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This study will begin a novel line of research on CCT in Denmark as a preventive intervention for caregivers of people suffering from a mental illness. The primary aim of the study is to investigate the effectiveness of a Compassion Cultivation Training (CCT) course on psychological distress of informal caregivers.
The caregivers of people who suffer from mental illness are at raised risk for mental health difficulties (Sorrell, 2014, Stansfeld, 2014, Clark et al., 2011) such as depression, stress and anxiety. Physical health can also be problematic (Clark et al., 2011). In Denmark alone, there are approximately 1.6 million who categorize themselves as caregivers of someone with a mental illness. Of those caregivers, a small, but significant, proportion provides care to a person with a mental illness for 15 hours per week or more (Bedre Psykiatri (Better Psychiatry).
Informal caregiving has come about, as a result of people living longer, and the deinstitutionalization of the health care system. The formal care that once was provided by nurses and other healthcare personnel has now, to a large degree, been given to family members. Caregivers become "hidden patients" who are struggling with their own psychological and physical health as well as providing care for someone with mental illness (The Lancet Editorial, 2017).
A study demonstrated that 25-50% of caregivers develop depression (Clark et al., 2011). If these figures can be translated to the Danish context, 40.000 - 80.000 Danes can be expected to develop depression as a direct result of caring for a loved one with mental illness. A 2012 analysis of National Statistics from Eurostat demonstrates, that the direct and indirect costs per person with depression in Europe is €3034 (Olesen, et al., 2012). Consequently, it is estimated that the cost to Danish society related to the increased incidence of depression among caregivers of the mentally ill amounts to between 120 - 240 million Euros. Det Nationale Forskningscenter for Arbejdsmiljø (The National Research Center for Work Milieu) estimate that the total direct and indirect costs due to mental health related issues in Denmark are 55 billion Danish kroner annually (Danish Mental Health Fund, 2017). Together, these findings provide impetus to study interventions to support caregivers, particularly preventive interventions that increase their psychological and physical health, thereby decreasing the economic burden on society (Jacobsen, 2011).
There is a call for research-based interventions for caregivers (Northouse et al., 2010). Systematic and meta-analysis reviews of intervention programs for caregivers have found conflicting evidence for the effectiveness of interventions programs (Knight et al., 1993) stating that there were too many interventions and too little information on what mechanisms within the interventions were helpful. Others suggest that interventions that specifically address the needs of informal caregivers lead to improvements in their quality of life, a decrease in burden and psychological distress (Yesufu-Udechuku et al., 2015, Northouse et al., 2010). Sörensen et al., (2002), concluded "interventions are on average, successful in alleviating burden and depression, increasing general subjective well-being, and increasing caregiving ability/knowledge. To our knowledge, no preventive interventions aiming at providing caregivers with the skills necessary to increase their emotional resiliency to the caregiver burden have been applied in Denmark.
Compassion training research:
There is a strong and growing interest in the scientific community to explore how compassion is trained, defined, measured and implemented into various settings (Kirby, 2016). Clinical scientists are examining the impact compassion training has on emotional experience, emotion regulation, and psychological flexibility" (Goldin & Jazaieri, 2017). Thus far, research on compassion training point to the potential of being a tool to enhance and sustain mental and physical health (Goldin & Jazaieri, 2017, Kirby, 2016, Hoffman et al., 2011). A systemic review on the impact of compassion training on the treatment of psychopathology the authors concluded that compassion interventions may be effective in treating a broad array of mental health issues such as improvement in psychological distress, levels of positive and negative affect, the frequency and intensity of positive thoughts and emotions, empathic accuracy, and interpersonal skills (Shonin et al., 2015). Another review found that compassion training was associated with reduction in stress and subjective distress, increased immune response, and improvements in the activation of brain areas that are involved in processing emotions and empathy (Hoffman et al., 2011).
Studies on compassion training further found that feeling compassionate decreased heart rate and feeling distressed increased heart rate (Gu et al., 2017), and that displaying compassionate concern for others lowered cortisol reactivity and blood pressure, increased heart rate variability, allowed participants to receive greater support from others, and increased participant's positive affect (Cosley et al., 2010). Other studies have found that a brief compassion exercise increased feelings of social connection and positivity towards strangers (Hutherson et al., 2008).
Klimicki et al., (2014) found that the participants receiving empathy training showed brain activation in areas associated with pain and empathy and when the same participants afterwards received compassion training the effects reversed not only by strengthening their positive affect but also by activating brain areas associated with affiliation and love. This research suggests that being exposed to the suffering of others may lead to two different and distinct emotional reactions: 1) empathetic distress, which when being exposed to empathetic distress over a long period of time, (such as loved ones suffering from a mental illness) negative feelings and withdrawal emerge and give rise to negative health outcomes, and 2) compassionate response that is based on other-oriented and positive feelings and activates pro-social motivational behavior. In sum, this body of research suggests that compassion training may benefit our mental and physical health by improving emotion regulation skills, interpersonal and social relationships, and by activating our parasympathetic system which aims to soothe and calm thereby promoting better physical health.
Compassion Cultivation Training (CCT):
Compassion is often defined as the feeling that arises when we witness someone suffering and we feel motivated to help the person who is suffering (Goetz et al., 2010, Kirby, 2016). Compassion Cultivation Training (CCT) is a comprehensive compassion training program, with a dialectical focus on training compassion for one's own suffering and the suffering of others (including a loved one, a stranger, a difficult person, and all living beings). While the foundation of compassion training is rooted in mindfulness (the paying attention to the present moment without judgment), the focus within compassion training is to notice and pay attention to the suffering within oneself or others thereby becoming motivated to relieve that suffering. The CCT program trains a variety of skills and techniques for emotional and mental well-being and is designed to promote qualities of compassion and empathy, and to cultivate kindness towards self, others and difficult people (Goldin & Jazaieri, 2017).
The theoretical model used in this study is the Process Model of Emotion Regulation developed by Gross & John (2003). Underlying this model is a conception of an emotion-generative process. This conception considers that emotions start with an evaluation of emotion cues. When the emotion cue is attended to and evaluated in different ways, the emotion cues then set in motion a coordinated set of responses that include experiential, physiological and behavioral systems. When the response tendencies arise, they may be regulated in different ways (Gross & John, 2003).
Reprinted from "Emotion Regulation in Adulthood: Timing Is Everything," by J. J. Gross, 2001, Current Directions in Psychological Sciences, 10, p. 215. Copyright 2001 by Blackwell Publishers. Reprinted with permission.
According to the model, emotions can be regulated at five points: 1) selection of the situation, 2) modification of the situation, 3) deployment of attention, 4) change of cognitions, and 5) modulation of the experiential, physiological, and behavioral responses (Gross & John, 2003).
The first four responses are antecedent- focused: Things we do before an emotion response tendency has become fully activated and has changed our behavior and physiological response. The fifth response is response-focused: Things we do once an emotion is already in process and after the response tendencies have already been created (Gross & John, 2003). One such response- focused strategy is emotion suppression and can be used as an emotion regulation strategy when faced with difficult emotions.
In a study by Gross & John (2003), emotion suppression in participants produced feelings of inauthenticity, masking of inner feelings, confusion about what they were feeling, less successful at mood repair, viewed their emotions less favorably and accepting, experienced more negative emotions and less positive emotions, more reluctant to share how they felt with others and avoided close relationships (Pendry & Wright, 2016). The application of this theory to compassion training is that in training caregivers' ability to regulate and accept difficult thoughts and emotions will allow for less emotion suppression and greater acceptance of their own emotional responses, leading to a decrease in overall psychological distress.
Current research on CCT:
Preliminary research findings on CCT have yielded several results: 1) increases in compassion for others and decreases in fear of compassion for self and others, 2) home meditation practice predicted CCT related changes such as a decrease in worry, 3) significant changes in emotion experience such as increased positive affect, decreased negative affect and perceived distress, 4) significant changes in emotion regulation such as increased cognitive reappraisal and acceptance and decreased suppression of emotion, 5) significant changes in cognitive regulations such as increased mindfulness skills, decreased negative rumination and mind-wandering (Jazaieri et al., 2013, 2014, 2015).
Results further indicate that when 1) participants have practiced a compassion meditation that same day, the probability of the participant having an other-focused caring behavior increase by 3.5 times, 2) having practiced a compassion meditation that same day increase the probability of self-caring behavior by 6.5 times, and 3) having engaged in self-care behavior that day participants are 9.3 times as likely to engage in an other-care behavior (Goldin & Jazaieri, 2017). Research on women with chronic pain receiving the CCT course found reduced pain severity and anger, and increased acceptance of pain (Chapin et al., 2014).
Two 2017 studies on the effects of CCT demonstrated significant improvements on self-compassion, mindfulness, and interpersonal conflict (Scarlet et al.,), increased skills in regulating affective experiences while simultaneously shifting towards not influencing affective states, indicating that participants of the CCT program may be more willing or able to accept their difficult emotions instead of suppressing or avoiding them allowing them to become self-efficacious in promoting acceptance of their affective experience (Jazaieri et al., 2017). Thus far, CCT has been studied in the general population, in people with chronic pain, and health care professionals (Jazaieri, 2013, 2014, 2015, 2017, Chapin et al., 2014, & Scarlet et al., 2017). The research on the CCT program is promising, yet more rigorous trials are needed to assess the effectiveness and utility of compassion interventions (Kirby, 2016).
The literature on interventions for caregivers along with compassion training suggests that the different components of psycho-educational group processes, training in compassion and mindfulness alongside meditation and dyadic exercises, may be helpful components in decreasing psychological distress, increase well-being and social connectedness (Hutcherson et al., 2008, Kok & Singer, 2016). The CCT program may be a helpful preventive intervention for caregivers of the mentally ill. Therefore, this study is of high value as it aims to bring skills to a "hidden" group within the Danish population of informal caregivers so that they may be better equipped to take care of their own emotional health. The skills they will acquire through the CCT course may allow caregivers greater flexibility in regulating emotions and greater acceptance of difficult emotions, increasing their emotional resiliency and decreasing psychological distress. This will not only benefit themselves and their loved one suffering from a mental illness but it will also benefit Denmark economically.
This study will begin a novel line of research on CCT in Denmark as a preventive intervention for caregivers of people suffering from a mental illness. The primary aim of the study is to investigate the effectiveness of a Compassion Cultivation Training (CCT) course.
Hypothesis 1: It is hypothesized that caregivers in CCT will reduce psychological distress, relative to control participants, as measured by the Depression Anxiety Stress Scale (DASS) at baseline (T0), post intervention (T1), 3-month (T2) and 6-month (T3).
Hypothesis 2: It is hypothesized that caregivers in CCT, relative to control participants, will increase compassion for self and others, show greater acceptance of difficult emotions and decrease emotion suppression as measured by Self-Compassion Scale Short Form (SCS-12), Multidimensional Compassions Scale (MCS), Perceived Stress Scale, (PSS), The Emotion Regulation Questionnaire (ERQ)), Brief Resilience Scale (BRS) and WHO-5 measured at T0, T1, T2, and T3.
Hypothesis of Mechanisms: Improvements on these skills will mediate the effects of treatment and outcome. Specifically: a) increase in compassion for self and others (SCS-12 and MCS) will mediate the effects of emotion regulation skills (i.e. greater acceptance of difficult emotions and therefore less suppression of difficult emotions) and b) increase in emotion regulation skills (ERQ) (i.e. greater acceptance of difficult emotions and therefore less suppression of difficult emotions) will mediate the effects of psychological distress (DASS) in informal caregivers.
The effect of CCT will be evaluated in a parallel randomised controlled trial including 77 participants in the intervention group and 77 in a wait-list group.
Participants and Recruitment A collaboration with The Center for Special Education and Counseling for Youth and Adults (CSV) in Kolding has begun, as CSV has extensive knowledge on working with informal caregivers and the difficulties they face daily. Approximately 40, of the 154 participants will be recruited in Southern Jutland (Kolding and Fredericia). Thus, not only will the study have participants from other parts of Denmark than Copenhagen, but knowledge about the feasibility of implementing an 8-week CCT course for informal caregivers within an organization like CSV will be gained, adding to the knowledge of how the project may improve practice in the field.
Participants will be recruited through primary care physicians. The Danish Center for Mindfulness, Aarhus University has a good history of recruiting participants for their trials, due to well established relationships primary care physicians. Recruitment will also be carried out in collaboration with the national association for caregivers; Bedre Psychiatri, Landsforeningen for pårørende (Better Psychiatry, national association for caregivers), through Psykiatrifonden (The Danish Mental Health Fund), who acknowledge and support this research as they are keenly aware of the great need for interventions for informal caregivers. Lastly, we will recruit through social media such as Facebook, Twitter, and the Danish Center for Mindfulness website. In addition, recruitment will be carried out through CSV's website, local newspapers and their collaborators. Participant's reporting some degree of difficulty in their daily lives as caregivers will be recruited.
After informed consent and T (0) measures, participants will be randomized to either CCT (N=77) or waitlist control group (N=77) using a computer algorithm with predefined, concealed random numbers. An independent statistician will manage the randomization by giving all registered participants either a number of "1" or "2" in sequence. The participants with "1" will be assigned to the immediate intervention group and those with "2" to a waitlist control group. We will not use "treatment" or "control" group to mention the allocation. All subjects will be told that they will be arranged into two groups to attend the CCT session separately due to resource limitations. The independent clinical assistant will call participants to let them know the group they belong to, either the immediate group or the waitlist group.
Eligible participants, meeting all study criteria, are asked to participate in the RCT. All participants will be given psychological, and demographic measurements at baseline (T0), and psychological measures at post intervention (T1), 3-month follow-up (T2) and 6-month follow-up (T3), The study will be registered in ClinicalTrails.gov before commencement. The investigators will specifically ask that the participants in the waitlist control group do not start any other intervention during the study period.
Eligible participants will receive an email with a link to the measurements that must be filled out online from their homes at baseline and is a requirement to be able to participate in the study. At post intervention, and the three and six-month follow up participants will again receive an email asking them to fill out the questionnaires packet online using the link in the email. The data will be collected in a secure university approved system, RedCap. Follow-up emails, phone calls, and text message reminders will be sent out encouraging participants to fill out the surveys if they have not already done so.
CCT is an eight-week group based two-hour course and incorporates practices of compassion, mindfulness, and meditation, with scientific research on compassion and related topics in the fields of psychology and neurology along with contemplative thinking.
CCT is a psycho-educational course and each week participants engage with material on the cultivation of compassion and other related topics, class discussions, formal meditations, and dyadic exercises. Participants are asked to meditate daily at home for 20-25 minutes on guided compassion meditations accessed through the website www.centerforcompassion.dk and engage in informal compassion practices. The CCT course is curriculum-based and consists of 6 steps. Step 1 involves learning to focus and settle the mind. Step 2 involves cultivating the psychosomatic experiences of warmth and caring for a loved one. Step 3 involves training compassion and loving kindness for oneself. Step 4 involves cultivating compassion towards others through embracing our shared common humanity and appreciating the interconnectedness of self and others. Step 5 involves training compassion towards all beings, and step 6 involves an ''active compassion'' practice where participants imagine taking away others' pain and sorrow and offering them one's own joy and happiness (Jinpa, 2010).
The CCT material has been translated into Danish by psychologist Nanja Holland Hansen, who is fluent in Danish and English and by psychiatrist Lone Fjorback, who after the main translation of all the material went through it again and corrected any errors that may have been present.
Compliance and attrition
Treatment compliance will be assessed by recording the number of completed CCT sessions, and by having participants fill out a daily practice log as research has shown that positive outcomes are dose dependent (Jazaieri et al., 2015). The Credibility and Efficiency Questionnaire (CEQ) (Borkovec & Nau, 1972) will also be administered. This is to rule out participants perceived credibility and efficiency of the treatment as alternative explanations for the differences observed in outcome between the CCT and Waitlist Control group. When applicable, participants will be asked for their reasons for poor compliance/drop-out and asked to continue participation in the assessments until six-months follow-up. Any adverse effects, reported by participants or observed by investigators, will be recorded and reported to the Research Ethics Committee (Duggan et al., 2014). An intention to treat (ITT) analysis will be used to circumvent noncompliance and missing outcomes, and to provide an unbiased estimate of treatment effects. When applicable, participants will be asked for their reasons for poor compliance/drop-out and asked to continue participation in the assessments until six-months follow-up.
We will compare the outcome variables (DASS, PSS, SCS-12, MCS, ERQ, BRS and WHO-5) correcting for multiple comparisons where appropriate using the Student t or Wilcoxon tests. Analysis of covariance (ANCOVA) will be conducted to assess whether CCT is related to changes between baseline and after 8 weeks of intervention in relation to psychological distress.
The four measurement points allow to test whether changes in the proposed mediators are associated with changes in the proposed outcomes. This is a crucial condition in order to investigate mediators and possible mechanisms (Kazdin A.E., 2007). We will use structural equation modelling to examine the proposed mechanisms of CCT by testing the following action theories and conceptual theories simultaneously (Chen, T-S., 1994; Goldsmith et al., 2018).
The current project assumes two conceptual theories, which will be tested: 1) changes in compassion for self and others will affect psychological distress (DASS) and 2) changes in emotion regulation skills of reappraisal and suppression (ERQ) will affect psychological distress (DASS). The action theories, that CCT changes 1) compassion for self (SCS-12) and others (MCS) and 2) emotion regulation skills of reappraisal and suppression (ERQ), will be tested. The indirect, direct and total effects will be estimated with 95% CI inspired by a framework suggested by Goldsmith et al., (2018). The statistical package M-Plus will be applied.
We will also use a random-effects repeated measures analysis to examine the impact of the CCT intervention on psychological distress, adjusting for confounding variables (age, gender, ethnicity, socio-economic status, and years as informal caretaker). The repeated measure analysis approach accounts for the same individual's different outcome measures across different points in time without assuming either linear or curvilinear growth pattern. Cronbach alpha's will be computed to determine the internal consistency of our outcome measures.
The sample size was calculated using effect sizes from related publications (Jazaieri et al., 2015, 2013, 2012, Kuhlmann et al., 2015, Galante, et al., 2014, & Brito-Pons, 2014), respective η-square-values, and Cohen's d) with G*Power. The power analysis gave an approximate value of a minimum of 77 participants in both groups where we expect a medium effect size of .5 Cohen's d (alpha .05, power 80%). A minimum of 77 participants per group allows for an attrition rate of 20%, which will give us a minimum sample size of 64 participants per group. Four groups of approximately 20 participants per group will be given the CCT intervention
2018: Ethics application has been approved (1 month). Recruitment of participants has begun (1 month -ongoing). A systematic review article: Mental Health interventions for caregivers of people with mental illness: A systematic review and meta-analysis has been accepted by Prospero. (approved in July and will conclude in December 2018). Teach the first CCT course (20 participants) as part of the RCT in Southern Jutland (November -December 2018).
2019: Continue to deliver the main RCT (CCT versus wait list) intervention. Three CCT courses will be taught with approximately 20 participants in each class (January - April 2019). Begin collecting and interpreting data from participants (April - December 2019) and prepare second article: 'CCT for Caregivers: A randomized controlled trial' (November - December 2019).
2020: Collect and interpret final data from participants (January 2019), write dissertation and article on the main study. The article 'Compassion for Caregivers: Can compassion be utilized as an emotion regulation strategy in decreasing psychological distress?' (February - September 2020).
Plan for dissemination
Both positive and negative research results will be published in peer-reviewed journals, presented at international and national conferences and disseminated via media such as facebook, twitter, and the Danish Center for Mindfulness website. Knowledge about how to help informal caregivers and how to increase compassion will be shared with relevant organizations. The Danish Center for Mindfulness will continue to share the results that come out of the research. We already know, based on the pilot data, that the CCT course is feasible within a Danish context and for professional caregivers (i.e. doctors, psychologists, nurses etc.). These results have already been disseminated at two international conferences: The International Conference on Mindfulness, Amsterdam, Holland, Summer 2018, and Mind and Life Summer Research Institute, Germany, 2018.
The Trygfond name and logo will be printed on all materials related to the project and the dissemination of the research and its findings. The logo and name will also be presented at workshops, and other public engagements including three research articles: 1) Mental Health interventions for caregivers of people with mental illness: A systematic review and meta-analysis, 2) CCT for Caregivers: A randomized controlled trial' and 3) 'Compassion for Caregivers: Can compassion be utilized as an emotion regulation strategy in decreasing psychological distress?', and on websites such as www.mindfulness.au.dk and www.centerforcompassion.dk.
The knowledge gained from this research will lead to a greater understanding of whether an 8-week compassion training course for informal caregivers is feasible but also the effect of the CCT course and possibility to ease the burden of being a caregiver. This is extremely important knowledge for implementation and improving current practice for informal caregivers.
Research Environment This PhD project is embedded in a strong academic and interdisciplinary environment with supervisors, collaborators and advisors from the Danish Centre for Mindfulness, Aarhus University, Interacting Minds Centre, Aarhus University, Oxford University and Stanford University.
Lone Fjorback (LF), Ph.D., MD is director of the Danish Mindfulness Centre, Institute of Clinical Medicine, Aarhus University with extensive expertise in clinical psychiatry and in constructing, advising and conducting high-quality research in the mindfulness field. Lone Fjorback is the main supervisor and principle investigator on this project.
Nanja Holland Hansen (NHH), cand.psych.aut and Ph.D.-student with Danish Center for Mindfulenss, Institute of Clinical Medicine, Aarhus University, will carry out the intervention as she is a senior level CCT instructor. Nanja has extensive knowledge on compassion and compassion training. She was trained at Stanford University with some of the world's top experts in compassion and compassion training. She is also an experienced clinical psychologist and has worked nationally and internationally with a wide range of diverse populations and clinical issues.
Christine Parsons (CP), Ph.D. is an Associate Professor, with expertise in psychological science and neuroscience, from Interacting Minds Centre, Aarhus University and Oxford University. Christine has extensive knowledge regarding psychometric properties, statistical analysis and is a formidable researcher.
Lise Juul (LJ), Ph.D., is an Associate professor at Danish Center for Mindfulness, Institute of Clinical Medicine, Aarhus University. She has expertise in evaluating public health interventions and has conducted RCTs in real life settings and is highly competent within mediation analysis.
Karen-Johanne Pallesen (KJP) Ph.D., is an Associate Professor at the Danish Center for Mindfulness, Institute of Clinical Medicine, Aarhus University. Her expertise lies within the field of neuropsychology, cognitive science, and cognitive psychology.
On an advisory level, Leah Weiss (LW), PhD, a member of the founding faculty of the CCT program with the Compassion Institute, USA and Stanford University will collaborate on any CCT related issues, such as teaching concerns and CCT material.
It is important to note that several other health professionals in Denmark are currently becoming certified to teach the CCT course, and would be able to teach the course, should something happen to NHH (i.e. illness). To address issues of researcher bias, the study will have a blinded clinical assessor (senior medical consultant) of clinical outcomes and diagnosis to conduct the evaluations.
The proposed project will enable a rigorous scientific investigation of a preventive treatment of hypothesized benefit to the mental health of caregivers. The findings will be of relevance to the scientific and clinical field of psychiatry, psychology, and prevention, but also society at large. It is expected that the results of the intervention could have direct implications for clinical guidelines in the prevention of caregivers.
It is paramount that preventive interventions for caregivers of mentally ill people are studied for their effectiveness and implemented, as it is widely known that these informal caregivers have a much greater risk of developing depression, anxiety, stress, and poor physical health. We already know that if we provide a mother or father with the resources they need, they are better able to care for their child and the child is more likely to succeed in society. This same knowledge and logic applies to the growing number of people who are caring for a loved one with minimal resources left at his/her disposal. In the Lancet Editorial it is written, "this unpaid compassionate cohort bears a huge burden for society (…) our neglect of primary social care has gone on for too long" (2017). If informal caregivers are not able to continue to care for their loved one, the detriment is not only to the caregiver, who is now sick, but also to the person being cared for. This proposal proposes a novel line of studying the effectiveness of a compassion training program as a preventive intervention program that may be of great benefit to informal caregivers, people with mental illness and the economical healthcare costs in Denmark.
University of Aarhus
Published on BioPortfolio: 2018-11-08T16:48:20-0500
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