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Delivery Techniques for Cognitive-Behavioural Stress Management: A Feasibility Study

Delivery Techniques for Cognitive-Behavioural Stress Management in Healthy Older Female Adults: A Feasibility Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000859987
Acronym
N/A
Enrollment
43
Registered
2020-08-28
Start date
2021-04-12
Completion date
2021-05-14
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 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.

Sponsors

The University of Auckland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
30 Years to No maximum
Healthy volunteers
Yes

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.

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 10, 2026