Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000341820
Ethics application status
Approved
Date submitted
16/02/2021
Date registered
25/03/2021
Date last updated
25/03/2021
Date data sharing statement initially provided
25/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effectiveness of a Trauma Sensitive Yoga Intervention with Survivors of Sexual Violence
Scientific title
The Effectiveness of an 8-week Trauma Sensitive Yoga Intervention with Survivors of Sexual Violence Presenting with Trauma Related Disorders
Secondary ID [1] 303464 0
Nil known
Universal Trial Number (UTN)
U1111-1260-7898
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 321220 0
Condition category
Condition code
Mental Health 319016 319016 0 0
Other mental health disorders
Mental Health 319063 319063 0 0
Anxiety
Mental Health 319064 319064 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To effectively and robustly measure the research objectives and questions, a mixed method sequential explanatory design is proposed, consisting of two distinct phases. Firstly, quantitative data collection and analysis followed by qualitative data collection analysis and final interpretation (Creswell et al., 2003).

In this study, quantitative methods will be used to measure and track specific variables (PTSD, depression, anxiety, dissociation, mindfulness, interoceptive awareness and self-compassion) to determine whether and how these change over time. The qualitative data collected and analysed in the second sequence can help explain, or elaborate on, the quantitative results obtained in the first phase by exploring participant’s views in more depth (Crewswell et al., 2003). Further, qualitative research methods will give participant’s an opportunity to voice their experiences of being engaged in the intervention (Emerson; 2015; Herman, 2015), and may lead to the discovery of the pathways and contexts in which symptomatic change may have occurred, enabling the unique effects and mechanisms at play to be highlighted.

The intervention is 60 minutes of trauma centre trauma sensitive yoga (TCTSY) delivered by the Principal Investigator (PI). The PI is a registered psychologist and 500-hour trained yoga teacher who has been facilitating trauma sensitive yoga groups to survivors of sexual violence for five years. The intervention will be at a yoga studio (face to face) and may be online (particularly if there are lockdown restrictions). The Lead facilitator is also experienced in facilitating these groups online via Zoom technology.

The study will include a baseline data collection phase (online or in person), the 8 weeks of the trauma sensitive yoga (60-minutes + 15 minutes approximately of answering questionnaires), and a two-month follow-up time point phase (online or in person).

Trauma sensitive yoga is yoga as exercise, adapted from 2002 onwards for work with individuals with complex trauma. Its goal is to help trauma survivors to develop a greater sense of mind-body connection, to ease their physiological experiences of trauma, to gain a greater sense of ownership over their bodies, and to augment their overall well-being.

The main differences include: environment (welcoming, safe, no potentially triggering props such as straps), physical exercise (trauma sensitive yoga supports clients to notice what is going on in their body and to make choices based on this noticing as opposed to trying to achieve a particular atheistic or shape), assists (strictly no hands on assists as may be present in a regular yoga class), teacher qualities (gentle and stays on their mat), language (every cue is preceded with an invitation as opposed to a normal yoga class where the language may be much more directive).

The qualitative phase is an individual interview that will take place either online or in-person at the office of the PI. The qualitative interview will take place once the intervention is complete.
Intervention code [1] 319758 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326568 0
Interoception. Multidimensional Assessment of Interoceptive Awareness (MAIA).
Timepoint [1] 326568 0
Baseline (1 week prior to starting intervention), Week 1-8 and 2-month follow-up / 2-months after the 8 week intervention is complete. The questionnaire is administered for a total of 10 times (once at baseline, once for each week of the intervention and once post-intervention at the 2-month follow-up). There is no primary timepoint as such.
Secondary outcome [1] 391920 0
Post-traumatic stress disorder. Clinician Administered PTSD Scale (CAPS-5).
Timepoint [1] 391920 0
Baseline (1 week prior to starting intervention), Week 1-8 and 2-month follow-up / 2-months after the 8 week intervention is complete. The questionnaire is administered for a total of 10 times (once at baseline, once for each week of the intervention and once post-intervention at the 2-month follow-up).
Secondary outcome [2] 391921 0
Depression. Beck Depression Inventory - Short Form (BDI-SF).
Timepoint [2] 391921 0
Baseline (1 week prior to starting intervention), Week 1-8 and 2-month follow-up / 2-months after the 8 week intervention is complete. The questionnaire is administered for a total of 10 times (once at baseline, once for each week of the intervention and once post-intervention at the 2-month follow-up).
Secondary outcome [3] 391922 0
Anxiety. State-Trait Anxiety Inventory (STAI-5).
Timepoint [3] 391922 0
Baseline (1 week prior to starting intervention), Week 1-8 and 2-month follow-up / 2-months after the 8 week intervention is complete. The questionnaire is administered for a total of 10 times (once at baseline, once for each week of the intervention and once post-intervention at the 2-month follow-up).
Secondary outcome [4] 391923 0
Dissociation. Dissociation Experiences Scale - Brief (DES-B).
Timepoint [4] 391923 0
Baseline (1 week prior to starting intervention), Week 1-8 and 2-month follow-up / 2-months after the 8 week intervention is complete. The questionnaire is administered for a total of 10 times (once at baseline, once for each week of the intervention and once post-intervention at the 2-month follow-up).
Secondary outcome [5] 391924 0
Mindfulness. Five-Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) .
Timepoint [5] 391924 0
Baseline (1 week prior to starting intervention), Week 1-8 and 2-month follow-up / 2-months after the 8 week intervention is complete. The questionnaire is administered for a total of 10 times (once at baseline, once for each week of the intervention and once post-intervention at the 2-month follow-up).
Secondary outcome [6] 391925 0
Self-Compassion. Self-Compassion Scale - Short Form (SCS-SF).
Timepoint [6] 391925 0
Baseline (1 week prior to starting intervention), Week 1-8 and 2-month follow-up / 2-months after the 8 week intervention is complete. The questionnaire is administered for a total of 10 times (once at baseline, once for each week of the intervention and once post-intervention at the 2-month follow-up).

Eligibility
Key inclusion criteria
• Participants have an approved claim with ACCISSC Sensitive Claims (necessary to be accepted into a trauma sensitive yoga group)
• Participants have approval to attend a trauma sensitive yoga group (the study has been designed specifically for participants who are engaging in ACCISS Sensitive Claims and have approval to attend a trauma sensitive yoga group)
• Participants remain in supportive talk therapy for the duration of the intervention (trauma sensitive yoga is an adjunctive treatment to talk therapy as it has been developed by the Centre for Trauma and Embodiment)
• Participants must identify as female (the groups are female-only as the exclusion of male identifying participants is necessary due to most perpetrators against females are male)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Participants will not have taken a yoga class in the past 6 months (to ensure that some participants do not begin in an advantageous position/are more familiar with a yoga practice from the outset)
• Participants will not have had a substance dependence problem in the past 3 months
• Participants will be psychiatric medication stable (if applicable)
• Participants will not be pregnant or breastfeeding
• Participants will be able to provide informed consent
• Participants will be able to read and write in English (so that they are able to fill out the questionnaires)
• Participants will not have an injury that will prevent them from participating in yoga
• Participants will not have a heart condition or any other self-reported condition that could preclude them from participating in a mild exercise routine
• Participants will not indicate current suicide or homicide risk

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
The Lead Investigator hopes to have 60 participants in the study. She has been facilitating trauma sensitive yoga groups for four years and calculated this number from the number of participants she has, on average, accessing the trauma sensitive yoga groups eaxh year, and from surveying previous group members, and asking them if they would have been interested in potentially participating in her research.

Descriptive statistical analyses will be performed to examine the range of scores on the CAPS, PCL, BDI-II, DES, STAI, MAIA, FFMQ, and SCS. A Repeated Measures Multivariate Analysis of Variance (RM MANOVA) will be used to examine changes across the intervention period. RM MANOVA is used to test one or more categorical independent variables, on several dependent variables across two or more time points (Mayers, 2013). RM MANOVA is used to test for an interaction effect between the within-subjects factor, time, and the between-subjects factor group, using pooled variances of the dependent variables (DV). Time is the independent variables while PTSD, depression, anxiety, dissociation, interoception, mindfulness, and self-compassion are the dependent variables.

Individual growth curve modelling will take place at two levels. The first level will consist of fitting a regression model (linear or nonlinear) to each participant’s repeated measures data (capturing intra-individual change). The second level will consist of estimating average parametres of change and the amount of individual variability around these average parametres (capturing inter-individual variability in intra-individual change). Individual growth modelling will allow the researcher to model individual variability in change with covariates of interest that may predict the shape and rate of change. A trajectory may show some complex combination of patterns over distinct pieces of the assessment period (Singer & Willet, 2003).

The qualitative data in this study will be gathered via semi-structured interviews ranging from approximately 1 hour to 2.5 hours. To note, the quantitative data will largely inform the qualitative questions so an example qualitative interview schedule has been created. The qualitative questions will be developed further following analysis of the quantitative data. The number of participants to be selected for qualitative interviewing is not determined prior to data collection. Instead, the appropriate sample size will be deemed sufficient when the research questions have been adequately answered (Mertens et al., 2010). Participant interviews will be recorded and transcribed verbatim, the most common form of transcription in qualitative interviews (Poland, 1995). Each interview will be checked against the recording for accuracy and quality. The primary researcher will be responsible for transcribing the interviews.
The data collection for the qualitative interviews is proposed to take place at the two-month post-treatment assessment. This time period was chosen to allow participants time to reflect on their experiences and assess any lasting effects, if any. Prior to starting the interview, participants will be reminded of their option to stop at any point, asked again for permission to video- or audiotape, and given information regarding the approximate length of the interview and its format.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/04/2021
Actual
Date of last participant enrolment
Anticipated
1/10/2021
Actual
Date of last data collection
Anticipated
9/12/2021
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 23468 0
New Zealand
State/province [1] 23468 0
Auckland

Funding & Sponsors
Funding source category [1] 307881 0
University
Name [1] 307881 0
Massey University
Country [1] 307881 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Massey University East Precinct Albany Expressway, SH17, Albany, Auckland 0632
Country
New Zealand
Secondary sponsor category [1] 308602 0
None
Name [1] 308602 0
Address [1] 308602 0
Country [1] 308602 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307881 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 307881 0
Ethics committee country [1] 307881 0
New Zealand
Date submitted for ethics approval [1] 307881 0
07/01/2021
Approval date [1] 307881 0
10/02/2021
Ethics approval number [1] 307881 0
21/STH/10

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

Contacts
Principal investigator
Name 108802 0
Miss Bridget McNamara
Address 108802 0
Bridget McNamara c/o Balanced Minds, 412a Richmond Road, Grey Lynn, Auckland
Country 108802 0
New Zealand
Phone 108802 0
+64273204279
Fax 108802 0
Email 108802 0
[email protected]
Contact person for public queries
Name 108803 0
Bridget McNamara
Address 108803 0
Massey University East Precinct Albany Expressway, SH17, Albany, Auckland 0632
Country 108803 0
New Zealand
Phone 108803 0
+64273204279
Fax 108803 0
Email 108803 0
[email protected]
Contact person for scientific queries
Name 108804 0
Bridget McNamara
Address 108804 0
Bridget McNamara c/o Balanced Minds, 412a Richmond Road, Grey Lynn, Auckland
Country 108804 0
New Zealand
Phone 108804 0
+64273204279
Fax 108804 0
Email 108804 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
Data will be pooled.


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.