Applying an Osteopathic Intervention to Improve Mild to Moderate Mental Health Symptoms: a Mixed-methods Feasibility Randomised Trial

Overview

Journal Chiropr Man Therap

Publisher Biomed Central

Date 2024 Nov 7

PMID 39506737

Authors

Josh Hope-Bell

Jerry Draper-Rodi

Darren J Edwards

Affiliations

Soon will be listed here.

Abstract

Background: The increasing prevalence of mental health disorders in the United Kingdom necessitates the exploration of novel treatment modalities. This study aimed to assess the feasibility and acceptability of conducting a randomised controlled trial (RCT) evaluating the efficacy of four osteopathic interventions on psychophysiological and mental health outcomes.

Methods: A mixed-methods feasibility study with an explanatory sequential design was implemented. The quantitative phase involved randomising 42 participants into four intervention groups: (1) high-velocity and articulation techniques (HVAT), (2) soft-tissue massage (STM), (3) craniosacral therapy (CST), and (4) a combination approach. Primary outcome measures encompassed recruitment rate, assessment duration, questionnaire completion, intervention attrition, and adverse events. Secondary outcomes included validated assessments of depression, anxiety, stress, psychological flexibility, heart rate variability (HRV), and interoception, administered pre- and post-intervention. Analysis of variance (ANOVA) was employed to evaluate pre-post intervention changes. The qualitative phase comprised semi-structured interviews analysed using thematic analysis.

Results: The study achieved a recruitment rate of 21 eligible participants per month, with 54.8% of respondents meeting eligibility criteria. All 33 participants who completed the study underwent interventions and assessments within the allocated one-hour timeframe, with full questionnaire completion. The attrition rate was 21%. No adverse events were reported. Qualitative analysis revealed positive participant experiences, with themes highlighting good practitioner communication, intervention accessibility, and increased bodily awareness. Some participants found the questionnaire battery burdensome. Exploratory quantitative analyses showed variations in effects across interventions for heart rate variability, interoceptive accuracy, and mental health measures, but these results should be interpreted cautiously due to the small sample size.

Conclusions: This study provides evidence supporting the feasibility and acceptability of a larger-scale RCT investigating osteopathic interventions for individuals presenting with mild psychological symptoms. The preliminary findings suggest potential efficacy in improving mental health outcomes, warranting further investigation. Trial registration NCT05674071, registered 06/01/2023.

References

Clement S, Schauman O, Graham T, Maggioni F, Evans-Lacko S, Bezborodovs N . What is the impact of mental health-related stigma on help-seeking? A systematic review of quantitative and qualitative studies. Psychol Med. 2014; 45(1):11-27. DOI: 10.1017/S0033291714000129. View

Khalsa S, Adolphs R, Cameron O, Critchley H, Davenport P, Feinstein J . Interoception and Mental Health: A Roadmap. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018; 3(6):501-513. PMC: 6054486. DOI: 10.1016/j.bpsc.2017.12.004. View

Baldwin D, Anderson I, Nutt D, Allgulander C, Bandelow B, den Boer J . Evidence-based pharmacological treatment of anxiety disorders, post-traumatic stress disorder and obsessive-compulsive disorder: a revision of the 2005 guidelines from the British Association for Psychopharmacology. J Psychopharmacol. 2014; 28(5):403-39. DOI: 10.1177/0269881114525674. View

Cipriani A, Furukawa T, Salanti G, Chaimani A, Atkinson L, Ogawa Y . Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: a systematic review and network meta-analysis. Lancet. 2018; 391(10128):1357-1366. PMC: 5889788. DOI: 10.1016/S0140-6736(17)32802-7. View

Chalmers J, Quintana D, Abbott M, Kemp A . Anxiety Disorders are Associated with Reduced Heart Rate Variability: A Meta-Analysis. Front Psychiatry. 2014; 5:80. PMC: 4092363. DOI: 10.3389/fpsyt.2014.00080. View

Schulz K, Grimes D . Sample size slippages in randomised trials: exclusions and the lost and wayward. Lancet. 2002; 359(9308):781-5. DOI: 10.1016/S0140-6736(02)07882-0. View

Munder T, Fluckiger C, Leichsenring F, Abbass A, Hilsenroth M, Luyten P . Is psychotherapy effective? A re-analysis of treatments for depression. Epidemiol Psychiatr Sci. 2018; 28(3):268-274. PMC: 6998909. DOI: 10.1017/S2045796018000355. View

Lancaster G, Dodd S, Williamson P . Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004; 10(2):307-12. DOI: 10.1111/j..2002.384.doc.x. View

Tsakiris M, Tajadura-Jimenez A, Costantini M . Just a heartbeat away from one's body: interoceptive sensitivity predicts malleability of body-representations. Proc Biol Sci. 2011; 278(1717):2470-6. PMC: 3125630. DOI: 10.1098/rspb.2010.2547. View

10.

Edwards D, Kemp A . A novel ACT-based video game to support mental health through embedded learning: a mixed-methods feasibility study protocol. BMJ Open. 2020; 10(11):e041667. PMC: 7670940. DOI: 10.1136/bmjopen-2020-041667. View

11.

Edwards D, Young H, Cutis A, Johnston R . The Immediate Effect of Therapeutic Touch and Deep Touch Pressure on Range of Motion, Interoceptive Accuracy and Heart Rate Variability: A Randomized Controlled Trial With Moderation Analysis. Front Integr Neurosci. 2018; 12:41. PMC: 6160827. DOI: 10.3389/fnint.2018.00041. View

12.

Girsberger W, Banziger U, Lingg G, Lothaller H, Endler P . Heart rate variability and the influence of craniosacral therapy on autonomous nervous system regulation in persons with subjective discomforts: a pilot study. J Integr Med. 2014; 12(3):156-61. DOI: 10.1016/S2095-4964(14)60021-2. View

13.

Craig A . How do you feel? Interoception: the sense of the physiological condition of the body. Nat Rev Neurosci. 2002; 3(8):655-66. DOI: 10.1038/nrn894. View

14.

Cerritelli F, Chiacchiaretta P, Gambi F, Perrucci M, Barassi G, Visciano C . Effect of manual approaches with osteopathic modality on brain correlates of interoception: an fMRI study. Sci Rep. 2020; 10(1):3214. PMC: 7035282. DOI: 10.1038/s41598-020-60253-6. View

15.

Mehling W, Acree M, Stewart A, Silas J, Jones A . The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018; 13(12):e0208034. PMC: 6279042. DOI: 10.1371/journal.pone.0208034. View

16.

Zegarra-Parodi R, Park P, Heath D, Makin I, Degenhardt B, Roustit M . Assessment of skin blood flow following spinal manual therapy: a systematic review. Man Ther. 2014; 20(2):228-49. DOI: 10.1016/j.math.2014.08.011. View

17.

Edwards D, Toutt C . An evaluation of osteopathic treatment on psychological outcomes with patients suffering from chronic pain: A prospective observational cohort study collected through a health and well-being academy. Health Psychol Open. 2018; 5(1):2055102918774684. PMC: 5952292. DOI: 10.1177/2055102918774684. View

18.

Bond F, Hayes S, Baer R, Carpenter K, Guenole N, Orcutt H . Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011; 42(4):676-88. DOI: 10.1016/j.beth.2011.03.007. View

19.

Read J, Williams J . Adverse Effects of Antidepressants Reported by a Large International Cohort: Emotional Blunting, Suicidality, and Withdrawal Effects. Curr Drug Saf. 2018; 13(3):176-186. DOI: 10.2174/1574886313666180605095130. View

20.

Lovibond P, LOVIBOND S . The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995; 33(3):335-43. DOI: 10.1016/0005-7967(94)00075-u. View