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Trial registered on ANZCTR


Registration number
ACTRN12617000909325
Ethics application status
Approved
Date submitted
19/06/2017
Date registered
21/06/2017
Date last updated
12/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Sensory Modulation for people with Anxiety in Primary Care
Scientific title
Sensory Modulation for Anxiety in Primary Care: A feasibility Study
Secondary ID [1] 292181 0
NZ Health Research Council reference 17/531
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 303651 0
Condition category
Condition code
Mental Health 303039 303039 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single arm feasibility study of sensory modulation for self-management of anxiety.
The intervention uses a range of individualised sensory tools and activities. Examples include weighted blankets, aromas, music, yoga, rocking chair, images from nature.
The intervention will be delivered in 6 x 1 hour sessions, once/ week for 6 weeks,
in participants' homes or another location mutually agreed on with the participant.

In session 1, participants will explore their sensory sensitivities and preferences, receive education about the relationship between sensory stimuli and autonomic/emotional arousal and discuss the results of their sensory profile assessment.
In session 2 participants will trial a range of sensory based strategies and tools and identify which work best for them in helping them to manage their anxiety/distress.
In session 3 participants will identify functional issues related to anxiety and develop a plan to use sensory-based strategies to manage their symptoms of anxiety and distress.
In session 4,-6 participants will be supported to apply the self-management strategies in everyday life. These sessions will involve working on progressions towards a desired level of functioning (eg. catching the bus to work) and participants will be supported to problem solve to address any issues in using the strategies.
Three occupational therapists with at least 5 years of experience in mental health practice will deliver the intervention, face to face with individual participants.
Intervention code [1] 298374 0
Behaviour
Intervention code [2] 298375 0
Treatment: Other
Comparator / control treatment
No control group in this feasibility study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302473 0
Change in anxiety as measured by mean scores on the Beck Anxiety Inventory (BAI)
Timepoint [1] 302473 0
Baseline, midway through six-week intervention, post six-week intervention and 3 month follow up after intervention
Primary outcome [2] 302482 0
The feasibility of the study design will be evaluated in relation to the following issues: 1.Recruitment: The trialling of two recruitment methods (GP referral and self-identification) across up to six GP surgeries will ascertain the relative success of each method and highlight the variations in volunteers from each. Avenues for self identification will be through advertising on posters and pamphlets in the waiting rooms of the primary care services and through social media websites (eg. Facebook Community pages). 2. Acceptability and utility of intervention: Qualitative data will be collected to capture the acceptability and utility of the Sensory Modulation intervention. This includes a post-intervention Participant Questionnaire and GP Questionnaire (both designed specifically for the study) as well as a participant focus group or individual interviews. Additionally, a focus group for those delivering the intervention, members of the research team, a GP representative and Cultural Advisors will meet to discuss the research process and the participant and GP feedback. 3. Cost of intervention: The clinical researchers will keep a record of their time (including session preparation and documentation) and the sensory modulation items provided in the delivery of the intervention, in order to calculate the total costs. Participants will also keep a simple diary of the items used during the intervention and follow up periods. 4. Measurement of secondary impact: The acceptability and relevance of the measures for participants and suitability for use in the full study will be evaluated. If the secondary measurements are too much of a burden or not focused or sensitive enough to capture specific changes, then the number and type of measures may be refined for the full study. 5. Sample size: The feasibility study will provide baseline and post-intervention measurements of the primary outcome in our target population, allowing estimation of the parameters entering the full trial sample size computation (including attrition
Timepoint [2] 302482 0
After 3 month follow-up
Secondary outcome [1] 336121 0
Changes in participant cortisol levels as measured by differences in mean scores of hair cortisol samples.
Timepoint [1] 336121 0
Baseline, post-intervention, 3mth Follow up
Secondary outcome [2] 336122 0
Changes in levels of worry as measured by means scores on the Penn State Worry Questionnaire
Timepoint [2] 336122 0
Baseline, post-intervention, 3mth Follow up
Secondary outcome [3] 336123 0
Changes in functioning/level of disability measured using the World Health Organization's Disability Assessment Schedule (WHODAS 2.0)
Timepoint [3] 336123 0
Baseline, post-intervention, 3mth follow up
Secondary outcome [4] 336124 0
Changes in Quality of Life as measured by mean scores on the World Health Organization's Quality of Life - Brief (WHOQOL-BREF) scale.
Timepoint [4] 336124 0
Baseline, post-intervention, 3mth follow up

Eligibility
Key inclusion criteria
To participate in the study, candidates must be: a) 18 years of age or over; b) currently experiencing clinically significant anxiety (requiring a score of > 40 on the State Trait Anxiety Inventory); c) if receiving medication or other treatments for anxiety, be on a stable dose for at least two months and intention to use the same dosage for the duration of the intervention; d) exhibit a willingness to abstain from taking on any new psychological or pharmacological treatment for the duration of the intervention.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Candidates may not participate in the study if they have: a) active symptoms of a co-existing DSMIV Axis 1 disorder other than Depression; b) significant cognitive impairment; c) are unable to speak English (as determined during screening interview). The criteria allow for co-morbid depression and physical health conditions as long as anxiety is clinically significant. This reflects the high percentage of people who present with both anxiety and depressive symptoms or physical health issues.

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 is 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)
Statistical methods / analysis
Descriptive statistics will be used to describe baseline, follow-up and change scores on all outcome measures to assess trends in change during the intervention and over a 3-month follow-up period.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8998 0
New Zealand
State/province [1] 8998 0
Auckland

Funding & Sponsors
Funding source category [1] 296717 0
Government body
Name [1] 296717 0
NZ Health Research Council
Address [1] 296717 0
Level 3, 110 Stanley street, Auckland, 1010
PO Box 5541, Wellesley Street, Auckland 1141
Country [1] 296717 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
AUT University
Northshore Campus
90 Akoranga Drive,
Northcote
Auckland
Private Bag 92006
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 295751 0
None
Name [1] 295751 0
None
Address [1] 295751 0
Country [1] 295751 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297945 0
Health and Disability Ethics Committee, NZ
Ethics committee address [1] 297945 0
Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011

Ethics committee country [1] 297945 0
New Zealand
Date submitted for ethics approval [1] 297945 0
22/06/2017
Approval date [1] 297945 0
26/07/2017
Ethics approval number [1] 297945 0
17/NTA/124

Summary
Brief summary
Sensory Modulation (SM) is a therapeutic approach that focuses on addressing the physiological arousal associated with hypersensitivity to stimuli (both conscious and subconscious) that is common in anxiety. The intervention is an emerging practice in mental health services and uses a range of specific calming and grounding sensory stimuli (eg. aromas, music, weighted modalities, proprioceptive input) to help with self management of anxiety symptoms. Training for the approach can be provided within 2 days and it has been found to be effective in de-escalating physiological arousal and practical to use in in-patient settings. However, evidence for the effectiveness of this approach for people living with anxiety in the community is lacking. Since CBT is regarded as the gold standard in psychological interventions for anxiety disorders, it is the most suitable benchmark against which to assess the efficacy of Sensory Modulation. Directly comparing SM and CBT would provide an opportunity to investigate different mechanisms for managing the symptoms of anxiety. A proposed full trial would aim to investigate whether a six-session SM intervention is non-inferior to six-sessions of CBT for reducing anxiety in adult primary care patients. This would be achieved through a multi-centre non-inferiority randomized controlled trial, comparing SM with CBT within primary care. However, prior to running the full trial, several issues need to be examined and this is the focus of the present feasibility study proposal.

Study Aims

In preparation for the full clinical trial described above, this feasibility study aims to evaluate the acceptability, utility, and impact of a sensory modulation intervention for adults accessing primary care services with clinically significant anxiety, with a focus on feasibility issues in the following areas:

1. Recruitment methods

2. Acceptability and utility of intervention

3. Cost of intervention

4. Measurement of secondary impact

5. Sample size

A single arm ‘before and after’ trial of Sensory Modulation will be conducted. Thirty people with a primary complaint of anxiety will be recruited and provided with a six-session Sensory Modulation intervention. Levels of anxiety as well as functioning and quality of life will be measured at baseline, mid-intervention, end of intervention, and 3-month follow-up. Qualitative data related to the acceptability and utility of the intervention will be collected from a cross section of participants through focus groups at the end of the 3 month follow up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75542 0
Dr Daniel Sutton
Address 75542 0
School of Clinical Sciences
AUT University
Northshore Campus
90 Akoranga Drive,
Northcote
Auckland
Private Bag 92006
Auckland 1142
Country 75542 0
New Zealand
Phone 75542 0
+64 9 921 9999 x 7732
Fax 75542 0
Email 75542 0
dsutton@aut.ac.nz
Contact person for public queries
Name 75543 0
Dr David Anstiss
Address 75543 0
Research Officer
School of Clinical Sciences
AUT University
Northshore Campus
90 Akoranga Drive,
Northcote
Auckland
Private Bag 92006
Auckland 1142
Country 75543 0
New Zealand
Phone 75543 0
+ 64 9 921 9999
Fax 75543 0
Email 75543 0
david.anstiss@aut.ac.nz
Contact person for scientific queries
Name 75544 0
Dr Daniel Sutton
Address 75544 0
School of Clinical Sciences
AUT University
Northshore Campus
90 Akoranga Drive,
Northcote
Auckland
Private Bag 92006
Auckland 1142
Country 75544 0
New Zealand
Phone 75544 0
+64 9 921 9999 x 7732
Fax 75544 0
Email 75544 0
dsutton@aut.ac.nz

No data has been provided for results reporting
Summary results
Not applicable