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.

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.

Metabolic syndrome improvement in depression six months after prescribing simple hygienic-dietary recommendations.

BACKGROUND: Changes in diet and exercise have been separately demonstrated to improve Depression, although scientific evidence available is scarce. In a previously published controlled study, just recommending these and other lifestyle measures (sleep restriction and sunlight exposure) in combination once, patients experienced improvements in their depressive symptoms six months later. In this sample, one in three depressive patients had metabolic syndrome (MetS) at baseline. First line treatment of MetS condition is hygienic-dietetic, being Mediterranean diet and exercise especially important. Therefore we analyzed if lifestyle recommendations also improved their metabolic profile. FINDINGS: During the sixth month evaluation, a smaller number of patients from the group receiving hygienic-dietary recommendations met MetS criteria comparing with the control group. CONCLUSIONS: This study suggests that costless lifestyle recommendations, such as exercise and Mediterranean diet, have the capacity to promote both mental and physical health in a significant proportion of depressive patients. Further research is needed to confirm or discard these preliminary findings.

The Mediterranean diet and micronutrient levels in depressive patients.

INTRODUCTION: An inverse association between depression and some serum micronutrient levels (selenium, zinc, iron, magnesium, vitamin B and folic acid) has been reported. In addition, other studies reported that this micronutrient supplementation may improve depressed mood. The Mediterranean diet contains a sufficient amount of the micronutrients mentioned, although no study has reported an association between diet prescription and increased levels of them in depressive patients. OBJECTIVE: To examine the impact of dietary patterns recommendations on micronutrient levels in depressive patients. METHODS: 77 outpatients were randomly assigned either to the active (hygienic-dietary recommendations on diet, exercise, sleep, and sun exposure) or control group. Outcome measures were assessed before and after the six month intervention period. RESULTS: Serum selenium and zinc levels were slightly low at basal point and serum selenium was inversely correlated with severity of depression (r=-0.233; p=0.041). A better outcome of depressive symptoms was found in the active group. Nevertheless, no significant differences in micronutrient levels were observed after the Mediterranean diet pattern prescription, probably due to an insufficient adherence. CONCLUSION: Selenium, zinc, iron, magnesium, vitamin B12 and folic acid serum levels didn`t increase in depressed patients after six months of the Mediterranean diet pattern prescription.

Introducción: Se ha comunicado una correlación inversa entre depresión y el nivel sérico de algunos micronutrientes (selenio, zinc, hierro, magnesio, vitamina B y acido fólico). Además, otros estudios han señalado que la suplementar de estos micronutrientes puede mejorar la depresión. La dieta mediterránea proporciona una suficiente cantidad de los micronutrientes mencionados, aunque ningún estudio ha probado si la prescripción de dicha dieta puede incrementar los niveles de micronutrientes en pacientes depresivos. Objetivo: Examinar el impacto de recomendar un patrón dietético mediterráneo en los niveles de micronutrientes de pacientes deprimidos. Material y Métodos: 77 pacientes ambulatorios se aleatorizaron entre un grupo de intervención (recomendaciones higiénico-dietéticas sobre dieta, ejercicio, sueño y exposición solar) y un grupo control. La evolución fue evaluada antes y después de los seis meses del periodo de intervención. Resultados: Los niveles de selenio y de zinc fueron ligeramente bajos en la determinación basal y el nivel de selenio correlacionaba inversamente con la severidad de la depresión (r=-0.233; p=0.041). El grupo activo evolucionó mejor de la clínica depresiva. Sin embargo, no se observaron diferencias significativas en los niveles de micronutrientes después de la prescripción del patrón de dieta mediterránea probablemente a causa de una insuficiente adherencia. Conclusión: Los niveles séricos de selenio, zinc, hierro, magnesio vitamina B12 y acido fólico no aumentaron en pacientes depresivos seis meses después de prescribir un patrón de dieta mediterránea.

Los hábitos de vida saludables tienen un efecto antidepresivo / Healthy life habits have an antidepressant effect

La depresión es un problema de salud importante y en crecimiento. Las dos piedras angulares de su tratamiento son la psicofarmacología y la psicoterapia, pero sus resultados están lejos de ser satisfactorios en algunos casos. Este artículo ofrece una visión general de cuatro estrategias complementarias para el tratamiento de la depresión. Se ha sugerido que los factores relacionados con el estilo de vida pueden contribuir a la aparición y el mantenimiento de la depresión. Además, hay una creciente cantidad de información acerca de que las recomendaciones sobre aspectos del estilo de vida como la dieta, el ejercicio físico, la exposición a la luz solar, así como técnicas conductuales para regular el ciclo vigilia sueño pueden ser útiles en el tratamiento. Sin embargo, hay poca investigación acerca de la utilidad de combinar estas sencillas medidas higiénico-dietarias y asociarlas con el tratamiento antidepresivo...

Adherencia a las recomendaciones sobre estilo de vida en pacientes con depresión / Adherence to lifestyle recommendations by patients with depression

Introducción. La práctica de ejercicio físico y la exposición a la luz solar cada vez tiene mayor respaldo experimental sobre su eficacia antidepresiva coadyuvante en pacientes con depresión leve o moderada. Sin embargo, no hay información objetiva disponible sobre el grado de adherencia que los pacientes depresivos son capaces de desarrollar frente a estas recomendaciones en condiciones de práctica habitual, lo que limita la tendencia del clínico a prescribirlas. Métodos. Se estudia una muestra de 15 pacientes con un episodio depresivo de más de un mes de evolución con tratamiento antidepresivo a los que se les colocó un actígrafo en forma de reloj de pulsera capaz de medir la actividad física y la exposición a la luz durante las 24 horas del día. Una semana después de la evaluación basal estos pacientes fueron aleatorizados en 2 grupos. En el primero de ellos se les pedía en una breve nota por escrito de forma explícita y concreta que aumentaran la actividad física y la exposición a la luz solar, mientras que en el segundo grupo no. Resultados. En la semana posterior a la entrega de las recomendaciones, solo el primer grupo aumentó su actividad física y su exposición a la luz (14,3 y 25,8% respectivamente). Conclusión. Los pacientes con depresión muestran un buen nivel de adherencia a recomendaciones sobre su estilo de vida a corto plazo(AU)

Introduction. There is an increasing amount of evidence showing that physical activity and sun exposure are effective coadjuvant treatments for patients with mild to moderate depression. However, there is a lack of information regarding patient's adherence to these recommendations in daily clinical practice. Methods. We conducted a study including 15 depressive patients who had been under antidepressant treatment for at least one month. They wore a wrist-watch-like actimetry sensor to measure physical activity and sun exposure 24h a day. After one week of baseline assessment, patients were randomized into one of the two arms of the study. Patients in the experimental group received a brief note in which they were explicitly asked to increase both their physical activity level and time of sun exposure, while control group patients did not receive these explicit recommendations. Results. One week after recommendations were delivered, only patients in the experimental group had increased time of sun exposure and physical activity (25.8% and 14.3%, respectively). Conclusions. Depressive patients are able to follow prescribed lifestyle recommendations in the short-term(AU)

Adherence to lifestyle recommendations by patients with depression.

INTRODUCTION: There is an increasing amount of evidence showing that physical activity and sun exposure are effective coadjuvant treatments for patients with mild to moderate depression. However, there is a lack of information regarding patient's adherence to these recommendations in daily clinical practice. METHODS: We conducted a study including 15 depressive patients who had been under antidepressant treatment for at least one month. They wore a wrist-watch-like actimetry sensor to measure physical activity and sun exposure 24 hours a day. After one week of baseline assessment, patients were randomised into one of the two arms of the study. Patients in the experimental group received a brief note in which they were explicitly asked to increase both their physical activity level and time of sun exposure, while control group patients did not receive these explicit recommendations. RESULTS: One week after recommendations were delivered, only patients in the experimental group had increased time of sun exposure and physical activity (25.8% and 14.3%, respectively). CONCLUSIONS: Depressive patients are able to follow prescribed lifestyle recommendations in the short-term.

Four hygienic-dietary recommendations as add-on treatment in depression: a randomized-controlled trial.

BACKGROUND: Modifying diet, exercise, sunlight exposure and sleep patterns may be useful in the treatment of depression. METHOD: Eighty nonseasonal depressive outpatients on anti-depressant treatment were randomly assigned either to the active or control group. Four hygienic-dietary recommendations were prescribed together. Outcome measures were blinded assessed before and after the six month intervention period. RESULTS: A better evolution of depressive symptoms, a higher rate of responder and remitters and a lesser psychopharmacological prescription was found in the active group. LIMITATIONS: Small sample size. Lacked homogeneity concerning affective disorders (major depression, dysthimia, bipolar depression). CONCLUSIONS: This study suggests lifestyle recommendations can be used as an effective antidepressant complementary strategy in daily practice.

Age predicts low-frequency transcranial magnetic stimulation efficacy in major depression.

BACKGROUND: Transcranial magnetic stimulation (TMS) effectiveness in major depression has so far been studied mainly with high-frequency (>1 Hz) administration (HF-TMS). However, some available studies with low-frequency TMS (LF-TMS) have provided similar response rates to HF-TMS with better tolerance, but the evidence is mixed and controversial. METHODS: Randomized, controlled, two arm, clinical trial. 34 Major Depression patients were randomly assigned to receive 20 sessions of real or sham TMS of the right dorsolateral prefrontal cortex as adjuvant treatment to pharmacotherapy. The main stimulation parameters were 20 trains at 110% of the motor threshold for 60 s at a frequency of 1 Hz. Blinded external evaluators administered the Hamilton Depression Rating Scale. RESULTS: Both treatment groups significantly improved, although there were no statistical differences between them. In the real TMS group patients age inversely correlated with improvement of depressive symptoms at the end of the study (r=-0683 p=0.002). The percentage of decrease in scores on the Hamilton Scale was greater in subjects younger than 45 years old vs. others (41.3 +/- 22.6 vs. 15.1 +/- 15.8; t=2.8 df=16, p=0.011). These real TMS subgroups did not differ significantly in their history of previous depressive disorders, or in the refractoriness indicators of the current episode. LIMITATIONS: Small size and highly refractory sample. CONCLUSION: Only younger patients benefited from LF-rTMS as adjuvant treatment to antidepressants in this study.

Effectiveness of hygienic-dietary recommendations as enhancers of antidepressant treatment in patients with depression: study protocol of a randomized controlled trial.

BACKGROUND: In recent years some studies have been published supporting the efficacy of light exposure, physical activity, sleep control and a Mediterranean diet pattern on the improvement or prevention of depression. However, to our knowledge, there have been no studies using all these measures together as an adjuvant antidepressant strategy. METHODS: Multicenter, randomized, controlled, two arm-parallel, clinical trial. Eighty depressed patients undergoing standard antidepressant treatment will be advised to follow four additional hygienic-dietary recommendations about exercise, diet, sunlight exposure and sleep. Outcome measures will be assessed before and after the 6 month intervention period. DISCUSSION: We expect the patients in the active recommendations group to experience a greater improvement in their depressive symptoms. If so, this would be a great support for doctors who might systematically recommend these simple and costless measures, especially in primary care. TRIAL REGISTRATION: ISRCTN59506583.

High (20-Hz) and low (1-Hz) frequency transcranial magnetic stimulation as adjuvant treatment in medication-resistant depression.

Studies of repetitive transcranial magnetic stimulation (rTMS) in depression have found antidepressant effects when high frequency stimulation (HF-rTMS; >1 Hz) is applied over the left prefrontal cortex (LPF). A few studies have also reported success with low frequency stimulation (LF-rTMS) to the right prefrontal cortex (RPF). Both HF-rTMS and LF-rTMS have been reported to work better in areas with cerebral hypometabolism or hypermetabolism, respectively. Thirty medication-resistant patients with major depression were randomized into three groups. The first group received sham rTMS and the second group received active rTMS (20-Hz rTMS to the LPF and 1-Hz rTMS to the RPF). The third group, however, received active rTMS that was focused on different regions of the brain after examination with single photon emission computed tomography (20-Hz rTMS to an area of relatively low activity and 1-Hz rTMS to an area showing relatively high activation). Patients and raters were blind to the treatment condition. Comparison of the sham rTMS group with the overall group that received active rTMS revealed statistically significant changes on the Hamilton Rating Scale for Depression after 10 sessions. This study demonstrated that combined 20+1-Hz rTMS was effective, but no additional advantages were obtained by focusing rTMS on areas identified by single photon emission tomography as showing high versus low levels of functional activity.