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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
Type of registration
Prospectively registered

Titles & IDs
Public title
Delivery Techniques for Cognitive-Behavioural Stress Management: A Feasibility Study
Scientific title
Delivery Techniques for Cognitive-Behavioural Stress Management in Healthy Older Female Adults: A Feasibility Study
Secondary ID [1] 301674 0
Nil known
Universal Trial Number (UTN)
U1111-1252-8484
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Stress 318115 0
Condition category
Condition code
Mental Health 316134 316134 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 317982 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 324324 0
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)
Timepoint [1] 324324 0
Immediately post-completion of CBSM module
Primary outcome [2] 324325 0
Acceptability of delivery method as assessed by intervention completion
Timepoint [2] 324325 0
Immediately post-completion of CBSM module, two-week follow-up
Primary outcome [3] 324326 0
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)
Timepoint [3] 324326 0
Immediately post-completion of CBSM module, two-week follow-up
Secondary outcome [1] 384320 0
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).
Timepoint [1] 384320 0
At completion of study
Secondary outcome [2] 384321 0
Feasibility of measurement tools as assessed by missing data from questionnaires
Timepoint [2] 384321 0
Immediately post-completion of CBSM module, two-week follow-up
Secondary outcome [3] 384322 0
Changes in perceived general stress as measured by the Perceived Stress Scale
Timepoint [3] 384322 0
Baseline, two-week follow-up
Secondary outcome [4] 384323 0
Changes in perceived present moment stress as measured by a 100mm visual analogue scale
Timepoint [4] 384323 0
Immediately post-completion of CBSM module, daily during two-week follow-up, two-week follow-up
Secondary outcome [5] 384324 0
Physiological stress as indicated by average heart rate (Empatica E4 wrist-worn sensor)
Timepoint [5] 384324 0
Continuously from 5 minutes prior to intervention through to 15 minutes post-intervention.
Secondary outcome [6] 384325 0
Stress management skills as assessed by the Measure of Current Status
Timepoint [6] 384325 0
Immediately post-completion of CBSM module, two-week follow-up
Secondary outcome [7] 384326 0
Changes in distress as measured by a composite score of the Profile of Mood States anxiety, depression, and anger subscales
Timepoint [7] 384326 0
Baseline, two-week follow-up
Secondary outcome [8] 384327 0
Therapist rapport as measured by the Working Alliance Inventory bond subscale
Timepoint [8] 384327 0
Immediately post-completion of CBSM module
Secondary outcome [9] 384328 0
Changes in optimism as measured by the Revised Life Orientation scale
Timepoint [9] 384328 0
Baseline, two-week follow-up
Secondary outcome [10] 385264 0
Physiological stress as measured by electrodermal activity (Empatica E4 wrist-worn sensor)
Timepoint [10] 385264 0
Continuously from 5 minutes prior to intervention through to 15 minutes post-intervention.
Secondary outcome [11] 385265 0
Physiological stress as measured by skin temperature (Empatica E4 wrist-worn sensor)
Timepoint [11] 385265 0
Continuously from 5 minutes prior to intervention through to 15 minutes post-intervention.

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.
Minimum age
30 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
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.
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/09/2020
Actual
12/04/2021
Date of last participant enrolment
Anticipated
7/12/2020
Actual
14/05/2021
Date of last data collection
Anticipated
21/12/2020
Actual
28/05/2021
Sample size
Target
36
Accrual to date
Final
43
Recruitment outside Australia
Country [1] 22709 0
New Zealand
State/province [1] 22709 0
Auckland

Funding & Sponsors
Funding source category [1] 306110 0
University
Name [1] 306110 0
The University of Auckland
Country [1] 306110 0
New Zealand
Funding source category [2] 306111 0
Commercial sector/Industry
Name [2] 306111 0
Soul Machines Ltd
Country [2] 306111 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Department of Psychological Medicine
The University of Auckland School of Medicine
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 306578 0
Commercial sector/Industry
Name [1] 306578 0
Soul Machines Ltd
Address [1] 306578 0
Soul Machines Ltd
106 Customs Street West
Auckland CBD
Auckland 1142
Country [1] 306578 0
New Zealand
Other collaborator category [1] 281379 0
University
Name [1] 281379 0
University of Miami
Address [1] 281379 0
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
Country [1] 281379 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306325 0
The University of Auckland Human Participants Ethics Committee (UAHPEC)
Ethics committee address [1] 306325 0
Ethics committee country [1] 306325 0
New Zealand
Date submitted for ethics approval [1] 306325 0
04/11/2019
Approval date [1] 306325 0
17/12/2019
Ethics approval number [1] 306325 0
024085

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

Contacts
Principal investigator
Name 103514 0
Prof Elizabeth Broadbent
Address 103514 0
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
Country 103514 0
New Zealand
Phone 103514 0
+6493737599
Fax 103514 0
Email 103514 0
[email protected]
Contact person for public queries
Name 103515 0
Elizabeth Broadbent
Address 103515 0
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
Country 103515 0
New Zealand
Phone 103515 0
+6493737599
Fax 103515 0
Email 103515 0
[email protected]
Contact person for scientific queries
Name 103516 0
Elizabeth Broadbent
Address 103516 0
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
Country 103516 0
New Zealand
Phone 103516 0
+6493737599
Fax 103516 0
Email 103516 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.