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Mindfulness, CompassionEMAPNCT04680559

Mindfulness Training for Psychotherapeutic Care

A study testing MCBI and Active Comparator in people with Mindfulness, Compassion and Empathy, Working Alliance, Patients' Symptomatology, Psychotherapeutic Process, run by University of Valencia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It has been shown that mindfulness-based interventions (MBI) applied to psychotherapists improve their empathy and increase the therapeutic alliance. It is expected that these improvements may beneficially affect the results of psychotherapy. Read more about this study

Who is it for?
Ages 25 to 75 yearsHealthy volunteers can take part
What is being tested?
MCBI and Active Comparator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
1 siteSpain
Study dates
29 Sep 2018to 30 Sep 2020
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 25 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Therapists inclusion criteria:
  • Have a psychology degree.
  • Be able to read and write using the Spanish language.
  • Be doing therapy with at least one patient.
  • Eligible participants were contacted through the main psychotherapeutic schools and university centers to invite them to an explanatory meeting of the study.
  • Patient inclusion criteria:
Show all 9Show fewer
  • Be between 18 and 75 years old.
  • Be able to read and write using the Spanish language.
  • Eligible participants were contacted by their personal psychotherapist, either by a phone call or regular therapy appointment to invite them to participate in the study.

Who cannot join

  • Therapists exclusion criteria:
  • Have extensive experience in mindfulness practice
  • Use mindfulness in therapy with your patients.
  • Do not engage in clinical psychology or psychotherapy
  • Patient exclusion criteria:
  • Serious active mental disorders (schizophrenia, bipolar disorder, psychotic disorders) • Disorders due to active substance use (if consumed in the last year)
  • Cognitive impairment
  • Take more than 2 and a half years in therapy with the same therapist

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universitat de València

    Valencia, 46010

Other trials in Spain

About this study

Official title: Influence of a Mindfulness and Compassion-Based Intervention in Psychotherapists: Analysis of Its Effects on Empathy, the Therapeutic Alliance and the Symptomatic Evolution of Their Patients

It has been shown that mindfulness-based interventions (MBI) applied to psychotherapists improve their empathy and increase the therapeutic alliance. It is expected that these improvements may beneficially affect the results of psychotherapy. However, new studies are needed to examine whether an MBI can have an effect on the healthy evolution of these professionals' patients.

The objective of this project is to analyze the influence of a mindfulness and compassion based intervention (MCBI) applied to psychotherapists, on the empathy perceived by their patients, the therapeutic alliance and their symptomatology.

Read more

This study is a randomized clinical trial of an intervention based on MBSR and adapted to the population of psychotherapists, including in the last two sessions the practice of compassion, called Mindfulness and Compassion Based Intervention (MCBI). The subjects (n = 63) were randomly assigned to MCBI (n = 33) or to a Waiting List group in which they fill in a self-record of their own feelings, thoughts, etc. in therapy for 8 weeks (n = 30). Participants in the MCBI intervention condition were asked to meet weekly during a two-hour session for two months. Pre / post-intervention and five-month evaluations were performed as a follow-up.

Mindfulness measures (FFMQ) will be taken for the evaluation of psychotherapists, Self-compassion (SCS-SF), negative symptomatology (DASS-21), empathy (EUS-T, TECA), personal therapist style (EPT-C) and mindfulness instructional style (MIQ).

For the evaluation of patients, measures of mindfulness (FFMQ), self-compassion (SCS-SF) will be taken - to try to control without these skills they can be vicariously modified without being directly trained-, subjective well-being (PHI), psychological well-being (BSI), therapeutic alliance (WATOCI, ENAT) and perceived empathy (EUS-P).

Read the detailed description

The practice of psychotherapy involves the formation and development of a series of skills by the professional. These skills encourage the establishment of a quality therapeutic link, which helps to improve the effectiveness of therapy sessions. In this sense, current research indicates that the link established between the psychotherapist and his patients has a high effect on the evolution and results of psychotherapy. This improvement is to a greater extent attributed to the establishment of the link than to the specific techniques that are applied in therapy.

Among the variables that favor the link, the empathy of the psychotherapist has been widely studied, and has proven to be highly related to the benefits of psychological interventions.

Therefore, the development of healthy empathy is one of the most important variables on which the benefits of psychotherapy are based. It facilitates a true understanding of the vital situations of the patients and is essential in establishing the therapeutic link.

The influence of the latter on the results of psychological interventions has meant that empathy training is one of the basic objectives to follow in the training of clinical and health psychologists, increasing research on effective strategies for this, among which mindfulness and compassion based interventions (MCBI) stand out.

In recent years, the MCBI have established themselves as a very useful intervention in the healthcare field, and several authors suggest the advantages of their application in psychotherapists, pointing out their beneficial influence on the therapeutic relationship and the psychotherapeutic process.

The MCBI are structured interventions in which a series of attitudes and mental states associated with mindfulness and compassion are trained through different meditation techniques. You also learn to generalize these states in the way we relate to the experiences we live. Based on this, the MCBI can be an especially useful strategy to train a series of skills that beneficially influence the therapeutic link and the results of psychotherapy. In relation to the above, it has been seen that MCBI have a beneficial effect on the levels of self-reported empathy of clinical and health psychologists. In addition, an interesting association has been observed between the levels of mindfulness and self-reported empathy in psychotherapists, and between these variables and the therapeutic alliance established with their patients. An association has also been found between the results of the therapeutic alliance measures between therapists and patients after a Mindfulness-based Intervention (MBI). Finally, it has been seen that the application of an MCBI in psychotherapists indirectly influences the evolution of their patients, helping to reduce their symptoms and increase their levels of well-being.

These results imply important support for the advantages of including the MCBI in the training of clinical and health psychologists, in order to increase their levels of empathy and the effectiveness of their interventions. However, there are many limitations we find in these results.

First, the studies that have analyzed the influence of MCBI on empathy only include a self-reported evaluation of psychotherapists on this variable. In addition, this evaluation does not give us information about whether the MCBI affects the empathy that patients perceive in their therapists, which prevents us from assessing whether these benefits exert a real influence on the therapeutic relationship and the psychotherapeutic process.

On the other hand, studies that have established a relationship between levels of mindfulness and direct results in therapeutic alliance include only mindfulness-based interventions (MBI), not including compassion training in a manner explicit. We are interested in observing whether a MCBI significantly influences the perception of the therapeutic alliance by patients.

Finally, in Grepmair's study in which the benefits of applying an MCBI in psychotherapists on the evolution of their patients have been observed, the mediating variables that could explain these results were not evaluated. The objective of this project is to identify the mechanisms of action of the MCBI and its effect on the different variables that could be influencing the results of psychotherapy, such as the empathy of the psychotherapist and the therapeutic alliance established with their patients.

Being tested
MCBI, Active Comparator

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MCBIBehavioural

    The topics covered in the sessions are: Week 1: Introduction to mindfulness and attention to breathing. Week 2. Open awareness of bodily sensations. Week 3: Work with thoughts, introductory theory and practice in attention to sounds. Week 4: Working with thoughts, advanced theory and practice in mental landscape. Week 5: Introductory theory and practice in labeling emotions. Session 6: Advanced theory in working with emotions and practice in difficult emotions. Week 7: Introductory theory on self-compassion and compassion. Practice in self-compassion. Week 8: Practice in compassion and active compassion (acts of kindness and shared humanity).

  • Active ComparatorBehavioural

    Free observation of the psychotherapist's own feelings, thoughts, distractions, biases and behavior in general for 8 weeks. Observations of these variables are recorded during psychotherapy sessions with patients participating in the research.

Study groups in NCT04680559
Study groupRoleWhat they receive
MCBI GroupExperimentalTraining in mindfulness and compassion (MCBI) is facilitated in eight weekly sessions of 2 hours. With a didactic format, through theory, class discussions, and guided meditation practices.
Receives: Behavioral: MCBI
Active-Wait List GroupActive comparatorCompletion of a record during these 8 weeks. Active work of introspection about one's own sensations, thoughts, distractions, judgments, etc. in therapy sessions. Registered after each session.
Receives: Behavioral: Active Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Empathic Understanding Scale Therapist's Version (EUS-TV)

    Designed to assess self-perceived empathy by the therapist himself during therapy sessions. It consists of 16 items and respondents are asked to indicate on a scale of 1 (no, I strongly believe that it is not true) to 6 (yes, I strongly believe that it is true). From this questionnaire a total empathy score is obtained. Higher scores indicate improvements in empathy.

    Used to measure empathy in therapists. EUS has proven effective (Andrade-González, 2009; Barrett-Lennard, 1978)

    Measured: 8 weeks, 6 months

  2. Empathic Understanding Scale Patient's Version (EUS-PV)

    Designed to assess the empathy of therapists perceived by their patients during therapy sessions. It consists of 16 items and respondents are asked to indicate on a scale of 1 (no, I strongly believe that it is not true) to 6 (yes, I strongly believe that it is true). From this questionnaire a total empathy score is obtained. Higher scores indicate improvements in empathy.

    Used to measure empathy in therapists. EUS has proven effective (Andrade-González, 2009; Barrett-Lennard, 1978)

    Measured: 8 weeks, 6 months

  3. Changes in Cognitive and Affective Empathy Test (TECA)

    Designed to evaluate self-reported empathy by the therapists themselves. It is made up of 33 items and respondents are asked to indicate on a scale of 1 (totally disagree) to 5 (totally agree). Four subscales are obtained from this questionnaire: perspective adoption, which refers to taking the patient's point of view; emotional understanding; empathic stress, referred to the contagion of the patient's negative emotions; and empathic joy, referring to the ability to feel joy for the positive emotions of others. You also get a total empathy score. Used to measure empathy in therapists.

    TECA has proven effective (López-Pérez, Fernández-Pinto \& Abad, 2008)

    Measured: 8 weeks, 6 months

  4. Changes in Working Alliance Theory of Change Inventory (WATOCI): reduced version of the Therapeutic Alliance Inventory (WAI-S)

    Designed to evaluate the therapeutic alliance, measured by the patient. It is divided into the subscales of tasks, link and joint goals in therapy and Theory of therapist change, with a general measure of therapeutic Alliance. Composed of 17 items with a Likert scale from 1 (Never) to 7 (Always).

    Used to measure therapeutic alliance in patients. WATOCI has proven effective (Corbella \& Botella, 2004; Duncan \& Miller, 1999).

    Measured: 8 weeks, 6 months

  5. Changes in Alliance Negotiation Scale (ANS)

    Designed to evaluate the flexibility, negotiation and expression of the therapist measured by the patient. Composed of 12 items with a Likert scale from 1 (Never) to 5 (Often).

    Used to measure therapeutic alliance in patients. ANS has proven effective (Díaz-Oropeza \& Peña-Leyva, 2016; Doran, Safran, Waizmann, Bolger \& Muran, 2012)

    Measured: 8 weeks, 6 months

  6. Changes in Brief Sympton Inventory (BSI-18)

    Designed to evaluate somatization, depression and anxiety. Composed of 18 items with a Likert scale from 0 (Nothing) to 4 (A lot).

    Used to measure psychological well-being in patients. BSI-18 has proven effective (Derogatis \& Melisaratos, 1983; Ruipérez, Ibáñez, Lorente, Moro \& Ortet, 2001)

    Measured: 8 weeks, 6 months

Secondary outcomes (10)

  1. Changes in Five Facet Mindfulness Questionnaire (FFMQ)

    Designed to evaluate mindfulness capabilities, through the sub-scales of observation, description, acting consciously, not judging one's own experience and not reacting to one's own experience. This short version is composed of 20 items, with a scale ranging from 1 (never or very rarely true) to 5 (very often or always true).

    Used to measure mindfulness in therapists and patients. FFMQ has proven effective (Baer, Smith, Hopkins, Krietemeyer \& Toney, 2006; Tran et al., 2014)

    Measured: 8 weeks, 6 months

  2. Changes in the short scale of self-compassion (SCS-SF)

    Designed to assess common humanity, mindfulness, self-judgment, excessive identification, isolation, personal goodness and general self-compassion. Composed of 12 items in its short version classified on a Likert scale from 1 (almost never) to 5 (almost always) with the total score obtained by adding the averages of each subscale.

    Used to measure self-compassion in therapists and patients. SCS-SF has proven effective (García-Campayo et al., 2014; Raes, Pommier, Neff \& Van Gucht, 2011)

    Measured: 8 weeks, 6 months

  3. Changes in the Mindfulness Instruction Questionnaire (MIQ; adapted from the Mindfulness In Parenting Questionnaire MIPQ)

    Designed to evaluate mindfulness styles in the instruction of therapists and their ability to be present in session. (Obtained from: Mindfulness in Parenting Questionnaire). Composed of 28 items, with a Likert scale from 1 (never) to 5 (almost always).

    Used to measure mindfulness instructional style in therapists. MIPQ has proven effective (McCaffrey, Reitman \& Black, 2017)

    Measured: 8 weeks, 6 months

  4. Changes in Personal Style of the Therapist (PST-Q)

    Designed to evaluate the instructional function, the expressive function, the involvement function, the attentional function and the operative function of the therapist. Composed of 36 items with a Likert scale from 1 (Total disagreement) to 7 (Total agreement).

    Used to measure the therapist's personal style in therapists PST-Q has proven effective (Fernández-Álvarez, García, LoBianco \& Corbella, 2003)

    Measured: 8 weeks, 6 months

  5. Changes in Depression Anxiety Stress Scale (DASS-21)

    Designed to assess levels of depression, anxiety and stress. Composed of 21 items with a Likert scale from 0 (It didn't happen to me) to 3 (It happened a lot, or most of the time) with an overall score obtained from the sum of all the items.

    Used to measure negative symptomatology in therapists. DASS-21 has proven effective (Lovibond \& Lovibond, 1993).

    Measured: 8 weeks, 6 months

  6. Changes in the Pemberton Happiness Index (PHI)

    Designed to assess remembered well-being (divided into the subscales of hedonic well-being, eudaimonic well-being, social well-being and a total score) and experienced well-being (divided into the subscales of positive experiences and experiences negative) Composed of a scale of 12 items that score from 0 to 10 the degree of agreement with each item.

    Used to measure subjective well-being in patients. PHI has proven effective (Hervás \& Vázquez, 2013).

    Measured: 8 weeks, 6 months

  7. Changes in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM)

    Designed to measure the psychotherapeutic process, it evaluates the state of the client or patient from a series of dimensions (subjective well-being, problems / symptoms and general functioning). It is a is a self-report questionnaire composed of 34 items. It also has short forms of 18 (forms A and B), 10 and 5 items to use in each session as a form of continuous monitoring of the therapeutic process. The short form with 5 items was used in this study.

    It consists of a Likert-type scale that goes from 0 (never) to 4 (always or almost always).

    Used to measure the therapeutic process in patients. CORE-OM has been shown to be effective (Evans et al., 2000; Feixas et al., 2012).

    Measured: 8 weeks, 6 months

  8. Changes in State Emotion Regulation Inventory (SERI)

    Designed to assess distraction, reassessment, self-criticism and acceptance. Composed of 16 items with a Likert scale from 1 (Strongly disagree) to 7 (Strongly agree).

    Used to measure emotional regulation in therapists. SERI has proven effective (Katz, Lustig, Assis \& Yovel, 2017).

    Measured: 8 weeks

  9. Changes in the State-Trait Anxiety Inventory (STAI)

    Designed to assess the subject's state anxiety, understood as the subjective feelings of tension and apprehension and the hyperactivity of the Autonomous Nervous System. Composed of 20 items on a Likert scale from 0 (Nothing) to 3 (Very good).

    Used to measure anxiety in therapists. STAI has proven effective (Spielberger, Gorsuch \& Lushene, 1970).

    Measured: 8 weeks

  10. Changes in Positive and Negative Affect Schedule (PANAS)

    Designed to assess negative affect and positive affect. Composed of 20 items with a Likert scale from 1 (Very little or nothing) to 5 (Extremely).

    Used to measure affections in therapists. PANAS has proven effective (Sandín et al., 1999; Watson, Clark \& Tellegen, 1988).

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2020
  2. Study start29 Sep 2018
  3. Primary completion30 Sep 2020
  4. Study completion30 Sep 2020

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04680559
Sponsor's protocol ID
168021
Acronym
EMAP
Status last verified
Dec 2020
First submitted
30 Nov 2020
Last updated
23 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.

    PubMed 16443717

  • Andrade-González, N. (2009). El papel del terapeuta en la alianza terapéutica. Trabajo presentado en la UNED, Guadalajara, España.

  • Barrett-Lennard, G. T. (1978). The Relationship Inventory: Later developments and adaptations. JSAS: Catalog of Selected Documents in Psychology, 8(68), 1-55

  • Brito, G. (2014). Rethinking mindfulness in the therapeutic relationship. Mindfulness, 5(4), 351-359.

  • Bruce N, Shapiro SL, Constantino MJ, Manber R. Psychotherapist mindfulness and the psychotherapy process. Psychotherapy (Chic). 2010 Mar;47(1):83-97. doi: 10.1037/a0018842.

    PubMed 22402003

  • Corbella, S., & Botella, L. (2004). Psychometric properties of the Spanish version of the Working Alliance Theory of Change Inventory (WATOCI). Psicothema, 16(4), 702-705.

  • Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.

    PubMed 6622612

  • Díaz-Oropeza, I. F., & Peña-Leyva, L. A. (2016). Validation of the Spanish version of the Therapeutic Alliance Negotiation Scale. Estudios de Psicología, 37(2-3), 604-632.

  • Doran JM, Safran JD, Waizmann V, Bolger K, Muran JC. The alliance negotiation scale: psychometric construction and preliminary reliability and validity analysis. Psychother Res. 2012;22(6):710-9. doi: 10.1080/10503307.2012.709326. Epub 2012 Aug 6.

    PubMed 22861685

  • Duncan, B. L., & Miller, S. D. (1999). Working Alliance Theory of Change Inventory (WATOCI). The Institute for the Study of Therapeutic Change (ISTC)

  • Fernández-Álvarez, H., García, F., LoBianco, J., & Corbella, S. (2003). Assessment questionnaire on the personal style of the therapist PST-Q. Clinical Psychology & Psychotherapy, 10(2), 116-125.

  • Garcia-Campayo J, Navarro-Gil M, Andres E, Montero-Marin J, Lopez-Artal L, Demarzo MM. Validation of the Spanish versions of the long (26 items) and short (12 items) forms of the Self-Compassion Scale (SCS). Health Qual Life Outcomes. 2014 Jan 10;12:4. doi: 10.1186/1477-7525-12-4.

    PubMed 24410742

  • Hervas G, Vazquez C. Construction and validation of a measure of integrative well-being in seven languages: the Pemberton Happiness Index. Health Qual Life Outcomes. 2013 Apr 22;11:66. doi: 10.1186/1477-7525-11-66.

    PubMed 23607679

  • Katz BA, Lustig N, Assis Y, Yovel I. Measuring regulation in the here and now: The development and validation of the State Emotion Regulation Inventory (SERI). Psychol Assess. 2017 Oct;29(10):1235-1248. doi: 10.1037/pas0000420. Epub 2016 Dec 12.

    PubMed 27936820

  • Khoury B, Sharma M, Rush SE, Fournier C. Mindfulness-based stress reduction for healthy individuals: A meta-analysis. J Psychosom Res. 2015 Jun;78(6):519-28. doi: 10.1016/j.jpsychores.2015.03.009. Epub 2015 Mar 20.

    PubMed 25818837

Questions about this trial

What is this clinical trial studying?

A study testing MCBI and Active Comparator in people with Mindfulness, Compassion and Empathy, Working Alliance, Patients' Symptomatology, Psychotherapeutic Process, run by University of Valencia at 1 site in Spain.

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 9 inclusion and 8 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 23 Dec 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 Spain. 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?

Changes in Empathic Understanding Scale Therapist's Version (EUS-TV) (time frame: 8 weeks, 6 months). The study lists 6 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 NCT04680559, which also lists 35 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 23 Dec 2020.

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