Soft Drinks and Symptoms of Depression and Anxiety in Overweight Subjects: A Longitudinal Analysis of an European Cohort.

BACKGROUND: Studies about the association of carbonated/soft drinks, coffee, and tea with depression and anxiety are scarce and inconclusive and little is known about this association in European adults. Our aim was to examine the association between the consumption of these beverages and depressive and anxiety symptom severity. METHODS: A total of 941 European overweight adults (mean age, 46.8 years) with subsyndromal depression that participated in the MooDFOOD depression prevention randomized controlled trial (Clinical Trials.gov identifier: NCT2529423; date of the study: from 2014 to 2018) were analyzed. Depressive and anxiety symptom severity and beverage consumption were assessed using multilevel mixed-effects ordinal logistic regression models for each beverage consumption (carbonated/soft drink with sugar, carbonated/soft drink with non-nutritive sweeteners, coffee, and tea) with the three repeated measures of follow-up (baseline and 6 and 12 months). A case report form for participants' sociodemographic and clinical characteristics, the Food Frequency Questionnaire, the Patient Health Questionnaire-9, the Generalized Anxiety Disorder 7-Item Scale, the MINI International Neuropsychiatric Interview 5.0, the Short Questionnaire to Assess Health-Enhancing Psychical Activity, and the Alcohol Use Disorders Identification Test were the research tools used. RESULTS: Daily consumption of carbonated/soft drinks with sugar was associated with a higher level of anxiety. Trends towards significance were found for associations between both daily consumption of carbonated/soft drinks with sugar and non-nutritive sweeteners and a higher level of depression. No relationship was found between coffee and tea consumption and the level of depression and anxiety. CONCLUSIONS: The high and regular consumption of carbonated/soft drink with sugar (amount of consumption: ≥1 unit (200 mL)/day) tended to be associated with higher level of anxiety in a multicountry sample of overweight subjects with subsyndromal depressive symptoms. It is important to point out that further research in this area is essential to provide valuable information about the intake patterns of non-alcoholic beverages and their relationship with affective disorders in the European adult population.

Effects of dietary interventions on depressive symptom profiles: results from the MooDFOOD depression prevention study.

BACKGROUND: Dietary interventions did not prevent depression onset nor reduced depressive symptoms in a large multi-center randomized controlled depression prevention study (MooDFOOD) involving overweight adults with subsyndromal depressive symptoms. We conducted follow-up analyses to investigate whether dietary interventions differ in their effects on depressive symptom profiles (mood/cognition; somatic; atypical, energy-related). METHODS: Baseline, 3-, 6-, and 12-month follow-up data from MooDFOOD were used (n = 933). Participants received (1) placebo supplements, (2) food-related behavioral activation (F-BA) therapy with placebo supplements, (3) multi-nutrient supplements (omega-3 fatty acids and a multi-vitamin), or (4) F-BA therapy with multi-nutrient supplements. Depressive symptom profiles were based on the Inventory of Depressive Symptomatology. RESULTS: F-BA therapy was significantly associated with decreased severity of the somatic (B = -0.03, p = 0.014, d = -0.10) and energy-related (B = -0.08, p = 0.001, d = -0.13), but not with the mood/cognition symptom profile, whereas multi-nutrient supplementation was significantly associated with increased severity of the mood/cognition (B = 0.05, p = 0.022, d = 0.09) and the energy-related (B = 0.07, p = 0.002, d = 0.12) but not with the somatic symptom profile. CONCLUSIONS: Differentiating depressive symptom profiles indicated that food-related behavioral interventions are most beneficial to alleviate somatic symptoms and symptoms of the atypical, energy-related profile linked to an immuno-metabolic form of depression, although effect sizes were small. Multi-nutrient supplements are not indicated to reduce depressive symptom profiles. These findings show that attention to clinical heterogeneity in depression is of importance when studying dietary interventions.

Associations of Non-Alcoholic Beverages with Major Depressive Disorder History and Depressive Symptoms Clusters in a Sample of Overweight Adults.

BACKGROUND: Meta-analysis of observational studies concluded that soft drinks may increase the risk of depression, while high consumption of coffee and tea may reduce the risk. Objectives were to explore the associations between the consumption of soft drinks, coffee or tea and: (1) a history of major depressive disorder (MDD) and (2) the severity of depressive symptoms clusters (mood, cognitive and somatic/vegetative symptoms). METHODS: Cross-sectional and longitudinal analysis based on baseline and 12-month-follow-up data collected from four countries participating in the European MooDFOOD prevention trial. In total, 941 overweight adults with subsyndromal depressive symptoms aged 18 to 75 years were analyzed. History of MDD, depressive symptoms and beverages intake were assessed. RESULTS: Sugar-sweetened soft drinks were positively related to MDD history rates whereas soft drinks with non-nutritive sweeteners were inversely related for the high vs. low categories of intake. Longitudinal analysis showed no significant associations between beverages and mood, cognitive and somatic/vegetative clusters. CONCLUSION: Our findings point toward a relationship between soft drinks and past MDD diagnoses depending on how they are sweetened while we found no association with coffee and tea. No significant effects were found between any studied beverages and the depressive symptoms clusters in a sample of overweight adults.

Supplementation-induced increase in circulating omega-3 serum levels is not associated with a reduction in depressive symptoms: Results from the MooDFOOD depression prevention trial.

BACKGROUND: There is ambiguity on how omega-3 (n-3) polyunsaturated fatty acids (PUFAs) are associated with depression, and what the temporality of the association might be. The present study aimed to examine whether (intervention-induced changes in) n-3 PUFA levels were associated with (changes in) depressive symptoms. METHODS: Baseline, 6- and 12-month follow-up data on 682 overweight and subclinically depressed persons from four European countries that participated in the MooDFOOD depression prevention randomized controlled trial were used. Participants were allocated to four intervention groups: (a) placebos, (b) placebos and food-related behavioral activation therapy (F-BA), (c) multinutrient supplements (fish oil and multivitamin), and (d) multinutrient supplements and F-BA. Depressive symptoms were measured using the inventory of depressive symptomatology. PUFA levels (µmol/L) were measured using gas chromatography. Analyses were adjusted for sociodemographics, lifestyle, and somatic health. RESULTS: Increases in n-3 PUFA, docosahexaenoic acid, and eicosapentaenoic acid levels over time were significantly larger in the supplement groups than in placebo groups. Change in PUFA levels was not significantly associated with the change in depressive symptoms (ß = .002, SE = 0.003, p = .39; ß = .003, SE = 0.005, p = .64; ß = .005, SE = 0.005, p = .29; ß = -.0002, SE = 0.0004, p = .69). Baseline PUFA levels did not modify the intervention effects on depressive symptoms. CONCLUSIONS: In overweight and subclinical depressed persons, multinutrient supplements led to significant increases in n-3 PUFA levels over time, which were not associated with changes in depressive symptoms. Multinutrient supplements do not seem to be an effective preventive strategy in lowering depressive symptoms over time in these at-risk groups.

Effect of Multinutrient Supplementation and Food-Related Behavioral Activation Therapy on Prevention of Major Depressive Disorder Among Overweight or Obese Adults With Subsyndromal Depressive Symptoms: The MooDFOOD Randomized Clinical Trial.

Importance: Effects of nutritional interventions on the prevention of major depressive disorder (MDD) in overweight adults are unknown. Objective: To examine the effect of 2 nutritional strategies (multinutrient supplementation, food-related behavioral activation therapy) and their combination for prevention of a new MDD episode in overweight adults with subsyndromal depressive symptoms. Design, Setting, and Participants: This multicenter 2 × 2 factorial randomized clinical trial included overweight adults (body mass index, 25-40) with elevated depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] scores ≥5) and no MDD episode in the past 6 months from 4 European countries. A total of 1025 adults were randomized (July 30, 2015-October 12, 2016) and followed up for 1 year (October 13, 2017). Interventions: Daily multinutrient supplements (1412-mg omega-3 fatty acids, 30-µg selenium, 400-µg folic acid, and 20-µg vitamin D3 plus 100-mg calcium) vs placebo and 21 individual or group therapy sessions vs none (blinded to researchers) for 1 year. Participants were allocated to placebo without therapy (n = 257), placebo with therapy (n = 256), supplements without therapy (n = 256), and supplements with therapy (n = 256). Main Outcome and Measures: Cumulative 1-year onset of MDD via the Mini International Neuropsychiatric Interview at 3, 6, and 12 months. Logistic regression using effect-coded variables (-1 indicating control, 1 indicating intervention) evaluated intervention effects both individually and in combination (interaction) on MDD onset. Results: Among 1025 participants (mean age, 46.5 years; 772 women [75%]; mean BMI, 31.4), 779 (76%) completed the trial. During the 12-month follow-up, 105 (10%) developed MDD: 25 (9.7%) patients in the placebo without therapy, 26 (10.2%) in the placebo with therapy, 32 (12.5%) in the supplement without therapy, and 22 (8.6%) in the supplement with therapy group. None of the treatment strategies affected MDD onset. The odds ratio (OR) for supplements was 1.06 (95% CI, 0.87-1.29); for therapy, 0.93 (95% CI, 0.76-1.13); and for their combination, 0.93 (95% CI, 0.76-1.14; P for interaction, .48). One person in the supplementation with therapy group, died. Twenty-four patients in each of the placebo groups and 24 patients in the supplementation with therapy group were hospitalized, and 26 patients in the supplementation-only group were hospitalized. Conclusions and Relevance: Among overweight or obese adults with subsyndromal depressive symptoms, multinutrient supplementation compared with placebo and food-related behavioral activation therapy compared with no therapy did not reduce episodes of major depressive disorder during 1 year. These findings do not support the use of these interventions for prevention of major depressive disorder. Trial registration: ClinicalTrials.gov Identifier: NCT02529423.

Cost and Outcome of BehaviouRal Activation (COBRA): a randomised controlled trial of behavioural activation versus cognitive-behavioural therapy for depression.

BACKGROUND: Depression is a common, debilitating and costly disorder. The best-evidenced psychological therapy - cognitive-behavioural therapy (CBT) - is complex and costly. A simpler therapy, behavioural activation (BA), may be an effective alternative. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of BA compared with CBT for depressed adults at 12 and 18 months' follow-up, and to investigate the processes of treatments. DESIGN: Randomised controlled, non-inferiority trial stratified by depression severity, antidepressant use and recruitment site, with embedded process evaluation; and randomisation by remote computer-generated allocation. SETTING: Three community mental health services in England. PARTICIPANTS: Adults aged ≥ 18 years with major depressive disorder (MDD) recruited from primary care and psychological therapy services. INTERVENTIONS: BA delivered by NHS junior mental health workers (MHWs); CBT by NHS psychological therapists. OUTCOMES: Primary: depression severity (as measured via the Patient Health Questionnaire-9; PHQ-9) at 12 months. Secondary: MDD status; number of depression-free days; anxiety (as measured via the Generalised Anxiety Disorder-7); health-related quality of life (as measured via the Short Form questionnaire-36 items) at 6, 12 and 18 months; and PHQ-9 at 6 and 18 months, all collected by assessors blinded to treatment allocation. Non-inferiority margin was 1.9 PHQ-9 points. We undertook intention-to-treat (ITT) and per protocol (PP) analyses. We explored cost-effectiveness by collecting direct treatment and other health- and social-care costs and calculating quality-adjusted life-years (QALYs) using the EuroQol-5 Dimensions, three-level version, at 18 months. RESULTS: We recruited 440 participants (BA, n = 221; CBT, n = 219); 175 (79%) BA and 189 (86%) CBT participants provided ITT data and 135 (61%) BA and 151 (69%) CBT participants provided PP data. At 12 months we found that BA was non-inferior to CBT {ITT: CBT 8.4 PHQ-9 points [standard deviation (SD) 7.5 PHQ-9 points], BA 8.4 PHQ-9 points (SD 7.0 PHQ-9 points), mean difference 0.1 PHQ-9 points, 95% confidence interval (CI) -1.3 to 1.5 PHQ-9 points, p = 0.89; PP: CBT 7.9 PHQ-9 points (SD 7.3 PHQ-9 points), BA 7.8 PHQ-9 points (SD 6.5 PHQ-9 points), mean difference 0.0 PHQ-9 points, 95% CI -1.5 to 1.6 PHQ-9 points, p = 0.99}. We found no differences in secondary outcomes. We found a significant difference in mean intervention costs (BA, £975; CBT, £1235; p < 0.001), but no differences in non-intervention (hospital, community health, social care and medication costs) or total (non-intervention plus intervention) costs. Costs were lower and QALY outcomes better in the BA group, generating an incremental cost-effectiveness ratio of -£6865. The probability of BA being cost-effective compared with CBT was almost 80% at the National Institute for Health and Care Excellence's preferred willingness-to-pay threshold of £20,000-30,000 per QALY. There were no trial-related adverse events. LIMITATIONS: In this pragmatic trial many depressed participants in both groups were also taking antidepressant medication, although most had been doing so for a considerable time before entering the trial. Around one-third of participants chose not to complete a PP dose of treatment, a finding common in both psychotherapy trials and routine practice. CONCLUSIONS: We found that BA is as effective as CBT, more cost-effective and can be delivered by MHWs with no professional training in psychological therapies. FUTURE WORK: Settings and countries with a paucity of professionally qualified psychological therapists, might choose to investigate the delivery of effective psychological therapy for depression without the need to develop an extensive and costly professional infrastructure. TRIAL REGISTRATION: Current Controlled Trials ISRCTN27473954. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 46. See the NIHR Journals Library website for further project information.

Prevention of depression through nutritional strategies in high-risk persons: rationale and design of the MooDFOOD prevention trial.

BACKGROUND: Obesity and depression are two prevalent conditions that are costly to individuals and society. The bidirectional association of obesity with depression, in which unhealthy dietary patterns may play an important role, has been well established. Few experimental studies have been conducted to investigate whether supplementing specific nutrients or improving diet and food-related behaviors can prevent depression in overweight persons. METHOD/DESIGN: The MooDFOOD prevention trial examines the feasibility and effectiveness of two different nutritional strategies [multi-nutrient supplementation and food-related behavioral change therapy (FBC)] to prevent depression in individuals who are overweight and have elevated depressive symptoms but who are not currently or in the last 6 months meeting criteria for an episode of major depressive disorder (MDD). The randomized controlled prevention trial has a two-by-two factorial design: participants are randomized to daily multi-nutrient supplement (omega-3 fatty acids, calcium, selenium, B-11 vitamin and D-3 vitamin) versus placebo, and/or FBC therapy sessions versus usual care. Interventions last 12 months. In total 1000 participants aged 18-75 years with body mass index between 25-40 kg/m(2) and with a Patient Health Questionnaire-9 score ≥ 5 will be recruited at four study sites in four European countries. Baseline and follow-up assessments take place at 0, 3, 6, and 12 months. Primary endpoint is the onset of an episode of MDD, assessed according to DSM-IV based criteria using the MINI 5.0 interview. Depressive symptoms, anxiety, food and eating behavior, physical activity and health related quality of life are secondary outcomes. During the intervention, compliance, adverse events and potentially mediating variables are carefully monitored. DISCUSSION: The trial aims to provide a better understanding of the causal role of specific nutrients, overall diet, and food-related behavior change with respect to the incidence of MDD episodes. This knowledge will be used to develop and disseminate innovative evidence-based, feasible, and effective nutritional public health strategies for the prevention of clinical depression. TRIAL REGISTRATION: ClinicalTrials.gov. Number of identification: NCT02529423 . August 2015.

Cost and outcome of behavioural activation versus cognitive behaviour therapy for depression (COBRA): study protocol for a randomised controlled trial.

BACKGROUND: Cognitive behaviour therapy (CBT) is an effective treatment for depression. However, CBT is a complex therapy that requires highly trained and qualified practitioners, and its scalability is therefore limited by the costs of training and employing sufficient therapists to meet demand. Behavioural activation (BA) is a psychological treatment for depression that may be an effective alternative to CBT and, because it is simpler, might also be delivered by less highly trained and specialised mental health workers. METHODS/DESIGN: COBRA is a two-arm, non-inferiority, patient-level randomised controlled trial, including clinical, economic, and process evaluations comparing CBT delivered by highly trained professional therapists to BA delivered by junior professional or para-professional mental health workers to establish whether the clinical effectiveness of BA is non-inferior to CBT and if BA is cost effective compared to CBT. Four hundred and forty patients with major depressive disorder will be recruited through screening in primary care. We will analyse for non-inferiority in per-protocol and intention-to-treat populations. Our primary outcome will be severity of depression symptoms (Patient Health Questionnaire-9) at 12 months follow-up. Secondary outcomes will be clinically significant change and severity of depression at 18 months, and anxiety (General Anxiety Disorder-7 questionnaire) and health-related quality of life (Short-Form Health Survey-36) at 12 and 18 months. Our economic evaluation will take the United Kingdom National Health Service/Personal Social Services perspective to include costs of the interventions, health and social care services used, plus productivity losses. Cost-effectiveness will explored in terms of quality-adjusted life years using the EuroQol-5D measure of health-related quality of life. DISCUSSION: The clinical and economic outcomes of this trial will provide the evidence to help policy makers, clinicians and guideline developers decide on the merits of including BA as a first-line treatment of depression. TRIAL REGISTRATION: Current Controlled Trials ISRCTN27473954.

How does mindfulness-based cognitive therapy work?

Mindfulness-based cognitive therapy (MBCT) is an efficacious psychosocial intervention for recurrent depression (Kuyken et al., 2008; Ma & Teasdale, 2004; Teasdale et al., 2000). To date, no compelling research addresses MBCT's mechanisms of change. This study determines whether MBCT's treatment effects are mediated by enhancement of mindfulness and self-compassion across treatment, and/or by alterations in post-treatment cognitive reactivity. The study was embedded in a randomized controlled trial comparing MBCT with maintenance antidepressants (mADM) with 15-month follow-up (Kuyken et al., 2008). Mindfulness and self-compassion were assessed before and after MBCT treatment (or at equivalent time points in the mADM group). Post-treatment reactivity was assessed one month after the MBCT group sessions or at the equivalent time point in the mADM group. One hundred and twenty-three patients with ≥3 prior depressive episodes, and successfully treated with antidepressants, were randomized either to mADM or MBCT. The MBCT arm involved participation in MBCT, a group-based psychosocial intervention that teaches mindfulness skills, and discontinuation of ADM. The mADM arm involved maintenance on a therapeutic ADM dose for the duration of follow-up. Interviewer-administered outcome measures assessed depressive symptoms and relapse/recurrence across 15-month follow-up. Mindfulness and self-compassion were measured using self-report questionnaire. Cognitive reactivity was operationalized as change in depressive thinking during a laboratory mood induction. MBCT's effects were mediated by enhancement of mindfulness and self-compassion across treatment. MBCT also changed the nature of the relationship between post-treatment cognitive reactivity and outcome. Greater reactivity predicted worse outcome for mADM participants but this relationship was not evident in the MBCT group. MBCT's treatment effects are mediated by augmented self-compassion and mindfulness, along with a decoupling of the relationship between reactivity of depressive thinking and poor outcome. This decoupling is associated with the cultivation of self-compassion across treatment.

Mindfulness-based cognitive therapy to prevent relapse in recurrent depression.

For people at risk of depressive relapse, mindfulness-based cognitive therapy (MBCT) has an additive benefit to usual care (H. F. Coelho, P. H. Canter, & E. Ernst, 2007). This study asked if, among patients with recurrent depression who are treated with antidepressant medication (ADM), MBCT is comparable to treatment with maintenance ADM (m-ADM) in (a) depressive relapse prevention, (b) key secondary outcomes, and (c) cost effectiveness. The study design was a parallel 2-group randomized controlled trial comparing those on m-ADM (N = 62) with those receiving MBCT plus support to taper/discontinue antidepressants (N = 61). Relapse/recurrence rates over 15-month follow-ups in MBCT were 47%, compared with 60% in the m-ADM group (hazard ratio = 0.63; 95% confidence interval: 0.39 to 1.04). MBCT was more effective than m-ADM in reducing residual depressive symptoms and psychiatric comorbidity and in improving quality of life in the physical and psychological domains. There was no difference in average annual cost between the 2 groups. Rates of ADM usage in the MBCT group was significantly reduced, and 46 patients (75%) completely discontinued their ADM. For patients treated with ADM, MBCT may provide an alternative approach for relapse prevention.

Rumination-focused cognitive behaviour therapy for residual depression: a case series.

The treatment of chronic and recurrent depression is a priority for the development of new interventions. The maintenance of residual symptoms following acute treatment for depression is a risk factor for both chronic depression and further relapse/recurrence. This open case series provides the first data on a cognitive-behavioural treatment for residual depression that explicitly targets depressive rumination. Rumination has been identified as a key factor in the onset and maintenance of depression, which is found to remain elevated following remission from depression. Fourteen consecutively recruited participants meeting criteria for medication--refractory residual depression [Paykel, E.S., Scott, J., Teasdale, J.D., Johnson, A.L., Garland, A., Moore, R. et al., 1999. Prevention of relapse in residual depression by cognitive therapy--a controlled trial. Archives of General Psychiatry 56, 829-835] were treated individually for up to 12 weekly 60-min sessions. Treatment specifically focused on switching patients from less helpful to more helpful styles of thinking through the use of functional analysis, experiential/imagery exercises and behavioural experiments. Treatment produced significant improvements in depressive symptoms, rumination and co-morbid disorders: 71% responded (50% reduction on Hamilton Depression Rating Scale) and 50% achieved full remission. Treating depressive rumination appears to yield generalised improvement in depression and co-morbidity. This study provides preliminary evidence that rumination-focused CBT may be an efficacious treatment for medication--refractory residual depression.