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Completed

NCT Number: NCT05674071

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 symptoms: a mixed-methods feasibility study protocol.

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Key information

Conditions

Mental Health Issue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swansea University

Swansea, Select State, SA28PP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Articulation/HVT

Behavioral

Osteopathy 1

Soft-tissue massage

Behavioral

Osteopathy 2

Craniosacral techniques

Behavioral

Osteopathy 3

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

Behavioral

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

Primary outcomes

  1. Feasibility of study recruitment

    Time frame: 3 months

    Recruitment rate

  2. Feasibility of time to complete study

    Time frame: 3 months

    Time to complete questionnaires

  3. Feasibility of study data collection

    Time frame: 3 months

    Missing data reported

  4. Feasibility of assessing physiological measurements

    Time frame: 3 months

    Time to take physiological measurements

  5. Acceptability of intervention to participants

    Time frame: 3 months

    Feedback from participants in qualitative interviews

  6. Acceptability of intervention and risk factors

    Time frame: 3 months

    Adverse events reported

Secondary outcomes

  1. Depression Anxiety and Stress Scale (DASS)

    Time frame: 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.

  2. Positive and negative affect schedule (PANAS)

    Time frame: 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.

  3. Acceptance and action questionnaire (AAQ)

    Time frame: 3 months

    Measure of psychological inflexibility. Scores range from 7-49 and higher scores indicate higher levels of psychological inflexibility.

  4. Self as context scale (SACS)

    Time frame: 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.

  5. Multidimensional Assessment of Interoceptive Awareness (MAIA)

    Time frame: 3 months

    Measure of interoceptive awareness. Uses 8 sub scales and higher scores indicate greater levels of each domain of interoceptive awareness.

  6. Heart rate variability

    Time frame: 3 months

    Measure by time-domain: root mean square of successive interval differences (RMSSD) and frequency domain: low frequency to high frequency ratio.

  7. Interoceptive accuracy

    Time frame: 3 months

    Measured using heartbeat detection task

  8. Blood pressure

    Time frame: 3 months

    Participants blood pressure will be recorded according to NICE guidelines

Sponsors and collaborators

Lead sponsor

Swansea University

Other

Collaborators

  • Osteopathic Foundation
  • University College of Osteopathy

Registry information

Official study title

Applying an Osteopathic Intervention to Improve Mild to Moderate Mental Health

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 6, 2023
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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