Empathy, Working Alliance, Patients' Symptomatology, Psychotherapeutic Process Clinical Trial
— EMAPOfficial 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
| Verified date | December 2020 |
| Source | University of Valencia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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. 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).
| Status | Completed |
| Enrollment | 204 |
| Est. completion date | September 30, 2020 |
| Est. primary completion date | September 30, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 25 Years to 75 Years |
| Eligibility | Inclusion Criteria: - 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: - 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. Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Universitat de València | Valencia |
| Lead Sponsor | Collaborator |
|---|---|
| University of Valencia |
Spain,
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* Note: There are 35 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Qualitative "Mindfulness and Compassion-Based Intervention" post-training measures | Has this training had any effect on your work in therapy? Do you think that the regular practice of mindfulness can provide specific qualities for the exercise of psychotherapy? Have you noticed changes in the way you perceive the feelings or attitudes of your patients? Have you noticed changes in the way you perceive your own feelings, attitudes, thoughts? Do you think that training has been able to affect your way of perceiving biases or interpretations both in yourself and in your patients during therapy? Have you practiced mindfulness, formally or informally, just before a difficult patient entered? Do you think it has helped you in more complex situations in therapy? Have you applied mindfulness with any of your patients? Formally, informally, psychoeducation, modeling? If you could, would you change some of this training? | 8 weeks | |
| Other | Quantitative record on "Mindfulness and Compassion-Based Intervention" post-training results | Questions Yes / No about psychotherapist training
Order of mindfulness interest Likert scale from 0 (Totally disagree) to 5 (Totally agree) of the MCBI improvements Likert scale from 0 (Not very valuable) to 5 (Extremely valuable) Indicate how relevant the different sections of the training have been for you Likert scale from 0 (Nothing) to 10 (Very much) Indicate to what degree you believe that the intervention based on mindfulness and compassion that has helped you control aspects that you would previously seek to change or improve. Indicate to what degree you notice a global improvement as a result of the intervention you have received. Indicate to what degree you have improved in your start-up objectives, as a result of the intervention you have received. Questions about Practice and Materials |
8 weeks | |
| Other | Qualitative measures post-registration Waiting List Group | Did you contribute something to fill in the records? Have you noticed changes in the way you perceive your changes, reactions, distractions...? Have you detected something concrete with any of your patients thanks to having to fill in the records? At what time of the day did you fill in the records? Difficulties when taking records During these last 2 months, have you done any kind of work of introspection, self-knowledge, personal therapy, etc.?
Observations, something to comment: |
8 weeks | |
| Other | Registration of attendance at sessions | Weekly record taken by the instructor attending each session. | 8 weeks | |
| Other | Record the mindfulness practice between sessions | Weekly registration outside the sessions recording: Day of the week, Audio / Type of meditation, minutes of practice, Difficulties / Observations. | 8 weeks | |
| Other | Introspective record during therapy sessions Wait List Group | It is proposed to carry out a diary or introspective self-registration of what you can happen in therapy sessions with their patients (patients who are participating in this study too). That is, make a weekly record of how it felt The therapist at different times of therapy, providing some examples of changes that can be detected:
Distractions of the patient's speech to another topic Postural changes or discomforts (we always talk about you, the therapist) Thoughts and emotions that may arise And in general, anything that wakes you up what your patient says or does This registration should be done, if possible, at the end of the session with the patient. If not Possible will be filled that same day at another time. In no case will personal data of any of the patients be entered. it is requested to indicate who the patient will be A: your e-mail and B: your e-mail (if you have more than 1). |
8 weeks | |
| Primary | 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) |
8 weeks, 6 months | |
| Primary | 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) |
8 weeks, 6 months | |
| Primary | 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) |
8 weeks, 6 months | |
| Primary | 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). |
8 weeks, 6 months | |
| Primary | 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) |
8 weeks, 6 months | |
| Primary | 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) |
8 weeks, 6 months | |
| Secondary | 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) |
8 weeks, 6 months | |
| Secondary | 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) |
8 weeks, 6 months | |
| Secondary | 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) |
8 weeks, 6 months | |
| Secondary | 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) |
8 weeks, 6 months | |
| Secondary | 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). |
8 weeks, 6 months | |
| Secondary | 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). |
8 weeks, 6 months | |
| Secondary | 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). |
8 weeks, 6 months | |
| Secondary | 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). |
8 weeks | |
| Secondary | 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). |
8 weeks | |
| Secondary | 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). |
8 weeks |