Physiological Response to Self-compassion Versus Relaxation

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04647318
• Other study ID #: UT-PSI000104
• Status: Completed
• Phase: N/A
• Start date: September 24, 2018
• Est. completion date: October 11, 2019

Study information

• Verified date: November 2020
• Source: University of Los Andes, Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Methods

Participants will complete an initial screening questionnaire online that consists of reading the study information and completing informed consent, demographics questions, ODSIS14, OASIS15 and FSCRS16. Eligible participants will be invited to attend in-person sessions, in which physiological and self-report responses will be collected. Participants will be asked to avoid exercising, drinking alcohol/caffeine, smoking nicotine and eating during the two hours prior to each session, since these are possible confounds to HRV measurements. Participants will also be asked each session to confirm that they have not made any medication changes, in line with inclusion criteria. HRV will be measured by a research assistant whilst the participant engages in three 4-minute activities, always in the following order: (i) reading a local city culture magazine (control task), (ii) engaging in relaxation imagery involving walking through a forest or on a beach, and (iii) engaging in self-compassion imagery.

Participants will be randomized to complete 3 or 4 trials using a 2:1 ratio. This was decided based upon the premise that more trials are helpful for answering the research questions regarding the impact of repeated trials, but also aiming to minimize dropout for a related study which explored the effects of psychotherapy which was offered following these 3-4 trials.

Although no study to date has explored the hypotheses of this study, the investigators have set a target sample of N=25 based upon other studies exploring effects of CFI on physiology, which have samples ranging from 22 to 25 participants and found significant between-group differences in physiological measures during CFI10,17.

Data analysis

The data will be uploaded to Open Science Framework. Paired sample t-tests will be used to explore differences in RMSSD HRV during the three tasks, and to test changes in positive and negative affect from pre- to post-CFI.

To complement group-level analyses, the investigators will use reliable or clinically-significant change analyses of individuals. A reliable change index (RCI,18) will be calculated for positive and negative affect. Each participant´s change scores (calculated by subtracting pre-CFI affect from post-CFI affect for each trial) will be compared against the RCIs. The investigators will also calculate how many individuals show a clinically-significant HRV response, defined as 5ms change in RMSSD during the experimental task (CFI or relaxation) compared to the control task. THis value was based upon literature on the differences in baseline levels of HRV between healthy controls and patients with depression19,20. The number of positive and negative clinically-significant responses will be compared (i) between relaxation and compassion at trial 1 in order to compare effects of both tasks, and (ii) over 3-4 trials for both relaxation and for compassion, to evaluate whether repeated trials improved response to each task.

Attrition and data loss

Participants will be included if they complete at least one trial of the three tasks, since they can still inform the research questions focused on the initial trial data. Participants will be excluded if HRV data at trial 1 is not interpretable, as this is the primary outcome measure. Individual HRV measurements will be excluded from analysis if the participant reports any of the external threats to HRV data validity mentioned above (e.g. medication changes, high caffeine use, exercise)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 11, 2019
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression

Intervention

Behavioral:
• Compassion focused imagery, relaxation imagery and control task
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.

Locations

Country	Name	City	State
Colombia	University of the Andes	Bogota

Sponsors (1)

Lead Sponsor	Collaborator
University of Los Andes, Columbia

Country where clinical trial is conducted

Colombia, 

References & Publications (27)

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

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.

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	Change in "Safe/warmth positive affect" during compassion imagery at session 1	Positive affect will be measured with two items from the Safe/warmth positive affect scale (safe, content) by Gilbert and colleagues23. Each item is scored from 0-4 (thus total scores will range from 0-8) with higher scores representing greater positive affect. These will be combined with the Relaxed positive affect scale (see below) into one soothing positive affect scale if acceptable internal consistency is achieved (alpha >.80), or will be analysed as two subscales if not.; Ref 23: Gilbert, P., McEwan, K., Mitra, R., Franks, L., Richter, A. & Rockliff, H. (2008). Feeling safe and content: A specific affect regulation system? Relationship to depression, anxiety, stress, and self-criticism. The Journal of Positive Psychology, 3, 182-191.	Session 1 (day 1), immediately pre- and immediately post-compassion-focused imagery
Secondary	Change in "Safe/warmth positive affect" during compassion imagery at session 2	See outcome 5	Session 2 (day 4), immediately pre- and immediately post-compassion-focused imagery
Secondary	Change in "Safe/warmth positive affect" during compassion imagery at session 3	See outcome 5	Session 3 (day 7), immediately pre- and immediately post-compassion-focused imagery
Secondary	Change in "Safe/warmth positive affect" during compassion imagery at session 4	See outcome 5	Session 4 (day 10), immediately pre- and immediately post-compassion-focused imagery
Secondary	Change in "Relaxed positive affect" during compassion imagery at session 1	Positive affect will be measured with two items from the Relaxed positive affect scale (calm, relaxed) by Gilbert and colleagues23. Each item is scored from 0-4 (thus total scores will range from 0-8) with higher scores representing greater positive affect. These will be combined with the items from the Safe/warmth positive affect scale into one soothing positive affect scale if acceptable internal consistency is achieved (alpha >.80), or will be analysed as two subscales if not.; Ref 23: Gilbert, P., McEwan, K., Mitra, R., Franks, L., Richter, A. & Rockliff, H. (2008). Feeling safe and content: A specific affect regulation system? Relationship to depression, anxiety, stress, and self-criticism. The Journal of Positive Psychology, 3, 182-191.	Session 1 (day 1), immediately pre- and immediately post-compassion-focused imagery
Secondary	Change in "Relaxed positive affect" during compassion imagery at session 2	See outcome 9	Session 2 (day 4), immediately pre- and immediately post-compassion-focused imagery
Secondary	Change in "Relaxed positive affect" during compassion imagery at session 3	See outcome 9	Session 3 (day 7), immediately pre- and immediately post-compassion-focused imagery
Secondary	Change in "Relaxed positive affect" during compassion imagery at session 4	See outcome 9	Session 4 (day 10), immediately pre- and immediately post-compassion-focused imagery
Secondary	Change in "negative threat-focused affect" during compassion imagery at session 1	Negative affect will be measured with four items selected by the authors of this study to tap into threat-focused emotions (anxious, distressed, vulnerable, insecure). These were selected by the authors as no appropriate validated measure was identified. Mirroring outcomes 5-12, each item will be scored from 0 (Not Characteristic of me) to 4 (Very Characteristic of me), thus total scores will range from 0-16), with higher scores representing greater negative affect.	Session 1 (day 1), immediately pre- and immediately post-compassion-focused imagery
Secondary	Change in "negative threat-focused affect" during compassion imagery at session 2	See outcome 13	Session 2 (day 4), immediately pre- and immediately post-compassion-focused imagery
Secondary	Change in "negative threat-focused affect" during compassion imagery at session 3	See outcome 13	Session 3 (day 7), immediately pre- and immediately post-compassion-focused imagery
Secondary	Change in "negative threat-focused affect" during compassion imagery at session 4	See outcome 13	Session 4 (day 10), immediately pre- and immediately post-compassion-focused imagery