Clinical trial NCT05674071: Applying an Osteopathic Intervention to Improve Mental Health Symptoms: a Mixed-methods Feasibility Study Protocol.
Official title: Applying an Osteopathic Intervention to Improve Mild to Moderate Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Lead sponsor: Swansea University
Sponsor class: OTHER
Collaborators: name: Osteopathic Foundation
name: University College of Osteopathy
First posted: 2023-01-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of study recruitment
timeFrame: 3 months
measure: Feasibility of time to complete study
timeFrame: 3 months
measure: Feasibility of study data collection
timeFrame: 3 months
measure: Feasibility of assessing physiological measurements
timeFrame: 3 months
measure: Acceptability of intervention to participants
timeFrame: 3 months
measure: Acceptability of intervention and risk factors
timeFrame: 3 months
Secondary outcomes:
measure: Depression Anxiety and Stress Scale (DASS)
timeFrame: 3 months
measure: Positive and negative affect schedule (PANAS)
timeFrame: 3 months
measure: Acceptance and action questionnaire (AAQ)
timeFrame: 3 months
measure: Self as context scale (SACS)
timeFrame: 3 months
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: 3 months
measure: Heart rate variability
timeFrame: 3 months
measure: Interoceptive accuracy
timeFrame: 3 months
measure: Blood pressure
timeFrame: 3 months
Other outcomes:
Locations:
city: Swansea
country: United Kingdom
facility: Swansea University
state: Select State
Study officials:
affiliation: Swansea University
name: Darren Edwards, PhD
role: PRINCIPAL_INVESTIGATOR
References: