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Couselling to improve symptoms of anxiety or depression for heart transplant recipients

A pilot study of nurse-led screening for anxiety and depression in adult heart transplant recipients followed by referral for cognitive behavioural therapy and co-ordination of communication with on-going specialist and primary care providers

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000740796
Enrollment
13
Registered
2013-07-03
Start date
2014-01-13
Completion date
2014-09-15
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This pilot study will assess the feasibility of undertaking a larger study to determine if telephone-delivered cognitive behaviour therapy followed by communication with on-going specialist and primary care providers is a successful and sustainable treatment option for adult heart transplant recipients with anxiety or depression. Additionally, this study will also help determine the accuracy of simple, self-adminsitered questionnaires to screen for anxiety and depression.

Interventions

All randomised participants will receive usual care, which involves receiving routine clinical advice from the Heart Transplant Nurse Practitioner for patients identified as experiencing psychological distress as well as a letter to the participant’s General Practitioner advising them of the severity of psychological symptoms and their participation in the study. Participants randomised to the intervention group will also receive: i) one telephone-delivered cognitive behaviour therapy sessions p

All randomised participants will receive usual care, which involves receiving routine clinical advice from the Heart Transplant Nurse Practitioner for patients identified as experiencing psychological distress as well as a letter to the participant’s General Practitioner advising them of the severity of psychological symptoms and their participation in the study. Participants randomised to the intervention group will also receive: i) one telephone-delivered cognitive behaviour therapy sessions per week for 8 weeks, of about 60 minutes, delivered by a Masters in Clinical Psychology student (with supervision from one of the Associate Investigators who is an accredited Clinical Psychologist); followed by ii) communication between the Heart Transplant Nurse Practitioner, a psychologist and the participant’s General Practitioner regarding the implications for on-going psychological care in light of response to the course of cognitive behaviour therapy. Following is a brief summary of the anticipated content of counselling sessions. Week 1 Orientation to therapy, goals and expectations of therapy Week 2 Identifying automatic thoughts in difficult situations during the previous week and practice reframing Weeks 3-6 Continued analysis of negative thoughts, identification of core beliefs, problem solving and coping strategies Week 7 Self-therapy guide and relapse prevention Week 8 Termination, review self-therapy guide and accomplishments of therapy The structure of the sessions will be standardised. During the initial part of a session, a ‘mood check’ will be performed, the agenda for the session will be set collaboratively between the patient and the therapist, the therapist will obtain an update from the patient, review their progress with cognitive and behaviour tasks and prioritise the agenda. The main component of the session will involve working on specific problems, including instruction on cognitive behaviour skills for that particular context. Cognitive and behaviour tasks will then be identified. Participants will be encouraged to perform these tasks in the time between their counselling sessions in order to reinforce learnt skills. At the end of each session, the therapist will either provide, or elicit from the patient, a summary of the session. Also, the therapist will review and reinforce the importance of completion of the identified cognitive and behaviour tasks and elicit feedback from the patient. A manual, including agenda templates and symptom assessment forms to assist with ‘mood checks’ (Beck Depression Inventory and the Beck Anxiety Inventory), will be used to guide the counselling sessions. The use of this manual will aid fidelity of the intervention. As surgical recovery will not be a focus of the intervention, any questions or concerns related to the clinical aspects of heart transplantation that may arise during counselling sessions will be directed to the Heart Transplant Nurse Practitioner for clarification. Following the course of cognitive behaviour therapy, the Research Nurse will invite the participant’s General Practitioner and the Heart Transplant Nurse Practitioner to participate in a case conference. The objective of the case conference is to discuss the patient’s case, their current symptoms, problems they will face and how the problems and symptoms can be managed, with particular attention paid to identifying who will be responsible for particular courses of action. The Research Psychologist who performed the counselling, as well as Dr Judith Sheridan, who will be the Clinical Supervisor for the student, will also attend the conference. It is anticipated that the case conference would take about 20-30 minutes. As this process is part of patient care, the General Practitioner would be eligible to claim the GP Multidisciplinary Case Conference Medicare item. Both the patient and each participating health care provider will be forwarded a summary of the case conference.

Sponsors

Queensland University of Technology
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

For screening: Heart transplant recipients aged over 18 years who are scheduled for a routine outpatient consultation with the Heart Transplant Nurse Practitioner at The Prince Charles Hospital (TPCH). For randomization: Participants who score more than 5 on the GAD-7 or the PHQ-9, which indicates at least mild symptoms of anxiety or depression, but who are not currently receiving regular psychological therapy from a mental health practitioner.

Exclusion criteria

Heart transplant recipients less than three months post transplant as well as those who are cognitively impaired (as confirmed by a treating clinician), unable to understand and speak English, have a diagnosed major psychiatric comorbidity (schizophrenia, bipolar, dementia) or have a terminal illness (such as cancer).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 28, 2026