DepressionNCT04647318
Physiological Response to Self-compassion Versus Relaxation
A study of Depression and Anxiety Disorders, run by University of Los Andes, Columbia at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety Disorders
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteColombia
- Study dates
- 24 Sep 2018to 11 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological Response to Self-compassion Versus Relaxation in a Clinical Population
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.
Read the 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:
- 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).
- 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)
- Conditions
- Depression, Anxiety Disorders
- Being tested
- Compassion focused imagery, relaxation imagery and control task
- Keywords
- Compassion, Heart-rate variability, Self-criticism
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion focused imagery, relaxation imagery and control taskBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Compassion focused imagery, relaxation imagery and control task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Session 4 (day 10)
Secondary outcomes (12)
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.
Measured: Session 1 (day 1), immediately pre- and immediately post-compassion-focused imagery
Change in "Safe/warmth positive affect" during compassion imagery at session 2
See outcome 5
Measured: Session 2 (day 4), immediately pre- and immediately post-compassion-focused imagery
Change in "Safe/warmth positive affect" during compassion imagery at session 3
See outcome 5
Measured: Session 3 (day 7), immediately pre- and immediately post-compassion-focused imagery
Change in "Safe/warmth positive affect" during compassion imagery at session 4
See outcome 5
Measured: Session 4 (day 10), immediately pre- and immediately post-compassion-focused imagery
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.
Measured: Session 1 (day 1), immediately pre- and immediately post-compassion-focused imagery
Change in "Relaxed positive affect" during compassion imagery at session 2
See outcome 9
Measured: Session 2 (day 4), immediately pre- and immediately post-compassion-focused imagery
Change in "Relaxed positive affect" during compassion imagery at session 3
See outcome 9
Measured: Session 3 (day 7), immediately pre- and immediately post-compassion-focused imagery
Change in "Relaxed positive affect" during compassion imagery at session 4
See outcome 9
Measured: Session 4 (day 10), immediately pre- and immediately post-compassion-focused imagery
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.
Measured: Session 1 (day 1), immediately pre- and immediately post-compassion-focused imagery
Change in "negative threat-focused affect" during compassion imagery at session 2
See outcome 13
Measured: Session 2 (day 4), immediately pre- and immediately post-compassion-focused imagery
Change in "negative threat-focused affect" during compassion imagery at session 3
See outcome 13
Measured: Session 3 (day 7), immediately pre- and immediately post-compassion-focused imagery
Change in "negative threat-focused affect" during compassion imagery at session 4
See outcome 13
Measured: Session 4 (day 10), immediately pre- and immediately post-compassion-focused imagery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start24 Sep 2018
- Primary completion11 Oct 2019
- Study completion11 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Los Andes, Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iona Naismith, DClinPsy, Principal investigator, University of the Andes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647318
- Sponsor's protocol ID
- UT-PSI000104
- Status last verified
- Nov 2020
- First submitted
- 27 Oct 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Werner AM, Tibubos AN, Rohrmann S, Reiss N. The clinical trait self-criticism and its relation to psychopathology: A systematic review - Update. J Affect Disord. 2019 Mar 1;246:530-547. doi: 10.1016/j.jad.2018.12.069. Epub 2018 Dec 25.
PubMed 30599378Gilbert 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.
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.
PubMed 30824257Kirby 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.
PubMed 29029675Gilbert P. The origins and nature of compassion focused therapy. Br J Clin Psychol. 2014 Mar;53(1):6-41. doi: 10.1111/bjc.12043.
PubMed 24588760Boersma 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.
Gilbert P. Compassion focused therapy: Distinctive features. London: Routledge; 2010.
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.
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.
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.
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.
PubMed 15487546McEwan 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.
PubMed 26454144Naismith 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.
PubMed 29251381Bentley 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.
PubMed 24708078Norman 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.
PubMed 16688739
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Response to Self-compassion Versus Relaxation in a Clinical Population
- ClinicalTrials.gov ID
- NCT04647318
- Acronym / sponsor ID
- UT-PSI000104
- Conditions
- Depression, Anxiety Disorders
- Keywords
- Compassion, Heart-rate variability, Self-criticism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Los Andes, ColumbiaUniversity, hospital or other
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 11 Oct 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compassion focused imagery, relaxation imagery and control task | Experimental | Behavioral: Compassion focused imagery, relaxation imagery and control taskParticipants engage in three tasks (compassion focused imagery, relaxation imagery and control task), three or four times every three days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compassion focused imagery, relaxation imagery and control taskParticipants 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. | Behavioural | Compassion focused imagery, relaxation imagery and control task |
Primary outcome
Difference in heart rate variability (HRV RMSSD) between three tasks: compassion, relaxation, control.
Time frame: Session 1 (day 1)
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.
Difference in heart rate variability (HRV RMSSD) between three tasks: compassion, relaxation, control.
Time frame: Session 2 (day 4)
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.
Difference in heart rate variability (HRV RMSSD) between three tasks: compassion, relaxation, control.
Time frame: Session 3 (day 7)
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.
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.
12 secondary outcomes
Change in "Safe/warmth positive affect" during compassion imagery at session 1
Time frame: Session 1 (day 1), immediately pre- and immediately post-compassion-focused imagery
Change in "Safe/warmth positive affect" during compassion imagery at session 2
Time frame: Session 2 (day 4), immediately pre- and immediately post-compassion-focused imagery
Change in "Safe/warmth positive affect" during compassion imagery at session 3
Time frame: Session 3 (day 7), immediately pre- and immediately post-compassion-focused imagery
Change in "Safe/warmth positive affect" during compassion imagery at session 4
Time frame: Session 4 (day 10), immediately pre- and immediately post-compassion-focused imagery
Change in "Relaxed positive affect" during compassion imagery at session 1
Time frame: Session 1 (day 1), immediately pre- and immediately post-compassion-focused imagery
Change in "Relaxed positive affect" during compassion imagery at session 2
Time frame: Session 2 (day 4), immediately pre- and immediately post-compassion-focused imagery
Change in "Relaxed positive affect" during compassion imagery at session 3
Time frame: Session 3 (day 7), immediately pre- and immediately post-compassion-focused imagery
Change in "Relaxed positive affect" during compassion imagery at session 4
Time frame: Session 4 (day 10), immediately pre- and immediately post-compassion-focused imagery
Change in "negative threat-focused affect" during compassion imagery at session 1
Time frame: Session 1 (day 1), immediately pre- and immediately post-compassion-focused imagery
Change in "negative threat-focused affect" during compassion imagery at session 2
Time frame: Session 2 (day 4), immediately pre- and immediately post-compassion-focused imagery
Change in "negative threat-focused affect" during compassion imagery at session 3
Time frame: Session 3 (day 7), immediately pre- and immediately post-compassion-focused imagery
Change in "negative threat-focused affect" during compassion imagery at session 4
Time frame: Session 4 (day 10), immediately pre- and immediately post-compassion-focused imagery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Background: PubMed 30599378Werner AM, Tibubos AN, Rohrmann S, Reiss N. The clinical trait self-criticism and its relation to psychopathology: A systematic review - Update. J Affect Disord. 2019 Mar 1;246:530-547. doi: 10.1016/j.jad.2018.12.069. Epub 2018 Dec 25.
- BackgroundGilbert 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: PubMed 30824257Krieger 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.
- Background: PubMed 29029675Kirby 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.
- Background: PubMed 24588760Gilbert P. The origins and nature of compassion focused therapy. Br J Clin Psychol. 2014 Mar;53(1):6-41. doi: 10.1111/bjc.12043.
- BackgroundBoersma 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.
- BackgroundGilbert P. Compassion focused therapy: Distinctive features. London: Routledge; 2010.
- BackgroundLincoln 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.
- BackgroundPetrocchi 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.
- BackgroundRockliff 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: PubMed 15487546Gilbert 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.
- Background: PubMed 26454144McEwan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iona Naismith, DClinPsy principal investigator
University of the Andes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Depression and Anxiety Disorders, run by University of Los Andes, Columbia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in heart rate variability (HRV RMSSD) between three tasks: compassion, relaxation, control. (time frame: Session 1 (day 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04647318, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.