Effects of heart rate variability biofeedback during exposure to fear-provoking stimuli within spider-fearful individuals: study protocol for a randomized controlled trial

Sarah K Schäfer, Frank R Ihmig, Karen A Lara H, Frank Neurohr, Stephan Kiefer, Marlene Staginnus, Johanna Lass-Hennemann, Tanja Michael, Sarah K Schäfer, Frank R Ihmig, Karen A Lara H, Frank Neurohr, Stephan Kiefer, Marlene Staginnus, Johanna Lass-Hennemann, Tanja Michael

Abstract

Background: Specific phobias are among the most common anxiety disorders. Exposure therapy is the treatment of choice for specific phobias. However, not all patients respond equally well to it. Hence, current research focuses on therapeutic add-ons to increase and consolidate the effects of exposure therapy. One potential therapeutic add-on is biofeedback to increase heart rate variability (HRV). A recent meta-analysis shows beneficial effects of HRV biofeedback interventions on stress and anxiety symptoms. Therefore, the purpose of the current trial is to evaluate the effects of HRV biofeedback, which is practiced before and utilized during exposure, in spider-fearful individuals. Further, this trial is the first to differentiate between the effects of a HRV biofeedback intervention and those of a low-load working memory (WM) task.

Methods: Eighty spider-fearful individuals participate in the study. All participants receive a training session in which they practice two tasks (HRV biofeedback and a motor pseudo-biofeedback task or two motor pseudo-biofeedback tasks). Afterwards, they train both tasks at home for 6 days. One week later, during the exposure session, they watch 16 1-min spider video clips. Participants are divided into four groups: group 1 practices the HRV biofeedback and one motor pseudo-task before exposure and utilizes HRV biofeedback during exposure. Group 2 receives the same training, but continues the pseudo-biofeedback task during exposure. Group 3 practices two pseudo-biofeedback tasks and continues one of them during exposure. Group 4 trains in two pseudo-biofeedback tasks and has no additional task during exposure. The primary outcome is fear of spiders (measured by the Fear of Spiders Questionnaire and the Behavioral Approach Test). Secondary outcomes are physiological measures based on electrodermal activity, electrocardiogram and respiration.

Discussion: This RCT is the first one to investigate the effects of using a pre-trained HRV biofeedback during exposure in spider-fearful individuals. The study critically contrasts the effects of the biofeedback intervention with those of pseudo-tasks, which also require WM capacity, but which do not have a physiological base. If HRV biofeedback is effective in reducing fear of spiders, it would represent an easy-to-use tool to improve exposure-therapy outcomes.

Trial registration: Deutsches Register Klinischer Studien, DRKS00012278 . Registered on 23 May 2017, amendment on 5 October 2017.

Keywords: Biofeedback; Exposition therapy; Exposure therapy; Fear of spiders; HRV biofeedback; Heart rate variability; Spider phobia.

Conflict of interest statement

Ethics approval and consent to participate

Ethical approval has been granted by the Ethical Committee of the Faculty of Human Science of Saarland University (reference: 17–03). Participants provide informed consent if they are interested in participating. Participants’ declaration of consent can be revoked at any time of the trial. Modifications of the trial are communicated to all relevant partners. The sponsor of the study is Prof. Tanja Michael, Saarland University (t.michael@mx.uni-saarland.de).

Consent for publication

Consent for publication is obtained from all participants as part of the informed consent process.

Competing interests

The authors declare that they have no competing interests. Saarland University and Fraunhofer Institute for Biomedical Engineering support the undertaking of this study, but did not have any influence on the expressed views in the manuscript. They purely express the scientific view of the authors.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Experimental flow chart including all trial phases
Fig. 2
Fig. 2
Schematic diagram of the Biofeedback System
Fig. 3
Fig. 3
Schematic illustration of the exposure session
Fig. 4
Fig. 4
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure of the current trial

References

    1. Michael T, Zetsche U, Margraf J. Epidemiology of anxiety disorders. Psychiatry. 2007;6:136–142. doi: 10.1016/j.mppsy.2007.01.007.
    1. Michael T. Classical Conditioning. In Wenzel; A.E., (Ed.). The SAGE Encyclopedia of Abnormal and Clinical Psychology. 2017. p. 660–663. 10.4135/9781483365817.n256.
    1. Michael T, Munsch S, Margraf J. Exposition und Konfrontation. In M. Hautzinger und P. Pauli (Eds.). Enzyklopädie der Psychologie – Psychotherapeutische Methoden (S. 325-386). Göttingen: Hogrefe; 2009.
    1. de Quervain DJ-F, Margraf J. Glucocorticoids for the treatment of post-traumatic stress disorder and phobias: a novel therapeutic approach. Eur J Pharmacol. 2008;583:365–371. doi: 10.1016/j.ejphar.2007.11.068.
    1. Duval ER, Javanbakht A, Liberzon I. Neural circuits in anxiety and stress disorders: a focused review. Ther Clin Risk Manag. 2015;11:115–126.
    1. Soravia LM, Orosz A, Schwab S, Nakataki M, Wiest R, Federspiel A. CBT reduces CBF: cognitive-behavioral therapy reduces cerebral blood flow in fear-relevant brain regions in spider phobia. Brain Behav. 2016;6:n/a. doi: 10.1002/brb3.510.
    1. Öst L-G. Intensive one-session treatment of specific phobias. New York: Springer; 2012. One-session treatment: principles and procedures with adults; pp. 59–95.
    1. Choy Y, Fyer AJ, Lipsitz JD. Treatment of specific phobia in adults. Clin Psychol Rev. 2007;27:266–286. doi: 10.1016/j.cpr.2006.10.002.
    1. Craske MG, Treanor M, Conway CC, Zbozinek T, Vervliet B. Maximizing exposure therapy: an inhibitory learning approach. Behav Res Ther. 2014;58:10–23. doi: 10.1016/j.brat.2014.04.006.
    1. Craske MG, Mystkowski JL. Exposure therapy and extinction: clinical studies. 2006.
    1. Singewald N, Schmuckermair C, Whittle N, Holmes A, Ressler K. Pharmacology of cognitive enhancers for exposure-based therapy of fear, anxiety and trauma-related disorders. Pharmacol Ther. 2015;149:150–190. doi: 10.1016/j.pharmthera.2014.12.004.
    1. De Quervain DJF, Bentz D, Michael T, Bolt OC, Wiederhold BK, Margraf J, et al. Glucocorticoids enhance extinction-based psychotherapy. Proc Natl Acad Sci. 2011;108:6621–6625. doi: 10.1073/pnas.1018214108.
    1. Gevirtz R. The promise of heart rate variability biofeedback: evidence-based applications. Biofeedback. 2013;41:110–120. doi: 10.5298/1081-5937-41.3.01.
    1. Tabachnick L. Biofeedback and anxiety disorders: a critical review of EMG, EEG, and HRV feedback. Concept. 2015;38
    1. Kemp AH, Quintana DS, Gray MA, Felmingham KL, Brown K, Gatt JM. Impact of depression and antidepressant treatment on heart rate variability: a review and meta-analysis. Biol Psychiatry. 2010;67:1067–1074. doi: 10.1016/j.biopsych.2009.12.012.
    1. Chalmers JA, Quintana DS, Abbott MJ, Kemp AH, et al. Anxiety disorders are associated with reduced heart rate variability: a meta-analysis. Front Psychiatry. 2014;5:80. doi: 10.3389/fpsyt.2014.00080.
    1. Kemp AH, Quintana DS. The relationship between mental and physical health: insights from the study of heart rate variability. Int J Psychophysiol. 2013;89:288–296. doi: 10.1016/j.ijpsycho.2013.06.018.
    1. Thayer JF, Åhs F, Fredrikson M, Sollers JJ, III, Wager TD. A meta-analysis of heart rate variability and neuroimaging studies: implications for heart rate variability as a marker of stress and health. Neurosci Biobehav Rev. 2012;36:747–756. doi: 10.1016/j.neubiorev.2011.11.009.
    1. Lehrer PM, Gevirtz R. Heart rate variability biofeedback: how and why does it work? Front Psychol. 2014;5 10.3389/fpsyg.2014.00756. Accessed 7 Mar 2018.
    1. Lehrer PM, Vaschillo E, Vaschillo B. Resonant frequency biofeedback training to increase cardiac variability: rationale and manual for training. Appl Psychophysiol Biofeedback. 2000;25:177–191. doi: 10.1023/A:1009554825745.
    1. Lehrer PM, Woolfolk RL. Research on clinical issues in stress management. Princ Pract Stress Manag. 2007;3:703–721.
    1. Goessl VC, Curtiss JE, Hofmann SG. The effect of heart rate variability biofeedback training on stress and anxiety: a meta-analysis. Psychol Med. 2017;47(15):2578–2586. doi: 10.1017/S0033291717001003.
    1. Zucker TL, Samuelson KW, Muench F, Greenberg MA, Gevirtz RN. The effects of respiratory sinus arrhythmia biofeedback on heart rate variability and posttraumatic stress disorder symptoms: a pilot study. Appl Psychophysiol Biofeedback. 2009;34:135. doi: 10.1007/s10484-009-9085-2.
    1. Gevirtz R, Dalenberg C. Heart rate variability biofeedback in the treatment of trauma symptoms. Biofeedback. 2008;36:22–23.
    1. Karavidas MK, Lehrer PM, Vaschillo E, Vaschillo B, Marin H, Buyske S, et al. Preliminary results of an open label study of heart rate variability biofeedback for the treatment of major depression. Appl Psychophysiol Biofeedback. 2007;32:19–30. doi: 10.1007/s10484-006-9029-z.
    1. Siepmann M, Aykac V, Unterdörfer J, Petrowski K, Mueck-Weymann M. A pilot study on the effects of heart rate variability biofeedback in patients with depression and in healthy subjects. Appl Psychophysiol Biofeedback. 2008;33:195–201. doi: 10.1007/s10484-008-9064-z.
    1. Shiban Y, Diemer J, Müller J, Brütting-Schick J, Pauli P, Mühlberger A. Diaphragmatic breathing during virtual reality exposure therapy for aviophobia: functional coping strategy or avoidance behavior? A pilot study. BMC Psychiatry. 2017;17 . Accessed 20 Feb 2017.
    1. Iyadurai L, Blackwell SE, Meiser-Stedman R, Watson PC, Bonsall MB, Geddes JR, et al. Preventing intrusive memories after trauma via a brief intervention involving Tetris computer game play in the emergency department: a proof-of-concept randomized controlled trial. Mol Psychiatry. 2017; 10.1038/mp.2017.23. Accessed 7 Mar 2018.
    1. Lilley SA, Andrade J, Turpin G, Sabin-Farrell R, Holmes EA. Visuospatial working memory interference with recollections of trauma. Br J Clin Psychol. 2009;48:309–321. doi: 10.1348/014466508X398943.
    1. Leer A, Engelhard IM, van den Hout MA. How eye movements in EMDR work: changes in memory vividness and emotionality. J Behav Ther Exp Psychiatry. 2014;45:396–401. doi: 10.1016/j.jbtep.2014.04.004.
    1. van den Hout MA, Engelhard IM. How does EMDR work? J Exp Psychopathol. 2012;3:724–738. doi: 10.5127/jep.028212.
    1. Wurtz H, El-Khoury-Malhame M, Wilhelm FH, Michael T, Beetz EM, Roques J, et al. Preventing long-lasting fear recovery using bilateral alternating sensory stimulation: a translational study. Neuroscience. 2016;321:222–235. doi: 10.1016/j.neuroscience.2015.06.012.
    1. Rinck M, Bundschuh S, Engler S, Muller A, Wissmann J, Ellwart T, et al. Reliability and validity of German versions of three instruments measuring fear of spiders. 2002.
    1. Becker E, Rinck M. Sensitivity and response bias in fear of spiders. Cogn Emot. 2004;18:961–976. doi: 10.1080/02699930341000329.
    1. Rinck M, Becker ES. Spider fearful individuals attend to threat, then quickly avoid it: Evidence from eye movements. J Abnorm Psychol. 2006;115:231–238. doi: 10.1037/0021-843X.115.2.231.
    1. Szymanski J, O’Donohue W. Fear of spiders questionnaire. J Behav Ther Exp Psychiatry. 1995;26:31–34. doi: 10.1016/0005-7916(94)00072-T.
    1. Gräfe K, Zipfel S, Herzog W, Löwe B. Screening psychischer Störungen mit dem “Gesundheitsfragebogen für Patienten (PHQ-D).”. Diagnostica. 2004;50:171–181. doi: 10.1026/0012-1924.50.4.171.
    1. Hautzinger M, Keller F, Kühner C, et al. Das Beck Depressionsinventar II. Deutsche Bearbeitung und Handbuch zum BDI II. Harcourt Test Services, Frankfurt a. M. 2006.
    1. Faul F, Erdfelder E, Buchner A, Lang A-G. Statistical power analyses using G*Power 3.1: Tests for correlation and regression analyses. Behav Res Methods. 2009;41:1149–1160. doi: 10.3758/BRM.41.4.1149.
    1. Brown TA, Barlow DH, DiNardo PA. Anxiety disorders interview schedule for DSM-IV (ADIS-IV): client interview schedule. San Antonio: Graywind Publications Incorporated; 1994.
    1. Schneider S, Margraf J. Diagnostisches Interview bei psychischen Störungen (DIPS für DSM-IV-TR) Berlin: Springer; 2006.
    1. Taylor S, Zvolensky MJ, Cox BJ, Deacon B, Heimberg RG, Ledley DR, et al. Robust dimensions of anxiety sensitivity: development and initial validation of the Anxiety Sensitivity Index-3. Psychol Assess. 2007;19:176. doi: 10.1037/1040-3590.19.2.176.
    1. Kemper CJ, Ziegler M, Taylor S. Überprüfung der psychometrischen Qualität der deutschen Version des Angstsensitivitätsindex-3. Diagnostica. 2009;55:223–233. doi: 10.1026/0012-1924.55.4.223.
    1. Martin A, Rief W, Klaiberg A, Braehler E. Validity of the brief Patient Health Questionnaire mood scale (PHQ-9) in the general population. Gen Hosp Psychiatry. 2006;28:71–77. doi: 10.1016/j.genhosppsych.2005.07.003.
    1. Löwe B, Kroenke K, Herzog W, Gräfe K. Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9) J Affect Disord. 2004;81:61–66. doi: 10.1016/S0165-0327(03)00198-8.
    1. Spielberger CD, Gorsuch RL, Lushene RE. Manual for the State-Trait Anxiety Inventory. 1970.
    1. Laux L, Glanzmann P, Schaffner P, Spielberger C. Das State-Trait-Anxiety-Inventory (STAI). Theor Found Instr. 1981;
    1. Arntz A, Lavy E, Van den Berg G, Van Rijsoort S. Negative beliefs of spider phobics: a psychometric evaluation of the spider phobia beliefs questionnaire. Adv Behav Res Ther. 1993;15:257–277. doi: 10.1016/0146-6402(93)90012-Q.
    1. Lass-Hennemann J, Michael T. Endogenous cortisol levels influence exposure therapy in spider phobia. Behav Res Ther. 2014;60:39–45. doi: 10.1016/j.brat.2014.06.009.
    1. Němcová A, Maršánová L, Smíšek R. Recommendations for ECG Acquisition using Bitalino. Conference paper EEICT. 2016;1:543–47.
    1. Ebben MR, Kurbatov V, Pollak CP. Moderating laboratory adaptation with the use of a heart-rate variability biofeedback device (StressEraser®) Appl Psychophysiol Biofeedback. 2009;34:245. doi: 10.1007/s10484-009-9086-1.
    1. Öst L-G. One-session treatment for specific phobias. Behav Res Ther. 1989;27:1–7. doi: 10.1016/0005-7967(89)90113-7.
    1. Leiner DJ. Sosci survey (version 2.5.00-I) [computer software] 2014.
    1. Corp IBM. IBM SPSS Statistics for Windows, Version 24.0. Armonk, NY; 2016. .
    1. Mühlberger A, Sperber M, Wieser MJ, Pauli P. A virtual reality behavior avoidance test (VR-BAT) for the assessment of spider phobia. ResearchGate. 2008;1:147–158.
    1. Diemer J, Lohkamp N, Mühlberger A, Zwanzger P. Fear and physiological arousal during a virtual height challenge—effects in patients with acrophobia and healthy controls. J Anxiety Disord. 2016;37:30–39. doi: 10.1016/j.janxdis.2015.10.007.

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere