Applying an osteopathic intervention to improve mild to moderate mental health symptoms: a mixed-methods feasibility study protocol.
Introduction: Mental health services are stretched in the UK and in need of support. One approach that could improve mental health symptoms is osteopathy. Research suggests that osteopathy influences psychophysiological factors, which could lead to improvements in mental health. The first objective of this protocol is to investigate the feasibility and acceptability of four osteopathic interventions. A secondary aim is to evaluate the interventions' effectiveness in improving psychophysiological and mental health outcomes. Methods and analysis: This study will be an explanatory mixed-methods design. Participants will be 30 adults who have mild to moderate mental health symptoms and not experiencing any issues with pain. The feasibility and acceptability of the interventions will be the first primary outcome. Secondary outcomes will be physiological measures including heart rate variability (HRV), interoceptive accuracy (IAc) and blood pressure (BP). Psychological outcomes will also be measured by standardised questionnaires. These are being collected pre-and post-intervention. Additional outcomes will include recruitment rates and any adverse events that occur during the study. Participants will be randomised to one of four interventions. These are: high-velocity and articulation techniques (HVAT), soft-tissue massage (STM), craniosacral therapy (CST), and a combination of these three approaches. Participants will be interviewed about their experiences of the study and interventions to aid in assessing the feasibility and acceptability. Discussion: This study will assess the feasibility and acceptability of conducting osteopathic interventions for improving mental health outcomes. These results from this will help to inform the running of a future randomised controlled trial. The study will also be producing original data which could provide preliminary evidence whether osteopathic approaches are of benefit to individual's mental health, even if they are pain-free.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
Osteopathy 1
Osteopathy 2
Osteopathy 3
Swansea University
Swansea, Select State, United Kingdom
Feasibility of study recruitment
Recruitment rate
Time frame: 3 months
Feasibility of time to complete study
Time to complete questionnaires
Time frame: 3 months
Feasibility of study data collection
Missing data reported
Time frame: 3 months
Feasibility of assessing physiological measurements
Time to take physiological measurements
Time frame: 3 months
Acceptability of intervention to participants
Feedback from participants in qualitative interviews
Time frame: 3 months
Acceptability of intervention and risk factors
Adverse events reported
Time frame: 3 months
Depression Anxiety and Stress Scale (DASS)
Measure of depression, anxiety and stress. Scores range from 0-21 for each of the 3 sub scales and higher scores indicate greater levels of depression, anxiety or stress.
Time frame: 3 months
Positive and negative affect schedule (PANAS)
Measure of positive and negative affect. Scores range from 10-50 for each of the 2 sub scales and higher scores indicate higher levels of positive and negative affect.
Time frame: 3 months
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This intervention will use a combination of the three interventions: HVT, soft-tissue and craniosacral techniques
Acceptance and action questionnaire (AAQ)
Measure of psychological inflexibility. Scores range from 7-49 and higher scores indicate higher levels of psychological inflexibility.
Time frame: 3 months
Self as context scale (SACS)
Measure of self-as-context and perspective taking. Has two sub scales of centering and transcending ranging from 5-35, with higher scores indicating greater levels of these.
Time frame: 3 months
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Measure of interoceptive awareness. Uses 8 sub scales and higher scores indicate greater levels of each domain of interoceptive awareness.
Time frame: 3 months
Heart rate variability
Measure by time-domain: root mean square of successive interval differences (RMSSD) and frequency domain: low frequency to high frequency ratio.
Time frame: 3 months
Interoceptive accuracy
Measured using heartbeat detection task
Time frame: 3 months
Blood pressure
Participants blood pressure will be recorded according to NICE guidelines
Time frame: 3 months