Comparative effectiveness of a mindfulness-based intervention (M-Body) on depressive symptoms: study protocol of a randomized controlled trial in a Federally Qualified Health Center (FQHC).

BACKGROUND: Mindfulness-based interventions have been shown to improve psychological outcomes including stress, anxiety, and depression in general population studies. However, effectiveness has not been sufficiently examined in racially and ethnically diverse community-based settings. We will evaluate the effectiveness and implementation of a mindfulness-based intervention on depressive symptoms among predominantly Black women at a Federally Qualified Health Center in a metropolitan city. METHODS: In this 2-armed, stratified, individually randomized group-treated controlled trial, 274 English-speaking participants with depressive symptoms ages 18-65 years old will be randomly assigned to (1) eight weekly, 90-min group sessions of a mindfulness-based intervention (M-Body), or (2) enhanced usual care. Exclusion criteria include suicidal ideation in 30 days prior to enrollment and regular (>4x/week) meditation practice. Study metrics will be assessed at baseline and 2, 4, and 6 months after baseline, through clinical interviews, self-report surveys, and stress biomarker data including blood pressure, heart rate, and stress related biomarkers. The primary study outcome is depressive symptom score after 6 months. DISCUSSION: If M-Body is found to be an effective intervention for adults with depressive symptoms, this accessible, scalable treatment will widely increase access to mental health treatment in underserved, racial/ethnic minority communities. TRIAL REGISTRATION: ClinicalTrials.gov NCT03620721. Registered on 8 August 2018.

Acceptability of a mindfulness intervention for depressive symptoms among African-American women in a community health center: A qualitative study.

INTRODUCTION: In this study we examined the acceptability and feasibility of a mindfulness based group intervention for socio-economically disadvantaged women in an urban community health center (M-Body). METHOD: Women ages 18-65 with depressive symptoms who participated in an 8-week mindfulness based group intervention were invited to attend follow up focus groups about their experience. Inductive content analysis was used to identify themes from transcripts. RESULTS: All participants were African-American (N = 27). Participants had limited past experience with mindfulness. They reported benefits included anger management, increased control of thoughts, emotions and behaviors, enhanced awareness/focus and feeling calm and relaxed. Barriers to session attendance included transportation, employment, family responsibilities and child care. Participants suggested modifications such as providing the audio in multiple formats, increasing time spent doing yoga, modifying yoga postures and providing an orientation session. They stated that the content and delivery format of the group was acceptable. DISCUSSION: The mindfulness based intervention for depression was acceptable, reduced stress and improved coping and functioning among women in a community health center.

Accessibility and feasibility of using technology to support mindfulness practice, reduce stress and promote long term mental health.

BACKGROUND AND PURPOSE: We evaluated the feasibility of using an activity monitor to support mindfulness practice, reduce self-reported stress and physiological indicators of stress. MATERIALS AND METHODS: Adult women (N = 19) who previously participated in a mindfulness intervention wore an activity monitor for eight-weeks. The activity monitor notified them when they were stressed (based on standard deviation pulse pressure). Heart rate and pulse pressure were continuously collected via the activity monitor. Mindfulness, stress, depression and trauma symptoms were collected via self-report surveys. RESULTS: There were no significant changes in self-reported stress, depression, post-traumatic stress and mindfulness from baseline to eight-weeks. Pulse pressure and standard deviation of pulse pressure increased over time. Those who were high on the non-judge mindfulness subscale had a lower standard deviation pulse pressure and spent less time stressed. CONCLUSION: Those who are more mindful are less likely to have physiological signs of stress.

Treatment of Peripartum Bipolar Disorder.

Bipolar disorder affects women throughout their childbearing years. During the perinatal period, women with bipolar disorder are vulnerable to depressive episode recurrences and have an increased risk for postpartum psychosis. Perinatal screening is critical to identify women at risk. Although medications are the mainstay of treatment, the choice of pharmacotherapy must be made by the patient based on a risk-benefit discussion with her physician. For optimal dosing in pregnancy, therapeutic drug monitoring may be required to maintain effective drug concentrations. Residual symptoms of bipolar depression are treatable with bright light therapy as an alternative to medication augmentation.

Adjunctive Bright Light Therapy for Bipolar Depression: A Randomized Double-Blind Placebo-Controlled Trial.

OBJECTIVE: Patients with bipolar disorder have recurrent major depression, residual mood symptoms, and limited treatment options. Building on promising pilot data, the authors conducted a 6-week randomized double-blind placebo-controlled trial to investigate the efficacy of adjunctive bright light therapy at midday for bipolar depression. The aims were to determine remission rate, depression symptom level, and rate of mood polarity switch, as well as to explore sleep quality. METHOD: The study enrolled depressed adults with bipolar I or II disorder who were receiving stable dosages of antimanic medication (excluding patients with hypomania or mania, mixed symptoms, or rapid cycling). Patients were randomly assigned to treatment with either 7,000-lux bright white light or 50-lux dim red placebo light (N=23 for each group). Symptoms were assessed weekly with the Structured Interview Guide for the Hamilton Depression Scale With Atypical Depression Supplement (SIGH-ADS), the Mania Rating Scale, and the Pittsburgh Sleep Quality Index. Remission was defined as having a SIGH-ADS score of 8 or less. RESULTS: At baseline, both groups had moderate depression and no hypomanic or manic symptoms. Compared with the placebo light group, the group treated with bright white light experienced a significantly higher remission rate (68.2% compared with 22.2%; adjusted odds ratio=12.6) at weeks 4-6 and significantly lower depression scores (9.2 [SD=6.6] compared with 14.9 [SD=9.2]; adjusted ß=-5.91) at the endpoint visit. No mood polarity switches were observed. Sleep quality improved in both groups and did not differ significantly between them. CONCLUSIONS: The data from this study provide robust evidence that supports the efficacy of midday bright light therapy for bipolar depression.

Perspectives from Patients and Healthcare Providers on the Practice of Maternal Placentophagy.

PURPOSE: Placentophagy (maternal consumption of the placenta) has become increasingly prevalent in the past decade among women seeking to promote health and healing during the postpartum period. The purpose of this study was to assess patient and provider familiarity with and attitudes toward placentophagy, as well as patients' willingness to try placentophagy. METHODS: Two cross-sectional surveys with questions regarding placentophagy practice were distributed to healthcare providers and patients. The provider survey was distributed via email listservers to international perinatal professional organizations and to obstetrics and gynecology, nurse midwifery, family medicine, and psychiatry departments at three urban hospitals. Patient surveys were administered in person at an urban hospital in Chicago, Illinois. RESULTS: Approximately two thirds (66%; n = 100) of patients and most (89%; n = 161) of providers were familiar with placentophagy. Patients with a history of a self-reported mental health disorder were more likely to be willing to consider placentophagy and to believe that healthcare providers should discuss it with their patients. CONCLUSIONS: Most providers and patients have heard of placentophagy but are unsure of its benefits and/or risks. Further research examining the potential therapeutic efficacy and/or risks of placentophagy is needed.

Mindfulness based stress reduction adapted for depressed disadvantaged women in an urban Federally Qualified Health Center.

BACKGROUND: In this study we examine the feasibility and preliminary effectiveness of mindfulness based stress reduction adapted for delivery in an urban Federally Qualified Health Center (FQHC). METHODS: Thirty-one African- American adult women ages 18-65 with depressive symptoms enrolled to participate in an 8-week mindfulness group intervention. The primary outcome (depression) and secondary outcomes (stress, mindfulness, functioning, well-being, and depression stigma) were assessed at baseline, 8 and 16-weeks. RESULTS: Depressive symptoms significantly decreased from baseline to 16 weeks. A significant decrease in stress and significant increase in mindfulness was found from baseline to 8 weeks and baseline to 16 weeks. Additionally, aspects of well-being-self-acceptance and growth-significantly increased from baseline to 8-weeks. Stigma significantly increased from baseline to 8 weeks and significantly decreased from 8 to 16 weeks (all p's < 0.05). CONCLUSIONS: Mindfulness-based interventions implemented in FQHCs may increase access to effective treatments for mental health symptoms.

Mind-Body Approaches to Treating Mental Health Symptoms Among Disadvantaged Populations: A Comprehensive Review.

Mind-body approaches are commonly used to treat a variety of chronic health conditions, including depression and anxiety. A substantial proportion of individuals with depression and anxiety disorders do not receive conventional treatment; disadvantaged individuals are especially unlikely to receive treatment. Mind-body approaches offer a potentially more accessible and acceptable alternative to conventional mental health treatment for disadvantaged individuals, who may not otherwise receive mental health treatment. This review examines evidence for the efficacy of mind-body interventions for mental health symptoms among disadvantaged populations. While rates of utilization were relatively lower for racial/ethnic minorities, evidence suggests that significant proportions of racial/ethnic minorities are using complementary health approaches as health treatments, especially prayer/healers and natural or herbal remedies. This review of studies on the efficacy of mind-body interventions among disadvantaged populations found evidence for the efficacy of mind-body approaches for several mental and physical health symptoms, functioning, self-care, and overall quality of life.

Pharmacotherapy of postpartum depression: an update.

INTRODUCTION: Postpartum depression (PPD) is a common and serious illness that affects up to 14% of women in the first month after childbirth. We present an update on the pharmacologic treatment of PPD, although there continues to be a lack of large, randomized controlled trials (RCTs). AREAS COVERED: A review of the literature on the use of antidepressants, hormonal supplements and omega-3 fatty acids for the prevention and the treatment of PPD published since the original review in 2009 and the authors' opinion on the current status of the pharmacological treatment of PPD are covered. An electronic search was performed by using PubMed, Medline and PsychINFO. Inclusion criteria were: i) empirical articles in peer-reviewed English-language journals; ii) well-validated measures of depression; and iii) a uniform scoring system for depression among the sample. EXPERT OPINION: Since the last Expert Opinion review, four antidepressant treatment studies and one prevention study of PPD have been published. Six RCTs evaluating the use of omega-3 fatty acids (four for prevention and two for treatment) have been published. There continues to be lack of data regarding the pharmacotherapy of PPD. However, serotonin reuptake inhibitors should be considered first-line for women with PPD after it has been determined that the proper diagnosis is not bipolar disorder. It is important to individualize treatment for women with PPD and consider the risks and benefits of treatment while breastfeeding.

A pilot study of the nutritional status of opiate-using pregnant women on methadone maintenance therapy.

Pregnant women in methadone maintenance therapy may have poor nutrition during pregnancy. In 2006-2008, methadone-treated pregnant women (n = 22) were recruited at an urban academic medical center and compared with nondrug-using pregnant women (n = 119) at 20-35 weeks' gestation. We measured adiposity using prepregnancy body mass index (BMI), dietary intake using a food frequency questionnaire, and micronutrient and essential fatty acid status using biomarkers. Methadone-treated women had lower BMI, consumed more calories, had lower serum carotenoid concentrations, and higher plasma homocysteine concentrations than controls. The study's limitations and implications for future research are discussed.

A randomized, double-blind, placebo-controlled study of light therapy for antepartum depression.

OBJECTIVE: Affective disorder during pregnancy is a common condition requiring careful judgment to treat the depression while minimizing risk to the fetus. Following up on promising pilot trials, we studied the efficacy of light therapy. METHOD: Twenty-seven pregnant women with nonseasonal major depressive disorder according to DSM-IV (outpatients, university polyclinic) were randomly assigned to 7,000 lux fluorescent bright white or 70 lux dim red (placebo) light administered at home in the morning upon awakening for 1 h/d in a 5-week double-blind trial carried out between October 2004 and October 2008. Clinical state was monitored weekly with the 29-item Structured Interview Guide for the Hamilton Depression Rating Scale (HDRS) with Atypical Depression Supplement (SIGH-ADS). Changes of rating scale scores over time were analyzed with the general linear model. Differences from baseline of SIGH-ADS and 17-item HDRS scores at every time point were the dependent variables, time was the within-subjects factor, and treatment was the between-subjects factor. The model also included baseline score of depression and gestational age at intervention start. RESULTS: The superiority of bright light over dim light placebo was shown for both SIGH-ADS (R² = 0.251; F(3,23) = 3.91; P < .05) and HDRS (R² = 0.338; F(3,23) = 5.42; P < .01) when analyzing the week-by-week change from baseline, and HDRS scores showed a significant interaction of treatment with time (F(4,92) = 2.91; P < .05). Categorical analysis revealed that the response rate (HDRS ≥ 50% improvement) at week 5 was significantly greater for bright light (81.3%, n = 16) than for placebo light (45.5%, n = 11) (P < .05). Remission (final score ≤ 8) was attained by 68.6% versus 36.4%, respectively (P < .05). Expectation ratings did not differ significantly between groups. CONCLUSIONS: Bright white light treatment for 5 weeks improved depression during pregnancy significantly more than placebo dim red light. The study provides evidence that light therapy, a simple, cost-effective antidepressant modality with minimal side effects for the mother and no known risk for the unborn child, may be a useful nonpharmacologic approach in this difficult situation. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01043289.

Complementary and alternative medicine in major depressive disorder: the American Psychiatric Association Task Force report.

OBJECTIVE: To review selected complementary and alternative medicine (CAM) treatments for major depressive disorder (MDD). PARTICIPANTS: Authors of this report were invited participants in the American Psychiatric Association's Task Force on Complementary and Alternative Medicine. EVIDENCE: The group reviewed the literature on individual CAM treatments for MDD, methodological considerations, and future directions for CAM in psychiatry. Individual CAM treatments were reviewed with regard to efficacy in MDD, as well as risks and benefits. Literature searches included MEDLINE and PsycINFO reviews and manual reference searches; electronic searches were limited to English-language publications from 1965 to January 2010 (but manual searches were not restricted by language). Treatments were selected for this review on the basis of (1) published randomized controlled trials in MDD and (2) widespread use with important clinical safety or public health significance relevant to psychiatric practice. An action plan is presented based on needs pertaining to CAM and psychiatry. CONSENSUS PROCESS: Consensus was reached by group conferences. Written iterations were drafted and sent out among group members prior to discussion, resolution of any differences of interpretation of evidence, and final approval. CONCLUSIONS: A review of randomized controlled trials for commonly used CAM treatments such as omega-3 fatty acids, St John's wort (Hypericum), folate, S-adenosyl-L-methionine (SAMe), acupuncture, light therapy, exercise, and mindfulness psychotherapies revealed promising results. More rigorous and larger studies are recommended. Each CAM treatment must be evaluated separately in adequately powered controlled trials. At this time, several CAM treatments appear promising and deserve further study. The greatest risk of pursuing a CAM therapy is the possible delay of other well-established treatments. Clinical, research, and educational initiatives designed to focus on CAM in psychiatry are clearly warranted due to the widespread use of CAM therapies.

Omega-3 fatty acids and supportive psychotherapy for perinatal depression: a randomized placebo-controlled study.

BACKGROUND: Perinatal major depressive disorder (MDD), including antenatal and postpartum depression, is common and has serious consequences. This study was designed to investigate the feasibility, safety, and efficacy of omega-3 fatty acids for perinatal depression in addition to supportive psychotherapy. METHODS: Perinatal women with MDD were randomized to eicosapentaenoic (EPA) and docosahexaenoic acids (DHA), 1.9g/day, or placebo for 8weeks. A manualized supportive psychotherapy was provided to all subjects. Symptoms were assessed with the Hamilton Rating Scale for Depression (HAM-D) and Edinburgh Postnatal Depression Scale (EPDS) biweekly. RESULTS: Fifty-nine women enrolled; N = 51 had two data collection points that allowed for evaluation of efficacy. Omega-3 fatty acids were well tolerated. Participants in both groups experienced significant decreases in EPDS and HAM-D scores (p<.0001) from baseline. We did not find a benefit of omega-3 fatty acids over placebo. Dietary omega-3 fatty acid intake was low among participants. LIMITATIONS: The ability to detect an effect of omega-3 fatty acids may have been limited by sample size, study length, or dose. The benefits of supportive psychotherapy may have limited the ability to detect an effect of omega-3 fatty acids. CONCLUSIONS: There was no significant difference between omega-3 fatty acids and placebo in this study in which all participants received supportive psychotherapy. The manualized supportive psychotherapy warrants further study. The low intake of dietary omega-3 fatty acids among participants is of concern, in consideration of the widely established health advantages in utero and in infants.

Light therapy for bipolar disorder: a case series in women.

OBJECTIVES: To perform a dose-ranging safety and efficacy study of bright light therapy for depression in women with bipolar disorder (BD). METHODS: Nine women with DSM-IV BD I or II in the depressed phase were exposed to 50 lux (illuminance at the receiving surface) red light for two weeks, after which they received 7,000 lux light therapy for two-week epochs of 15, 30 and 45 min daily. The Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement and the Mania Rating Scale were used to assess mood symptoms. Four patients received morning light and five patients received midday light. RESULTS: Three of the four subjects treated with morning light developed mixed states. The fourth subject achieved a full, sustained response. To decrease the risk of inducing mixed episodes, we changed the time of light exposure to midday. Of the five women who received midday light therapy, two achieved full response and two showed early improvement but required a dose increase to sustain response. One woman remained depressed with 45 min of midday light but responded fully to a switch to morning light, 30 min daily. CONCLUSIONS: Women with bipolar illness are highly sensitive to morning bright light treatment; the induction of mixed states is a substantial risk. Initiating treatment with a brief duration (15 min) of midday light for bipolar depression is advisable.

Collaborative management of women with bipolar disorder during pregnancy and postpartum: pharmacologic considerations.

Bipolar disorder is a chronic condition characterized by periods of mania, depression, or mixed states (co-occurring mania and depression). The postpartum period is associated with a high risk for symptom relapse or intensification, which can be reduced with the use of medications. Abrupt discontinuation of these medications increases the probability of relapse, which is associated with high-risk behaviors, significant family dysfunction, and suicide. Drugs used to treat patients with bipolar disorder vary in teratogenic potential. Although first trimester lithium use is associated with Ebstein's anomaly, the risk was overestimated in the past. Valproate and its derivatives and carbamazepine are human teratogens. Lamotrigine does not negatively impact major reproductive outcomes, but the data are limited. Typical antipsychotic medications are relatively well studied and the data do not identify major morphologic teratogenicity. There are fewer studies of newer atypical antipsychotic medications, and registries have been developed to collect prospective data. Clinical management of bipolar disorder during pregnancy, postpartum, and lactation requires a careful balancing of maternal and fetal risks and benefits. Communication and careful comanagement between the obstetric and psychiatric team is essential when treating women with bipolar disorder during the reproductive years.

Nutrition and depression: implications for improving mental health among childbearing-aged women.

Adequate nutrition is needed for countless aspects of brain functioning. Poor diet quality, ubiquitous in the United States, may be a modifiable risk factor for depression. The objective was to review and synthesize the current knowledge of the role of nutrition in depression, and address implications for childbearing-aged women. Poor omega-3 fatty acid status increases the risk of depression. Fish oil and folic acid supplements each have been used to treat depression successfully. Folate deficiency reduces the response to antidepressants. Deficiencies of folate, vitamin B12, iron, zinc, and selenium tend to be more common among depressed than nondepressed persons. Dietary antioxidants have not been studied rigorously in relation to depression. Childbearing-aged women are particularly vulnerable to the adverse effects of poor nutrition on mood because pregnancy and lactation are major nutritional stressors to the body. The depletion of nutrient reserves throughout pregnancy and a lack of recovery postpartum may increase a woman's risk of depression. Prospective research studies are needed to clarify the role of nutrition in the pathophysiology of depression among childbearing-aged women. Greater attention to nutritional factors in mental health is warranted given that nutrition interventions can be inexpensive, safe, easy to administer, and generally acceptable to patients.

The efficacy of light therapy in the treatment of mood disorders: a review and meta-analysis of the evidence.

OBJECTIVE: The purpose of this study was to assess the evidence base for the efficacy of light therapy in treating mood disorders. METHOD: The authors systematically searched PubMed (January 1975 to July 2003) to identify randomized, controlled trials of light therapy for mood disorders that fulfilled predefined criteria. These articles were abstracted, and data were synthesized by disease and intervention category. RESULTS: Only 13% of the studies met the inclusion criteria. Meta-analyses revealed that a significant reduction in depression symptom severity was associated with bright light treatment (eight studies, having an effect size of 0.84 and 95% confidence interval [CI] of 0.60 to 1.08) and dawn simulation in seasonal affective disorder (five studies; effect size=0.73, 95% CI=0.37 to 1.08) and with bright light treatment in nonseasonal depression (three studies; effect size=0.53, 95% CI=0.18 to 0.89). Bright light as an adjunct to antidepressant pharmacotherapy for nonseasonal depression was not effective (five studies; effect size=-0.01, 95% CI=-0.36 to 0.34). CONCLUSIONS: Many reports of the efficacy of light therapy are not based on rigorous study designs. This analysis of randomized, controlled trials suggests that bright light treatment and dawn simulation for seasonal affective disorder and bright light for nonseasonal depression are efficacious, with effect sizes equivalent to those in most antidepressant pharmacotherapy trials. Adopting standard approaches to light therapy's specific issues (e.g., defining parameters of active versus placebo conditions) and incorporating rigorous designs (e.g., adequate group sizes, randomized assignment) are necessary to evaluate light therapy for mood disorders.