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Clinical Trials/NCT04647318
NCT04647318CompletedNot Applicable

Physiological Response to Self-compassion Versus Relaxation in a Clinical Population

University of Los Andes, Columbia1 site in 1 country25 target enrollmentStarted: September 24, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
25
Locations
1
Primary Endpoint
Difference in heart rate variability (HRV RMSSD) between three tasks: compassion, relaxation, control.

Study Overview

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.

Detailed Description

Introduction

Self-criticism represents a crucial phenomenon in a variety of mental disorders1. Highly self-critical individuals show a poorly regulated threat emotional system and underdeveloped capacities for emotional regulation2,3. Self-criticism is considered a vulnerability risk factor for most psychopathological conditions. Several interventions aiming at increasing compassion as an antidote to self-criticism have been developed4. One of the most empirically validated is Compassion Focused Therapy (CFT, 5), which aims to increase acceptance and compassion for one's own suffering in order to generate a self-soothing response6.

Compassion-focused imagery (CFI) is a key technique in CFT, which involves visualizing compassion towards others, or imagining people, places or objects directing compassion towards oneself7. Single trials of CFI have shown a reduction of negative affect, an increase in self-esteem, and physiological changes associated with the attenuation of threat-focused behaviors8-10. Regular CFI practice has increased self-compassion and reduced negative affect in clinical and non-clinical populations10-13. Despite these promising findings, CFI can create threat-focused responses in some individuals; however, these findings have been based on tasks involving receiving compassion from others.

This study will explore two empirical questions:

  1. How do clinical participants initially respond to self-compassionate imagery in an initial trial? The investigators hypothesize that CFI and relaxation imagery would be associated with similar levels of HRV, and that both would be associated with higher HRV than during the control task (both in terms of group means and number of people showing clinically-significant changes). It is also hypothesized that some participants would show reliable increase in positive affect and reliable decrease in negative affect during CFI, but that others would show the opposite pattern (due to inhibitors of compassion).
  2. Do any threat responses reduce following repeated trials of self-compassionate imagery? It is hypothesized that the number of individuals responding negatively to CFI would decrease over time.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • (Note: these were added subsequent to seeking ethical approval but before study commencement):
  • 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

Outcomes

Primary Outcomes

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

Time Frame: Session 4 (day 10)

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.

Secondary Outcomes

  • Change in "Relaxed 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 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)
  • Change in "Relaxed 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 3(Session 3 (day 7), immediately pre- and immediately post-compassion-focused imagery)
  • Change in "Relaxed positive affect" during compassion imagery at session 4(Session 4 (day 10), immediately pre- and immediately post-compassion-focused imagery)
  • 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 "negative threat-focused affect" during compassion imagery at session 2(Session 2 (day 4), immediately pre- and immediately post-compassion-focused imagery)
  • Change in "negative threat-focused affect" during compassion imagery at session 3(Session 3 (day 7), immediately pre- and immediately post-compassion-focused imagery)
  • Change in "negative threat-focused affect" during compassion imagery at session 4(Session 4 (day 10), immediately pre- and immediately post-compassion-focused imagery)
  • Change in "negative threat-focused affect" during compassion imagery at session 1(Session 1 (day 1), immediately pre- and immediately post-compassion-focused imagery)

Investigators

Sponsor
University of Los Andes, Columbia
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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