NCT05674071

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

December 20, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

December 6, 2022

Last Update Submit

November 20, 2023

Conditions

Mental Health Issue

Outcome Measures

Primary Outcomes (6)

  • Feasibility of study recruitment

    Recruitment rate

    3 months

  • Feasibility of time to complete study

    Time to complete questionnaires

    3 months

  • Feasibility of study data collection

    Missing data reported

    3 months

  • Feasibility of assessing physiological measurements

    Time to take physiological measurements

    3 months

  • Acceptability of intervention to participants

    Feedback from participants in qualitative interviews

    3 months

  • Acceptability of intervention and risk factors

    Adverse events reported

    3 months

Secondary Outcomes (8)

  • Depression Anxiety and Stress Scale (DASS)

    3 months

  • Positive and negative affect schedule (PANAS)

    3 months

  • Acceptance and action questionnaire (AAQ)

    3 months

  • Self as context scale (SACS)

    3 months

  • Multidimensional Assessment of Interoceptive Awareness (MAIA)

    3 months

  • +3 more secondary outcomes

Study Arms (4)

Articulation/HVT

EXPERIMENTAL

This intervention will use articulation and high-velocity thrust techniques

Behavioral: Articulation/HVT

Soft-tissue massage

EXPERIMENTAL

This intervention will use soft-tissue massage

Behavioral: Soft-tissue massage

Craniosacral techniques

EXPERIMENTAL

This intervention will use craniosacral techniques

Behavioral: Craniosacral techniques

Combination

EXPERIMENTAL

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

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

Interventions

Articulation/HVTBEHAVIORAL

Osteopathy 1

Articulation/HVT
Soft-tissue massageBEHAVIORAL

Osteopathy 2

Soft-tissue massage
Craniosacral techniquesBEHAVIORAL

Osteopathy 3

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

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

Combination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mild to moderate mental health symptoms as measured by DASS
  • Ability to read/write English.

You may not qualify if:

  • No mental health symptoms or severe mental health symptoms (as measured by DASS)
  • acute or chronic pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swansea University

Swansea, Select State, SA28PP, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 39506737DERIVED

  • Hope-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.

    PMID: 37369421DERIVED

Study Officials

  • Darren Edwards, PhD

    Swansea University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 6, 2022

First Posted

January 6, 2023

Study Start

December 20, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations

GB(1)