Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000740796
Ethics application status
Approved
Date submitted
3/07/2013
Date registered
3/07/2013
Date last updated
7/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Couselling to improve symptoms of anxiety or depression for heart transplant recipients
Scientific title
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
Secondary ID [1] 282778 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Transplant 289538 0
Anxiety 289539 0
Depression 289540 0
Condition category
Condition code
Cardiovascular 289860 289860 0 0
Other cardiovascular diseases
Mental Health 289861 289861 0 0
Depression
Mental Health 289862 289862 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 287451 0
Treatment: Other
Intervention code [2] 287455 0
Early detection / Screening
Intervention code [3] 287456 0
Behaviour
Comparator / control treatment
The control group 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.
Control group
Active

Outcomes
Primary outcome [1] 289924 0
The primary objective of this study is to assess the feasibility of telephone-delivered cognitive behaviour therapy followed by case conferencing with specialist and primary care services in improving psychological and clinical outcomes for heart transplant recipients. Assessment of feasibility includes recruitment issues, likely attrition rates and acceptability of interventions (measured by dropout rates due to the nature of intervention during the study), which are important considerations in planning a larger clinical trial. It will also help determine the effect size for sample size estimation to adequately power a future larger clinical trial.
Timepoint [1] 289924 0
9 weeks and 6 months
Secondary outcome [1] 303578 0
To determine the accuracy of brief, self-administered tools to screen for anxiety and depression in heart transplant recipients. Receiver Operating Characteristics with the MINI as the criterion will be calculated to assess accuracy of GAD-7 and PHQ-9 results. The Youden Index will be the metric used for cut-off decisions.
Timepoint [1] 303578 0
Baseline assessment data
Secondary outcome [2] 303585 0
Process Data: All counselling sessions will be tape recorded and transcribed verbatim for analysis. These data will be used to: (1) document the frequency with which various strategies were used and the perceived effectiveness and satisfaction with the strategies; (2) identify common themes that reflect issues impacting the intervention, including environmental, situational, patient-related, or intervention-related factors. By providing qualitative data about intervention processes, these data act as a check on compliance with the study protocols, as well as an assessment of the perceived effectiveness of intervention procedures. After the completion of each intervention session, the Research Psychologist will respond to a structured list of questions, which assess: duration of the intervention; topics discussed; strategies used; patient responses to strategies used; the effectiveness of each strategy used; environmental issues perceived to be impacting the intervention; and other issues arising from the intervention.
Timepoint [2] 303585 0
9 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An experienced research nurse will liaise with clinical staff on a regular basis to identify potentially eligible inpatients or outpatients using a standard screening assessment sheet. Clinicians will be asked to identify potentially eligible patients.

Prior to their consultation with the Nurse Practitioner, all consenting participants will complete the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder-7 (GAD-7) and questionnaires to evaluate quality of life (Short Form-36 [SF-36]), and transplant-specific self-care (Transplant Care Index [TCI]). The PHQ-9 and GAD-7 results will be made available to the Nurse Practitioner during the clinic visit so that usual clinical advice and referrals for patients experiencing psychological distress can be actioned. Participants with scores over 5 on the GAD-7 or PHQ-9 (indicating at least mild anxiety or depressive symptoms) will be randomised to the intervention or control group. After the clinic visit the Research Psychologist will perform a structured interview with each participant using the Mini-International Neuropsychiatric Interview (MINI). This interview will be conducted as soon as possible after the clinic visit via the phone in order to identify participants that fit DSM-IV criteria for current psychological disorder.

Participants who score more than 5 on the GAD-7 or the PHQ-9, which indicates at least mild symptoms of anxiety or depression, will be randomised to the intervention or control groups. Allocation involved contacting the holder of the allocation schedule who will be located at the central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using a computer generated table of random sequence, all recruited patients will be allocated randomly to one of two conditions (intervention/control).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2013
Actual
13/01/2014
Date of last participant enrolment
Anticipated
Actual
15/09/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 287548 0
University
Name [1] 287548 0
Institute of Health and Biomedical Innovation, Queensland University of Technology
Country [1] 287548 0
Australia
Funding source category [2] 291208 0
Charities/Societies/Foundations
Name [2] 291208 0
Sigma Theta Tau International
Country [2] 291208 0
United States of America
Primary sponsor type
University
Name
Queensland University of Technology
Address
60 Musk Ave
Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 286301 0
None
Name [1] 286301 0
Address [1] 286301 0
Country [1] 286301 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289528 0
The Prince Charles Hospital
Ethics committee address [1] 289528 0
Ethics committee country [1] 289528 0
Australia
Date submitted for ethics approval [1] 289528 0
23/07/2013
Approval date [1] 289528 0
14/10/2013
Ethics approval number [1] 289528 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41198 0
Dr Aaron Conway
Address 41198 0
Queensland University of Technology
60 Musk Ave
Kelvin Grove, QLD, 4059
Country 41198 0
Australia
Phone 41198 0
+61731386124
Fax 41198 0
Email 41198 0
[email protected]
Contact person for public queries
Name 41199 0
Aaron Conway
Address 41199 0
Queensland University of Technology
60 Musk Ave
Kelvin Grove, QLD, 4059
Country 41199 0
Australia
Phone 41199 0
+61731386124
Fax 41199 0
Email 41199 0
[email protected]
Contact person for scientific queries
Name 41200 0
Aaron Conway
Address 41200 0
Queensland University of Technology
60 Musk Ave
Kelvin Grove, QLD, 4059
Country 41200 0
Australia
Phone 41200 0
+61731386124
Fax 41200 0
Email 41200 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.