LOFIT (Lifestyle front Office For Integrating lifestyle medicine in the Treatment of patients): a novel care model towards community-based options for lifestyle change-study protocol.

BACKGROUND: A healthy lifestyle is indispensable for the prevention of noncommunicable diseases. However, lifestyle medicine is hampered by time constraints and competing priorities of treating physicians. A dedicated lifestyle front office (LFO) in secondary/tertiary care may provide an important contribution to optimize patient-centred lifestyle care and connect to lifestyle initiatives from the community. The LOFIT study aims to gain insight into the (cost-)effectiveness of the LFO. METHODS: Two parallel pragmatic randomized controlled trials will be conducted for (cardio)vascular disorders (i.e. (at risk of) (cardio)vascular disease, diabetes) and musculoskeletal disorders (i.e. osteoarthritis, hip or knee prosthesis). Patients from three outpatient clinics in the Netherlands will be invited to participate in the study. Inclusion criteria are body mass index (BMI) ≥25 (kg/m2) and/or smoking. Participants will be randomly allocated to either the intervention group or a usual care control group. In total, we aim to include 552 patients, 276 in each trial divided over both treatment arms. Patients allocated to the intervention group will participate in a face-to-face motivational interviewing (MI) coaching session with a so-called lifestyle broker. The patient will be supported and guided towards suitable community-based lifestyle initiatives. A network communication platform will be used to communicate between the lifestyle broker, patient, referred community-based lifestyle initiative and/or other relevant stakeholders (e.g. general practitioner). The primary outcome measure is the adapted Fuster-BEWAT, a composite health risk and lifestyle score consisting of resting systolic and diastolic blood pressure, objectively measured physical activity and sitting time, BMI, fruit and vegetable consumption and smoking behaviour. Secondary outcomes include cardiometabolic markers, anthropometrics, health behaviours, psychological factors, patient-reported outcome measures (PROMs), cost-effectiveness measures and a mixed-method process evaluation. Data collection will be conducted at baseline, 3, 6, 9 and 12 months follow-up. DISCUSSION: This study will gain insight into the (cost-)effectiveness of a novel care model in which patients under treatment in secondary or tertiary care are referred to community-based lifestyle initiatives to change their lifestyle. TRIAL REGISTRATION: ISRCTN ISRCTN13046877 . Registered 21 April 2022.

Recovery from recurrent depression: Randomized controlled trial of the efficacy of mindfulness-based compassionate living compared with treatment-as-usual on depressive symptoms and its consolidation at longer term follow-up.

INTRODUCTION: Mindfulness-Based Cognitive Therapy (MBCT) has been shown to reduce depressive symptoms in patients with recurrent or chronic depression. However, sequential, follow-up interventions are needed to further improve outcome for this group of patients. One possibility is to cultivate mechanisms thought to support recovery from depression, such as (self-)compassion. The current study examined the efficacy of mindfulness-based compassionate living (MBCL) in recurrently depressed patients who previously received MBCT, and consolidation effects of MBCL at follow-up. METHODS: Part one is a randomized controlled trial (RCT) comparing MBCL in addition to treatment as usual (TAU) with TAU alone. The primary outcome measure was severity of depressive symptoms. Possible mediators and moderators of treatment outcome were examined. Part two is an uncontrolled study of both intervention- and control group on the consolidation of treatment effect of MBCL over the course of a 6-months follow-up period. RESULTS: Patients were recruited between July 2013 and December 2014 (N = 122). MBCL participants (n = 61) showed significant improvements in depressive symptoms (Cohen's d = 0.35), compared to those who only received TAU (n = 61). The results at 6-months follow-up showed a continued improvement of depressive symptoms. LIMITATIONS: As MBCL was not compared with an active control condition, we have little information about the possible effectiveness of non-specific factors. CONCLUSION: MBCL appears to be effective in reducing depressive symptoms in a population suffering from severe, prolonged, recurrent depressive symptoms. To optimise the (sequential) treatment trajectory, replication of the study in a prospective sequential trial is needed. Registered at ClinicalTrials.gov:NCT02059200.

The Co-creation and Feasibility of a Compassion Training as a Follow-up to Mindfulness-Based Cognitive Therapy in Patients with Recurrent Depression.

The aim of this study was to assess the feasibility, acceptability and preliminary effectiveness of Mindfulness - Based Compassionate Living (MBCL) as a follow-up intervention to Mindfulness Based Cognitive Therapy in adults with recurrent depression. We conducted an uncontrolled study in 17 patients with recurrent depression, in two successive groups. The first group contained novices to compassion training (N = 14); in the second group, ten of these participated again, in addition to three new participants (N = 13). The overall group contained 15 females and 2 males, aged between 37 and 71. The MBCL program was qualitatively evaluated using post-intervention focus group interviews in both groups. In addition, self-report questionnaires assessing depressive symptoms, worry and both self-compassion and mindfulness skills were administered before and after MBCL. No patients dropped out of the intervention. Average attendance was 7.52 (SD 0.73) out of eight sessions. Helpful elements were theory on the emotion regulation systems, practicing self-compassion explicitly and embodiment of a compassionate attitude by the teachers. Unhelpful elements were the lack of a clear structure, lack of time to practice compassion for self and the occurrence of the so-called back draft effect. We adapted the program in accordance with the feedback of the participants. Preliminary results showed a reduction in depressive symptoms in the second group, but not in the first group, and an increase in self-compassion in both groups. Worry and overall mindfulness did not change. MBCL appears to be feasible and acceptable for patients suffering from recurrent depressive symptoms who previously participated in MBCT. Selection bias may have been a factor as only experienced and motivated participants were used; this, however, suited our intention to co-create MBCL in close collaboration with knowledgeable users. Examination of the effectiveness of MBCL in a sufficiently powered randomised controlled trial is needed.

A parallel-group, randomized controlled trial into the effectiveness of Mindfulness-Based Compassionate Living (MBCL) compared to treatment-as-usual in recurrent depression: Trial design and protocol.

BACKGROUND: Mindfulness Based Cognitive Therapy (MBCT) has been shown to reduce the risk of relapse in patients with recurrent depression, but relapse rates remain high. To further improve outcome for this group of patients, follow-up interventions may be needed. Compassion training focuses explicitly on developing self-compassion, one of the putative working mechanisms of MBCT. No previous research has been done on the effectiveness of compassion training following MBCT in patients with recurrent depression. AIMS: To investigate the effectiveness of Mindfulness-Based Compassionate Living (MBCL) in reducing (residual) depressive symptoms in patients with recurrent depression who previously participated in MBCT. METHODS/DESIGN: A randomized controlled trial comparing MBCL in addition to treatment as usual (TAU) with TAU only, in patients suffering from recurrent depressive episodes who completed an MBCT course in the past. Assessments will take place at baseline, post-treatment and at six months follow-up. After the control period, patients randomized to the TAU condition will be offered MBCL as well. OUTCOME MEASURES: Primary outcome measure is severity of depressive symptoms according to the Beck Depression Inventory-II (BDI-II) at post-treatment. Secondary outcome measures are presence or absence of DSM-IV depressive disorder, rumination, self-compassion, mindfulness skills, positive affect, quality of life, experiential avoidance and fear of self-compassion. DISCUSSION: Our study is the first randomized controlled trial to examine the effectiveness of compassion training following MBCT in a recurrently depressed population. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02059200, registered 30 January 2014.