Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04854161 |
| Other study ID # |
UPC-21-02-Compassi-ON |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 11, 2021 |
| Est. completion date |
June 20, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Universidad Pontificia Comillas |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
TThis research wants to observe the effectiveness of an Empathic attunement online training
program for psychologists. This training is based on emotion-focused therapy.
The present research has one main objective and two secondary objectives. The main objective
of is to explore the impact of compassion training as a facilitator of empathic attunement
training. For this reason, an experimental design will be conducted, randomly assigning
therapists to two training programs on empathy, one of them accompanied by compassion
training and the other accompanied by focusing training.
Secondary objectives:
- To validate in Spanish three empathy measures, the empathic understanding subscale from
Barrett-Lennard´s relational inventory, Watson´s Observation of expressed empathy
measure and the empathy subscale made from the Sussex-Oxford Compassion for Others
Scale.
- To explore patient variables related to empathy perception, especially the role of
self-critic.
Description:
This research wants to observe the effectiveness of an Empathic attunement online training
program for psychologists. This training is based on emotion-focused therapy.
The present research has one main objective and two secondary objectives. The main objective
of is to explore the impact of compassion training as a facilitator of empathic attunement
training. For this reason, an experimental design will be conducted, randomly assigning
therapists to two training programs on empathy, one of them accompanied by compassion
training and the other accompanied by focusing training.
Secondary objectives:
- To validate in Spanish three empathy measures, the empathic understanding subscale from
Barrett-Lennard´s relational inventory, Watson´s Observation of expressed empathy
measure and the empathy subscale made from the Sussex-Oxford Compassion for Others Scale
(SOCS-O).
- To explore patient variables related to empathy perception, especially the role of
self-critic.
Detailed Description
Objectives and hypothesis
I. The main objective of the present paper: Explore the impact of compassion empathy on an
empathic attunement training program.
The following hypothesis will be contrasted:
1. Presumably, the training on empathy/compassion will increase therapeutic presence to a
larger extent than the empathy/focusing training. A statistically significant effect of
the interaction of time x group on presence scores is expected.
2. Presumably, the training on empathy/ compassion will increase the emotional regulation
abilities of the therapists to a larger extent than the empathy/focusing training. A
statistically significant effect of the interaction of time x group on the DERS
subscales ratings is expected.
3. Presumably, the empathy/compassion training will increase the therapists therapeutic
Alliance scoring to a larger extent than the empathy/focusing training. A statistically
significant effect of the interaction of time x group on the alliance scoring is
expected.
4. Presumably, the empathy/compassion training will reduce empathic distress (Interpersonal
Reactivity Index) and the empathic distress (Cognitive and Emotional Empathy Test), it
will increase empathic happiness (Cognitive and Emotional Empathy Test) and the empathic
worry (Interpersonal Reactivity Index) to a larger extent than the empathy/focusing
training. A statistically significant effect of the interaction of time x group on these
measures is expected. Specifically on the Interpersonal Reactivity Index and Cognitive
and Emotional Empathy Test subscales scores. On the other hand, fantasy (Interpersonal
Reactivity Index), empathic perspective (Interpersonal Reactivity Index), perspective
adoption (Cognitive and Emotional Empathy Test) and emotional understanding (Cognitive
and Emotional Empathy Test), are expected to remain unchanged on both empathy training
groups.
5. Mediation hypothesis: Changes of the therapist's empathy (Cognitive and Emotional
Empathy Test, Interpersonal Reactivity Index, empathic understanding, expressed empathy)
on empathy/compassion compared to empathy/focusing, will be mediated by changes on
facets of mindfulness (Five Facet Mindfulness Questionnaire) and self-compassion
(Self-Compassion Scale; Sussex-Oxford Compassion Scale).
II. Spanish validation of empathy measures (empathic understanding subscale from
Barrett-Lennard´s relational inventory, expressed empathy, and the Sussex-Oxford Compassion
Scale.
1. Criterion Validity: Statistically significant correlation between the expressed empathy
measure and empathic understanding measures are expected. Significant correlations
between self-report measures (Interpersonal Reactivity Index, Cognitive and Emotional
Empathy Test) and the measures of expressed empathy and the empathic understanding
measures, as well as therapeutic presence, are expected.
2. Evidence for adequate reliability (Cronbach´s alfa and McDonald´s omega) on the empathic
understanding measures of the relational inventory, both on the therapists and the
patient's version, is expected.
3. Evidence for an adequate interrater reliability on the expressed empathy measures is
expected.
4. Incremental validity: The patient's version of empathic understanding explain will show
statistically significant associations with the session evaluation (alliance), once
controlled the empathic understanding assessed by the therapists and expressed empathy
(assessed by external raters). However, the empathic understanding version of the
therapist will not explain variance once discounted the effect of the patient's version
and expressed empathy.
III. Explore patient variables related to empathy evaluation: the role of patient´s
self-critic.
1. Empathy perceived by patients with higher self-critic scoring will be inferior to the
empathy perceived by patients with less self-critic scoring.
2. Empathy/compassion training will get higher scores on these patients than the
empathy/focusing training.
Recruitment
Phase 1:
To recruit people as patients, students from Comillas University will be asked to
participate, coming from Psychology and other degrees. They will be informed about the
research goals, as well as their role and personal data protection. If they wish to
participate, they will be asked to sign an informed consent to use the data and ask them to
facilitate their email so they can be contacted, and self-critic questionnaire will be
administered.
In every moment participants will have available the contact information of the main
researcher so they can ask any question or doubt. Participants will also be informed that
they can revoke their participation and the storage of their data at any moment.
Regarding the therapists, a brochure will be disseminated on social networks with all the
information about the research.
Phase 2:
Patients and therapists will receive an email, with all the information about the research
development and will be asked to sign the informed consent about the usage of their
information, as well as a specific confidentiality document for the therapists about the
information they are going to gather from the patients during the online interview.
Participants
1. Therapists in training Based on previous meta-analysis, we predict a mean effect size (g
of Hedge=0.51) on the change between previous and subsequent moments to treatment. A
power analysis assuming an alfa of 0.05, with a potency of 0.8, reveals that 26
participants are necessary. A total of 30 participants for each condition is aimed in
this study.
To handle the high drop-out rate, usually present in online interventions, 80 therapists
will be randomly allocated between two conditions: compassion training and focusing
training.
Exclusion criteria for the therapists group: every student that has taken the "empathic
attunement" course will be excluded. Subjects that have received training in either
focusing or compassion will also be excluded.
Inclusion criteria for the therapists group: Psychologists with experience in
Psychotherapy (at least one client).
2. Participants interviewed as patients A total of 40 people will be interviewed by the
therapists. Exclusion criteria for participants/patients: Participants presenting severe
mental illness (schizophrenia, psychotic and personality disorders) will be excluded,
those presenting severe addictions or eating disorders will also be excluded. The
presence of these diagnoses will be inquired.
Inclusion criteria for participants/patients: voluntary participation, above 18 years-old
• Quality assurance plan that addresses data validation and registry procedures, including
any plans for site monitoring and auditing: Two external experts will monitor and audit the
research project, and data registry.
Method Once the voluntary therapists are inscribed, they will be randomized on one
randomizing session using sample function to generate random numbers on R statistical
package.
The therapists in training who participate will receive the measures exposed on table 2.
Therapist self-report measures. Pre and post self-report measures: Cognitive and Emotional
Empathy Test, Interpersonal Reactivity Index, Self-Compassion Scale, Five Facet Mindfulness
Questionnaire, Sussex-Oxford Compassion Scale Measures after the pre and post interview:
Presence and RI, Adherence to program measures
With this group of measures affective, cognitive and behavioral aspects of empathy are
encompassed. Participants on the patient's role will receive the measures depicted on Table
3. Two external judges will evaluate the 10 final minutes of the intervention, evaluating the
expressed empathy of the therapist.
Table 3. Self- report measures for the participants on the patient role. BAI FSCRS RI-EU
therapist empathy (patient version) Therapist presence (patient version) SRS (session
evaluation)
Interview method To make the interview, each patient and therapist will receive and
appointment by means of an online Teams session, to ensure data confidentiality.
To simulate a psychotherapy session, and activate emotional processes previous to the
empathic exploration, the participant will be invited to do a two-chair dialogue to explore
his/her self-critic voice and his/her experiencing voice. Lastly, the therapist is asked to
explore empathically for 20 minutes.
Data analysis
Mixed linear models will be used to analyze the impact of different types of training on the
dependent variables analyzed. The statistical package lme4 will be used (Bates, Mächler,
Bolker and Walker, 2015), of R (R Core Team, 2020).
The mediation analysis will be done using SPSS and the process syntax of Hayes (2017).
Working with adherence criterion: Participants that do not attend more than a 25% of the
sessions will be eliminated. G * Power 3.1. 9. 6 (Faul, Erdfelder, Lang, and Buchner, 2007)
was used for the potency calculations.
