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Trial registered on ANZCTR
Registration number
ACTRN12620000859987
Ethics application status
Approved
Date submitted
3/07/2020
Date registered
28/08/2020
Date last updated
22/10/2021
Date data sharing statement initially provided
28/08/2020
Date results information initially provided
22/10/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Delivery Techniques for Cognitive-Behavioural Stress Management: A Feasibility Study
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Scientific title
Delivery Techniques for Cognitive-Behavioural Stress Management in Healthy Older Female Adults: A Feasibility Study
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Secondary ID [1]
301674
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Nil known
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Universal Trial Number (UTN)
U1111-1252-8484
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Trial acronym
N/A
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Linked study record
N/A
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Health condition
Health condition(s) or problem(s) studied:
Stress
318115
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Condition category
Condition code
Mental Health
316134
316134
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0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants who are randomly allocated to the intervention group will complete one module of Cognitive-Behavioural Stress Management (CBSM) therapy delivered by a digital human (“DH-CBSM”). A digital human is an animated, embodied conversational agent that is presented on a computer screen. It uses artificial intelligence to provide social and emotional engagement.
Participation will occur in a private clinic room at the University of Auckland Clinical Research Centre, Auckland, New Zealand. Participants will interact with the digital human software for 90 minutes to complete one module of CBSM. This module involves learning about stress management and practicing two stress management skills: stress symptom awareness and a deep breathing exercise (guided 6 slow breaths of 10 seconds in length). Participants will be provided with a paper therapy manual that includes supporting information and exercises for learning about stress awareness and planning their deep breathing practice. Participants will complete the therapy module individually and in private with a research assistant accessible in a nearby room for technical support if needed.
In the two weeks after the face-to-face session, participants will be required to complete online homework exercises remotely. These involve watching three psychoeducation videos on stress management and practicing a deep breathing exercise. Homework exercises will take up to one hour to complete over the two weeks. Overall, participation in the study will require a total of two hours and 45 minutes per participant (face-to-face session plus homework exercises).
The therapy manual and psychoeducation videos were adapted to this study from a 10-week Cognitive-Behavioral Stress Management group therapy program that are not publicly available.
Intervention adherence (homework completion) will be assessed using a self-report measure administered at two weeks follow-up.
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Intervention code [1]
317982
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Behaviour
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Comparator / control treatment
This study includes two comparator conditions which involve delivery of one module of Cognitive-Behavioural Stress Management (CBSM) therapy by either: (1) An electronic self-help book (“SH-CBSM”); (2) A human therapist over video call (“HV-CBSM”).
Participation will occur in a private clinic room at the University of Auckland Clinical Research Centre, Auckland, New Zealand. Participants will either read an electronic manual on a website or interact with a human therapist over video call for 90 minutes to complete one module of CBSM. The human therapist will be a Masters level pre-intern health psychologist who will be trained in CBSM and supervised by a senior health psychologist. The electronic manual is designed specifically for this study. The CBSM module participants complete in the control conditions contains identical content to the intervention condition. Participants will complete the therapy module individually and in private with a research assistant accessible in a nearby room for technical support if needed.
Participants in both control conditions will be required to remotely complete the same online homework exercises as the intervention group in the two weeks after the face-to-face session. Overall, participation in the study will require a total of two hours and 45 minutes per participant (face-to-face session plus homework exercises).
Intervention adherence (homework completion) will be assessed using a self-report measure administered at two weeks follow-up.
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Control group
Active
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Outcomes
Primary outcome [1]
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Acceptability of delivery method as assessed by self-report measures designed for the study (2 7-point likert scale items, 8 written open-ended qualitative questions, 4 visual analogue scales)
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Assessment method [1]
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Timepoint [1]
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Immediately post-completion of CBSM module
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Primary outcome [2]
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Acceptability of delivery method as assessed by intervention completion
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Assessment method [2]
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Timepoint [2]
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Immediately post-completion of CBSM module, two-week follow-up
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Primary outcome [3]
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Feasibility of delivery method as assessed by number of technical difficulties during the intervention (participant self-report answer to written open-ended question in post-intervention questionnaire; reported by therapist; data from audiovisual recording of participant interaction with digital human)
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Assessment method [3]
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Timepoint [3]
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Immediately post-completion of CBSM module, two-week follow-up
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Secondary outcome [1]
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Feasibility of recruitment process as measured by number of participants from different recruitment methods (flyers posted: physically at University of Auckland Clinical Research Centre, physically at Auckland City Hospital, online at University of Auckland Faculty of Medical and Health Sciences [FMHS] Research Recruitment website, online at University of Auckland FMHS social media accounts with posts targeted to older adult females in the greater Auckland area).
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Assessment method [1]
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Timepoint [1]
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At completion of study
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Secondary outcome [2]
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Feasibility of measurement tools as assessed by missing data from questionnaires
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Assessment method [2]
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Timepoint [2]
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Immediately post-completion of CBSM module, two-week follow-up
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Secondary outcome [3]
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Changes in perceived general stress as measured by the Perceived Stress Scale
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Assessment method [3]
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Timepoint [3]
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Baseline, two-week follow-up
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Secondary outcome [4]
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Changes in perceived present moment stress as measured by a 100mm visual analogue scale
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Assessment method [4]
384323
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Timepoint [4]
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Immediately post-completion of CBSM module, daily during two-week follow-up, two-week follow-up
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Secondary outcome [5]
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Physiological stress as indicated by average heart rate (Empatica E4 wrist-worn sensor)
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Assessment method [5]
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Timepoint [5]
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Continuously from 5 minutes prior to intervention through to 15 minutes post-intervention.
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Secondary outcome [6]
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Stress management skills as assessed by the Measure of Current Status
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Assessment method [6]
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Timepoint [6]
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Immediately post-completion of CBSM module, two-week follow-up
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Secondary outcome [7]
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Changes in distress as measured by a composite score of the Profile of Mood States anxiety, depression, and anger subscales
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Assessment method [7]
384326
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Timepoint [7]
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Baseline, two-week follow-up
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Secondary outcome [8]
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Therapist rapport as measured by the Working Alliance Inventory bond subscale
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Assessment method [8]
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Timepoint [8]
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Immediately post-completion of CBSM module
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Secondary outcome [9]
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Changes in optimism as measured by the Revised Life Orientation scale
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Assessment method [9]
384328
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Timepoint [9]
384328
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Baseline, two-week follow-up
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Secondary outcome [10]
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Physiological stress as measured by electrodermal activity (Empatica E4 wrist-worn sensor)
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Assessment method [10]
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Timepoint [10]
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Continuously from 5 minutes prior to intervention through to 15 minutes post-intervention.
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Secondary outcome [11]
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Physiological stress as measured by skin temperature (Empatica E4 wrist-worn sensor)
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Assessment method [11]
385265
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Timepoint [11]
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Continuously from 5 minutes prior to intervention through to 15 minutes post-intervention.
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Eligibility
Key inclusion criteria
To be included in this study, potential participants must be female adults aged 30 years or older with English fluency, who identify as experiencing general stress at the time of recruitment.
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Minimum age
30
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
None
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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)
Participants will be randomly allocated into one of the DH-CBSM, SH-CBSM, or HV-CBSM conditions by a researcher using Research Randomizer software. Group allocations will be concealed in sealed opaque envelopes.
Another researcher will conduct eligibility screens and enrol participants into the study over email. Once a participant has been enrolled into the study, provided written informed consent, and completed a baseline questionnaire online, the researcher will open the envelope to reveal which condition the participant has been allocated to and schedule a time for the participant to attend a face-to-face session at University of Auckland Clinical Research Centre.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
A total of 36 participants will be recruited as a minimum of 12 participants per group is recommended for a feasibility study due to precision about the mean and variance (Julious, 2005).
Data will be analysed using SPSS Version 26 software. A series of one-way analyses of variance (ANOVA) and analyses of covariance (ANCOVA) with post hoc tests will be conducted to analyse the effect of CBSM delivery method on the following outcomes: feasibility, acceptability, stress, distress, stress management skills, optimism, and rapport (for the DH-CBSM and HV-CBSM conditions). Qualitative data on intervention acceptability will be coded by two independent raters using conventional content analysis methods. Raters will derive a list of themes that represent the data.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
7/09/2020
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Actual
12/04/2021
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Date of last participant enrolment
Anticipated
7/12/2020
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Actual
14/05/2021
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Date of last data collection
Anticipated
21/12/2020
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Actual
28/05/2021
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Sample size
Target
36
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Accrual to date
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Final
43
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Recruitment outside Australia
Country [1]
22709
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New Zealand
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State/province [1]
22709
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Auckland
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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The University of Auckland
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Address [1]
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Department of Psychological Medicine
The University of Auckland School of Medicine
Private Bag 92019
Auckland 1142
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Country [1]
306110
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New Zealand
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Funding source category [2]
306111
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Commercial sector/Industry
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Name [2]
306111
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Soul Machines Ltd
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Address [2]
306111
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Soul Machines Ltd
106 Customs Street West
Auckland CBD
Auckland 1010
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Country [2]
306111
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New Zealand
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Primary sponsor type
University
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Name
The University of Auckland
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Address
Department of Psychological Medicine
The University of Auckland School of Medicine
Private Bag 92019
Auckland 1142
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Country
New Zealand
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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Soul Machines Ltd
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Address [1]
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Soul Machines Ltd
106 Customs Street West
Auckland CBD
Auckland 1142
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Country [1]
306578
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New Zealand
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Other collaborator category [1]
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University
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Name [1]
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University of Miami
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Address [1]
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Department of Psychology and Center for Psycho-Oncology Research
University of Miami
Flipse Building 413, 0751
5555 Ponce de Leon Blvd
Coral Gables, FL 33146
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Country [1]
281379
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United States of America
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The University of Auckland Human Participants Ethics Committee (UAHPEC)
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Ethics committee address [1]
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The University of Auckland Human Participants Ethics Committee
The University of Auckland
Research Office
Private Bag 92019, Auckland 1142
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Ethics committee country [1]
306325
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New Zealand
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Date submitted for ethics approval [1]
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04/11/2019
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Approval date [1]
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17/12/2019
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Ethics approval number [1]
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024085
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Summary
Brief summary
This study will investigate whether a digital human is a feasible way to deliver Cognitive-Behavioural Stress Management (CBSM) therapy to healthy older adult women experiencing stress, compared to an electronic self-help manual and a human therapist over video call. Participants will be randomly allocated to complete one module of CBSM therapy using one of the three delivery methods. The session will take place in a private clinic room at the University of Auckland Clinical Research Centre, Auckland, New Zealand. The module takes 90 minutes to complete and involves learning about stress management and practicing two stress management skills: stress symptom awareness and deep breathing. Participants will be provided with a paper manual and a homework website that contains psychoeducational videos and exercises to be completed in the two weeks following the face-to-face session. Overall, participation in the study will require a total of two hours and 45 minutes per participant (face-to-face session plus homework exercises). Data will be collected on the acceptability of the delivery method and intervention, intervention feasibility, stress, distress, stress management skills, optimism, and therapist rapport (where applicable).
It is hypothesized that a digital human will be a feasible way to deliver Cognitive-Behavioural Stress Management therapy to healthy older adult women. Results will inform the design of a larger scale randomized controlled trial to evaluate the effectiveness of a digital human at delivering a 10-week CBSM therapy to older adult women with breast cancer.
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Trial website
N/A
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Trial related presentations / publications
N/A
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Public notes
N/A
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Contacts
Principal investigator
Name
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Prof Elizabeth Broadbent
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Address
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Department of Psychological Medicine
The University of Auckland School of Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019, Auckland, 1142
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Country
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New Zealand
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Phone
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+6493737599
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Elizabeth Broadbent
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Address
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Department of Psychological Medicine
The University of Auckland School of Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019, Auckland, 1142
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Country
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New Zealand
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Phone
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+6493737599
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Fax
103515
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Elizabeth Broadbent
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Address
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Department of Psychological Medicine
The University of Auckland School of Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019, Auckland, 1142
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Country
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New Zealand
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Phone
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+6493737599
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Fax
103516
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Email
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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
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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
No additional documents have been identified.
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