Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000245392
Ethics application status
Approved
Date submitted
13/02/2017
Date registered
17/02/2017
Date last updated
17/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of early motivational interviewing on post-stroke depressive symptoms: a pilot randomised controlled trial of the Good Mood Intervention program.
Scientific title
Effects of early motivational interviewing on post-stroke depressive symptoms: a pilot randomised controlled trial of the Good Mood Intervention program.
Secondary ID [1] 291164 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
Good Mood Study
Linked study record
Nil known

Health condition
Health condition(s) or problem(s) studied:
Depression 302030 0
Anxiety 302060 0
Stroke 302106 0
Condition category
Condition code
Stroke 301666 301666 0 0
Ischaemic
Mental Health 301667 301667 0 0
Anxiety
Mental Health 301725 301725 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group patients will receive early motivational interviewing (MI), provided by facilitators (nurses or social workers) during the acute in-patient hospitalisation after presentation with stroke. Facilitators will have completed a full-day workshop and completed an online training module.
MI will comprise 3, 30-minute individual sessions, performed prior to hospital discharge from the acute episode.. Generally, the sessions will occur on 3 separate and consecutive days. The rationale for using multiple sessions is (a) due to the complexity of the problems of stroke and depression, and (b) there is a significant positive relationship between the amount of MI a person receives and treatment outcomes.
A summary of the 3 sessions follows:
1: Setting agenda and encouraging patient to talk about adjustment to stroke;
2: Eliciting realistic goals for recovery, and barriers to achieving goals; and,
3: Identifying ambivalence about achieving goals; supporting patient’s optimism and self-efficacy, and identifying solutions to problems.
Fidelity will be assessed for all facilitators on an individual basis after review of recorded interviews. Further training will be provided for facilitators who do not demonstrate appropriate technique for MI.
Intervention code [1] 297158 0
Treatment: Other
Intervention code [2] 297178 0
Rehabilitation
Intervention code [3] 297201 0
Behaviour
Comparator / control treatment
The control treatment is defined as the routine care provided by nursing, medical and allied health staff. Patients ordinarily receive, on an ad-hoc basis, technical brochures regarding depression after stroke from nurse clinicians.
Control group
Active

Outcomes
Primary outcome [1] 301062 0
Change in Anxiety levels using the Hospital Anxiety and Depression Scale.
Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatricia Scandinavica 1983;67:361-70.
Timepoint [1] 301062 0
Baseline prior to intervention.
One-month and 3-months post-intervention commencement.
Primary outcome [2] 301063 0
Change in Depression levels using the Hospital Anxiety and Depression Scale and Patient Health Questionnaire (PHQ9).
Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatricia Scandinavica 1983;67:361-70.
Kroenke K1, Spitzer RL, Williams JB.The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13.
Timepoint [2] 301063 0
Baseline prior to intervention.
One-month and 3-months post-intervention commencement.
Primary outcome [3] 301064 0
Change in Quality of Life using the Quality of Life Index.
Ferrans CE, Powers BR. Quality of Life Index: development and psychometric properties. Advances in Nursing Science 1985;8:15-25.
Timepoint [3] 301064 0
Baseline prior to intervention.
One-month and 3-months post-intervention commencement.
Secondary outcome [1] 331629 0
Differences in activities of daily living using the Modified Rankin Scale,
Mahoney FI, Barthel DW. Functional evaluation: the Barthel Index. Maryland State Medical Journal 1965;14:61-65.
Timepoint [1] 331629 0
Baseline prior to intervention.
One-month and 3-months post-intervention commencement.

Eligibility
Key inclusion criteria
acute presentation after an acute stroke (cerebral infarction/intracerebral haemorrhage); cognitively alert;
aged 18 years and over;
patients who could speak and read English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
subarachnoid haemorrhage;
subdural haematoma;
severe cognitive/communication problems such as significant dysphasia or aphasia; mental health conditions including depressive symptoms requiring professional support one month prior to stroke;
concurrent neurological disease/trauma; and,
myocardial infarction.

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)
To avoid selection bias and secure allocation concealment, codes will not be revealed to the Research Assistant.
Allocation was concealed by sealed opaque envelopes.
Intervention group participants will be assigned to a facilitator (multi-disciplinary stroke team member including nurse or allied health staff member), who will not be involved in initial assessment, randomisation or assignment of patients to them for MI.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by a computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Summary statistics were used for demographic characteristics and baseline and follow-up time-point measures.
Participant characteristics were compared using chi-square test (including Fisher’s Exact test for fields with n<5) and T-Test using SPSS.
General Linear Model with Repeated-measures was performed to explore predictors of treatment response, with statistical significance set at p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/09/2013
Date of last participant enrolment
Anticipated
Actual
14/08/2014
Date of last data collection
Anticipated
Actual
3/11/2014
Sample size
Target
30
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7471 0
Western Hospital - Footscray - Footscray
Recruitment postcode(s) [1] 15300 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 295605 0
University
Name [1] 295605 0
Victoria University
Country [1] 295605 0
Australia
Funding source category [2] 295608 0
Charities/Societies/Foundations
Name [2] 295608 0
National Stroke Foundation (Victoria)
Country [2] 295608 0
Australia
Primary sponsor type
Individual
Name
Debra Kerr
Address
College of Health and Biomedicine
Victoria University
PO Box 14428
Melbourne
Victoria
8001
Country
Australia
Secondary sponsor category [1] 294443 0
None
Name [1] 294443 0
Not applicable
Address [1] 294443 0
Not applicable
Country [1] 294443 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296924 0
Western Hospital Low Risk Ethics Panel
Ethics committee address [1] 296924 0
Ethics committee country [1] 296924 0
Australia
Date submitted for ethics approval [1] 296924 0
07/01/2012
Approval date [1] 296924 0
20/02/2013
Ethics approval number [1] 296924 0
HREC/13/WH/9

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

Contacts
Principal investigator
Name 72446 0
A/Prof Debra Kerr
Address 72446 0
Deakin University
1 Gheringhap St
Geelong
Victoria
3220
Country 72446 0
Australia
Phone 72446 0
61 3 5227 2501
Fax 72446 0
Email 72446 0
[email protected]
Contact person for public queries
Name 72447 0
Debra Kerr
Address 72447 0
Deakin University
1 Gheringhap St
Geelong
Victoria
3220
Country 72447 0
Australia
Phone 72447 0
61 3 5227 2501
Fax 72447 0
Email 72447 0
[email protected]
Contact person for scientific queries
Name 72448 0
Debra Kerr
Address 72448 0
Deakin University
1 Gheringhap St
Geelong
Victoria
3220
Country 72448 0
Australia
Phone 72448 0
61 3 5227 2501
Fax 72448 0
Email 72448 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.