ANZCTR - Registration

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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]

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

Condition category

Condition code

Mental Health

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]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

No control group in this feasibility study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in anxiety as measured by mean scores on the Beck Anxiety Inventory (BAI)

Timepoint [1]

Baseline, midway through six-week intervention, post six-week intervention and 3 month follow up after intervention

Primary outcome [2]

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]

After 3 month follow-up

Secondary outcome [1]

Changes in participant cortisol levels as measured by differences in mean scores of hair cortisol samples.

Timepoint [1]

Baseline, post-intervention, 3mth Follow up

Secondary outcome [2]

Changes in levels of worry as measured by means scores on the Penn State Worry Questionnaire

Timepoint [2]

Baseline, post-intervention, 3mth Follow up

Secondary outcome [3]

Changes in functioning/level of disability measured using the World Health Organization's Disability Assessment Schedule (WHODAS 2.0)

Timepoint [3]

Baseline, post-intervention, 3mth follow up

Secondary outcome [4]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/08/2017

Actual

24/10/2017

Date of last participant enrolment

Anticipated

21/12/2018

Actual

Date of last data collection

Anticipated

30/04/2019

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NZ Health Research Council

Address [1]

Level 3, 110 Stanley street, Auckland, 1010
PO Box 5541, Wellesley Street, Auckland 1141

Country [1]

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]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committee, NZ

Ethics committee address [1]

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]

New Zealand

Date submitted for ethics approval [1]

22/06/2017

Approval date [1]

26/07/2017

Ethics approval number [1]

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

Dr Daniel Sutton

Address

School of Clinical Sciences
AUT University
Northshore Campus
90 Akoranga Drive,
Northcote
Auckland
Private Bag 92006
Auckland 1142

Country

New Zealand

Phone

+64 9 921 9999 x 7732

Fax

dsutton@aut.ac.nz

Contact person for public queries

Name

David Anstiss

Address

Research Officer
School of Clinical Sciences
AUT University
Northshore Campus
90 Akoranga Drive,
Northcote
Auckland
Private Bag 92006
Auckland 1142

Country

New Zealand

Phone

+ 64 9 921 9999

Fax

david.anstiss@aut.ac.nz

Contact person for scientific queries

Name

Daniel Sutton

Address

School of Clinical Sciences
AUT University
Northshore Campus
90 Akoranga Drive,
Northcote
Auckland
Private Bag 92006
Auckland 1142

Country

New Zealand

Phone

+64 9 921 9999 x 7732

Fax

dsutton@aut.ac.nz

No information has been provided regarding IPD availability

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.

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