Applying an Osteopathic Intervention to Improve Mental Health Symptoms: a Mixed-methods Feasibility Study Protocol.
- Conditions
- Mental Health Issue
- Interventions
- Behavioral: Articulation/HVTBehavioral: Soft-tissue massageBehavioral: Craniosacral techniques
- Registration Number
- NCT05674071
- Lead Sponsor
- Swansea University
- Brief Summary
Applying an osteopathic intervention to improve mild to moderate mental health symptoms: a mixed-methods feasibility study protocol.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- Mild to moderate mental health symptoms as measured by DASS
- Ability to read/write English.
- No mental health symptoms or severe mental health symptoms (as measured by DASS)
- acute or chronic pain
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Articulation/HVT Articulation/HVT This intervention will use articulation and high-velocity thrust techniques Soft-tissue massage Soft-tissue massage This intervention will use soft-tissue massage Craniosacral techniques Craniosacral techniques This intervention will use craniosacral techniques
- Primary Outcome Measures
Name Time Method Feasibility of study recruitment 3 months Recruitment rate
Feasibility of assessing physiological measurements 3 months Time to take physiological measurements
Feasibility of time to complete study 3 months Time to complete questionnaires
Feasibility of study data collection 3 months Missing data reported
Acceptability of intervention to participants 3 months Feedback from participants in qualitative interviews
Acceptability of intervention and risk factors 3 months Adverse events reported
- Secondary Outcome Measures
Name Time Method Blood pressure 3 months Participants blood pressure will be recorded according to NICE guidelines
Self as context scale (SACS) 3 months 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.
Interoceptive accuracy 3 months Measured using heartbeat detection task
Depression Anxiety and Stress Scale (DASS) 3 months 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.
Multidimensional Assessment of Interoceptive Awareness (MAIA) 3 months Measure of interoceptive awareness. Uses 8 sub scales and higher scores indicate greater levels of each domain of interoceptive awareness.
Positive and negative affect schedule (PANAS) 3 months 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.
Acceptance and action questionnaire (AAQ) 3 months Measure of psychological inflexibility. Scores range from 7-49 and higher scores indicate higher levels of psychological inflexibility.
Heart rate variability 3 months Measure by time-domain: root mean square of successive interval differences (RMSSD) and frequency domain: low frequency to high frequency ratio.
Trial Locations
- Locations (1)
Swansea University
🇬🇧Swansea, Select State, United Kingdom