Compassion Cultivation Training (CCT): An Intervention for Caregivers
Condition: Psychological Distress
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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 Compassion Scale (MCS), Perceived Stress Scale, (PSS), The Emotion
      Regulation Questionnaire (ERQ)), The Five Facet Mindfulness Questionnaire (FFMQ-15), 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.

      Methods Research design 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 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
      Psykiatri, 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. Randomization 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.

      Procedure Eligible participants, meeting all study criteria, are asked to participate in the
      Randomized Controlled Trail (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.

      Data Collection 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.

      Intervention:

      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).

      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). 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.

      Measures

      Statistical Analysis:

      We will compare the outcome variables (DASS, PSS, SCS-12, MCS, ERQ, BRS, FFMQ-15, 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, H-T., 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.

      Power:

      The sample size was calculated using effect sizes from related publications (Jazaieri et al.,
      2013, 2014, 2015, 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.

      Timeline 2018: Address the key points highlighted by the CCT participants who have taken the
      course (1-2 months). 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).

      Research group:

      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
      Mindfulness, 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.

      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.

      Perspective 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.
    

Intervention name(s): CCT intervention.
Intervention type(s): Other
Intervention description(s): 8-week course with 2 hours sessions weekly. Participants should meditate 25 min. pr. day during the 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention