Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000761369p
Ethics application status
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Submitted, not yet approved
Date submitted
Help: Date submitted
9/06/2026
Date registered
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25/06/2026
Date last updated
Help: Date last updated
28/08/2026
Date data sharing statement initially provided
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25/06/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Exploring trauma-sensitive yoga (TCTSY) as an aid for women after birth trauma.
Scientific title
Analysis of the effects of trauma-sensitive yoga as a somatic-based intervention for women with subclinical post-traumatic stress symptoms following childbirth.
Additional trial identifiers [1] 317528 0
NIL
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Child-Birth related Post Traumatic Stress Symptoms (CB-PTSS) 342271 0
Condition category
Condition code
Mental Health 338383 338383 0 0
Other mental health disorders
Reproductive Health and Childbirth 338384 338384 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
TCTSY is a structured, body-based intervention developed at the Trauma Centre at the Justice Resource Institute. It uses invitational language, choice-making, non-coercion, present-moment experience, and shared authentic experience to support participants in developing a sense of agency, self-efficacy, interoceptive awareness, and bodily ownership. No physical materials or equipment are required. Participants attend from a private space of their choosing.
The intervention is delivered by the researcher, who holds a Trauma Centre Trauma-Sensitive Yoga Facilitator (TCTSY-F) credential and has several years of facilitation experience with trauma-affected populations. The researcher is also the principal investigator of the study.
The intervention consists of 8 individual online sessions delivered once per week over 8 weeks via the University of Canterbury (UC) -licensed Zoom. Sessions are 45 minutes each, except for the first session, which is 60 minutes to allow time for questions. TCTSY core elements (choice-making, effective action, interoceptive awareness, present-moment experience and creating rhythm) are introduced gradually and built upon each week, following TCTSY protocol. The sequence prioritises effective action before interoceptive awareness, in line with clinical reasoning for a CB-PTSS population.
The intervention is embedded within a 16-week single-case experimental design (SCED). It is preceded by a 4-week baseline phase and followed by a 4-week follow-up phase. There is no control group; each participant serves as her own control. Session attendance and questionnaire completion are supported by weekly reminder texts to participants. The researcher maintains a session log following each session.

TCTSY Elements:
Choice-making (CM) – Allowing space to make choices is fundamental to empowerment. The majority of trauma survivors had choice taken from them. A TCTSY session creates opportunities for participants to practice choice making within forms/shapes, titration of movement, positioning of their body, whether they engage or not etc.

Interoception(IC) – For many trauma survivors, a sense of self or connection to self is removed. This includes connection to their bodies. TCTSY sessions aim to co-create, with participants, a sense of power-sharing and relational safety. They may experience enough safety to stop trying to manage the facilitator as an external threat and turn inward to notice what they and their body are feeling.

Present-moment Experience – Many trauma survivors can struggle to experience the present moment, as trauma can cause an individual to become “stuck” in the past. They may also struggle with being in the moment, as that can be directly linked to being in the body, something survivors struggle with. Through interceptive awareness, choice-making, and effective action, TCTSY seeks to create a space where participants feel safe being present in the moment.

Taking effective action (TEA) – A sense of control and power can be removed from someone who exepreinces trauma. TCTSY session encourages a sense of control and power in participants by suggesting possible aysin which a participants might take effective action. They might choose to change a form as it feels uncomfortable fort them or do a different form they realise their body wants in that moment. They are taking action to help themselves feel more comfortable.

Creating Rhythms (CR) – Unpredictability can create a sense of high alert in trauma survivors. An example of creating rhythm in this study is that each TCTSY session is structured around a set of simple, core forms. Additional forms are offered over the following weeks while retaining the core structure. That core structure of forms creates a sense of known rhythm to each session. Repetitive movement within forms creates a sense of rhythm within the body, allowing the nervous system to slowly begin to understand that movement and the body are safe.


Facilitation Principles:
Non-coercion (NC)– Power imposed on others can be detrimental. Sharing of power is central in a TCTSY session. A facilitator suggests how a body can be moved and creates structure. Participants can enforce their power by choosing how to move within that structure, the may choose not to move. Compassion underpins this collective sharing, which directs the facilitator's guidance and structuring, while understanding that the goal is for the participants to learn to make choices. That includes choosing something different to the facilitator's guidance.

Invitational Language (IL) – Unlike yoga classes that command poses, TCTSY uses specific trauma-sensitive invitational language to provide participants an opportunity to consider what they want and need to do in the moment. The language promotes as sense that they have control of what they choose to do with their body. Examples of guidance language: “feel free to begin your practice today in a way that is useful to you…”, “when you are ready…”, “perhaps you feel the size of your arm movement…”, “perhaps the sensation in your shoulder, might guide your choice in shape or movement…”. Examples of trigger words/phrases not used in TCTSY due to their connections to forms of abuse: pose, spread your legs apart, touch, sigh, …do…, get down, stay etc. Sanskrit names for forms are not used as this can cause a sense of separation and trigger those who have had negative experiences in traditional yoga settings. In one-on-one sessions, facilitators and participants identify if there are particular words that the participants find distressing.

Shared authentic experience – Power is shared in a TCTSY session. No one person's experience is more valid than another's. Everyone in the session is involved in the yoga and it is ok for the participant and facilitator to be authentic in actions, relationship with self and others.

An example of TCTSY sessions:
A TCTSY session uses the facilitation principles to create the conditions in which the TCTSY elements are introduced and practised. Each TCTSY session is built on the previous one, introducing new forms and TCTSY elements slowly. Participants can choose to use a chair, a mat on the floor, stand, or lie down. Forms can be altered to accommodate any space they choose. The forms used week by week are also built upon, depending on the participants' needs and abilities. For example, a participant may not move to interoceptive cues until week 7, as it may be too uncomfortable for them in an earlier session. Another participant may move to interoceptive cues in week 4 as they are ready. TCTSY is adaptable for each participant's physical and mental situation.

For Example:

Week 1:
Invitational Language (IL) only – e.g. “you are welcome to move in a way that suits you today.
Forms:
Seated mountain
Head drop/Flexion/Rolls
Shoulder Rolls or lifts
Torso circle/forward/backward
Rounding and extending spine
Twist
Ankle flexion/circles
Leg raise/lower
Lean back
Forward Fold
Rest

Week 2:
IL Only
Forms:
As week one with Standing mountain, Lean side to side, warrior 1

Week 3:
IL & Choice making (CM) (One additional choice e.g. – “perhaps you choose to raise your arms or maybe you place them on your legs”.)
Forms:
As week 2 with seated cat/cow

Week 4:
IL, CM (Two additional Choices = “you might choose to twist your body to the right, perhaps twisting your body to the left feels better today or you might choose to lean forward”) & Taking Effective Action (TEA) = “…would raising your arms to your shoulders suit your body today or would a completely different movement suit more”, “…this is your practice for your body…”
Forms:
As week 3 with Lifting/lower arms

Week 5:
IL, CM & TEA
Forms: As week 4 with half sun salutation x 2


Week 6:
IL, CM, TEA & Interoception (IC) = “If you are interested you might notice how your side feels in the stretch…”
Forms: As week 5 with half sun salutation x 4

Week 7: IL, CM, TEA & IC (if participant is comfortable to perhaps introduce breath work – “…if it's helpful for you, perhaps you notice if you breathe in or out as you raise your arms…”
Forms: As week 6 with offer of Tree.

Week 8: As Week 7.

Follow-up Phase (no TCTSY sessions) = Weeks 13, 14, 15, 16; include the weekly questionnaire measured in the baseline and intervention phases. In week 16, the primary measures are taken for the last time. This structure allows monitoring of maintenance or changes in potential gains from the intervention. Week 16 will include a debrief with the researcher for the participants and a final questionnaire to assess if the intervention is acceptable.

Intervention code [1] 334325 0
Treatment: Other
Intervention code [2] 334326 0
Behaviour
Description of the comparator or control
This is a single-case research design (SCRD) in which each participant serves as her own control through a 4-week baseline phase preceding the intervention. Baseline phase (No TCTSY sessions) = This study is a single case research design (SCRD) in which participants act as their own control. Weeks 1,2,3,4 include an 11-item weekly questionnaire that will be given once a week for the four weeks. This questionnaire is a combination of the primary questionnaires used throughout the study.During the screening process the possible participants with complete the City Birth Trauma Scale (City BiTS): to assess CB-PTSS severity and check for eligibility. In the first week the participants will then be asked to complete the General Self-Efficacy Scale (GSE-10): to assess sense of self-efficacy, Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2): to assess interoception (connection to their body). They will be asked to complete those primary questionnaires (City BiTS, MAIA-2, GSE-10) again in the 4th week before the intervention begins in the 5th week. This allows for monitoring of CB-PTSS symptoms, self-efficacy, and body awareness over time with no intervention. The data from this phase will be compared to the data from the intervention phase and follow-up phase to assess if the intervention created any change and if that change was maintained.
Control group
Active

Outcomes
Primary outcome [1] 345697 0
Childbirth-related post-traumatic stress symptoms
Timepoint [1] 345697 0
Screening (week 0), end of baseline phase (week 4), end of intervention phase (week 12), end of follow-up phase (week 16)
Secondary outcome [1] 462943 0
Self-efficacy
Timepoint [1] 462943 0
Start of baseline (week 1), end of baseline (week 4), end of intervention (week 12), end of follow-up (week 16)
Secondary outcome [2] 462944 0
Interoceptive awareness
Timepoint [2] 462944 0
Start of baseline (week 1), end of baseline (week 4), end of intervention (week 12), end of follow-up (week 16)
Secondary outcome [3] 462945 0
Weekly symptom trajectory across study phases
Timepoint [3] 462945 0
Weekly across all three phases (weeks 1–16)
Secondary outcome [4] 462946 0
Intervention acceptability
Timepoint [4] 462946 0
End of follow-up phase (week 16)
Secondary outcome [5] 463409 0
Intervention appropriateness
Timepoint [5] 463409 0
End of follow-up phase (week 16)
Secondary outcome [6] 463410 0
Intervention feasibility
Timepoint [6] 463410 0
End of follow-up phase (week 16)

Eligibility
Key inclusion criteria
Adult women (18 years or older) living in Aotearoa New Zealand who gave birth in Aotearoa New Zealand. Has given birth to a live infant within the previous 11 months. Primiparous or multiparous. Scores in the mild-to-moderate range on the City Birth Trauma Scale (City BiTS). Able to participate in online sessions in English and complete questionnaires. Has access to a private space and an appropriate device for video sessions. Has written GP or midwife consent to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Healthy volunteers
No
Key exclusion criteria
Scores in the moderate-to-severe range on the City Birth Trauma Scale (City BiTS). Currently trying to conceive or within the first trimester of pregnancy. High current risk (e.g. active suicidality). Physical or medical conditions that make gentle yoga unsafe (e.g. grade 4 perineal tear, C-section infection). Current severe mental health or substance use difficulties. Unable to follow instructions in English. Has an existing relationship with the researcher.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study uses a single-case research design (SCRD), which does not require traditional power-based sample size calculations. Individual participant data are analysed as separate cases rather than aggregated. A sample of up to 10 participants is consistent with SCRD pilot study conventions and is sufficient to examine individual response patterns and variability across cases. Analysis will include visual analysis using modified Brinley plots and time-series plots, with effect size calculated using Cohen's d.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2026
Actual
Date of last participant enrolment
Anticipated
14/09/2026
Actual
Date of last data collection
Anticipated
21/12/2026
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 28194 0
New Zealand
State/province [1] 28194 0

Funding & Sponsors
Funding source category [1] 322090 0
University
Name [1] 322090 0
University Of Canterbury
Country [1] 322090 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
Country
New Zealand
Secondary sponsor category [1] 324977 0
None
Name [1] 324977 0
Address [1] 324977 0
Country [1] 324977 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 320619 0
Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 320619 0
Ethics committee country [1] 320619 0
New Zealand
Date submitted for ethics approval [1] 320619 0
18/06/2026
Approval date [1] 320619 0
Ethics approval number [1] 320619 0

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

Contacts
Principal investigator
Name 151066 0
Ms Gemma Dwane
Address 151066 0
University of Canterbury, 20 Kirkwood Avenue, Ilam, Christchurch, 8041, New Zealand
Country 151066 0
New Zealand
Phone 151066 0
+64 220864707
Fax 151066 0
Email 151066 0
[email protected]
Contact person for public queries
Name 151067 0
Gemma Dwane
Address 151067 0
University of Canterbury, 20 Kirkwood Avenue, Ilam, Christchurch, 8041, New Zealand
Country 151067 0
New Zealand
Phone 151067 0
+64 220864707
Fax 151067 0
Email 151067 0
[email protected]
Contact person for scientific queries
Name 151068 0
Gemma Dwane
Address 151068 0
University of Canterbury, 20 Kirkwood Avenue, Ilam, Christchurch, 8041, New Zealand
Country 151068 0
New Zealand
Phone 151068 0
+64 220864707
Fax 151068 0
Email 151068 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data will not be shared. The study involves sensitive health data from a small sample (up to 10 participants), where sharing raw data would risk participant re-identification. Data will be retained in accordance with NZ health data requirements.



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.