None listed
Conditions
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.
Interventions
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
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.
Sponsors
Auckland University of Technology
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed