within 6 months before the acute cardiac event will be excluded. The nurse will also exclude patients where there is evidence of alcohol or drug dependency, being acutely suicidal, or having poorly controlled bipolar disorder or psychosis/psychotic symptoms based on a clinical review (and seeking external confirmation from the general practitioner or other clinicians as required).

Previous exclusion criteria:
The following patient exclusion criteria will be applied during routine cardiac rehabilitation screening by a nurse specialist. Patients who report having been actively treated for depression (psychological or drug therapy) within 6 months before the acute cardiac event will be excluded. The nurse will also exclude patients where there is evidence of alcohol or drug dependency, being acutely suicidal or cognitively impaired (e.g. diagnosed dementia), or having a bipolar disorder or psychosis/psychotic symptoms based on a clinical review (and seeking external confirmation from the general practitioner or other clinicians as required).

Study & Design

• Study Type: Interventional
• Study Design: Not specified