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

Applying an Osteopathic Intervention to Improve Mild to Moderate Mental Health

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

Study Overview

• Status: Completed
• Conditions: Mental Health Issue
• Intervention / Treatment: Behavioral: Articulation/HVT; Behavioral: Soft-tissue massage; Behavioral: Craniosacral techniques; Behavioral: Combination of the three interventions: HVT, soft-tissue and craniosacral techniques

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Select State
    • Swansea, Select State, United Kingdom, SA28PP
      • Swansea University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Swansea University
• Collaborators: Osteopathic Foundation; University College of Osteopathy
• Investigators: Principal Investigator: Darren Edwards, PhD, Swansea University

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: DEdwardsOsteopathy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No