Trial Review

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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
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reducing Risk Factors for Cognitive Decline Through Psychological Interventions: A Pilot Randomised Controlled Trial
Scientific title
Pilot Randomised Controlled Trial of low and high intensity psychosocial therapy for reducing emotional risk factors for cognitive decline in older adults.
Secondary ID [1] 294629 0
NIL
Universal Trial Number (UTN)
U1111-1214-7131
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Decline 307467 0
Depression 307468 0
Anxiety 307469 0
Condition category
Condition code
Neurological 306553 306553 0 0
Dementias
Mental Health 306554 306554 0 0
Depression
Mental Health 307056 307056 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 300933 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 306026 0
Changes in diagnostic severity according to the Anxiety Disorders Interview Schedule
Timepoint [1] 306026 0
Immediately Post treatment, and maintenance of gains at follow up (3 months post-treatment).
Secondary outcome [1] 347384 0
Change in Geriatric Anxiety Inventory total score
Timepoint [1] 347384 0
Immediately Post treatment
Secondary outcome [2] 347531 0
Change in Geriatric Anxiety Inventory total score
Timepoint [2] 347531 0
Three months post-intervention
Secondary outcome [3] 347532 0
Centre for Epidemiological Studies -Depression Scale total score
Timepoint [3] 347532 0
Immediately post-intervention
Secondary outcome [4] 347533 0
Centre for Epidemiological Studies - Depression Scale total score
Timepoint [4] 347533 0
Three months post intervention
Secondary outcome [5] 347534 0
World Health Organisation Quality of Life Measure Brief - Psychological and Social Relationship subscales total score
Timepoint [5] 347534 0
Immediately post intervention
Secondary outcome [6] 347535 0
World Health Organisation Quality of Life Scale - Brief; Psychological and Social Relationship subscales total score
Timepoint [6] 347535 0
Three months post-intervention
Secondary outcome [7] 347536 0
Mini Addenbrooke Cognitive Examination Revised total score
Timepoint [7] 347536 0
Immediate post treatment
Secondary outcome [8] 347537 0
Mini Addenbrooke Cognitive Examination Delayed memory subscale
Timepoint [8] 347537 0
Three months post-intervention
Secondary outcome [9] 347538 0
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.
Timepoint [9] 347538 0
Immediately post treatment
Secondary outcome [10] 347539 0
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.
Timepoint [10] 347539 0
Three months post treatment
Secondary outcome [11] 347540 0
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.
Timepoint [11] 347540 0
Immediately post treatment
Secondary outcome [12] 347541 0
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.
Timepoint [12] 347541 0
Three months post treatment
Secondary outcome [13] 347542 0
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.
Timepoint [13] 347542 0
Immediately post treatment
Secondary outcome [14] 347543 0
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.
Timepoint [14] 347543 0
Three months post treatment
Secondary outcome [15] 347544 0
Number of Cigarettes smoked in past week recorded by participants in a survey developed for the study
Timepoint [15] 347544 0
Immediately post treatment
Secondary outcome [16] 347545 0
Number of Cigarettes smoked in past week recorded by participants in a survey developed for the study
Timepoint [16] 347545 0
Three months post treatment
Secondary outcome [17] 347546 0
Number of alcohol drinks in past week recorded by participants in a survey developed for the study
Timepoint [17] 347546 0
Immediately post treatment
Secondary outcome [18] 347547 0
Number of alcohol drinks in past week recorded by participants in a survey developed for the study
Timepoint [18] 347547 0
Immediately post treatment
Secondary outcome [19] 347548 0
Number of alcohol drinks in past week recorded by participants in a survey developed for the study
Timepoint [19] 347548 0
Three months post treatment
Secondary outcome [20] 347549 0
BMI calculating using participant response to a survey of current height and weight
Timepoint [20] 347549 0
Immediately post treatment
Secondary outcome [21] 347550 0
BMI calculating using participant response to a survey of current height and weight
Timepoint [21] 347550 0
Three months post treatment

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)
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Delirium, likely dementia (Mini Addenbrooke Cognitive Examination Scores less than or equal to 21), active suicidal ideation, and psychosis

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)
Sealed envelopes.
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.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/04/2015
Date of last participant enrolment
Anticipated
Actual
2/09/2016
Date of last data collection
Anticipated
Actual
20/04/2017
Sample size
Target
27
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299246 0
University
Name [1] 299246 0
Macquarie University Research Development Grant
Country [1] 299246 0
Australia
Primary sponsor type
University
Name
Centre for Emotional Health, Macquarie University
Address
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road,
North Ryde,
NSW, Australia 2109
Country
Australia
Secondary sponsor category [1] 298519 0
None
Name [1] 298519 0
Address [1] 298519 0
Country [1] 298519 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300167 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 300167 0
Ethics committee country [1] 300167 0
Date submitted for ethics approval [1] 300167 0
Approval date [1] 300167 0
10/03/2015
Ethics approval number [1] 300167 0

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

Contacts
Principal investigator
Name 82762 0
A/Prof Viviana Wuthrich
Address 82762 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road,
North Ryde,
NSW, Australia 2109
Country 82762 0
Australia
Phone 82762 0
+61 2 9850 4866
Fax 82762 0
Email 82762 0
Viviana.Wuthrich@mq.edu.au
Contact person for public queries
Name 82763 0
Viviana Wuthrich
Address 82763 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road,
North Ryde,
NSW, Australia 2109
Country 82763 0
Australia
Phone 82763 0
+61 2 9850 4866
Fax 82763 0
Email 82763 0
Viviana.Wuthrich@mq.edu.au
Contact person for scientific queries
Name 82764 0
Viviana Wuthrich
Address 82764 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Road,
North Ryde,
NSW, Australia 2109
Country 82764 0
Australia
Phone 82764 0
+61 2 9850 4866
Fax 82764 0
Email 82764 0
Viviana.Wuthrich@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Means and averages for the sample are reported in the scientific paper.


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
SourceTitleYear of PublicationDOI
EmbaseReducing risk factors for cognitive decline through psychological interventions: A pilot randomized controlled trial.2019https://dx.doi.org/10.1017/S1041610218001485
N.B. These documents automatically identified may not have been verified by the study sponsor.