Authors
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The University of Auckland -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2020
INTERVENTION: 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 tha CONDITION: Mental Health ‐ Studies of normal psychology, cognitive function and behaviour Stress; ; Stress PRIMARY OUTCOME: Acceptability of delivery method as assessed by intervention completion [Immediately post‐completion of CBSM module, two‐week follow‐up] 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) [Immediately post‐completion of CBSM module] 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)[Immediately post‐completion of CBSM module, two‐week follow‐up] INCLUSION CRITERIA: To be included in this study, potential participants must be female adults aged 50 years or older with English fluency, who identify as experiencing general stress at the time of recruitment. SECONDARY OUTCOME: Changes in distress as measured by a composite score of the Profile of Mood States anxiety, depression, and anger subscales[Baseline, two‐week follow‐up] Changes in optimism as measured by the Revised Life Orientation scale [Baseline, two‐week follow‐up] Changes in perceived general stress as measured by the Perceived Stress Scale[Baseline, two‐week follow‐up] Changes in perceived present moment stress as measured by a 100mm visual analogue scale[Immediately post‐completion of CBSM module, daily during two‐week follow‐up, two‐week follow‐up] Feasibility of measurement tools as assessed by missing data from questionnaires[Immediately post‐completion of CBSM module, two‐week follow‐up] 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). [At completion of study ] Physiological stress as indicated by average heart rate (Empatica E4 wrist‐worn sensor)[Continuously from 5 minutes prior to intervention through to 15 minutes post‐intervention.] Physiological stress as measured by electrodermal activity (Empatica E4 wrist‐worn sensor)[Continuously from 5 minutes prior to intervention through to 15 minutes post‐intervention. ] Physiological stress as measured by skin temperature (Empatica E4 wrist‐worn sensor)[Continuously from 5 minutes prior to intervention through to 15 minutes post‐intervention. ] Stress management skills as assessed by the Measure of Current Status [Immediately post‐completion of CBSM module, two‐week follow‐up] Therapist rapport as measured by the Working Alliance Inventory bond subscale[Immediately post‐completion of CBSM module]
Epistemonikos ID: d89b9bfa00f52b962cef9ed89757c547483b2db2
First added on: Aug 24, 2024