Mental Health IssueNCT05674071
Applying an Osteopathic Intervention to Improve Mental Health Symptoms: a Mixed-methods Feasibility Study Protocol.
A study testing Articulation/HVT, Soft-tissue massage and Craniosacral techniques in people with Mental Health Issue, run by Swansea University at 1 site in United Kingdom.
Trial summary
Applying an osteopathic intervention to improve mild to moderate mental health symptoms: a mixed-methods feasibility study protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Articulation/HVT, Soft-tissue massage and Craniosacral techniques
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Dec 2022to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate mental health symptoms as measured by DASS
- Ability to read/write English.
Who cannot join
- No mental health symptoms or severe mental health symptoms (as measured by DASS)
- acute or chronic pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health Issue
- Being tested
- Articulation/HVT, Soft-tissue massage, Craniosacral techniques, Combination of the three interventions: HVT, soft-tissue and craniosacral techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articulation/HVTBehavioural
Osteopathy 1
Soft-tissue massageBehavioural
Osteopathy 2
Craniosacral techniquesBehavioural
Osteopathy 3
Combination of the three interventions: HVT, soft-tissue and craniosacral techniquesBehavioural
This intervention will use a combination of the three interventions: HVT, soft-tissue and craniosacral techniques
| Study group | Role | What they receive |
|---|---|---|
| Articulation/HVT | Experimental | This intervention will use articulation and high-velocity thrust techniques Receives: Behavioral: Articulation/HVT |
| Soft-tissue massage | Experimental | This intervention will use soft-tissue massage Receives: Behavioral: Soft-tissue massage |
| Craniosacral techniques | Experimental | This intervention will use craniosacral techniques Receives: Behavioral: Craniosacral techniques |
| Combination | Experimental | This intervention will use a combination of the three interventions: HVT, soft-tissue and craniosacral Receives: Behavioral: Combination of the three interventions: HVT, soft-tissue and craniosacral techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of study recruitment
Recruitment rate
Measured: 3 months
Feasibility of time to complete study
Time to complete questionnaires
Measured: 3 months
Feasibility of study data collection
Missing data reported
Measured: 3 months
Feasibility of assessing physiological measurements
Time to take physiological measurements
Measured: 3 months
Acceptability of intervention to participants
Feedback from participants in qualitative interviews
Measured: 3 months
Acceptability of intervention and risk factors
Adverse events reported
Measured: 3 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Interoceptive accuracy
Measured using heartbeat detection task
Measured: 3 months
Blood pressure
Participants blood pressure will be recorded according to NICE guidelines
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start20 Dec 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Collaborators
- Osteopathic Foundation, University College of Osteopathy
- Responsible party
- Principal investigator, Darren Edwards, Swansea University
- Investigators
- Darren Edwards, PhD, Principal investigator, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674071
- Sponsor's protocol ID
- DEdwardsOsteopathy
- Status last verified
- Nov 2023
- First submitted
- 6 Dec 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hope-Bell J, Draper-Rodi J, Edwards DJ. Applying an osteopathic intervention to improve mild to moderate mental health symptoms: a mixed-methods feasibility randomised trial. Chiropr Man Therap. 2024 Nov 6;32(1):32. doi: 10.1186/s12998-024-00556-x.
PubMed 39506737Hope-Bell J, Draper-Rodi J, Edwards DJ. Applying an osteopathic intervention to improve mild to moderate mental health symptoms: a mixed-methods feasibility study protocol. BMJ Open. 2023 Jun 27;13(6):e071680. doi: 10.1136/bmjopen-2023-071680.
PubMed 37369421
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying an Osteopathic Intervention to Improve Mild to Moderate Mental Health
- ClinicalTrials.gov ID
- NCT05674071
- Acronym / sponsor ID
- DEdwardsOsteopathy
- Conditions
- Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Collaborators
- Osteopathic Foundation, University College of Osteopathy
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Articulation/HVT | Experimental | Behavioral: Articulation/HVTThis intervention will use articulation and high-velocity thrust techniques |
| Soft-tissue massage | Experimental | Behavioral: Soft-tissue massageThis intervention will use soft-tissue massage |
| Craniosacral techniques | Experimental | Behavioral: Craniosacral techniquesThis intervention will use craniosacral techniques |
| Combination | Experimental | Behavioral: Combination of the three interventions: HVT, soft-tissue and craniosacral techniquesThis intervention will use a combination of the three interventions: HVT, soft-tissue and craniosacral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mild to moderate mental health symptoms as measured by DASS
- Ability to read/write English.
Key exclusion criteria (2 listed)
- No mental health symptoms or severe mental health symptoms (as measured by DASS)
- acute or chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Articulation/HVTOsteopathy 1 | Behavioural | Articulation/HVT |
| Soft-tissue massageOsteopathy 2 | Behavioural | Soft-tissue massage |
| Craniosacral techniquesOsteopathy 3 | Behavioural | Craniosacral techniques |
| Combination of the three interventions: HVT, soft-tissue and craniosacral techniquesThis intervention will use a combination of the three interventions: HVT, soft-tissue and craniosacral techniques | Behavioural | Combination |
Primary outcome
Feasibility of study recruitment
Time frame: 3 months
Recruitment rate
Feasibility of time to complete study
Time frame: 3 months
Time to complete questionnaires
Feasibility of study data collection
Time frame: 3 months
Missing data reported
Feasibility of assessing physiological measurements
Time frame: 3 months
Time to take physiological measurements
Acceptability of intervention to participants
Time frame: 3 months
Feedback from participants in qualitative interviews
Acceptability of intervention and risk factors
Time frame: 3 months
Adverse events reported
8 secondary outcomes
Depression Anxiety and Stress Scale (DASS)
Time frame: 3 months
Positive and negative affect schedule (PANAS)
Time frame: 3 months
Acceptance and action questionnaire (AAQ)
Time frame: 3 months
Self as context scale (SACS)
Time frame: 3 months
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time frame: 3 months
Heart rate variability
Time frame: 3 months
Interoceptive accuracy
Time frame: 3 months
Blood pressure
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 39506737Hope-Bell J, Draper-Rodi J, Edwards DJ. Applying an osteopathic intervention to improve mild to moderate mental health symptoms: a mixed-methods feasibility randomised trial. Chiropr Man Therap. 2024 Nov 6;32(1):32. doi: 10.1186/s12998-024-00556-x.
- Derived from this study: PubMed 37369421Hope-Bell J, Draper-Rodi J, Edwards DJ. Applying an osteopathic intervention to improve mild to moderate mental health symptoms: a mixed-methods feasibility study protocol. BMJ Open. 2023 Jun 27;13(6):e071680. doi: 10.1136/bmjopen-2023-071680.
Related trials for Mental Health Issue
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Active, not recruiting
Digital Therapeutics for Behavior Problems
Problem Behavior, Child Behavior
Recruiting
VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
Lewy Bodies Disease, Depression Disorder
Active, not recruiting
Tailoring CPP for the Foster Care Setting
Behavior Problem
Active, not recruiting
Supporting Health in Veterans With Heart Failure
Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Edwards, PhD principal investigator
Swansea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Articulation/HVT, Soft-tissue massage and Craniosacral techniques in people with Mental Health Issue, run by Swansea University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of study recruitment (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05674071, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.