Physiological Response to Self-compassion Versus Relaxation

NCT04647318 | Completed

• 1 other identifier: UT-PSI000104
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Compassion-focused imagery (CFI, in which one imagines receiving or giving compassion) can be an effective emotion-regulation technique but some individuals respond as if it is a threat. However, these findings have been based on tasks involving receiving compassion from others. This study sought to examine whether CFI involving self-compassion is less threatening than relaxation and whether any threat-responses decrease with practice. This study will compare the effects of CFI, relaxation and a control task and will explore their effects on self-report symptoms and physiology. It is hypothesized that CFI involving self-compassion is less threatening than relaxation and that any threat-responses decrease with practice.

Conditions

Depression; Anxiety Disorders

Keywords

Compassion; Heart-rate variability; Self-criticism

Outcome Measures

Primary Outcomes (4)

• Difference in heart rate variability (HRV RMSSD) between three tasks: compassion, relaxation, control.

  The physiological measurement system BIOPAC MP15024 will be used to collect ECG data during each task. A standard electrode configuration will be used for collecting ECG data. The ECG signal will be digitized at 2000 Hz and inspected offline using Kubios software25. Successive R waves (identified by an automatic beat detection algorithm) will be visually inspected, and any irregularities will be edited. A time domain index of HRV (RMSSD) will then be obtained for baseline, induction and each experimental condition using HRV Analysis Software26. RMSSD has been chosen because, according to the Task Force guidelines27, it reflects the integrity of vagus nerve-mediated autonomic control of the heart. Additionally, clinically-significant change can be calculated for this.

  Session 1 (day 1)

• Difference in heart rate variability (HRV RMSSD) between three tasks: compassion, relaxation, control.

  The physiological measurement system BIOPAC MP15024 will be used to collect ECG data during each task. A standard electrode configuration will be used for collecting ECG data. The ECG signal will be digitized at 2000 Hz and inspected offline using Kubios software25. Successive R waves (identified by an automatic beat detection algorithm) will be visually inspected, and any irregularities will be edited. A time domain index of HRV (RMSSD) will then be obtained for baseline, induction and each experimental condition using HRV Analysis Software26. RMSSD has been chosen because, according to the Task Force guidelines27, it reflects the integrity of vagus nerve-mediated autonomic control of the heart. Additionally, clinically-significant change can be calculated for this.

  Session 2 (day 4)

• Difference in heart rate variability (HRV RMSSD) between three tasks: compassion, relaxation, control.

  The physiological measurement system BIOPAC MP15024 will be used to collect ECG data during each task. A standard electrode configuration will be used for collecting ECG data. The ECG signal will be digitized at 2000 Hz and inspected offline using Kubios software25. Successive R waves (identified by an automatic beat detection algorithm) will be visually inspected, and any irregularities will be edited. A time domain index of HRV (RMSSD) will then be obtained for baseline, induction and each experimental condition using HRV Analysis Software26. RMSSD has been chosen because, according to the Task Force guidelines27, it reflects the integrity of vagus nerve-mediated autonomic control of the heart. Additionally, clinically-significant change can be calculated for this.

  Session 3 (day 7)

• Difference in heart rate variability (HRV RMSSD) between three tasks: compassion, relaxation, control.

  The physiological measurement system BIOPAC MP15024 will be used to collect ECG data during each task. A standard electrode configuration will be used for collecting ECG data. The ECG signal will be digitized at 2000 Hz and inspected offline using Kubios software25. Successive R waves (identified by an automatic beat detection algorithm) will be visually inspected, and any irregularities will be edited. A time domain index of HRV (RMSSD) will then be obtained for baseline, induction and each experimental condition using HRV Analysis Software26. RMSSD has been chosen because, according to the Task Force guidelines27, it reflects the integrity of vagus nerve-mediated autonomic control of the heart. Additionally, clinically-significant change can be calculated for this.

  Session 4 (day 10)

Secondary Outcomes (12)

• Change in "Safe/warmth positive affect" during compassion imagery at session 1

  Session 1 (day 1), immediately pre- and immediately post-compassion-focused imagery

• Change in "Safe/warmth positive affect" during compassion imagery at session 2

  Session 2 (day 4), immediately pre- and immediately post-compassion-focused imagery

• Change in "Safe/warmth positive affect" during compassion imagery at session 3

  Session 3 (day 7), immediately pre- and immediately post-compassion-focused imagery

• Change in "Safe/warmth positive affect" during compassion imagery at session 4

  Session 4 (day 10), immediately pre- and immediately post-compassion-focused imagery

• Change in "Relaxed positive affect" during compassion imagery at session 1

  Session 1 (day 1), immediately pre- and immediately post-compassion-focused imagery

Study Arms (1)

Compassion focused imagery, relaxation imagery and control task

EXPERIMENTAL

Participants engage in three tasks (compassion focused imagery, relaxation imagery and control task), three or four times every three days.

Behavioral: Compassion focused imagery, relaxation imagery and control task

Interventions

Compassion focused imagery, relaxation imagery and control task BEHAVIORAL

Participants will engage in three tasks (control task, relaxation imagery, and CFI) every three days on a total of 3-4 occasions. Audio-recordings of scripts will be used for both relaxation and compassion imagery. The 4-minute relaxation imagery will involve the following components (i) breathing deeply and bringing mindful awareness to the breath, (ii) relaxing the body, (iii) multisensory mental imagery of a beach or a forest, (iv) noticing feelings that arise. The 4-minute self-compassion imagery scripts will involve the following components: (i) informing participants that showing ourselves self-compassion is an effective emotional-regulation tool, (ii) breathing deeply and attending mindfully to the breath, (iii) imagining oneself embodying the four characteristics of compassion according to Gilbert5, (iv) imagine wishing oneself free of suffering using a warm voice tone and (v) noticing feelings that arise. The control task will involve reading a local city culture magazine.

Compassion focused imagery, relaxation imagery and control task

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being ≥18 years old
• A clinical level of depression or anxiety (defined as ≥ 8 on the ODSIS14 or OASIS15)
• High self-criticism or low self-reassurance, as measured by the FSCRS16 (≥24 on self-inadequacy, ≥ 8 on self-hatred, or ≤18 on self-reassurance). These cut-offs correspond to 0.5 SD above the mean in self-inadequacy/self-hatred, and 0.5 SD below the mean on self-reassurance, based on a validation of the FSCRS17 in Colombia28.

You may not qualify if:

• Positive screen on the Mood Disorder Questionnaire (MDQ), following the norms published by the authors
• Positive screen on the Standardised Assessment of Personality - Abbreviated Scale (SAPAS), defined as scoring 4+
• Severity of Dependence Scale (SDS): scoring 3+ for alcohol use or 5+ for other substances.
• Significant suicidal ideation. Participants were asked, "On a scale of 1 to 7, what is your intent to end your life right now?" from 1 (low) to 7 (high), and "Are you uncertain about being able to control suicidal impulses?" (Yes/No). Participants were excluded for responding ≥5 on item 1 or "yes" to item 2

Sponsors & Collaborators

• University of Los Andes, Columbia: lead

Study Sites (1)

University of the Andes

Bogotá, Colombia

Location

Related Publications (28)

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  PMID: 30599378 BACKGROUND

• Gilbert P, Procter S. Compassionate mind training for people with high shame and self-criticism: overview and pilot study of a group therapy approach. Clin Psychol Psychother [Internet]. 2006 Nov;13(6):353-79.

  BACKGROUND

• Krieger T, Reber F, von Glutz B, Urech A, Moser CT, Schulz A, Berger T. An Internet-Based Compassion-Focused Intervention for Increased Self-Criticism: A Randomized Controlled Trial. Behav Ther. 2019 Mar;50(2):430-445. doi: 10.1016/j.beth.2018.08.003. Epub 2018 Aug 17.

  PMID: 30824257 BACKGROUND

• Kirby JN, Tellegen CL, Steindl SR. A Meta-Analysis of Compassion-Based Interventions: Current State of Knowledge and Future Directions. Behav Ther. 2017 Nov;48(6):778-792. doi: 10.1016/j.beth.2017.06.003. Epub 2017 Jun 21.

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• Gilbert P. The origins and nature of compassion focused therapy. Br J Clin Psychol. 2014 Mar;53(1):6-41. doi: 10.1111/bjc.12043.

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• Boersma K, Håkanson A, Salomonsson E, Johansson I. Compassion Focused Therapy to Counteract Shame, Self-Criticism and Isolation. A Replicated Single Case Experimental Study for Individuals With Social Anxiety. J Contemp Psychother [Internet]. 2015 Jun 6;45(2):89-98.

  BACKGROUND

• Gilbert P. Compassion focused therapy: Distinctive features. London: Routledge; 2010.

  BACKGROUND

• Lincoln TM, Hohenhaus F, Hartmann M. Can Paranoid Thoughts be Reduced by Targeting Negative Emotions and Self-Esteem? An Experimental Investigation of a Brief Compassion-Focused Intervention. Cognit Ther Res [Internet]. 2013 Apr 14;37(2):390-402.

  BACKGROUND

• Petrocchi N, Ottaviani C, Couyoumdjian A. Compassion at the mirror: Exposure to a mirror increases the efficacy of a self-compassion manipulation in enhancing soothing positive affect and heart rate variability. J Posit Psychol [Internet]. 2017 Nov 2;12(6):525-36.

  BACKGROUND

• Rockliff H, Gilbert P, McEwan K, Lightman S, Glover D. A pilot exploration of heart rate variability and salivary cortisol responses to compassion-focused imagery. 2008.

  BACKGROUND

• Gilbert P, Irons C. A pilot exploration of the use of compassionate images in a group of self-critical people. Memory. 2004 Jul;12(4):507-16. doi: 10.1080/09658210444000115.

  PMID: 15487546 BACKGROUND

• McEwan K, Gilbert P. A pilot feasibility study exploring the practising of compassionate imagery exercises in a nonclinical population. Psychol Psychother. 2016 Jun;89(2):239-43. doi: 10.1111/papt.12078. Epub 2015 Oct 10.

  PMID: 26454144 BACKGROUND

• Naismith I, Mwale A, Feigenbaum J. Inhibitors and facilitators of compassion-focused imagery in personality disorder. Clin Psychol Psychother. 2018 Mar;25(2):283-291. doi: 10.1002/cpp.2161. Epub 2017 Dec 18.

  PMID: 29251381 BACKGROUND

• Bentley KH, Gallagher MW, Carl JR, Barlow DH. Development and validation of the Overall Depression Severity and Impairment Scale. Psychol Assess. 2014 Sep;26(3):815-830. doi: 10.1037/a0036216. Epub 2014 Apr 7.

  PMID: 24708078 BACKGROUND

• Norman SB, Cissell SH, Means-Christensen AJ, Stein MB. Development and validation of an Overall Anxiety Severity And Impairment Scale (OASIS). Depress Anxiety. 2006;23(4):245-9. doi: 10.1002/da.20182.

  PMID: 16688739 BACKGROUND

• Gilbert P, Clarke M, Hempel S, Miles JN, Irons C. Criticizing and reassuring oneself: An exploration of forms, styles and reasons in female students. Br J Clin Psychol. 2004 Mar;43(Pt 1):31-50. doi: 10.1348/014466504772812959.

  PMID: 15005905 BACKGROUND

• Duarte J, McEwan K, Barnes C, Gilbert P, Maratos FA. Do therapeutic imagery practices affect physiological and emotional indicators of threat in high self-critics? Psychol Psychother. 2015 Sep;88(3):270-84. doi: 10.1111/papt.12043. Epub 2014 Oct 28.

  PMID: 25347984 BACKGROUND

• Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12-9. doi: 10.1037//0022-006x.59.1.12.

  PMID: 2002127 BACKGROUND

• Hu MX, Lamers F, de Geus EJ, Penninx BW. Differential Autonomic Nervous System Reactivity in Depression and Anxiety During Stress Depending on Type of Stressor. Psychosom Med. 2016 Jun;78(5):562-72. doi: 10.1097/PSY.0000000000000313.

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• Moon E, Lee SH, Kim DH, Hwang B. Comparative Study of Heart Rate Variability in Patients with Schizophrenia, Bipolar Disorder, Post-traumatic Stress Disorder, or Major Depressive Disorder. Clin Psychopharmacol Neurosci. 2013 Dec;11(3):137-43. doi: 10.9758/cpn.2013.11.3.137. Epub 2013 Dec 24.

  PMID: 24465250 BACKGROUND

• López Cavada C, Hornillos Cárdenas T, López-Romero HY. Self-criticism: measure and Treatment. Int Soc Emot Focus Ther (ISEFT), Toronto. 2017;

  BACKGROUND

• Gilbert P, McEwan K, Mitra R, Franks L, Richter A, Rockliff H. Feeling safe and content: A specific affect regulation system? Relationship to depression, anxiety, stress, and self-criticism. J Posit Psychol [Internet]. 2008 Jul;3(3):182-91.

  BACKGROUND

• BIOPAC Systems, Inc., Goleta, CA, United States.

  BACKGROUND

• Kubios version 3.3, 2019, Biosignal Analysis and Medical Imaging Group, University of Kuopio, Finland, MATLAB.

  BACKGROUND

• Niskanen JP, Tarvainen MP, Ranta-Aho PO, Karjalainen PA. Software for advanced HRV analysis. Comput Methods Programs Biomed. 2004 Oct;76(1):73-81. doi: 10.1016/j.cmpb.2004.03.004.

  PMID: 15313543 BACKGROUND

• Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.

  PMID: 8737210 BACKGROUND

• Naismith I, Ferro CD, Ingram G, Leal WJ. Compassion-focused imagery reduces shame and is moderated by shame, self-reassurance and multisensory imagery vividness. Res Psychother. 2019 Jan 17;22(1):329. doi: 10.4081/ripppo.2019.329. eCollection 2019 Apr 19.

  PMID: 32913776 BACKGROUND

• Naismith I, Otto Scheiber CS, Gonzalez Rodriguez D, Petrocchi N. Physiological response to self-compassion versus relaxation in a clinical population. PLoS One. 2023 Feb 7;18(2):e0272198. doi: 10.1371/journal.pone.0272198. eCollection 2023.

  PMID: 36749746 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Iona Naismith, DClinPsy

  University of the Andes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 30, 2020
• Study Start: September 24, 2018
• Primary Completion: October 11, 2019
• Study Completion: October 11, 2019
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

CO (1)