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

Swansea University

Status: Completed

Conditions: Mental Health Issue

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05674071

DEdwardsOsteopathy

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 4 patient groups

Articulation/HVT

Experimental group

Description:

This intervention will use articulation and high-velocity thrust techniques

Treatment:

Behavioral: Articulation/HVT

Soft-tissue massage

Experimental group

Description:

This intervention will use soft-tissue massage

Treatment:

Behavioral: Soft-tissue massage

Craniosacral techniques

Experimental group

Description:

This intervention will use craniosacral techniques

Treatment:

Behavioral: Craniosacral techniques

Combination

Experimental group

Description:

This intervention will use a combination of the three interventions: HVT, soft-tissue and craniosacral

Treatment:

Behavioral: Combination of the three interventions: HVT, soft-tissue and craniosacral techniques