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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001145392
Ethics application status
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Approved
Date submitted
Help: Date submitted
25/08/2026
Date registered
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15/09/2026
Date last updated
Help: Date last updated
15/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
15/09/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
A pilot feasibility trial of a sensory engagement and reflective practice for flourishing bundled with Lemon Balm tea among health care professionals
Scientific title
Feasibility of a bundled sensory engagement and reflective practice for flourishing (SERF) protocol with Lemon Balm tea, assessed by recruitment, retention and adherence, among registered health care professionals: A randomised pilot trial
Additional trial identifiers [1] 318262 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Occupational stress 343353 0
Condition category
Condition code
Mental Health 339448 339448 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
What the intervention is:
Both arms follow the same Sensory Engagement and Reflective Practice for Flourishing (SERF) protocol — a daily micro-practice combining mindful tea preparation, controlled breathing, sensory awareness, and reflective journaling. Group allocation determines only the tea: Lemon Balm (Melissa officinalis) tea in the intervention arm, Rooibos (Aspalathus linearis) tea in the comparator arm.

Who delivers it and their relevant expertise:
The protocol is self-administered by participants — there is no clinician-delivered or facilitator-led component. Materials (written SERF practice card, tea, physical journal) are designed and dispatched by the Chief Investigator, Dr Carrie Thomson-Casey (registered Clinical Psychologist; Advanced Diplomas in Naturopathy and Nutritional Medicine), with logistics support from the Research Assistant. No direct instruction, coaching, or supervision is provided during the daily practice itself.

How it is delivered:
Individual, not group-based. Delivered via: (1) a printed SERF Tea Practice card provided at commencement, guiding the daily sensory/breathing/reflection sequence; (2) a private physical journal for optional unstructured reflection (not collected); (3) weekly structured reflective prompts delivered online via REDCap. No face-to-face or synchronous contact with the research team occurs at any stage.

How often and for how long:
Daily: ~10–15 minutes/day for 28 days (tea preparation, SERF micro-practice, optional journaling)
Weekly: brief structured REDCap reflective prompt, ~10 minutes/week, for 4 weeks
Single non-intervention follow-up assessment at Day 56 (28 days after intervention ends), no further practice required

Where it is delivered:
Participant's own home or workplace, at a time of their choosing. All structured data collection and reflective prompts occur via REDCap (SCU-hosted online platform); no physical research site or clinic visit is involved at any stage.

Adherence:
Self-reported via items embedded in the weekly REDCap prompts (number of days in the preceding week the daily practice was completed). The Research Assistant monitors weekly REDCap completion rates and maintains a participant tracking log; non-completion or low adherence is itself treated as feasibility data rather than a protocol deviation to be corrected.

Sensory, breathing, and reflection sequence (SERF micro-practice): A brief (5–10 minute) daily self-administered practice conducted during tea preparation and consumption. Participants engage in structured sensory attention (aroma, warmth, colour, taste of the tea), controlled breathing, and present-moment awareness, guided by a written SERF Tea Practice card provided at study commencement. This is undertaken independently by participants without facilitator contact.

Private physical journaling: Participants are provided with a physical journal to optionally record reflections during the 28-day intervention period. This journaling is for personal use only; it is not collected, accessed, or analysed by the research team and does not form part of the study dataset. It is intended to support personal engagement with the SERF practice rather than serve as a research measure. Participants may use their entries when responding to weekly prompts about their engagement with the practice.

Tea preparation: Participants prepare and consume one cup of brewed tea daily (one teabag per cup) for 28 days.

Intervention arm: Planet Organic Certified Organic Lemon Balm (Melissa officinalis) tea.
Comparator arm: Planet Organic Certified Organic Rooibos (Aspalathus linearis) tea, selected for pharmacological neutrality with no anxiolytic, sedative, or mood-modifying properties at dietary doses.

All three components are self-reported weekly via structured REDCap prompts.
Intervention code [1] 335156 0
Prevention
Intervention code [2] 335157 0
Treatment: Other
Intervention code [3] 335158 0
Behaviour
Description of the comparator or control
What the comparator is:
Rooibos (Aspalathus linearis) tea — a caffeine-free herbal tisane with no established anxiolytic, sedative, or mood-modifying properties at dietary tea doses. Selected as an active, pharmacologically neutral comparator (not a placebo — a genuine, different tea, openly disclosed to participants) to isolate the ritual and sensory contribution of the SERF protocol from any residual pharmacological effect specific to Lemon Balm. Comparator arm participants follow the identical SERF protocol to the intervention arm, differing only in which tea is consumed.

Who delivers it and their relevant expertise:
Self-administered by participants; no clinician-delivered or facilitator-led component. Materials (SERF practice card, Rooibos tea, physical journal) are prepared and dispatched by the Chief Investigator, Dr Carrie Thomson-Casey (registered Clinical Psychologist; Advanced Diplomas in Naturopathy and Nutritional Medicine), with logistics support from the Research Assistant. No direct coaching or supervision occurs during the daily practice.

How it is delivered:
Individual, not group-based. Delivered via: (1) a printed SERF Tea Practice card guiding the daily sensory/breathing/reflection sequence; (2) an optional private physical journal (not collected); (3) weekly structured reflective prompts via REDCap. No face-to-face or synchronous contact with the research team at any stage.

How often and for how long:
Daily: ~10–15 minutes/day for 28 days (tea preparation, SERF micro-practice, optional journaling)
Weekly: brief REDCap reflective prompt, ~10 minutes/week, for 4 weeks
Single non-intervention follow-up assessment at Day 56, no further practice required

Where it is delivered:
Participant's own home or workplace, at a time of their choosing. All data collection occurs via REDCap; no physical research site or clinic visit involved.

Adherence:
Self-reported via weekly REDCap items (number of days in the preceding week the daily practice was completed). Research Assistant monitors weekly REDCap completion and maintains the participant tracking log; adherence itself is a primary feasibility outcome, not a deviation to correct.
Control group
Active

Outcomes
Primary outcome [1] 346656 0
Recruitment - Both the number of participants consenting to participate and the time taken to reach the recruitment target of 24–26 participants
Timepoint [1] 346656 0
Both assessed continuously across the recruitment period, from commencement of recruitment advertising to the point the target of 24–26 participants is reached (planned 8-week window)
Primary outcome [2] 346657 0
Retention rate
Timepoint [2] 346657 0
Assessed at day 28 (end of intervention), with final retention through follow-up assessed at day 56
Primary outcome [3] 346658 0
Frequency of daily tea consumption
Timepoint [3] 346658 0
Assessed weekly across the 28-day intervention period (day 7, 14, 21, 28)
Secondary outcome [1] 466920 0
Perceived stress
Timepoint [1] 466920 0
Baseline, Day 14, Day 28, and Day 56
Secondary outcome [2] 466921 0
Anxiety symptoms
Timepoint [2] 466921 0
Baseline, Day 14, Day 28, and Day 56
Secondary outcome [3] 466922 0
Global wellbeing
Timepoint [3] 466922 0
Baseline, Day 14, Day 28, and Day 56
Secondary outcome [4] 466923 0
Reflective functioning
Timepoint [4] 466923 0
Baseline, Day 14, Day 28, and Day 56
Secondary outcome [5] 466924 0
Participant experience of the intervention protocol
Timepoint [5] 466924 0
Weeks 1 to 4 of the intervention period
Secondary outcome [6] 466925 0
(Primary) — Adverse event occurrence - Proportion of participants experiencing an adverse event
Timepoint [6] 466925 0
Assessed continuously throughout the 28-day intervention period and at the day 56 follow-up
Secondary outcome [7] 467202 0
(Primary) — Practice engagement - Frequency of daily SERF micro-practice engagement
Timepoint [7] 467202 0
Assessed weekly across the 28-day intervention period (day 7, 14, 21, 28)
Secondary outcome [8] 467203 0
(Primary) — Survey completion - Completion rate of weekly online (REDCap) surveys
Timepoint [8] 467203 0
Assessed weekly across the 28-day intervention period, with final completion rate calculated at day 28
Secondary outcome [9] 467204 0
(Primary) — Acceptability - Acceptability of the SERF protocol to participants
Timepoint [9] 467204 0
Assessed across the 28-day intervention period via weekly prompts, with overall acceptability evaluated following completion of day 28 and day 56 data collection
Secondary outcome [10] 467207 0
(Primary) — Withdrawal due to adverse event - Proportion of participants withdrawing from the study due to an adverse event
Timepoint [10] 467207 0
Assessed continuously throughout the 28-day intervention period and at the day 56 follow-up

Eligibility
Key inclusion criteria
Registered or accredited health professional (e.g. psychologist, counsellor, nurse, midwife, social worker, occupational therapist, or other allied health professional) currently working directly with clients in a clinical or therapeutic capacity; aged 18 years or over; able to read and write English; has access to email and internet sufficient to complete online survey-based data collection; willing and able to commit to a 28-day intervention period; and is a generally healthy adult. (NB No upper age limit is applied; the maximum age field reflects a platform-required numeric entry, not a study exclusion criterion.)
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Naturopath, herbalist, or clinical nutritionist with specific professional knowledge of Lemon Balm (Melissa officinalis); current use of sedative medications, thyroid medications, or other medications with a known interaction with Melissa officinalis; pregnant or breastfeeding; known allergy to Lemon Balm or other Lamiaceae family plants; a Generalized Anxiety Disorder scale score of 10 or above at baseline screening; and currently receiving active treatment for a diagnosed anxiety or mood disorder.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed by an independent associate, not otherwise involved in eligibility screening, enrolment, intervention delivery, or data analysis, who both generates and holds the computer-generated randomisation sequence. Participant eligibility is fully determined — via consent and baseline health screening — before this associate releases the allocation for each participant. The Chief Investigator has no access to the sequence at any stage prior to allocation release, and is only informed of a participant's group assignment after their eligibility has been confirmed and enrolment finalised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation sequence using permuted block randomisation (block size of 4), generated and held by an independent associate not otherwise involved in eligibility screening, enrolment, or intervention delivery, to ensure approximately equal allocation to the intervention (Lemon Balm tea) and comparator (Rooibos tea) arms throughout the rolling recruitment period. No stratification factors are applied. The Chief Investigator has no access to the sequence at any stage prior to allocation release
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Quantitative data from the PSS-10, GAD-7, Flourishing Scale, and RFQ-8 will be analysed descriptively, given the feasibility nature of this study. Descriptive statistics (means, standard deviations, ranges) will be reported for each measure at baseline, Day 14, Day 28, and Day 56, by group. Within-group change scores from baseline to Day 28 will be calculated for both arms. Between-group comparison of change scores will use independent samples t-tests, reported with effect sizes (Cohen's d) and 95% confidence intervals, interpreted descriptively and exploratorily rather than as confirmatory hypothesis tests, given the small sample size. Feasibility outcomes (recruitment rate, retention rate, adherence) will be reported as proportions and descriptive summaries. Missing data will not be formally imputed; missingness patterns will be reported descriptively as feasibility findings in their own right. Qualitative reflective journal data will be analysed using Braun and Clarke's reflexive thematic analysis, supported by Delve CAQDAS software, following the six-phase process (familiarisation, initial coding, theme generation, theme review, theme definition, write-up). Analysis will be conducted using SPSS.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/09/2026
Actual
Date of last participant enrolment
Anticipated
1/11/2026
Actual
Date of last data collection
Anticipated
31/01/2027
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 322812 0
University
Name [1] 322812 0
Southern Cross University
Country [1] 322812 0
Australia
Funding source category [2] 322818 0
Commercial sector/Industry
Name [2] 322818 0
Planet Organic
Country [2] 322818 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
Country
Australia
Secondary sponsor category [1] 325750 0
None
Name [1] 325750 0
Address [1] 325750 0
Country [1] 325750 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321252 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 321252 0
Ethics committee country [1] 321252 0
Australia
Date submitted for ethics approval [1] 321252 0
10/08/2026
Approval date [1] 321252 0
08/09/2026
Ethics approval number [1] 321252 0

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

Contacts
Principal investigator
Name 153154 0
Dr Carrie Thomson-Casey
Address 153154 0
Southern Cross University, PO Box 157, Lismore NSW 2480
Country 153154 0
Australia
Phone 153154 0
+61 7 5589 3234
Fax 153154 0
Email 153154 0
[email protected]
Contact person for public queries
Name 153155 0
Carrie Thomson-Casey
Address 153155 0
Southern Cross University, PO Box 157, Lismore NSW 2480
Country 153155 0
Australia
Phone 153155 0
+61 7 5589 3234
Fax 153155 0
Email 153155 0
[email protected]
Contact person for scientific queries
Name 153156 0
Carrie Thomson-Casey
Address 153156 0
Southern Cross University, PO Box 157, Lismore NSW 2480
Country 153156 0
Australia
Phone 153156 0
+61 7 5589 3234
Fax 153156 0
Email 153156 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.