None listed
Conditions
Brief summary
Background: Depression is at least three times more common in people with coronary heart disease (CHD) but is underdiagnosed and inadequately treated. Psychological treatments are preferred by most patients with depression but are complex and costly to deliver. Behavioural activation (BA) is a simpler alternative that could potentially be delivered by therapists (physio, occupational) as an add on to cardiac rehabilitation. Objective: To determine the feasibility of providing therapist delivered BA as an adjunct to cardiac rehabilitation to patients with depression and coronary heart disease. Design: Feasibility – before and after – trial. Methods: Patients referred to the North East Rehabilitation Center for cardiac rehabilitation program will be screened for depression using the PHQ-2. Those with a score >3 (indicative of at least mild depression) will be invited to take part in the study. Patients already receiving depression treatment (either medication or psychological), who are alcohol or drug dependent, are suicidal, have cognitive impairment or psychosis will be excluded from the trial. Key outcomes: 1. To determine the number of patients we need to ask to participate in the trial to get one to consent, 2. Proportion of patients who complete treatment (and the number of sessions they attend), 3. Completion of outcome measures, 4. Acceptability of behavioral activation as part of cardiac rehabilitation, 5. Proportion of patients that complete the trial. Unexpected harms associated with combining behavioral activation and cardiac rehabilitation will be closely monitored. Discussion: This study will provide evidence on the feasibility of conducting a trial to evaluate the efficacy of incorporating behavioral activation as part of routine cardiac rehabilitation for depressed patients with coronary heart disease.
Interventions
Patients will receive 12, weekly, 1-to-1, sessions of behavioral activation, each lasting 45 minutes, delivered immediately preceding cardiac rehabilitation sessions. Sessions will be delivered in a private consulting room in the hospital. Patients will be determined to have completed treatment if they attend 50% of the behavioral activation sessions. We are using standard behavioral activation treatment protocols. These are based on previous trials, expert consensus opinion, NICE (National Inst
Patients will receive 12, weekly, 1-to-1, sessions of behavioral activation, each lasting 45 minutes, delivered immediately preceding cardiac rehabilitation sessions. Sessions will be delivered in a private consulting room in the hospital. Patients will be determined to have completed treatment if they attend 50% of the behavioral activation sessions. We are using standard behavioral activation treatment protocols. These are based on previous trials, expert consensus opinion, NICE (National Institute for Health and Care Excellence) recommendations for the frequency and duration of behavioral activation. The intervention will be provided by physiotherapists under the supervision of a clinical psychologist. Specific behavioral activation techniques that will be applied include identification of depressed behaviors, analysis of the triggers and consequences of depressed behaviors, monitoring of activities, development of alternative goal-orientated behaviors, scheduling of activities and development of alternative behavioral reposes to rumination. The techniques used will be based on an initial assessment with the patient at the start of treatment. Treatment fidelity will be determined by audio recording randomly selected (therapist, beginning, middle, end of treatment) sessions that will then be assessed by experienced psychologists using the quality of behavioral activation scale. We do not plan to provide feedback to therapists about fidelity to treatment.
Sponsors
La Trobe University
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A clinical diagnosis of coronary heart disease Referred to a participating Healthscope cardiac rehabilitation program A positive screen for depression (defined as a PHQ2 score >3) at the time of the cardiac rehabilitation assessment Able to give written informed consent Over 18 years of age
Exclusion criteria
Physically frail (as they may not be able to fully participate in the cardiac rehabilitation/behavioral activation program) Experience mental confusion, cognitive impairment, or psychosis. These comorbidities may make it difficult to deliver the behavioral activation intervention. Have serious co-existing diseases (e.g. cancer) because of the risk of hospitalization or death during the course of the study Have previously attended a cardiac rehabilitation program as this may contaminate the effectiveness of the intervention. Are currently receiving psychological or pharmacological (antidepressant) treatment for depression as this may limit the effectiveness of the behavioural activation intervention. Are alcohol or drug dependent as patients may not be able to engage in treatment. Are suicidal or have made a suicide attempt in the past month because this is an experimental intervention and patients should receive standard of care in this situation
Outcome results
None listed