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

Mental Health Issue Clinical Trial

Official title:

Applying an Osteopathic Intervention to Improve Mild to Moderate Mental Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05674071
• Other study ID #: DEdwardsOsteopathy
• Status: Completed
• Phase: N/A
• Start date: December 20, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: November 2023
• Source: Swansea University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

Behavioral:
• Articulation/HVT
Osteopathy 1
• Soft-tissue massage
Osteopathy 2
• Craniosacral techniques
Osteopathy 3
• 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

Locations

Country	Name	City	State
United Kingdom	Swansea University	Swansea	Select State

Sponsors (3)

Lead Sponsor	Collaborator
Swansea University	Osteopathic Foundation, University College of Osteopathy

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of study recruitment	Recruitment rate	3 months
Primary	Feasibility of time to complete study	Time to complete questionnaires	3 months
Primary	Feasibility of study data collection	Missing data reported	3 months
Primary	Feasibility of assessing physiological measurements	Time to take physiological measurements	3 months
Primary	Acceptability of intervention to participants	Feedback from participants in qualitative interviews	3 months
Primary	Acceptability of intervention and risk factors	Adverse events reported	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Interoceptive accuracy	Measured using heartbeat detection task	3 months
Secondary	Blood pressure	Participants blood pressure will be recorded according to NICE guidelines	3 months