Improving the effectiveness of psychological interventions for depression and anxiety in the cardiac rehabilitation pathway: a single-blind randomised controlled trial

Not Applicable

Completed

• Conditions: Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular; Circulatory System

• Registration Number: ISRCTN74643496
• Lead Sponsor: Manchester Mental Health & Social Care Trust

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32912974/ protocol (added 15/09/2020) 2018 Protocol article in https://pubmed.ncbi.nlm.nih.gov/29615092/ protocol (added 11/02/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34148379/ (added 28/09/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35722590/ (added 21/06/2022) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32714216/ internal pilot acceptability and feasibility study (added 09/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-08
• Study Completion: 2019-08-31
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

1. Heart disease patients referred to CR who meet DoH and/or BACPR CR eligibility criteria
2. Minimum of 18 years old
3. Competent level of English language skills (able to read, understand and complete questionnaires in English).
4. Acute coronary syndrome used for any condition brought on by sudden, reduced blood flow to the heart
5. Following revascularisation is the restoration of perfusion to a body part or organ that has suffered ischemia
6. Stable heart failure
7. Stable angina is chest pain or discomfort that most often occurs with activity or stress
8. Following implantation of cardioverter defibrillators/cardiac resynchronisation devices
9. Heart valve repair/replacement
10. Heart transplantation and ventricular assist devices
11. Adult congenital heart disease identified in adulthood
12. A score of = 8 on either the depression or anxiety subscale of the HADS.

Exclusion Criteria

1. Cognitive impairment which precludes informed consent or ability to participate
2. Acute suicidality
3. Active psychotic disorders (i.e., two [or more] of the following: delusions, hallucinations, disorganized speech, grossly disorganized or catatonic behaviour, negative symptoms)
4. Current drug/alcohol abuse a maladaptive pattern of drinking, leading to clinically significant impairment or distress
5. Concurrent psychological intervention for emotional distress
6. Antidepressant or anxiolytic medications initiated in the previous 8 weeks
7. Life expectancy of less than 12 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Hospital Anxiety and Depression Scale (HADS) [Time Frame: Baseline pre treatment, four-month post baseline, 12 months follow-up]

Secondary Outcome Measures

Name	Time	Method
1. Metacognitions Questionnaire<br>2. Cognitive Attentional Syndrome<br>3. Impact of Event Scale-Revised<br>4. Health Related Quality of Life<br>5. Economic Patient Questionnaire (EPQ)