Effectiveness of Mind–Body Intervention for Inflammatory Conditions: Results from a 26-Week Randomized, Non-Blinded, Parallel-Group Trial

Biopsychosocial intervention has been suggested as a complementary treatment strategy for patients with chronic conditions. We compared the effect of a mind–body intervention (MBI), relative to treatment-as-usual (TAU) on WHO-5 Well-being Index during an intensive period of 12 weeks and follow-up at week 26 among patients with either psoriasis (PsO) or rheumatoid arthritis (RA). The MBI was based on the ‘Relaxation Response Resiliency Program’ and the ‘Open and Calm Program’, as well as ‘Mindfulness Based Stress Reduction’ (MBSR). The trial was randomized, management-as-usual, and controlled. Statistical analyses were based on the intention-to-treat population using repeated measures and mixed effects models (NCT03888261). We screened 39 potential participants, 35 of which (PsO, n = 20; RA, n = 15) met the eligibility criteria and were randomized: 17 in the MBI group and 18 in the TAU group. Attrition from the intervention program was 19%, with 65% of MBI patients and 71% of TAU patients completing the outcome assessments. After 12 weeks, a statistically significant difference in WHO-5 was observed between the groups (p = 0.019). However, according to the protocol, during the entire trial period, the average (least squares mean values) WHO-5 score was higher although not statistically significant in the MBI group (65.3) compared with the TAU group (59.1), corresponding to a between-group difference over 26 weeks of 6.15 (95% CI: −0.26 to 12.56; p = 0.060). All things considered, adding biopsychosocial intervention to clinical practice to patients with conditions, such as PsO and RA, could potentially improve health-related quality of life.

Biopsychosocial intervention for stroke carers (BISC): results of a feasibility randomised controlled trial and nested qualitative interview study

Objective: To determine the feasibility of recruiting to and delivering a biopsychosocial intervention for carers of stroke survivors. Design: Feasibility randomised controlled study with nested qualitative interview study. Setting: The intervention was delivered in the community in either a group or one-to-one format. Subjects: Carers and stroke survivors within one year of stroke onset. Interventions: A carer targeted intervention delivered by a research psychologist in six structured two-hour sessions or usual care control. The intervention combined education about the biological, psychological and social effects of stroke with strategies and techniques focussing on adjustment to stroke and caregiving. Stroke survivors in both groups received baseline and follow-up assessment but no intervention. Main Outcome: Recruitment rate, study attrition, fidelity of intervention delivery, acceptability and sensitivity of outcome measures used (health related quality of life, anxiety and depression and carer burden six months after randomisation). Results: Of the 257 carers approached, 41 consented. Six withdrew before randomisation. Eighteen participants were randomised to receive the intervention and 17 to usual care. Attendance at sessions was greater when treated one-to-one. Feedback interviews suggested that participants found the intervention acceptable and peer support particularly helpful in normalising their feelings. Thirty participants were assessed at follow-up with improvements from baseline on all health measures for both groups. Conclusions: Our results suggest that a biopsychosocial intervention was acceptable to carers and can be delivered in group and one-to-one formats. Timing of approach and mode of intervention delivery is critical and requires tailoring to the carers individual needs.

Effectiveness of a culturally adapted biopsychosocial intervention (POHON SIHAT) in improving self-efficacy in patients with diabetes attending primary healthcare clinics in Putrajaya, Malaysia: study protocol of a randomised controlled trial

IntroductionPeople with diabetes are often associated with multifaceted factors and comorbidities. Diabetes management frameworks need to integrate a biopsychosocial, patient-centred approach. Despite increasing efforts in promotion and diabetes education, interventions integrating both physical and mental health components are still lacking in Malaysia. The Optimal Health Programme (OHP) offers an innovative biopsychosocial framework to promote overall well-being and self-efficacy, going beyond education alone and has been identified as relevant within the primary care system. Following a comprehensive cultural adaptation process, Malaysia’s first OHP was developed under the name ‘Pohon Sihat’ (OHP). The study aims to evaluate the effectiveness of the mental health-based self-management and wellness programme in improving self-efficacy and well-being in primary care patients with diabetes mellitus.Methods and analysisThis biopsychosocial intervention randomised controlled trial will engage patients (n=156) diagnosed with type 2 diabetes mellitus (T2DM) from four primary healthcare clinics in Putrajaya. Participants will be randomised to either OHP plus treatment as usual. The 2-hour weekly sessions over five consecutive weeks, and 2-hour booster session post 3 months will be facilitated by trained mental health practitioners and diabetes educators. Primary outcomes will include self-efficacy measures, while secondary outcomes will include well-being, anxiety, depression, self-care behaviours and haemoglobin A1c glucose test. Outcome measures will be assessed at baseline, immediately postintervention, as well as at 3 months and 6 months postintervention. Where appropriate, intention-to-treat analyses will be performed.Ethics and disseminationThis study has ethics approval from the Medical Research and Ethics Committee, Ministry of Health Malaysia (NMRR-17-3426-38212). Study findings will be shared with the Ministry of Health Malaysia and participating healthcare clinics. Outcomes will also be shared through publication, conference presentations and publication in a peer-reviewed journal.Trial registration numberNCT03601884.

Effectiveness of a multidisciplinary BIOPSYCHOSOCIAL intervention for non-specific SUBACUTE low back pain in a working population: a cluster randomized clinical trial

Background Low back pain (LBP) is a multifactorial condition with individual and societal impact that affects populations globally. Current guidelines for the treatment of LBP recommend pharmacological and non-pharmacological strategies. The aim of this study was to compare usual clinical practice with the effectiveness of a biopsychosocial multidisciplinary intervention in reducing disability, severity of pain and improving quality of life in a working population of patients with subacute (2–12 weeks), non-specific LBP. Methods Longitudinal cluster randomized clinical trial conducted in 39 Primary Health Care Centres (PHCC) of Barcelona, with patients aged 18–65 years (n = 501; control group = 239; 26 PHCC, intervention group = 262; 13 PHCC). The control group received usual clinical care. The intervention group received usual clinical care plus a biopsychosocial multidisciplinary intervention, which consisted of physiotherapy, cognitive-behavioural therapy and medication. The main outcomes were changes in the Roland Morris Disability Questionnaire (RMDQ), and the minimal clinically important differences. Secondary outcomes were changes in the McGill Pain (MGPQ) and Quality of Life (SF-12) questionnaires. Assessment was conducted at baseline, 3 and 12 months. Analysis was by intention-to-treat and analyst-blinded. Multiple imputations were used. Results Of the 501 enrolled patients, 421 (84%) provided data at 3 months, and 387 (77.2%) at 12 months. Mean age was 46.8 years (SD: 11.5) and 64.7% were women. In the adjusted analysis of the RMDQ outcome, only the intervention group showed significant changes at 3 months (− 1.33 points, p = 0.005) and at 12 months (− 1.11 points, p = 0.027), but minimal clinically important difference were detected in both groups. In the adjusted analysis of the RMDQ outcome, the intervention group improvement more than the control group at 3 months (− 1.33 points, p = 0.005) and at 12 months (− 1.11 points, p = 0.027). The intervention group presented a significant difference. Both groups presented a minimal clinically important difference, but more difference in the intervention group. The intervention group presented significant differences in the MGPQ scales of current pain intensity and VAS scores at 3 months. No statistically significant differences were found in the physical and mental domains of the SF-12. Conclusions A multidisciplinary biopsychosocial intervention in a working population with non-specific subacute LBP has a small positive impact on disability, and on the level of pain, mainly at short-term, but no difference on quality of life. Trial registration ISRCTN21392091 (17 oct 2018) (Prospectively registred).

Barriers to and Facilitators of Implementing DEPENAS Biopsychosocial Intervention in Primary Care: A Study Protocol

Background: Our team has developed a biopsychosocial intervention called DEPENAS that has shown to be effective in primary health care in improving health and quality of life of patients with medically unexplained symptoms. We also found that general practitioners participating in the clinical trial do not use the intervention systematically because of barriers related to psychological determinants among professionals themselves. Based on the Theoretical Domains Framework (TDF) of Susan Michie, our study aims (1) to identify psychological determinants among professionals who are perceived to be facilitators of or barriers to the systematic and generalized use of the intervention in the consultation room and (2) to design an implementation strategy that considers these determinants and helps us to address them with a series of predesigned and validated techniques. Method: A qualitative exploratory study has been designed based on semistructured individual interviews conducted following a script based on the 14 TDF domains and analyzed in a deductive way. Participants will be doctors and nurses previously trained in the intervention that was put into practice under real-world conditions, from different health centers. Results of the analysis of the interviews will be used as the basis for designing the implementation strategy. Discussion: The implementation of the DEPENAS intervention in primary care to achieve its sustained and widespread use among primary care professionals involves changes in the model of patient care and the model of the health system, toward models that are more in tune with the needs of modern society. Investigating psychological determinants in professionals and addressing them with validated techniques, as part of the strategy for implementing a given intervention, is a novel approach that has the potential to help change the way in which we tackle change in healthcare organizations.