Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000467932
Ethics application status
Approved
Date submitted
10/03/2020
Date registered
9/04/2020
Date last updated
9/04/2020
Date data sharing statement initially provided
9/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of Transcendental Meditation on the quality of life, perceived stress and mood of women affected by domestic violence
Scientific title
Transcendental Meditation for women affected by domestic violence: a pilot randomised, controlled trial
Secondary ID [1] 300752 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Domestic violence 316599 0
Family violence 316600 0
Intimate partner violence 316601 0
Condition category
Condition code
Mental Health 314826 314826 0 0
Depression
Mental Health 314827 314827 0 0
Anxiety
Mental Health 314828 314828 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcendental Meditation® (TM) is a simple, effortless, mantra-based relaxation technique, which is practiced 20 minutes twice daily. Participants assigned to the intervention group will complete 12 hours (9 face-to-face sessions) of standardised training in the TM technique over an 8-week period, with a follow-up session held 2 months after completion of the training (week 16). Training will be delivered using a combination of one-on-one and group-based sessions, and will comprise of a 2-hour introductory TM session (one-on-one; week 1) and four x 1.5-hour sessions (group-based; week 2) to learn TM, and three x 1-hour sessions (2 x one-on-one and 1 x group-based; weeks 2, 4 and 8) to refine the technique. The 1-hour follow-up session (group-based; week 16) will serve to evaluate and refine the technique, and problem-solve any issues relating to TM. The training will be delivered by qualified and experienced instructors of the Transcendental Meditation® technique. Participants also will be required to practice TM (2 x 20 minutes daily) over the 8-week intervention period. Fidelity to the intervention will be monitored using self-administered daily meditation records, and instructor-administered training attendance/participation records.
Intervention code [1] 317084 0
Behaviour
Comparator / control treatment
Participants assigned to the control group will participate in 1.5-hour weekly facilitated group support sessions over an 8-week period. During these sessions, participants will listen to and share personal experiences and information, and discuss challenges and strategies to improving wellbeing. The support group sessions, and 2-month follow-up session, will be delivered by a qualified and experienced social worker. Fidelity to the control will be measured using facilitator-administered session attendance/participation records.
Control group
Active

Outcomes
Primary outcome [1] 323183 0
Health-related quality of life: This outcome will be measured using the 35-item Australian Quality of Life – 8 dimension (AQoL-8D) instrument.
Timepoint [1] 323183 0
Baseline, week 8 and week 16 [primary timepoint]
Secondary outcome [1] 381097 0
Severity of perceived stress: This outcome will be assessed using the 7-item stress subscale of the 21-item Depression Anxiety Stress Scale (DASS-21).
Timepoint [1] 381097 0
Baseline, week 8 and week 16
Secondary outcome [2] 381098 0
Severity of anxiety: This outcome will be measured using the 7-item anxiety subscale of the 21-item Depression Anxiety Stress Scale (DASS-21).
Timepoint [2] 381098 0
Baseline, week 8 and week 16
Secondary outcome [3] 381099 0
Severity of depression: This outcome will be assessed using the 7-item depression subscale of the 21-item Depression Anxiety Stress Scale (DASS-21).
Timepoint [3] 381099 0
Baseline, week 8 and week 16
Secondary outcome [4] 381100 0
Severity of post-traumatic stress disorder symptoms: This outcome will be measured using the 20-item PTSD Checklist for DSM-5 (PCL-5).
Timepoint [4] 381100 0
Baseline, week 8 and week 16
Secondary outcome [5] 381101 0
Subjective experience: Participants will be invited to share their experiences of the intervention and control, as well as the trial, through free written text. These experiences will be captured using a customised open-ended question in the data collection form [week 8] and trial exit form [week 16].
Timepoint [5] 381101 0
Week 8 and week 16 post-baseline.

Eligibility
Key inclusion criteria
(a) aged >18 years,
(b) female,
(c) experienced domestic violence (i.e. emotional, psychological, physical, verbal, social, financial or sexual abuse within the home environment) in their lifetime,
(d) live in metropolitan Adelaide, South Australia,
(e) able to commit to the intervention/control schedule,
(f) able to speak, read and understand English, and
(g) capable of providing informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) in a current violent domestic relationship,
(b) completed training in the Transcendental Meditation® technique, or
(c) has a serious psychiatric condition such as bipolar disorder or schizophrenia.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation codes will be held in sequentially numbered opaque sealed envelopes. This process will be undertaken by a third party not involved in the direct administration of the study. Each envelope will be selected by a member of the research team (who will be unaware of the allocation sequence) in consecutive order at the time of enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to the intervention or control group, at a ratio of 1:1. Block randomisation will be used with computer-generated randomly permuted blocks of four.
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
SAMPLE SIZE: Based on an effect size of 0.3 (for the primary outcome, AQoL-8D utility score [as informed by an unpublished quasi-experimental feasibility study of TM for women affected by domestic violence, conducted by the authors in 2017]), and an attrition rate of 10%, a total of 88 participants (44 in each arm) will have 90% power for a linear mixed model (testing for the interaction between time and group) to detect a statistically significant difference in AQoL-8D utility scores with a two-tailed alpha level set at 0.05.

PLANNED ANALYSES: Data will be analysed by intention-to-treat. Missing data will be managed using the multiple imputation method. We will report descriptive data using means and standard deviations (where values are normally distributed) and medians and the interquartile range (if data are not normally distributed). Categorical data will be described using frequency distributions and percentages. We will test for baseline differences between groups using independent samples t-tests (for means) and independent samples median tests (for medians), where variables are continuous. For categorical variables, we will use the Fisher’s Exact test to measure baseline differences between groups. To estimate the intervention effect for AQoL-8D index scores and subscores, DASS-21 subscores and PCL-5 scores, we will use Linear mixed-effects models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2020
Actual
Date of last participant enrolment
Anticipated
29/04/2021
Actual
Date of last data collection
Anticipated
27/08/2021
Actual
Sample size
Target
88
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 29617 0
5163 - Hackham West

Funding & Sponsors
Funding source category [1] 305208 0
Charities/Societies/Foundations
Name [1] 305208 0
David Lynch Foundation Australia
Country [1] 305208 0
Australia
Primary sponsor type
Individual
Name
A/Prof Matthew Leach
Address
Southern Cross University, Military Road, East Lismore, NSW, 2480.
Country
Australia
Secondary sponsor category [1] 305567 0
Individual
Name [1] 305567 0
Mrs Heather Lorenzon
Address [1] 305567 0
GMDO Ltd, Australia, Meadow Way, Hackham West, Adelaide, SA, 5163.
Country [1] 305567 0
Australia
Secondary sponsor category [2] 305571 0
Individual
Name [2] 305571 0
Prof Sandy Nidich
Address [2] 305571 0
Center for Social-Emotional Health and Consciousness, Maharishi International University, 1000 North Fourth Street, Fairfield, Indianapolis, 52557.
Country [2] 305571 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305560 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 305560 0
GPO Box 2471, Adelaide SA 5001
Ethics committee country [1] 305560 0
Australia
Date submitted for ethics approval [1] 305560 0
25/10/2019
Approval date [1] 305560 0
16/12/2019
Ethics approval number [1] 305560 0
202647

Summary
Brief summary
Almost one in three women worldwide will be exposed to domestic and family violence at some time in their life. Such violence can contribute to physical, social, economic and psychological harm. This pilot randomised controlled trial will compare the effectiveness of two different approaches to improving stress, mood and quality of life in women affected by domestic violence. Women assigned to the first group will complete training in Transcendental Meditation® (TM; an effortless relaxation technique), which will be delivered by qualified and experienced instructors of TM. Women in the second group will participate in weekly group support sessions facilitated by a qualified social worker. During the eight-week intervention/control period, and eight-week follow-up period, participants will complete a series of questionnaires asking about their quality of life, and their perceived levels of stress, anxiety and depression. The study will be conducted in the Southern suburbs of Adelaide, South Australia; however, if the findings show promise, they will help inform the development of related, larger-scale projects not only in South Australia, but nationwide.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100778 0
A/Prof Matthew Leach
Address 100778 0
National Centre for Naturopathic Medicine, Southern Cross University, Military Road, East Lismore, NSW 2480
Country 100778 0
Australia
Phone 100778 0
+61 2 6620 3298
Fax 100778 0
Email 100778 0
[email protected]
Contact person for public queries
Name 100779 0
A/Prof Matthew Leach
Address 100779 0
National Centre for Naturopathic Medicine, Southern Cross University, Military Road, East Lismore, NSW 2480
Country 100779 0
Australia
Phone 100779 0
+61 2 6620 3298
Fax 100779 0
Email 100779 0
[email protected]
Contact person for scientific queries
Name 100780 0
A/Prof Matthew Leach
Address 100780 0
National Centre for Naturopathic Medicine, Southern Cross University, Military Road, East Lismore, NSW 2480
Country 100780 0
Australia
Phone 100780 0
+61 2 6620 3298
Fax 100780 0
Email 100780 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
It is yet to be decided whether the individual participant data will be shared, and if so, in which form. The study protocol and study findings will be shared once these are published.


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
SourceTitleYear of PublicationDOI
EmbaseTranscendental Meditation for women affected by domestic violence: Study protocol of a pilot randomised, controlled trial.2020https://dx.doi.org/10.1016/j.imr.2020.100432
N.B. These documents automatically identified may not have been verified by the study sponsor.