Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001301752
Ethics application status
Approved
Date submitted
18/09/2013
Date registered
22/11/2013
Date last updated
22/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treating depression and anxiety in Heart Failure outpatients in managed care.
Scientific title
Treating depression and anxiety in Heart Failure outpatients in managed care: A pilot study investigating the therapeutic effect of a group mood management program.
Secondary ID [1] 283248 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 290265 0
Anxiety 290266 0
Heart Failure 290580 0
Condition category
Condition code
Cardiovascular 290503 290503 0 0
Other cardiovascular diseases
Mental Health 290504 290504 0 0
Depression
Mental Health 290654 290654 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Behaviour Therapy
Treatment will compose of weekly, eight 2-hr group sessions for as per Nathan, P. R., Rees, C. S., & Smith, L. M. (2001). Mood management course: A group cognitive behavioral programme for anxiety disorders and depression. Perth, Australia: Rioby. (Available from http:// www.cci.health.wa.gov.au/index.html). Therapist intervention will be monitored in weekly supervision sessions with a Registered Clinical Psychologist.
Intervention code [1] 287977 0
Behaviour
Intervention code [2] 288334 0
Treatment: Other
Comparator / control treatment
Uncontrolled pilot study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290525 0
Scores on Depression Anxiety Stress Scale (DASS-21)
Timepoint [1] 290525 0
Pre treatment and at eighth session (post treatment)
Secondary outcome [1] 304727 0
Scores on Health Anxiety Inventory (HAI),
Timepoint [1] 304727 0
Pre treatment and at eighth session (post treatment)
Secondary outcome [2] 305004 0
Minnesota Living with Heart Failure Questionnaire (MLwHF).
Timepoint [2] 305004 0
Pre treatment and at eighth session (post treatment)

Eligibility
Key inclusion criteria
Have a diagnosis of NYHA Class I, II or III heart failure.
Case managed by a case- worker within the Heart Failure Service .
Meet a diagnosis for depression or anxiety disorder.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychotic comorbid diagnosis,
Suicide risk
Abuse of alcohol and other drugs
Concurrent or recent (past 6 months) psychotherapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Assessment to determine meets inclusion criteria, then offered place in program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Due to a restricted data collection period (i.e., this is a student project with a limited data collection period) - clinically significant changes on measures will be reported for each participant in the study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/09/2013
Actual
Date of last participant enrolment
Anticipated
20/12/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 287985 0
Self funded/Unfunded
Name [1] 287985 0
nil
Country [1] 287985 0
Primary sponsor type
University
Name
Curtin University
Address
Kent Street,
Bentley WA 6845
Country
Australia
Secondary sponsor category [1] 286705 0
None
Name [1] 286705 0
Address [1] 286705 0
Country [1] 286705 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289914 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 289914 0
Kent Street
Bentley WA 6845
Ethics committee country [1] 289914 0
Australia
Date submitted for ethics approval [1] 289914 0
Approval date [1] 289914 0
20/08/2013
Ethics approval number [1] 289914 0
HR 121/2013

Summary
Brief summary
Heart Failure (HF) is a debilitating and chronic disease that is associated with a high rate of comorbid mental illness. Depression is associated with increased risk of mortality and cardiac events. Cognitive Behaviour Therapy (CBT) is recommended as a preferred treatment in HF and cardiovascular disease (CVD) management. However determining the effect of CBT in CVD and HF patients is implicated by a history of limited randomised controlled trials, confounded sampling issues and reduced functioning ability. Furthermore, research in the field of anxiety management in cardiac patients is lacking although emerging research indicates that clinical anxiety is as prevalent as depression. This study seeks to investigate the therapeutic impact of a CBT intervention targeted to both depression and anxiety on HF outpatients in managed care. The treatment model “mood management” has been trialled and evaluated to be efficacious in depressed and anxious nonmedical clients. Participants (n=5) will be offered the program as a treatment option from a HF nurse and self refer to the study. It is hypothesised that participants will display improved scores on measures of depression and anxiety. Results will help inform current and future research on effective therapeutic treatment of CBT group therapy and the utility for depressed and anxious HF outpatients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43058 0
Dr Rebecca Anderson
Address 43058 0
Curtin University
School of Psychology and Speech Pathology
Kent Street, Bentley WA 6845
Country 43058 0
Australia
Phone 43058 0
+61892663012
Fax 43058 0
Email 43058 0
[email protected]
Contact person for public queries
Name 43059 0
Dr Rebecca Anderson
Address 43059 0
Curtin University
School of Psychology and Speech Pathology
Kent Street, Bentley WA 6845
Country 43059 0
Australia
Phone 43059 0
+61892663012
Fax 43059 0
Email 43059 0
[email protected]
Contact person for scientific queries
Name 43060 0
Dr Rebecca Anderson
Address 43060 0
Curtin University
School of Psychology and Speech Pathology
Kent Street, Bentley WA 6845
Country 43060 0
Australia
Phone 43060 0
+61892663012
Fax 43060 0
Email 43060 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.