Applying an Osteopathic Intervention to Improve Mental Health Symptoms: a Mixed-methods Feasibility Study Protocol.

Study Overview
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Brief Summary
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Applying an osteopathic intervention to improve mild to moderate mental health symptoms: a mixed-methods feasibility study protocol.

Detailed Description
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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.

Official Title
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Applying an Osteopathic Intervention to Improve Mild to Moderate Mental Health

Conditions
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Mental Health Issue

Intervention / Treatment
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* Behavioral: Articulation/HVT
* Behavioral: Soft-tissue massage
* Behavioral: Craniosacral techniques
* Behavioral: Combination of the three interventions: HVT, soft-tissue and craniosacral techniques


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild to moderate mental health symptoms as measured by DASS Ability to read/write English. Exclusion Criteria: No mental health symptoms or severe mental health symptoms (as measured by DASS) acute or chronic pain

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Articulation/HVT<br>This intervention will use articulation and high-velocity thrust techniques | Behavioral: Articulation/HVT<br>* Osteopathy 1<br>|
| Experimental: Soft-tissue massage<br>This intervention will use soft-tissue massage | Behavioral: Soft-tissue massage<br>* Osteopathy 2<br>|
| Experimental: Craniosacral techniques<br>This intervention will use craniosacral techniques | Behavioral: Craniosacral techniques<br>* Osteopathy 3<br>|
| Experimental: Combination<br>This intervention will use a combination of the three interventions: HVT, soft-tissue and craniosacral | Behavioral: Combination of the three interventions: HVT, soft-tissue and craniosacral techniques<br>* This intervention will use a combination of the three interventions: HVT, soft-tissue and craniosacral techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of study recruitment | Recruitment rate | 3 months | 
| Feasibility of time to complete study | Time to complete questionnaires | 3 months | 
| Feasibility of study data collection | Missing data reported | 3 months | 
| Feasibility of assessing physiological measurements | Time to take physiological measurements | 3 months | 
| Acceptability of intervention to participants | Feedback from participants in qualitative interviews | 3 months | 
| Acceptability of intervention and risk factors | Adverse events reported | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3 months | 
| Acceptance and action questionnaire (AAQ) | Measure of psychological inflexibility. Scores range from 7-49 and higher scores indicate higher levels of psychological inflexibility. | 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. | 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. | 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. | 3 months | 
| Interoceptive accuracy | Measured using heartbeat detection task | 3 months | 
| Blood pressure | Participants blood pressure will be recorded according to NICE guidelines | 3 months |