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.

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 food-related behavioral activation therapy on food intake and the environmental impact of the diet: results from the MooDFOOD prevention trial.

PURPOSE: Food-based dietary guidelines are proposed to not only improve diet quality, but to also reduce the environmental impact of diets. The aim of our study was to investigate whether food-related behavioral activation therapy (F-BA) applying Mediterranean-style dietary guidelines altered food intake and the environmental impact of the diet in overweight adults with subsyndromal symptoms of depression. METHODS: In total 744 adults who either received the F-BA intervention (F-BA group) or no intervention (control group) for 12 months were included in this analysis. Food intake data were collected through a food frequency questionnaire at baseline and after 6 and 12 months. Greenhouse gas emissions (GHGE), land use (LU), and fossil energy use (FEU) estimates from life-cycle assessments and a weighted score of the three (pReCiPe score) were used to estimate the environmental impact of each individual diet at each timepoint. RESULTS: The F-BA group reported increased intakes of vegetables (19.7 g/day; 95% CI 7.8-31.6), fruit (23.0 g/day; 9.4-36.6), fish (7.6 g/day; 4.6-10.6), pulses/legumes (4.0 g/day; 1.6-6.5) and whole grains (12.7 g/day; 8.0-17.5), and decreased intake of sweets/extras (- 6.8 g/day; - 10.9 to - 2.8) relative to control group. This effect on food intake resulted in no change in GHGE, LU, and pReCiPe score, but a relative increase in FEU by 1.6 MJ/day (0.8, 2.4). CONCLUSIONS: A shift towards a healthier Mediterranean-style diet does not necessarily result in a diet with reduced environmental impact in a real-life setting. TRIAL REGISTRATION: ClinicalTrials.gov. Number of identification: NCT02529423. August 2015.

Rumination-focused cognitive behaviour therapy for non-responsive chronic depression: an uncontrolled group study.

BACKGROUND: One-third of patients with depression do not respond satisfactorily to treatment, and approximately 20% of all patients treated for depression develop a chronic depression. One approach to more effective treatment of chronic and treatment-resistant depression is to target rumination - an underlying mechanism implicated in the development and maintenance of depression. AIM: The purpose of this uncontrolled group study was to investigate the feasibility of individual rumination-focused cognitive behavioural therapy (RfCBT) for patients with chronic and treatment-resistant depression. METHOD: A total of 10 patients with chronic and treatment-resistant depression were offered 12-16 individual sessions of RfCBT. The primary outcome was depressive symptoms as measured by Hamilton Depression Scale at pre-, post- and 3-month follow-up. Secondary symptoms measured included self-reported rumination and worry. RESULTS: There was a significant reduction in depressive symptoms (p < 0.05), rumination (p < 0.01) and worry (p < 0.5) from pre- to post-treatment. Half of the participants (n = 5) showed significant reliable change on levels of depressive symptoms post-treatment. The reduction in depressive symptoms, rumination and worry were maintained at follow-up. CONCLUSIONS: RfCBT was associated with significant reductions in depressive symptoms in a small sample with chronic and treatment-resistant depression. Despite limitations of being a small uncontrolled study with limited follow-up, these results are promising in a difficult to treat population. RfCBT warrants further systematic evaluation.

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 versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial.

BACKGROUND: Depression is a common, debilitating, and costly disorder. Many patients request psychological therapy, but the best-evidenced therapy-cognitive behavioural therapy (CBT)-is complex and costly. A simpler therapy-behavioural activation (BA)-might be as effective and cheaper than is CBT. We aimed to establish the clinical efficacy and cost-effectiveness of BA compared with CBT for adults with depression. METHODS: In this randomised, controlled, non-inferiority trial, we recruited adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder from primary care and psychological therapy services in Devon, Durham, and Leeds (UK). We excluded people who were receiving psychological therapy, were alcohol or drug dependent, were acutely suicidal or had attempted suicide in the previous 2 months, or were cognitively impaired, or who had bipolar disorder or psychosis or psychotic symptoms. We randomly assigned participants (1:1) remotely using computer-generated allocation (minimisation used; stratified by depression severity [Patient Health Questionnaire 9 (PHQ-9) score of <19 vs ≥19], antidepressant use, and recruitment site) to BA from junior mental health workers or CBT from psychological therapists. Randomisation done at the Peninsula Clinical Trials Unit was concealed from investigators. Treatment was given open label, but outcome assessors were masked. The primary outcome was depression symptoms according to the PHQ-9 at 12 months. We analysed all those who were randomly allocated and had complete data (modified intention to treat [mITT]) and also all those who were randomly allocated, had complete data, and received at least eight treatment sessions (per protocol [PP]). We analysed safety in the mITT population. The non-inferiority margin was 1·9 PHQ-9 points. This trial is registered with the ISCRTN registry, number ISRCTN27473954. FINDINGS: Between Sept 26, 2012, and April 3, 2014, we randomly allocated 221 (50%) participants to BA and 219 (50%) to CBT. 175 (79%) participants were assessable for the primary outcome in the mITT population in the BA group compared with 189 (86%) in the CBT group, whereas 135 (61%) were assessable in the PP population in the BA group compared with 151 (69%) in the CBT group. BA was non-inferior to CBT (mITT: CBT 8·4 PHQ-9 points [SD 7·5], BA 8·4 PHQ-9 points [7·0], mean difference 0·1 PHQ-9 points [95% CI -1·3 to 1·5], p=0·89; PP: CBT 7·9 PHQ-9 points [7·3]; BA 7·8 [6·5], mean difference 0·0 PHQ-9 points [-1·5 to 1·6], p=0·99). Two (1%) non-trial-related deaths (one [1%] multidrug toxicity in the BA group and one [1%] cancer in the CBT group) and 15 depression-related, but not treatment-related, serious adverse events (three in the BA group and 12 in the CBT group) occurred in three [2%] participants in the BA group (two [1%] patients who overdosed and one [1%] who self-harmed) and eight (4%) participants in the CBT group (seven [4%] who overdosed and one [1%] who self-harmed). INTERPRETATION: We found that BA, a simpler psychological treatment than CBT, can be delivered by junior mental health workers with less intensive and costly training, with no lesser effect than CBT. Effective psychological therapy for depression can be delivered without the need for costly and highly trained professionals. FUNDING: National Institute for Health Research.

Heightened ruminative disposition is associated with impaired attentional disengagement from negative relative to positive information: support for the "impaired disengagement" hypothesis.

Information processing accounts of rumination propose that impaired attentional disengagement from negative information may underpin heightened disposition to experience ruminative brooding in response to negative mood. The present study examined the relationship between individual differences in ruminative disposition and selective attention, using a paradigm capable of distinguishing between biases in the engagement and disengagement of attention. Results showed that higher dispositional ruminative brooding, as measured by both the brooding subscale of the RRS and an in-vivo assessment of ruminative disposition, was associated with greater relative impairment disengaging attention from negative compared to positive stimuli. These findings thus provide support for the "impaired disengagement" account of ruminative brooding.

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.

Do Females with Bulimia Nervosa and Eating Disorder Not Otherwise Specified Have Selective Memory Biases?

BACKGROUND: The cognitive model suggests memory biases for weight/shape and food related information could be important in the maintenance of eating disorders. AIMS: The current study aims to evaluate this and extend previous research by (a) including females with eating disorder not otherwise specified (EDNOS) as a discreet group; (b) considering whether levels of hunger and the pleasantness of the stimulus words are important in word recall. METHOD: The study includes three groups of females, 16 with bulimia nervosa, 18 with EDNOS and 17 non-dieting general population controls. All participants completed a self-referential encoding and memory recall task. RESULTS: A main effect of word type (p < .01) with no group by word type interaction or between group difference was found. A priori contrasts indicated that both eating disorder groups recalled significantly more weight/shape and food words compared to all other word categories (p < .01) compared to the control group; with no significant difference found between the eating disorder groups. In relation to the recall of food words, no significant differences were found between groups for levels of hunger. Both eating disorder groups rated the negative weight/shape (p < .01), negative food (p < .01) and neutral body words (p < .01) as more unpleasant than the control group. CONCLUSIONS: The implications for cognitive theory and future research are discussed.

Development and assessment of brief versions of the Penn State Worry Questionnaire and the Ruminative Response Scale.

OBJECTIVES: Worry and depressive rumination have been found to be involved in the onset and maintenance of a range of psychological disorders. The development of brief screening measures for excessive worry and depressive rumination is therefore desirable to facilitate the assessment of worry and rumination in prevention and treatment settings where routine administration of full questionnaires is not practical due to time-related constraints. DESIGN AND METHODS: Using the Penn State Worry Questionnaire (PSWQ) and the Ruminative Response Scale (RRS) as gold standard starting points, brief versions of these measures were developed in a large sample of adolescents (N = 1,952) and results were cross-validated in two independent samples (N = 1,954; N = 457). RESULTS: The brief versions demonstrated acceptable to high internal consistency (brief PSWQ: α = .84-.91; brief RRS: α = .78-.81) and correlated highly with the full questionnaires (brief PSWQ: r = .91-.94; brief RRS: r = .88-.91). In addition, they showed high sensitivity (brief PSWQ: .90-.92; brief RRS: .90-.93), and high specificity (brief PSWQ: .88-.90; brief RRS: .80-.87) to detect excessive worry and rumination. The validity of the brief measures was further supported by demonstrating that the brief measures showed similar differences in scores between males and females as the full measures as well as substantial relationships to other measures of repetitive negative thinking and symptom measures of anxiety and depression. Finally, the brief measures predicted future symptoms of anxiety and depression. CONCLUSIONS: The brief versions of the PSWQ and RRS are time-efficient and valid instruments for the screening of worry and depressive rumination. Their use in clinical practice is recommended to inform treatment and/or to select individuals at risk for development of psychological disorders who may benefit from preventive interventions.

Assessing the impact of university students' involvement in the first year of Nurture-U: a national student wellbeing research project.

BACKGROUND: Students experience lower levels of wellbeing than the general, age-matched population. A whole-university approach to mental health is encouraged, which must work for individuals from all backgrounds and experiences. Student input is vital in researching and designing these solutions. Nurture-U is a national, large-scale research project exploring better ways to support student wellbeing, with a Student Advisory Group (SAG) that feeds into project decision making. With the first year of the project now completed, we now critically review the processes and effectiveness of the SAG and how well the project is engaging and working with students. METHODS: Assessment of the SAG's impact on the project, the student advisors, and the researchers was undertaken through a content analysis of team meetings and collection of advisor and researcher feedback using the Patient Engagement Quality Guidance Tool. RESULTS: 142 students worked on different tasks in the first year of the Nurture-U project. The SAG was involved in the project branding and marketing, and in the development and co-design of interventions and tools. They reported a positive experience, with involvement boosting confidence. They felt valued but reported not always knowing whether their input was implemented in final decisions. They also recommended different methods of providing feedback. Researchers found student input beneficial to communicate the viewpoint of a different generation and increase the relevance of the study, but also suggested improvements for communication between the research team and the student group. CONCLUSIONS: This critical reflection of the SAG's public advisor role in this large-scale research project was important in highlighting what worked well and areas to improve. As the project unfolds, we aim to adapt our methods of student input, increase the transparency of decision-making processes, and in turn increase student-led decision making within the project.

University students face many challenges to their wellbeing, including academic stress, frequent changes of location, distancing of support systems, and new social and cultural surroundings. The Nurture-U research project is looking at how universities can support student wellbeing. It is supported by a Student Advisory Group (SAG) that is helping us design the research. The aim of this paper is to reflect on the input of the SAG in the first year of the 4-year Nurture-U project. 142 students worked on different tasks in the first year of the Nurture-U project, including marketing and designing therapeutic apps. The SAG described feeling valued, gaining confidence and an understanding of mental health and research. Researchers felt the SAG improved Nurture-U, making it more relevant to students. However, all were concerned that final decisions were researcher-led, not student-led. There was also a lack of diversity, with most of the SAG being female. The SAG advised different ways for researchers and students to work together. This included having different ways for student advisors to voice their opinions, for example in smaller or face-to-face groups, or on online boards. Also, researchers could engage with the SAG differently, through newsletters or videos, to make it clearer how final decisions are made. This formal reflection activity has helped the Nurture-U team consider ways to improve working with the SAG for the rest of the project, which we hope will ensure that student voices guide how the project unfolds.

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.

BMI and well-being in people of East Asian and European ancestry: a Mendelian randomisation study.

Previous studies have linked higher body mass index (BMI) to lower subjective well-being in adult European ancestry populations. However, our understanding of these relationships across different populations is limited. Here, we investigated the association between BMI and well-being in people of (a) East Asian and (b) European ancestry in the China Kadoorie Biobank (CKB) and UK Biobank (UKB), respectively. Mendelian randomisation (MR) methods were used to test the relationship between BMI with (a) health satisfaction and (b) life satisfaction. One-sample MR enabled us to test effects in men and women separately and to test the role of cultural contexts by stratifying our analyses by urban and rural home location in both China and the UK. Further, we implemented a control function method to test the linearity of the BMI-well-being relationship. We found evidence of different associations between BMI and well-being in individuals of East Asian versus European ancestry. For example, a genetically instrumented higher BMI tentatively associated with higher health satisfaction in people of East Asian ancestry, especially in females (ß: 0.041, 95% CI: 0.002, 0.081). In contrast, there was a robust inverse association between higher genetically instrumented BMI and health satisfaction in all European ancestry UKB participants (ß: -0.183, 95% CI: -0.200, -0.165, Pdifference < 1.00E-15). We also showed the importance of considering non-linear relationships in the MR framework by providing evidence of non-linear relationships between BMI and health and life satisfaction. Overall, our study suggests potential setting-specific causality in the relationship between BMI and subjective well-being, with robust differences observed between East Asians and Europeans when considering very similar outcomes. We highlight the importance of (a) considering potential non-linear relationships in causal analyses and (b) testing causal relationships in different populations, as the casual nature of relationships, especially relationships influenced by social processes, may be setting-specific.

A brief guided self-help intervention for psychological distress in palliative care patients: a randomised controlled trial.

BACKGROUND: Previous findings implicated rumination (recurrent dwelling on abstract concerns) in elevated psychological distress in palliative patients. We hypothesised that reducing rumination may be important in addressing psychological distress in palliative care. AIM: This study tested the prediction that a brief guided self-help technique targeting abstract rumination would reduce psychological distress in palliative patients. DESIGN: A randomised controlled trial evaluated 4 weeks of guided self-help that involved patients practising thinking more concretely by recalling specific and vivid memories of when they were completely absorbed in an activity or scene. Participants completed a combination of standardised questionnaires to assess anxiety, depression, and quality of life. SETTING/PARTICIPANTS: Palliative care patients who were reporting clinically significant psychological distress, whilst also physically well enough to take part in the trial were recruited from hospices in Devon and Somerset and randomised to either a treatment condition (n = 19) receiving 4 weeks of guided self-help, or a waiting-list control condition (n = 15) receiving treatment as usual. RESULTS: As predicted, the palliative patients receiving the intervention reported significantly greater reductions in anxiety than the waiting-list controls (F(1,23) = 20.55, p < 0.001, partial η (2) = 0.47). However, no significant effect was found on depression or quality of life. CONCLUSION: The findings suggest that a brief guided self-help intervention based on concreteness training can be effective in addressing anxiety in palliative care.

How well do Cognitive Behavioural Therapy and Behavioural Activation for depression repair anhedonia? A secondary analysis of the COBRA randomized controlled trial.

A secondary analysis of the COBRA randomized controlled trial was conducted to examine how well Cognitive Behavioural Therapy (CBT) and Behavioural Activation (BA) repair anhedonia. Patients with current major depressive disorder (N = 440) were randomized to receive BA or CBT, and anhedonia and depression outcomes were measured after acute treatment (six months) and at two further follow up intervals (12 and 18 months). Anhedonia was assessed using the Snaith Hamilton Pleasure Scale (SHAPS; a measure of consummatory pleasure). Both CBT and BA led to significant improvements in anhedonia during acute treatment, with no significant difference between treatments. Participants remained above healthy population averages of anhedonia at six months, and there was no further significant improvement in anhedonia at 12-month or 18-month follow up. Greater baseline anhedonia severity predicted reduced repair of depression symptoms and fewer depression-free days across the follow-up period in both the BA and CBT arms. The extent of anhedonia repair was less marked than the extent of depression repair across both treatment arms. These findings demonstrate that CBT and BA are similarly and only partially effective in treating anhedonia. Therefore, both therapies should be further refined or novel treatments should be developed in order better to treat anhedonia.

A Patient Stratification Approach to Identifying the Likelihood of Continued Chronic Depression and Relapse Following Treatment for Depression.

BACKGROUND: Subgrouping methods have the potential to support treatment decision making for patients with depression. Such approaches have not been used to study the continued course of depression or likelihood of relapse following treatment. METHOD: Data from individual participants of seven randomised controlled trials were analysed. Latent profile analysis was used to identify subgroups based on baseline characteristics. Associations between profiles and odds of both continued chronic depression and relapse up to one year post-treatment were explored. Differences in outcomes were investigated within profiles for those treated with antidepressants, psychological therapy, and usual care. RESULTS: Seven profiles were identified; profiles with higher symptom severity and long durations of both anxiety and depression at baseline were at higher risk of relapse and of chronic depression. Members of profile five (likely long durations of depression and anxiety, moderately-severe symptoms, and past antidepressant use) appeared to have better outcomes with psychological therapies: antidepressants vs. psychological therapies (OR (95% CI) for relapse = 2.92 (1.24-6.87), chronic course = 2.27 (1.27-4.06)) and usual care vs. psychological therapies (relapse = 2.51 (1.16-5.40), chronic course = 1.98 (1.16-3.37)). CONCLUSIONS: Profiles at greater risk of poor outcomes could benefit from more intensive treatment and frequent monitoring. Patients in profile five may benefit more from psychological therapies than other treatments.

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.

Effects of food-related behavioral activation therapy on eating styles, diet quality and body weight change: Results from the MooDFOOD Randomized Clinical Trial.

OBJECTIVE: Depression and obesity are bi-directionally related, eating styles and diet quality are two important factors associated with both. It remains uncertain if and how these two factors can be modified. Therefore the current study aims to investigate whether food-related behavioral activation therapy (F-BA), targeting mood, dietary habits and food related behavior, can improve eating styles, and diet quality and reduce body weight in adults with overweight or obesity and subsyndromal depressive symptoms. METHODS: Data were derived from the MooDFOOD prevention trial, a 2x2 factorial RCT investigating the effect of nutritional strategies on prevention of depression. Changes in emotional, uncontrolled, and cognitive restrained eating (Three Factor Eating Questionnaire Revised), Mediterranean Diet Score (MDS), and body weight were analyzed among 1025 adults who either received F-BA or no intervention for 12 months. Intervention effect was tested by longitudinal analysis of covariance using mixed model analysis. RESULTS: The F-BA group showed a small decrease in emotional (ß=-5.68, p<.001) and uncontrolled eating (ß=-4.05, p=.03), and increase in cognitive restrained eating (ß=5.53, p<.01), compared to no F-BA. The effect of the F-BA therapy on emotional and uncontrolled eating was stronger in those with higher baseline depressive symptoms (IDS-SR). The F-BA did also lead to small improvements in MDS (ß=1.95, p<.001), but not to change in body weight. CONCLUSION: Our trial showed no reduction in bodyweight, but provides support for the possibility to improve both unhealthy eating styles and diet quality using an intervention targeting these specifically, although effects were small [Trial registration: clinicaltrials.gov NCT02529423].

An overview of statistical methods for handling nonadherence to intervention protocol in randomized control trials: a methodological review.

OBJECTIVE: To undertake a methodological review of statistical methods used in randomized controlled trials (RCTs) for handling intervention nonadherence. STUDY DESIGN AND SETTING: Bibliographic databases were searched using predefined search terms. RESULTS: A substantive number of identified studies (56%) were excluded as they only used naive per protocol analysis for handling nonadherence. Our review included 58 articles published between 1991 and 2015. A total of 88 methodological applications were made by these studies. The two most used methods were complier average causal effect (56%) and instrumental variable (23%) predominantly with the use of maximum likelihood (ML) estimators. These alternative applications typically produced treatment effects greater than the intention-to-treat effect but as their standard errors were larger there was no statistical difference between the methods. CONCLUSION: A substantive proportion of RCTs rely on naive per protocol for handling nonadherence. Recent years have seen an increasing number of applications of more appropriate statistical methods, in particular complier average causal effect and instrumental variable methods. However, these later methods rely on strong underlying assumptions that may be vulnerable to violation. More empirical studies are needed that directly compare the usability and performance of different statistical methods for nonadherence in RCTs.

Depressive Symptom Clusters in Relation to Body Weight Status: Results From Two Large European Multicenter Studies.

Background: There is strong evidence for a bidirectional association between depression and obesity. Several biological, psychological, and behavior-related factors may influence this complex association. Clinical impression and preliminary evidence suggest that patients with a diagnosis of major depressive disorder may endorse very different depressive symptom patterns depending on their body weight status. Until now, little is known about potential differences in depressive symptoms in relation to body weight status. Objective: The aim of this analysis is the investigation of potential differences in depressive symptom clusters (mood symptoms, somatic/vegetative symptoms, and cognitive symptoms) in relation to body weight status. Methods: Cross-sectional baseline data were derived from two large European multicenter studies: the MooDFOOD Trial and the NESDA cohort study, including persons with overweight and obesity and normal weight reporting subthreshold depressive symptoms (assessment via Inventory of Depressive Symptomatology Self-Report, IDS-SR30). Different measures for body weight status [waist-to-hip ratio (WHR) and body mass index (BMI)] were examined. Propensity score matching was performed and multiple linear regression analyses were conducted. Results: A total of n = 504 individuals (73.0% women) were analyzed. Results show that more somatic/vegetative depressive symptoms, such as pain, change in appetite and weight, gastrointestinal symptoms, and arousal-related symptoms, were significantly associated with both a higher BMI and higher WHR, respectively. In addition, being male and older age were significantly associated with higher WHR. Mood and cognitive depressive symptoms did not yield significant associations for both body weight status measures. Conclusions: Somatic/vegetative symptoms and not mood and cognitive symptoms of depression are associated with body weight status. Thus, the results support previous findings of heterogeneous depressive symptoms in relation to body weight status. In addition to BMI, other body weight status measures for obesity should be taken into account in future studies. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02529423.