Compassion Cultivation Training (CCT): A Preventive Intervention for Caregivers of People Who Suffer From a Mental Illness

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.