Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000178640
Ethics application status
Not yet submitted
Date submitted
7/02/2014
Date registered
14/02/2014
Date last updated
14/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Posttraumatic Stress Disorder after cardiac surgery: assessing the efficacy of psychoeducation as a pre-Intensive Care Unit intervention.
Scientific title
Posttraumatic Stress Disorder after cardiac surgery: assessing the efficacy of psychoeducation as a pre-Intensive Care Unit intervention.
Secondary ID [1] 284045 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The symptoms of Post Traumatic Stress Disorder in survivors of cardiac intensive care treatment during recovery from surgery. 291100 0
Condition category
Condition code
Mental Health 291444 291444 0 0
Depression
Cardiovascular 291480 291480 0 0
Other cardiovascular diseases
Surgery 291481 291481 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A self-administered psychoeducational package will be given to the participants in the experimental group 1 week prior to their surgery. The pack is in printed form and will include a relaxation CD. They are expected to take the information pack home with them and practice the exercises and read the information regarding PTSD and their surgery. They are required to complete a self assessment battery once a week to monitor progress (takes a half hour to complete) as well as complete 3 psychological assessments during their meetings with the researcher. The package will contain breathing and relaxation exercises, basic cognitive training skills, and medical information regarding their surgery which they are expected to practice every day for 6 weeks. This will take approximately half an hour. The participants will be asked to keep a daily log indicating adherence to the intervention.
Intervention code [1] 288738 0
Prevention
Intervention code [2] 288770 0
Behaviour
Comparator / control treatment
A control group will receive standard treatment that includes information regarding their surgery and psychoinformation regarding Post Traumatic Stress Disorder. They will not be required to practice relaxation and cognitive behavioral exercises, but will be asked to monitor their progress using the same weekly self-assessment as the experimental group. The control group will be required to complete 3 psychological tests to assess baseline functioning and any changes during the study. Immediately following the end of the treatment period (10 weeks after surgery) the control group will receive the same self-administered treatment package and full instructions. Both groups and their welfare will be continuously monitored by a registered Clinical Psychologist.
Control group
Active

Outcomes
Primary outcome [1] 291426 0
Clients will be assessed for baseline PTSD score using the Impact of Events Scale before and following treatment.
Timepoint [1] 291426 0
Participants will assessed prior to admission for cardiac surgery, ideally 1 - 2 weeks prior, 6 weeks later at the end of the intervention, and again four weeks later during a follow-up meeting.
Primary outcome [2] 291427 0
Subjective Units of Distress self-measure to assess surgery-related distress
Timepoint [2] 291427 0
Weekly from the point of baseline measure prior to surgery until the end of the intervention (approximately 8 weeks).
Secondary outcome [1] 306747 0
nil
Timepoint [1] 306747 0
nil

Eligibility
Key inclusion criteria
Males and females aged between 25 and 65, and awaiting cardiac surgery.
Minimum age
25 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No prior incidence of major psychological disorders. Surgery not related to a traumatic incident.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participant is awaiting cardiac surgery and has signed consent to participate. Subject will undertake initial screening to evaluate incidence of pre-existing PTSD or similar. They will receive an pack of information related to the study with full instructions on how to self-administer it. The allocation concealment will be performed by a computer program, and the treatment will be allocated according to the number that is assigned to each participant. The control and experimental treatments are issued to the participants in sealed opaque envelopes that is concealed from the researcher and distributor.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will involve the simple randomization generated from a computer program/software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5809 0
New Zealand
State/province [1] 5809 0
Auckland

Funding & Sponsors
Funding source category [1] 288673 0
University
Name [1] 288673 0
Massey University
Country [1] 288673 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Private Bag 11-222
Palmerston North
Manawatu 4442
Country
New Zealand
Secondary sponsor category [1] 287381 0
None
Name [1] 287381 0
Nil
Address [1] 287381 0
Nil
Country [1] 287381 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290523 0
Health & Disability Ethics Committee
Ethics committee address [1] 290523 0
Ministry of Health
No 1, The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 290523 0
New Zealand
Date submitted for ethics approval [1] 290523 0
13/02/2014
Approval date [1] 290523 0
Ethics approval number [1] 290523 0

Summary
Brief summary
This study aims to investigate the efficacy of a psychoeducational treatment for people who survive the ICU, but develop post traumatic reactions to the medical interventions involved. The treatment will be given prior to surgery and outcomes measured. Previous research has suggested that people may benefit from using cognitive self-assessment skills and education regarding their surgery. It is intended that the treatment will alleviate PTSD symptomology.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46082 0
Ms Fleur Bethell
Address 46082 0
Massey University
26 Norwood Road
Bayswater
Auckland 0622
Country 46082 0
New Zealand
Phone 46082 0
+64 276411886
Fax 46082 0
Email 46082 0
bethell@windowslive.com
Contact person for public queries
Name 46083 0
Dr Ian de Terte
Address 46083 0
Massey University
PO Box 756
Wellington 6140
Country 46083 0
New Zealand
Phone 46083 0
+64 48015799 x62033
Fax 46083 0
Email 46083 0
i.deterte@massey.ac.nz
Contact person for scientific queries
Name 46084 0
Ms Fleur Bethell
Address 46084 0
Massey University
26 Norwood Road
Bayswater
Auckland 0622
Country 46084 0
New Zealand
Phone 46084 0
+64 276411886
Fax 46084 0
Email 46084 0
bethell@windowslive.com

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.