Efficacy of an adjuvant non-face-to-face multimodal lifestyle modification program for patients with treatment-resistant major depression: A randomized controlled trial.

BACKGROUND: The high prevalence of depression is partly attributable to the poor response of patients to first-line antidepressants. Multimodal programs that promote a healthy lifestyle are successful in treating depression when used as a complementary therapy, but their medium- and long-term benefits have not been demonstrated for patients with treatment-resistant depression (TRD). The main aim of this study was to compare the effectiveness of a lifestyle modification program (LMP) with mindfulness-based cognitive therapy (MBCT) and a placebo-control (written suggestions for lifestyle changes) in Spanish patients with TRD. METHODS: This controlled clinical trial randomized 94 patients with TRD into 3 arms. The primary outcome was the Beck Depression Inventory-II (BDI-II) score at baseline, 2, 6 and 12 months. The secondary outcomes were changes in scores that evaluated quality-of-life, adherence to the Mediterranean diet, physical activity, and social support. RESULTS: Relative to the placebo group, the LMP and MBCT groups had significantly better quality of life (p = 0.017; p = 0.027), and the LMP group had significantly better adherence to the Mediterranean diet (p<0.001) and reduced use of antidepressants (p = 0.036). However, the three groups showed no significant differences in BDI-II score. LIMITATIONS: Only about half of the planned 180 patients were recruited, in part due to the COVID-19 pandemic. CONCLUSIONS: There was no evidence that the LMP treatment significantly reduced symptoms of depression relative to the other groups during the COVID-19 lockdown.

Associations Between Severity of Depression, Lifestyle Patterns, and Personal Factors Related to Health Behavior: Secondary Data Analysis From a Randomized Controlled Trial.

Background: Depression is a prevalent condition that has a significant impact on psychosocial functioning and quality of life. The onset and persistence of depression have been linked to a variety of biological and psychosocial variables. Many of these variables are associated with specific lifestyle characteristics, such as physical activity, diet, and sleep patterns. Some psychosocial determinants have an impact on people' health-related behavior change. These include personal factors such as sense of coherence, patient activation, health literacy, self-efficacy, and procrastination. This study aims to analyze the association between the severity of depression, lifestyle patterns, and personal factors related to health behavior. It also aims to analyze whether personal factors moderate the relationship between lifestyles and depression. Methods: This study is a secondary data analysis (SDA) of baseline data collected at the start of a randomized controlled trial (RCT). A sample of 226 patients with subclinical, mild, or moderate depression from primary healthcare centers in two sites in Spain (Zaragoza and Mallorca) was used, and descriptive, bivariate, multivariate, and moderation analyses were performed. Depression was the primary outcome, measured by Beck II Self-Applied Depression Inventory. Lifestyle variables such as physical exercise, adherence to Mediterranean diet and sleep quality, social support, and personal factors such as self-efficacy, patient activation in their own health, sense of coherence, health literacy, and procrastination were considered secondary outcomes. Results: Low sense of coherence (ß = -0.172; p < 0.001), poor sleep quality (ß = 0.179; p = 0.008), low patient activation (ß = -0.119; p = 0.019), and sedentarism (more minutes seated per day; ß = 0.003; p = 0.025) are predictors of having more depressive symptoms. Moderation analyses were not significant. Discussion: Lifestyle and personal factors are related to depressive symptomatology. Our findings reveal that sense of coherence, patient's activation level, sedentarism, and sleep quality are associated with depression. Further research is needed regarding adherence to Mediterranean diet, minutes walking per week and the interrelationship between lifestyles, personal factors, and depression.

Effectiveness and cost-effectiveness of a lifestyle modification programme in the prevention and treatment of subclinical, mild and moderate depression in primary care: a randomised clinical trial protocol.

INTRODUCTION: Major depression is a highly prevalent pathology that is currently the second most common cause of disease-induced disability in our society. The onset and continuation of depression may be related to a wide variety of biological and psychosocial factors, many of which are linked to different lifestyle aspects. Therefore, health systems must design and implement health promotion and lifestyle modification programmes (LMPs), taking into account personal factors and facilitators. The main objective of this protocol is to analyse the clinical effectiveness, cost-effectiveness and cost utility of an LMP and an LMP with information and communication technologies (ICTs) as adjunctive treatment for depression in primary care patients. The secondary objectives are to analyse the clinical effectiveness in the subgroup that presents comorbidity and to analyse the correlation between personal factors on health behaviour and lifestyle patterns. METHODS AND ANALYSIS: A randomised, multicenter pragmatic clinical trial with three parallel groups consisting of primary healthcare patients suffering from subclinical, mild or moderate depression. The following interventions will be used: (1) Usual antidepressant treatment with psychological advice and/or psychotropic drugs prescribed by the general practitioner (treatment as usual (TAU)). (2) TAU+LMP. A programme to be imparted in six weekly 90-minute group sessions, intended to improve the following aspects: behavioural activation+daily physical activity+adherence to the Mediterranean diet pattern+sleep hygiene+careful exposure to sunlight. (3) TAU+LMP+ICTs: healthy lifestyle recommendations (TAU+LMP)+monitoring using ICTs (a wearable smartwatch). The primary outcome will be the depressive symptomatology and the secondary outcomes will be the quality of life, the use of health and social resources, personal factors on health behaviour, social support, lifestyle patterns and chronic comorbid pathology. Data will be collected before and after the intervention, with 6-month and 12-month follow-ups. ETHICS AND DISSEMINATION: This study has been approved by the Clinical Research Ethics Committee of Aragón (approval number: C.P.-C.I. PI18/286) and the Research Ethics Committee of the Balearic Islands (IB3950/19 PI). Data distribution will be anonymous. Results will be disseminated via conferences and papers published in peer-reviewed, open-access journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03951350).

Effectiveness of a healthy lifestyle promotion program as adjunctive teletherapy for treatment-resistant major depression during COVID 19 pandemic: A randomized clinical trial protocol.

INTRODUCTION: Treatment-resistant depression (TRD) has a high prevalence and can be exacerbated by poor physical health and economic hardships, which have become common stressors during the current COVID-19 pandemic. The therapeutic approaches used to treat these patients are not always available, may be not be accepted by some patients, and often require face-to-face interactions. OBJECTIVE: The main aim of this study will be to evaluate the effectiveness of an Internet-based adjuvant lifestyle-based intervention for patients with TRD. METHODS: This will be a parallel, randomized, and controlled clinical trial. A total of 180 patients with TRD will be randomly allocated (1:1:1) to 1 of 3 groups: treatment prescribed by the mental health team and written suggestions for lifestyle changes (placebo control group); treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week mindfulness-based cognitive therapy program (active control group); or treatment prescribed by the mental health team, written suggestions for lifestyle changes, and an 8-week lifestyle change promotion program (intervention group). We will perform this study during the COVID-19 pandemic, and will administer interventions by teletherapy, and contact participants by telephone calls, text messages, and/or teleconferences. We will collect patient data using questionnaires administered at baseline, immediately after the intervention, and after 6 and 12 months. The primary outcome will be score on the Beck Depression Inventory-II. The secondary outcomes will be score on the Clinical Global Impressions Scale (used to quantify and track patient progress and treatment response over time) and health-related quality of life measured using the European Quality of Life-5 Dimensions Questionnaire. DISCUSSION: Patients with TRD are especially vulnerable when face-to-face psychotherapy is unavailable. The main strength of the proposed study is the novelty of the intervention to be used as an adjuvant therapy. Our results may provide guidance for treatment of patients with TRD in future situations that require lockdown measures. CLINICALTRIALS REGISTRATION NUMBER: NCT04428099.

Gender differences in mental health during the economic crisis.

BACKGROUND: Economic crises have a negative effect on mental health. Little evidence has been published on the impact of economic downturns on male and female. The aim of the study was to analyze gender differences in specific mental disorders in primary care during the current economic recession in Spain. METHOD: A total of 7,914 patients in 2006 and 5,876 patients in 2010 were recruited to collect sociodemographic data and the Primary Care Evaluation of Mental Disorders. RESULTS: Between 2006 and 2010 the prevalence of Major Depressive Disorder increased 155.7% in men and 104.9% in women; Generalized Anxiety Disorder increased 98.3% in men and 71.3% in women; and Multisomatoform Disorder increased 100.05% in men and 37% in women. The effect of the Employment confounder was significant across all comparisons:  Major Depressive Disorder Generalized Odds Ratio=2.557 for Men (p<.001), 2.046 for Women (p=.002); Generalized Anxiety Disorder Generalized Odds Ratio= 2.153 (p<.001) for Men, 1.546 for Women (p<.001); and for Non-specific Multisomatoform Disorder Generalized Odds Ratio=1.680 for Men (p<.001) and 1.301 for women (p=.014). CONCLUSION: Overall prevalence of mental disorders increased significantly between 2006 and 2010, especially in males, who are more sensitive to the effect of the current economic recession than women.

Gender differences on functioning in depressive patients.

BACKGROUND: Depression is one of the most common disorders in primary care and the fourth most disabling medical condition worldwide. Although gender differences in the prevalence of depression are well established, the little available data on gender-related differences in disabilities among depression patients gives controversial results. This study aims to analyse whether there are gender differences in the disabilities experienced by patients with depression. METHODS: A cross-sectional, multicentre, nationwide epidemiological study was conducted, with 1226 patients. A Case Report Form was used to collect sociodemographic data and the 12-item version of the World Health Organization Disability Assessment Schedule II (WHO-DAS-II) was used to assess functioning. Depression severity was assessed using the Quick Inventory of Depressive Symptomatology (QIDS). RESULTS: Non-statistically significant differences in functioning were found between males and females. An item-by-item analysis of the WHO-DAS-II shows significant differences between both sexes in specific areas. Women obtained higher scores than men for standing for long periods and walking a long distance. Males scored higher than women in dealing with people you did not know well and maintaining a friendship. LIMITATIONS: Given the descriptive and cross-sectional nature of the study, the results are limited, highlighting the need for further research. Also, other variables that might influence disability, such as medical illnesses, were not considered. CONCLUSIONS: The effect of depression on disability is similar for both sexes but not uniform in terms of the impact on different aspects of the quality of life. These findings could be an important factor in the assessment of functioning and management of depression.