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Trial registered on ANZCTR
Registration number
ACTRN12618000939291
Ethics application status
Approved
Date submitted
25/05/2018
Date registered
4/06/2018
Date last updated
13/02/2019
Date data sharing statement initially provided
13/02/2019
Date results information initially provided
13/02/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Reducing Risk Factors for Cognitive Decline Through Psychological Interventions: A Pilot Randomised Controlled Trial
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Scientific title
Pilot Randomised Controlled Trial of low and high intensity psychosocial therapy for reducing emotional risk factors for cognitive decline in older adults.
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Secondary ID [1]
294629
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NIL
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Universal Trial Number (UTN)
U1111-1214-7131
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cognitive Decline
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Depression
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Anxiety
307469
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Condition category
Condition code
Neurological
306553
306553
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0
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Dementias
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Mental Health
306554
306554
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0
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Depression
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Mental Health
307056
307056
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A 1 hour one-on-one session per week for 16 weeks using a manualised Cognitive Behavioural Therapy with Motivational Interviewing program. Skills included: Psychoeducation, Mood Monitoring, Activity scheduling, Cognitive Restructuring, Graded Exposure, Problem Solving applied to mood management and lifestyle risks (smoking, alcohol use, obesity, physical inactivity). The program was delivered by Clinical Psychologists and Clinical Psychology registrars, supervised by the Chief Investigator to ensure treatment adherence.
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Intervention code [1]
300933
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Behaviour
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Comparator / control treatment
A 16 week work-at-home Cognitive Behavioural Therapy workbook. Sessions were supported by weekly 15 minute phone calls from Clinical Psychologists and Clinical Psychology registrars, supervised by the Chief Investigator to ensure treatment adherence, monitor participant risk and maintain motivation.
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Control group
Active
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Outcomes
Primary outcome [1]
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Changes in diagnostic severity according to the Anxiety Disorders Interview Schedule
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Assessment method [1]
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Timepoint [1]
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Immediately Post treatment, and maintenance of gains at follow up (3 months post-treatment).
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Secondary outcome [1]
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Change in Geriatric Anxiety Inventory total score
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Assessment method [1]
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Timepoint [1]
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Immediately Post treatment
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Secondary outcome [2]
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Change in Geriatric Anxiety Inventory total score
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Assessment method [2]
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Timepoint [2]
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Three months post-intervention
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Secondary outcome [3]
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Centre for Epidemiological Studies -Depression Scale total score
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Assessment method [3]
347532
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Timepoint [3]
347532
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Immediately post-intervention
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Secondary outcome [4]
347533
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Centre for Epidemiological Studies - Depression Scale total score
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Assessment method [4]
347533
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Timepoint [4]
347533
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Three months post intervention
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Secondary outcome [5]
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World Health Organisation Quality of Life Measure Brief - Psychological and Social Relationship subscales total score
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Assessment method [5]
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Timepoint [5]
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Immediately post intervention
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Secondary outcome [6]
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World Health Organisation Quality of Life Scale - Brief; Psychological and Social Relationship subscales total score
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Assessment method [6]
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Timepoint [6]
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Three months post-intervention
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Secondary outcome [7]
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Mini Addenbrooke Cognitive Examination Revised total score
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Assessment method [7]
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Timepoint [7]
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Immediate post treatment
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Secondary outcome [8]
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Mini Addenbrooke Cognitive Examination Delayed memory subscale
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Assessment method [8]
347537
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Timepoint [8]
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Three months post-intervention
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Secondary outcome [9]
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Number of High Quality Social Activities per week recorded by participants in a diary and coded by two raters against scoring criteria developed for the study.
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Assessment method [9]
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Timepoint [9]
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Immediately post treatment
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Secondary outcome [10]
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Number of High Quality Social Activities per week recorded by participants in a diary and coded by two raters against scoring criteria developed for the study.
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Assessment method [10]
347539
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Timepoint [10]
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Three months post treatment
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Secondary outcome [11]
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Number of High Quality Mental Activities per week recorded by participants in a diary and coded by two raters against scoring criteria developed for the study.
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Assessment method [11]
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Timepoint [11]
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Immediately post treatment
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Secondary outcome [12]
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Number of High Quality Mental Activities per week recorded by participants in a diary and coded by two raters against scoring criteria developed for the study.
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Assessment method [12]
347541
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Timepoint [12]
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Three months post treatment
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Secondary outcome [13]
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Number of High Quality Physical Activities per week recorded by participants in a diary and coded by two raters against scoring criteria developed for the study.
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Assessment method [13]
347542
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Timepoint [13]
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Immediately post treatment
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Secondary outcome [14]
347543
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Number of High Quality Physical Activities per week recorded by participants in a diary and coded by two raters against scoring criteria developed for the study.
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Assessment method [14]
347543
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Timepoint [14]
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Three months post treatment
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Secondary outcome [15]
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Number of Cigarettes smoked in past week recorded by participants in a survey developed for the study
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Assessment method [15]
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Timepoint [15]
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Immediately post treatment
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Secondary outcome [16]
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Number of Cigarettes smoked in past week recorded by participants in a survey developed for the study
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Assessment method [16]
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Timepoint [16]
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Three months post treatment
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Secondary outcome [17]
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Number of alcohol drinks in past week recorded by participants in a survey developed for the study
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Assessment method [17]
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Timepoint [17]
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Immediately post treatment
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Secondary outcome [18]
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Number of alcohol drinks in past week recorded by participants in a survey developed for the study
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Assessment method [18]
347547
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Timepoint [18]
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Immediately post treatment
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Secondary outcome [19]
347548
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Number of alcohol drinks in past week recorded by participants in a survey developed for the study
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Assessment method [19]
347548
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Timepoint [19]
347548
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Three months post treatment
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Secondary outcome [20]
347549
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BMI calculating using participant response to a survey of current height and weight
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Assessment method [20]
347549
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Timepoint [20]
347549
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Immediately post treatment
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Secondary outcome [21]
347550
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BMI calculating using participant response to a survey of current height and weight
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Assessment method [21]
347550
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Timepoint [21]
347550
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Three months post treatment
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Eligibility
Key inclusion criteria
Older adults aged 65 years of older
Primary Anxiety or Unipolar Mood Disorder as assessed by the Anxiety Disorders Interview Schedule (ADIS)
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Delirium, likely dementia (Mini Addenbrooke Cognitive Examination Scores less than or equal to 21), active suicidal ideation, and psychosis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was based on a computer generated randomisation sequence entered into sealed envelopes.
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
8/04/2015
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Date of last participant enrolment
Anticipated
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Actual
2/09/2016
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Date of last data collection
Anticipated
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Actual
20/04/2017
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Sample size
Target
27
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Accrual to date
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Final
27
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
299246
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University
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Name [1]
299246
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Macquarie University Research Development Grant
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Address [1]
299246
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Macquarie University
Balaclava Road,
North Ryde,
NSW, Australia, 2109.
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Country [1]
299246
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Australia
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Primary sponsor type
University
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Name
Centre for Emotional Health, Macquarie University
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Address
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road,
North Ryde,
NSW, Australia 2109
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Country
Australia
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Secondary sponsor category [1]
298519
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None
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Name [1]
298519
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Address [1]
298519
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Country [1]
298519
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
300167
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Macquarie University Human Research Ethics Committee Medical Sciences
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Ethics committee address [1]
300167
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Ethics committee country [1]
300167
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Date submitted for ethics approval [1]
300167
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Approval date [1]
300167
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10/03/2015
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Ethics approval number [1]
300167
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Summary
Brief summary
A randomised controlled trial was used to compare the effectiveness of two psychological interventions for reducing risk for cognitive decline in older adults. It was hypothesised that the more intensive intervention would show greater benefits for risk reduction.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Viviana Wuthrich
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Address
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Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road,
North Ryde,
NSW, Australia 2109
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Country
82762
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Australia
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Phone
82762
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+61 2 9850 4866
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Fax
82762
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Email
82762
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[email protected]
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Contact person for public queries
Name
82763
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A/Prof Viviana Wuthrich
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Address
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Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road,
North Ryde,
NSW, Australia 2109
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Country
82763
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Australia
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Phone
82763
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+61 2 9850 4866
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Fax
82763
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Email
82763
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[email protected]
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Contact person for scientific queries
Name
82764
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A/Prof Viviana Wuthrich
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Address
82764
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Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road,
North Ryde,
NSW, Australia 2109
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Country
82764
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Australia
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Phone
82764
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+61 2 9850 4866
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Fax
82764
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Email
82764
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Means and averages for the sample are reported in the scientific paper.
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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
Source
Title
Year of Publication
DOI
Embase
Reducing risk factors for cognitive decline through psychological interventions: A pilot randomized controlled trial.
2019
https://dx.doi.org/10.1017/S1041610218001485
N.B. These documents automatically identified may not have been verified by the study sponsor.
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