Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001384246
Ethics application status
Approved
Date submitted
26/07/2018
Date registered
17/08/2018
Date last updated
29/07/2019
Date data sharing statement initially provided
29/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of yoga on combat-related Post-traumatic stress disorder (PTSD) symptoms and associated outcomes.
Scientific title
Effects of yoga on combat-related Post-traumatic stress disorder (PTSD) symptoms and associated outcomes,
Secondary ID [1] 293671 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-traumatic stress disorder 305966 0
Condition category
Condition code
Mental Health 305160 305160 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a 6-month programme of trauma-sensitive yoga (TSY), with mindfulness elements. Each session is 90 minutes and will be delivered face to face each week by clinical staff ( senior psychiatrists and nurses) who have been trained in this form of yoga therapy. It will be delivered in the Jamie Larcombe Centre, a clinical facility for veteran mental health. In TSY, Mindfulness is an integral part of the yoga practise. Awareness and focus being the main elements of sensing the breath, body shape and movement .
The key elements of TSY are:
*Interoception – Sensing the body
*Bringing choice into the movement
*Taking effective action, awareness of the shapes and movements chosen
*Being present in the moment
*Sensing muscle dynamics
*Creating rhythms in flowing movements and sequences.
Examples of exercises include:
*Standing or sitting ‘Mountain’ at the start of the class is an example of arriving and settling by bringing awareness to the still body and noticing how the body feels at that moment.
*‘Sunbreaths’, where arm movements are coordinated with the breath in a rhythm,
*Shoulder rolls, ankle and wrist rotations are examples noticing the movements and their range in the joints. Noticing discomfort or tension and learning to release and ‘let go ‘as a deliberate choice.
Each session will start with 15 minutes of 'settling'. This can involve being still or moving with an emphasis on noticing how the body and mind are feeling and orienting the self to being at the session. This will be followed by 60 minutes of yoga practices, postures and movements within the range comfortable for the individual participant. The final 15 minutes will be spent wrapping up. This involves meditation and a focus on the body and breath awareness.
Each session will be jointly delivered by a psychiatrist and a nurse with each taking the lead at different times. The intervention will be delivered in group format with 7-14 participants in each group. An attendance check list will be used to monitor attendance.
Intervention code [1] 299931 0
Treatment: Other
Intervention code [2] 312108 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304310 0
The primary outcome is change in mean PTSD score using the PCL 5 to measure PTSD symptom severity. The PCL5 will be administered at 5 different time points and changes in mean scores over these time points will be calculated using repeated measures ANOVA. This will assess the magnitude and statistical significance of change in PTSD symptom severity.
Timepoint [1] 304310 0
The PCL 5 will be administered at baseline and repeated at 1, 3, and 6 months (primary endpoint) after the participant starts the intervention. It will then be administered at 9 months post start of intervention which constitutes a 3-month follow-up period.
Primary outcome [2] 304311 0
The second primary outcome is change in mean depression, anxiety and stress scores using the DASS 21 to measure severity of each sub score. The DASS 21 will be administered at 5 different time points and changes in mean scores over these time points will be calculated using repeated measures ANOVA. This will assess the magnitude and statistical significance of change in the severity of depression, anxiety and stress symptoms.
Timepoint [2] 304311 0
The DASS21 will be administered at baseline and repeated at 1, 3, and 6 months (primary endpoint) after the participant starts the intervention. It will then be administered at 9 months post start of intervention which constitutes a 3-month follow-up period.
Primary outcome [3] 307057 0
Changes in mean sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). The PSQI will be administered at 5 different time points and changes in mean scores over these time points will be calculated using repeated measures ANOVA. This will assess the magnitude and statistical significance of change in the severity of sleep quality.
Timepoint [3] 307057 0
The PSQI will be administered at baseline and repeated at 1, 3, and 6 months after the participant starts the intervention. It will then be administered at 9 months post start of intervention which constitutes a 3-month follow-up period.
Secondary outcome [1] 341552 0
A secondary outcome is to evaluate the self-reported benefits for partners of participating with their veteran in the intervention. This will be done by use of a questionnaire specifically developed by the research team for this purpose.
Timepoint [1] 341552 0
The questionnaire will be administered to partners at baseline and again at 9 months post start of intervention.
Secondary outcome [2] 341553 0
A secondary outcome is to measure change in self-reported quality of life for partners participating in the intervention using the SF36.
Timepoint [2] 341553 0
The SF36 will be administered to partners at baseline and again at 9 months post start of the intervention.

Eligibility
Key inclusion criteria
Potential participants must be ex-Defence members with PTSD directly related to their military service. Initial screening would be undertaken using the Clinician Administered PTSD Scale (CAPS) to confirm a PTSD diagnosis. Participants must be cognitively able to give informed consent. Partners of veteran participants must be cognitively able to give informed consent and aged over 18 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded if there is evidence of a psychotic disorder or significant cognitive impairment at initial screening. Participants will be withdrawn from the study after commencement if they sustain any cognitive impairment (psychosis, substance abuse) that impacts on their ability to participate. Partners of veteran participants would be excluded on evidence of any cognitive impairment that impacts on their ability to participate.

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)
Allocation not concealed
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
Self-reported measures will be collected at baseline, one, three, six and nine months. The nine months is a 3-month follow up period. On the assumption that data will be normally distributed, the primary statistical analysis will be analysis of difference among means. As participants will be undergoing repeated measured at 5 different time points, the changes in mean scores over these time points will be calculated using repeated measures ANOVA. This will assess the magnitude and statistical significance of change for each of the measures with continuous variables.
A p-value is considered significant if less than 0.05, 95% confidence intervals will be reported and all analyses will be conducted with statistical software.
Based on an effect size of 8% pre/post PCL scores from the previous study by McCarthy et al (2017) demonstrating statistical and clinical significance, the proposed study aims to recruit a sample which is at least as large. With a Type 1 error probability of 0.05 and a power of 80%, 28 veteran participants will be required for this study. To account for possible attrition over the study phase, an additional 20% will be recruited giving a total minimum sample of 34 veteran participants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/08/2018
Actual
1/09/2018
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
30/09/2020
Actual
Sample size
Target
34
Accrual to date
28
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 18399 0
5065 - Glenside

Funding & Sponsors
Funding source category [1] 298291 0
Government body
Name [1] 298291 0
Southern Adelaide Local Health Network
Country [1] 298291 0
Australia
Primary sponsor type
Individual
Name
Dr Linda McCarthy
Address
Jamie Larcombe Centre
Eucalyptus Lane, Glenside SA 5065
Country
Australia
Secondary sponsor category [1] 298718 0
None
Name [1] 298718 0
Address [1] 298718 0
Country [1] 298718 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299290 0
Departments of Defence and Veterans' Affairs Human Research Ethics Committee
Ethics committee address [1] 299290 0
CP3-7-038, Campbell Park Offices, PO Box 7912, Canberra BC ACT 2610
Ethics committee country [1] 299290 0
Australia
Date submitted for ethics approval [1] 299290 0
21/01/2018
Approval date [1] 299290 0
30/04/2018
Ethics approval number [1] 299290 0
029-18
Ethics committee name [2] 301075 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [2] 301075 0
Office for Research
Flinders Medical Centre
Ward 6C, Room 6A219
Flinders Drive Bedford Park, SA 5042
Ethics committee country [2] 301075 0
Australia
Date submitted for ethics approval [2] 301075 0
24/01/2018
Approval date [2] 301075 0
23/05/2018
Ethics approval number [2] 301075 0
7.18

Summary
Brief summary
The primary aim is to evaluate the effectiveness of a 6month programme of trauma-sensitive yoga (TSY), with mindfulness elements in a sample of ex-serving Defence members with a clinical diagnosis of combat-related PTSD. A secondary aim is to evaluate the effectiveness of the intervention for partners of participating ex-serving members. The study will be conducted at the Jamie Larcombe Centre by clinical staff trained in TSY. A sample of no less than 34 ex-serving Defence members will be recruited and provided with a 90minute session of TSY each week for 6 months. Data will be collected before the intervention and repeated at one, three and six months and after an additional three month follow-up. Analysis will determine change in PTSD and associated mental health symptoms in veterans. Outcomes will contribute to the emerging evidence base for yoga as an adjuvant treatment for PTSD. A convenience sample of partners will be recruited with qualitative analysis undertaken to understand their views on the effects of the programme on themselves, their partners and their relationships. The term 'partner' refers to the domestic/domiciliary partners of ex-serving Defence members. They have been included on the basis that they are in a position to offer support to the ex-serving Defence members that are the primary subjects of the study, and may also stand to benefit from participation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79930 0
Dr Linda McCarthy
Address 79930 0
Jamie Larcombe Centre, Veterans Mental Health Unit
Eucalyptus Lane, Glenside SA 5065
Country 79930 0
Australia
Phone 79930 0
+61 1300043175
Fax 79930 0
Email 79930 0
[email protected]
Contact person for public queries
Name 79931 0
Dr Linda McCarthy
Address 79931 0
Jamie Larcombe Centre, Veterans Mental Health Unit
Eucalyptus Lane, Glenside SA 5065
Country 79931 0
Australia
Phone 79931 0
+61 1300043175
Fax 79931 0
Email 79931 0
[email protected]
Contact person for scientific queries
Name 79932 0
Dr Linda McCarthy
Address 79932 0
Jamie Larcombe Centre, Veterans Mental Health Unit
Eucalyptus Lane, Glenside SA 5065
Country 79932 0
Australia
Phone 79932 0
+61 1300043175
Fax 79932 0
Email 79932 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 only be collected and used for this study.


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.