Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000240044
Ethics application status
Approved
Date submitted
22/03/2010
Date registered
23/03/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The relationship between positive mastery recollections and hopelessness in older adults
Scientific title
The efficacy of a reminiscence based intervention for reducing reportedly high levels of hopelessness in older adults
Secondary ID [1] 1533 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hopelessness 256906 0
Mood 256907 0
Self efficacy 256908 0
Condition category
Condition code
Mental Health 257055 257055 0 0
Depression
Mental Health 257056 257056 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of a reminiscence activity (lasting approximately 20 minutes in a single session). In the face-to-face session, participants are asked by a psychologist several questions that prompt memories of situations in which they were successful at solving problems or overcoming obstacles. These questions are designed to prime the participant to remember mastery related experiences.
Intervention code [1] 256105 0
Behaviour
Intervention code [2] 256186 0
Treatment: Other
Comparator / control treatment
Participants in the control condition are not administered this reminiscence activity.
Control group
Active

Outcomes
Primary outcome [1] 258049 0
Mean level of hopelessness, as measured by Beck Hopelessness Scale (BHS)
Timepoint [1] 258049 0
Baseline (time 1), post-treatment (time 2), 1 month after baseline (time 3) and 2 months after baseline (time 4)
Secondary outcome [1] 263629 0
Mean level of self-efficacy as measured by Pearline Mastery Scale
Timepoint [1] 263629 0
Baseline (time 1), post-treatment (time 2), 1 month after baseline (time 3) and 2 months after baseline (time 4)
Secondary outcome [2] 263630 0
Mean level of depressed mood as measured by the Profile of Mood States (Short form depressed subscale)
Timepoint [2] 263630 0
Baseline (time 1), post-treatment (time 2), 1 month after baseline (time 3) and 2 months after baseline (time 4)

Eligibility
Key inclusion criteria
To be eligible for the study, participants must (a) be at least 60 years (b) report high levels of hopeleness (as indicated by a score of 2 or more on item 2 of the Beck Depression Inventory –II), (c) demonstrate adequate cognitive functioning (as indicated by a score of 23 or more on the Mini Mental Status Examination).
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants who appear unable to participate in screening procedures due to health or language related limitations will not be eligible for participation. .

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Referrals will be sought from health professionals, aged care facilities and public notices. Individuals interested in participating will be invited to to speak to their health professional or researchers.
Potential participants will be screened for study eligibility. Eligible participants will be consented. Allocation codes will be concealed from researchers who are responsible for enrolling the participants or administering study procedures. Codes will be sealed in opaque enveloped and revealed after enrollment and pre-treatment procedurs.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to one of two conditions using an unrestricted method of randomization. Simple randomisation is accomplished by using a randomisation table created by a computer software (i.e., computerised sequence generation).
Masking / blinding
Blinded (masking 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
Recruiting
Date of first participant enrolment
Anticipated
1/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2620 0
3128
Recruitment postcode(s) [2] 2621 0
3101

Funding & Sponsors
Funding source category [1] 256682 0
Charities/Societies/Foundations
Name [1] 256682 0
American Foundation for Suicide Prevention
Country [1] 256682 0
United States of America
Primary sponsor type
Individual
Name
Sunil Bhar
Address
Faculty of Life and Social Sciences, Mail H24, PO Box 218, Hawthorn, Victoria 3122
Country
Australia
Secondary sponsor category [1] 255971 0
None
Name [1] 255971 0
Address [1] 255971 0
Country [1] 255971 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258707 0
Swinburne Human Research and Ethics
Ethics committee address [1] 258707 0
Mail H28, PO Box 218, Hawthorn Victoria 3122
Ethics committee country [1] 258707 0
Australia
Date submitted for ethics approval [1] 258707 0
Approval date [1] 258707 0
24/08/2009
Ethics approval number [1] 258707 0
2009/179

Summary
Brief summary
This study examines if reminiscing about past mastery experiences results in reduced hopelessness, improved mood and increased self-efficacy in older adults.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30896 0
Address 30896 0
Country 30896 0
Phone 30896 0
Fax 30896 0
Email 30896 0
Contact person for public queries
Name 14143 0
Dr Sunil Bhar
Address 14143 0
Mail H24, PO Box 218, Hawthorn Victoria 3122
Country 14143 0
Australia
Phone 14143 0
+ 61 3 9214 8317
Fax 14143 0
+61 3 9819 0821
Email 14143 0
[email protected]
Contact person for scientific queries
Name 5071 0
Dr Sunil Bhar
Address 5071 0
Mail H24, PO Box 218, Hawthorn Victoria 3122
Country 5071 0
Australia
Phone 5071 0
+ 61 3 9214 8317
Fax 5071 0
+61 3 9819 0821
Email 5071 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.