Improving movement behavior in office workers: effects of two multi-level cluster-RCT interventions on mental health.

BACKGROUND: We have previously reported on the design and efficacy of two cluster-randomized multi-level workplace interventions, attempting to decrease sedentary behavior (SED) or increase moderate to vigorous physical activity (MVPA) among office workers to improve mental health outcomes. The aim of this study was to investigate intervention effects on mental health outcomes, i.e., mental wellbeing, depression or anxiety symptoms, and stress immediately after the 6-month intervention period. METHODS: Teams of 263 office workers were cluster-randomized to one of two interventions or a waitlist control group. The PA intervention (iPA) focused on increasing MVPA and the SED intervention (iSED) on reducing SED. Both multi-level interventions targeted individual office workers and their social, physical, and organizational work environment, incorporating counseling based on cognitive behavioral therapy and motivational interviewing. Mental health outcomes were assessed using validated questionnaires before and immediately after the intervention. Intervention effects were analyzed using linear mixed effects models. RESULTS: Participants were mostly female and highly educated, with a mean age of 42 years and had favorable levels of mental health at baseline. Mental wellbeing improved for the iSED group (ß = 8, 95% CI 1 to 15, p = 0.030) but not for the iPA group (ß = 6, 95% CI -1 to 12, p = 0.072) compared to the control group. No effects were found for depression or anxiety symptoms or stress. CONCLUSIONS: The multi-level interventions improved mental wellbeing among this population of office workers, reaching statistical significance in the iSED group. The size of the effect can be regarded meaningful, considering favorable mental health and high PA level at baseline. Thus, workplace interventions that provide support on multiple levels appear to have potential for improving mental wellbeing, but not reducing ill-health variables, among healthy office workers. More research is needed to understand the mechanisms through which such improvements can be achieved and to identify the most effective intervention components. TRIAL REGISTRATION: ISRCTN92968402 (27 February 2018).

The role of acute changes in mBDNF, cortisol and pro-BDNF in predicting cognitive performance in old age.

The interplay between biomarkers of relevance to neuroplasticity and its association with learning and cognitive ability in old age remains poorly understood. The present study investigated acute changes in plasma concentrations of mature brain-derived neurotrophic factor (mBDNF), its precursor protein (pro-BDNF), and cortisol, in response to acute physical exercise and cognitive training interventions, their covariation and role in predicting cognitive performance. Confirmatory results provided no support for mBDNF, pro-BDNF and cortisol co-varying over time, as the acute interventions unfolded, but did confirm a positive association between mBDNF and pro-BDNF at rest. The confirmatory results did not support the hypothesis that mBDNF change following physical exercise were counteracted by temporally coupled changes in cortisol or pro-BDNF, or by cortisol at rest, in its previously demonstrated faciliatory effect on cognitive training outcome. Exploratory results instead provided indications of a general and trait-like cognitive benefit of exhibiting greater mBDNF responsiveness to acute interventions when coupled with lesser cortisol responsiveness, greater pro-BDNF responsiveness, and lower cortisol at rest. As such, the results call for future work to test whether certain biomarker profiles are associated with preserved cognition in old age.

The effect of two multi-component behavior change interventions on cognitive functions.

BACKGROUND: We previously reported the effects of two cluster-randomized 6-month multi-component workplace interventions, targeting reducing sedentary behavior or increasing physical activity among office workers, on movement behaviors and cardiorespiratory fitness. The primary aim of this study was to investigate the effects of these interventions on cognitive functions compared to a wait-list control group. The secondary aims were to examine if changes in cognition were related to change in cardiorespiratory fitness or movement behaviors and if age, sex, or cardiorespiratory fitness moderated these associations. METHODS: Both interventions encompassed multi-components acting on the individual, environmental, and organizational levels and aimed to change physical activity patterns to improve mental health and cognitive function. Out of 263 included participants, 139 (mean age 43 years, 76% females) completed a neuropsychological test battery and wore accelerometers at baseline and 6-month follow-up. The intervention effect (aim 1) on cognitive composite scores (i.e., Executive Functions, Episodic Memory, Processing Speed, and Global Cognition) was investigated. Additionally, associations between changes in movement behaviors and cardiorespiratory fitness, and changes in cognition were examined (aim 2). Moreover, age, sex, and cardiorespiratory fitness level were investigated as possible moderators of change associations (aim 3). RESULTS: Overall, cognitive performance improved from baseline to follow-up, but the change did not differ between the intervention groups and the control group. Changes in cardiorespiratory fitness or any movement behavior category did not predict changes in cognitive functions. The association between changes in time in bed and changes in both Executive Function and Global Cognition were moderated by age, such that a more positive relation was seen with increasing age. A less positive association was seen between changes in sedentary behavior and Processing Speed for men vs. women, whereas higher cardiorespiratory fitness was related to a more positive association between changes in moderate-intensity physical activity and Global Cognition. CONCLUSION: The lack of an intervention effect on cognitive functions was expected since the intervention did not change movement behavior or fitness. Age, sex, and cardiorespiratory fitness level might moderate the relationships between movement behaviors and cognitive functions changes. TRIAL REGISTRATION: ISRCTN92968402 . Registered 09/04/2018.

Higher VO2max is associated with thicker cortex and lower grey matter blood flow in older adults.

VO2max (maximal oxygen consumption), a validated measure of aerobic fitness, has been associated with better cerebral artery compliance and measures of brain morphology, such as higher cortical thickness (CT) in frontal, temporal and cingular cortices, and larger grey matter volume (GMV) of the middle temporal gyrus, hippocampus, orbitofrontal cortex and cingulate cortex. Single sessions of physical exercise can promptly enhance cognitive performance and brain activity during executive tasks. However, the immediate effects of exercise on macro-scale properties of the brain's grey matter remain unclear. We investigated the impact of one session of moderate-intensity physical exercise, compared with rest, on grey matter volume, cortical thickness, working memory performance, and task-related brain activity in older adults. Cross-sectional associations between brain measures and VO2max were also tested. Exercise did not induce statistically significant changes in brain activity, grey matter volume, or cortical thickness. Cardiovascular fitness, measured by VO2max, was associated with lower grey matter blood flow in the left hippocampus and thicker cortex in the left superior temporal gyrus. Cortical thickness was reduced at post-test independent of exercise/rest. Our findings support that (1) fitter individuals may need lower grey matter blood flow to meet metabolic oxygen demand, and (2) have thicker cortex.

Second Language Learning in Older Adults: Effects on Brain Structure and Predictors of Learning Success.

It has previously been demonstrated that short-term foreign language learning can lead to structural brain changes in younger adults. Experience-dependent brain plasticity is known to be possible also in older age, but the specific effect of foreign language learning on brain structure in language-and memory-relevant regions in the old brain remains unknown. In the present study, 160 older Swedish adults (65-75 years) were randomized to complete either an entry-level Italian course or a relaxation course, both with a total duration of 11 weeks. Structural MRI scans were conducted before and after the intervention in a subset of participants to test for differential change in gray matter in the two groups in the inferior frontal gyrus, the superior temporal gyrus, and the hippocampus, and in white matter microstructure in the superior longitudinal fasciculus (SLF), inferior longitudinal fasciculus (ILF), fronto-occipital fasciculus, and the hippocampal (HC) section of the cingulum. The study found no evidence for differential structural change following language training, independent of achieved vocabulary proficiency. However, hippocampal volume and associative memory ability before the intervention were found to be robust predictors of vocabulary proficiency at the end of the language course. The results suggest that having greater hippocampal volume and better associative memory ability benefits vocabulary learning in old age but that the very initial stage of foreign language learning does not trigger detectable changes in brain morphometry in old age.

Immediate effects of a single session of physical exercise on cognition and cerebral blood flow: A randomized controlled study of older adults.

BACKGROUND: Regular physical activity is beneficial for cognitive performance in older age. A single bout of aerobic physical exercise can transiently improve cognitive performance. Researchers have advanced improvements in cerebral circulation as a mediator of long-term effects of aerobic physical exercise on cognition, but the immediate effects of exercise on cognition and cerebral perfusion are not well characterized and the effects in older adults are largely unknown. METHODS: Forty-nine older adults were randomized to a 30-min aerobic exercise at moderate intensity or relaxation. Groups were matched on age and cardiovascular fitness (VO2 max). Average Grey Matter Blood Flow (GMBF), measured by a pulsed arterial-spin labeling (pASL) magnetic resonance imaging (MRI) acquisition, and working memory performance, measured by figurative n-back tasks with increasing loads were assessed before and 7 min after exercising/resting. RESULTS: Accuracy on the n-back task increased from before to after exercising/resting regardless of the type of activity. GMBF decreased after exercise, relative to the control (resting) group. In the exercise group, higher n-back performance after exercise was associated with lower GMBF in the right hippocampus, left medial frontal cortex and right orbitofrontal cortex, and higher cardiovascular fitness was associated with lower GMBF. CONCLUSION: The decrease of GMBF reported in younger adults shortly after exercise also occurs in older adults and relates to cardiovascular fitness, potentially supporting the link between cardiovascular fitness and cerebrovascular reactivity in older age.

Peripheral BDNF Response to Physical and Cognitive Exercise and Its Association With Cardiorespiratory Fitness in Healthy Older Adults.

Physical exercise (PE) has been shown to improve brain function via multiple neurobiological mechanisms promoting neuroplasticity. Cognitive exercise (CE) combined with PE may show an even greater effect on cognitive function. Brain-derived neurotrophic factor (BDNF) is important for neuroplastic signaling, may reduce with increasing age, and is confounded by fitness. The source and physiological role of human peripheral blood BDNF in plasma (pBDNF) is thought to differ from that in serum (sBDNF), and it is not yet known how pBDNF and sBDNF respond to PE and CE. A training intervention study in healthy older adults investigated the effects of acute (35 min) and prolonged (12 weeks, 30 sessions) CE and PE, both alone and in combination, on pBDNF and sBDNF. Cross-sectional associations between baseline pBDNF, sBDNF and cardiorespiratory fitness (CRF) were also investigated. Participants (65-75 years) were randomly assigned to four groups and prescribed either CE plus 35 min of rest (n = 21, 52% female); PE [performed on a cycle ergometer at moderate intensity (65-75% of individual maximal heart rate)] plus 35 min of rest (n = 27, 56% female); CE plus PE (n = 24, 46% female), or PE plus CE (n = 25, 52% female). Groups were tested for CRF using a maximal treadmill ergometer test (VO2peak); BDNF levels (collected 48 h after CRF) during baseline, after first exercise (PE or CE) and after second exercise (PE, CE or rest); and cognitive ability pre and post 12-week training. At both pre and post, pBDNF increased after CE and PE (up to 222%), and rest (∼67%), whereas sBDNF increased only after PE (up to 18%) and returned to baseline after rest. Acute but not prolonged PE increased both pBDNF and sBDNF. CE induced acute changes in pBDNF only. Baseline pBDNF was positively associated with baseline sBDNF (n = 93, r = 0.407, p < 0.001). No changes in CRF were found in any of the groups. Baseline CRF did not correlate with baseline BDNF. Even though baseline pBDNF and sBDNF were associated, patterns of changes in pBDNF and sBDNF in response to exercise were explicitly different. Further experimental scrutiny is needed to clarify the biological mechanisms of these results.

Effects of daily L-dopa administration on learning and brain structure in older adults undergoing cognitive training: a randomised clinical trial.

Cognitive aging creates major individual and societal burden, motivating search for treatment and preventive care strategies. Behavioural interventions can improve cognitive performance in older age, but effects are small. Basic research has implicated dopaminergic signalling in plasticity. We investigated whether supplementation with the dopamine-precursor L-dopa improves effects of cognitive training on performance. Sixty-three participants for this randomised, parallel-group, double-blind, placebo-controlled trial were recruited via newspaper advertisements. Inclusion criteria were: age of 65-75 years, Mini-Mental State Examination score >25, absence of serious medical conditions. Eligible subjects were randomly allocated to either receive 100/25 mg L-dopa/benserazide (n = 32) or placebo (n = 31) prior to each of twenty cognitive training sessions administered during a four-week period. Participants and staff were blinded to group assignment. Primary outcomes were latent variables of spatial and verbal fluid intelligence. Compared to the placebo group, subjects receiving L-dopa improved less in spatial intelligence (-0.267 SDs; 95%CI [-0.498, -0.036]; p = 0.024). Change in verbal intelligence did not significantly differ between the groups (-0.081 SDs, 95%CI [-0.242, 0.080]; p = 0.323). Subjects receiving L-dopa also progressed slower through the training and the groups displayed differential volumetric changes in the midbrain. No statistically significant differences were found for the secondary cognitive outcomes. Adverse events occurred for 10 (31%) and 7 (23%) participants in the active and control groups, correspondingly. The results speak against early pharmacological interventions in older healthy adults to improve broader cognitive functions by targeting the dopaminergic system and provide no support for learning-enhancing properties of L-dopa supplements in the healthy elderly. The findings warrant closer investigation about the cognitive effects of early dopamine-replacement therapy in neurological disorders. This trial was preregistered at the European Clinical Trial Registry, EudraCT#2016-000891-54 (2016-10-05).

Acute increases in brain-derived neurotrophic factor in plasma following physical exercise relates to subsequent learning in older adults.

Multidomain lifestyle interventions represents a promising strategy to counteract cognitive decline in older age. Brain-derived neurotrophic factor (BDNF) is essential for experience-dependent plasticity and increases following physical exercise, suggesting that physical exercise may facilitate subsequent learning. In a randomized-controlled trial, healthy older adults (65-75 years) completed a 12-week behavioral intervention that involved either physical exercise immediately before cognitive training (n = 25; 13 females), physical exercise immediately after cognitive training (n = 24; 11 females), physical exercise only (n = 27; 15 females), or cognitive training only (n = 21; 12 females). We hypothesized that cognition would benefit more from cognitive training when preceded as opposed to followed by physical exercise and that the relationship between exercise-induced increases in peripheral BDNF and cognitive training outcome would be greater when cognitive training is preceded by physical exercise. Greater increases of plasma BDNF were associated with greater cognitive training gains on trained task paradigms, but only when such increases preceded cognitive training (ß = 0.14, 95% CI [0.04, 0.25]). Average cognitive training outcome did not differ depending on intervention order (ß = 0.05, 95% CI [-0.10, 0.20]). The study provides the first empirical support for a time-critical but advantageous role for post-exercise increases in peripheral BDNF for learning at an interindividual level in older adults, with implications for future multidomain lifestyle interventions.

Foreign language learning in older age does not improve memory or intelligence: Evidence from a randomized controlled study.

Foreign language learning in older age has been proposed as a promising avenue for combatting age-related cognitive decline. We tested this hypothesis in a randomized controlled study in a sample of 160 healthy older participants (aged 65-75 years) who were randomized to 11 weeks of either language learning or relaxation training. Participants in the language learning condition obtained some basic knowledge in the new language (Italian), but between-groups differences in improvements on latent factors of verbal intelligence, spatial intelligence, working memory, item memory, or associative memory were negligible. We argue that this is not due to either poor measurement, low course intensity, or low statistical power, but that basic studies in foreign languages in older age are likely to have no or trivially small effects on cognitive abilities. We place this in the context of the cognitive training and engagement literature and conclude that while foreign language learning may expand the behavioral repertoire, it does little to improve cognitive processing abilities. (PsycINFO Database Record (c) 2020 APA, all rights reserved).

Criterion validity of the Ekblom-Bak and the Åstrand submaximal test in an elderly population.

PURPOSE: The aim of this study was to validate the submaximal Ekblom-Bak test (EB-test) and the Åstrand test (Å-test) for an elderly population. METHODS: Participants (n = 104), aged 65-75 years, completed a submaximal aerobic test on a cycle ergometer followed by an individually adjusted indirect calorimetry VO2max test on a treadmill. The HR from the submaximal test was used to estimate VO2max using both the EB-test and Å-test equations. RESULTS: The correlation between measured and estimated VO2max using the EB method and Å method in women was r = 0.64 and r = 0.58, respectively and in men r = 0.44 and r = 0.44, respectively. In women, the mean difference between estimated and measured VO2max was - 0.02 L min-1 (95% CI - 0.08 to 0.04) for the EB method and - 0.12 L min-1 (95% CI - 0.22 to - 0.02) for the Å method. Corresponding values for men were 0.05 L min-1 (95% CI - 0.04 to 0.14) and - 0.28 L min-1 (95% CI - 0.42 to - 0.14), respectively. However, the EB method was found to overestimate VO2max in men with low fitness and the Å method was found to underestimate VO2max in both women and men. For women, the coefficient of variance was 11.1%, when using the EB method and 19.8% when using the Å method. Corresponding values for men were 11.6% and 18.9%, respectively. CONCLUSION: The submaximal EB-test is valid for estimating VO2max in elderly women, but not in all elderly men. The Å-test is not valid for estimating VO2max in the elderly.

No evidence for any effect of multiple sessions of frontal transcranial direct stimulation on mood in healthy older adults.

The dorsolateral prefrontal cortex (DLPFC) is part of a network important for emotional regulation and the possibility of modulating activity in this region with transcranial direct current stimulation (TDCS) to change mood has gained great interest, particularly for application in clinical populations. Whilst results in major depressive disorder have been promising, less is known about the effects of TDCS on mood in non-clinical populations. We hypothesized that multiple sessions of anodal TDCS applied over the left DLPFC would enhance mood, primarily as measured by the Profile of Mood States questionnaire, in healthy older adults. In addition, in an exploratory analysis, we examined the potentially moderating role of working memory training. Working memory, just like emotional regulation, taxes the DLPFC, which suggests that engaging in a working memory task whilst receiving TDCS may have a different effect on activity in this region and consequently mood. A total of 123 participants between 65 and 75 years of age were randomly assigned to receive either 20 sessions of TDCS, with or without working memory training, or 20 sessions sham stimulation, with or without working memory training. We found no support for enhancement of mood due to TDCS in healthy older adults, with or without cognitive training and conclude that the TDCS protocol used is unlikely to improve mood in non-depressed older individuals.

The importance of the ventromedial prefrontal cortex for associative memory in older adults: A latent structural equation analysis.

Older adults show relatively minor age-related decline in memory for single items, while their memory for associations is markedly reduced. Inter-individual differences in memory function in older adults are substantial but the neurobiological underpinnings of such differences are not well understood. In particular, the relative importance of inter-individual differences in the medio-temporal lobe (MTL) and the lateral prefrontal cortex (PFC) for associative and item recognition in older adults is still ambiguous. We therefore aimed to first establish the distinction between inter-individual differences in associative memory (recollection-based) performance and item memory (familiarity-based) performance in older adults and subsequently link these two constructs to differences in cortical thickness in the MTL and lateral PFC regions, in a latent structural equation modelling framework. To this end, a sample of 160 older adults (65-75 years old) performed three intentional item-associative memory tasks, of which a subsample (n â€‹= â€‹72) additionally had cortical thickness measures in MTL and PFC regions of interest available. The results provided support for a distinction between familiarity-based item memory and recollection-based associative memory performance in older adults. Cortical thickness in the ventro-medial prefrontal cortex was positively correlated with associative recognition performance, above and beyond any relationship between item recognition performance and cortical thickness in the same region and between associative recognition performance and brain structure in the MTL (parahippocampus). The findings highlight the relative importance of the ventromedial prefrontal cortex in allowing for intentional recollection-based associative memory functioning in older adults.

Education Does Not Affect Cognitive Decline in Aging: A Bayesian Assessment of the Association Between Education and Change in Cognitive Performance.

Education is positively associated with level of cognitive function but the association between education and rate of cognitive decline remains unresolved, partly for methodological reasons. In this article, we address this issue using linear mixed models and Bayesian hypothesis testing, using data from the Betula cohort-sequential longitudinal study. Our results support the null hypothesis that education does not alter the rate of cognitive decline for visuospatial ability, semantic knowledge, and episodic memory. We propose that education is only a relevant variable for understanding cognitive performance in older age because of the association between performance and education that is formed in early development.

Naming is not explaining: future directions for the "cognitive reserve" and "brain maintenance" theories.

Contemporary imaging measures of the human brain explain less than half of the differences in cognitive functioning and change among older adults. Researchers have advanced several theories and concepts to guide research that aims to better explain these individual differences in cognitive aging. Taking the fundamental measurement model in the empirical sciences as a starting point, we here scrutinize two such complementary theories, brain maintenance and cognitive reserve, in an attempt to clarify these theories, gauge their usefulness, and identify ways in which they can be further developed. We demonstrate that, although both theories are highly useful for spawning theorizing and empirical work, they can be further developed by detailing the theoretical and operational definitions of the concepts that they propose. We propose a few ways forward in these directions.

Working Memory and Reasoning Benefit from Different Modes of Large-scale Brain Dynamics in Healthy Older Adults.

Researchers have proposed that solving complex reasoning problems, a key indicator of fluid intelligence, involves the same cognitive processes as solving working memory tasks. This proposal is supported by an overlap of the functional brain activations associated with the two types of tasks and by high correlations between interindividual differences in performance. We replicated these findings in 53 older participants but also showed that solving reasoning and working memory problems benefits from different configurations of the functional connectome and that this dissimilarity increases with a higher difficulty load. Specifically, superior performance in a typical working memory paradigm ( n-back) was associated with upregulation of modularity (increased between-network segregation), whereas performance in the reasoning task was associated with effective downregulation of modularity. We also showed that working memory training promotes task-invariant increases in modularity. Because superior reasoning performance is associated with downregulation of modular dynamics, training may thus have fostered an inefficient way of solving the reasoning tasks. This could help explain why working memory training does little to promote complex reasoning performance. The study concludes that complex reasoning abilities cannot be reduced to working memory and suggests the need to reconsider the feasibility of using working memory training interventions to attempt to achieve effects that transfer to broader cognition.

Direct-Current Stimulation Does Little to Improve the Outcome of Working Memory Training in Older Adults.

The promise of transcranial direct-current stimulation (tDCS) as a modulator of cognition has appealed to researchers, media, and the general public. Researchers have suggested that tDCS may increase effects of cognitive training. In this study of 123 older adults, we examined the interactive effects of 20 sessions of anodal tDCS over the left prefrontal cortex (vs. sham tDCS) and simultaneous working memory training (vs. control training) on change in cognitive abilities. Stimulation did not modulate gains from pre- to posttest on latent factors of either trained or untrained tasks in a statistically significant manner. A supporting meta-analysis ( n = 266), including younger as well as older individuals, showed that, when combined with training, tDCS was not much more effective than sham tDCS at changing working memory performance ( g = 0.07, 95% confidence interval, or CI = [-0.21, 0.34]) and global cognition performance ( g = -0.01, 95% CI = [-0.29, 0.26]) assessed in the absence of stimulation. These results question the general usefulness of current tDCS protocols for enhancing the effects of cognitive training on cognitive ability.

How does intentionality of encoding affect memory for episodic information?

Episodic memory enables the detailed and vivid recall of past events, including target and wider contextual information. In this paper, we investigated whether/how encoding intentionality affects the retention of target and contextual episodic information from a novel experience. Healthy adults performed (1) a What-Where-When (WWW) episodic memory task involving the hiding and delayed recall of a number of items (what) in different locations (where) in temporally distinct sessions (when) and (2) unexpected tests probing memory for wider contextual information from the WWW task. Critically, some participants were informed that memory for WWW information would be subsequently probed (intentional group), while this came as a surprise for others (incidental group). The probing of contextual information came as a surprise for all participants. Participants also performed several measures of episodic and nonepisodic cognition from which common episodic and nonepisodic factors were extracted. Memory for target (WWW) and contextual information was superior in the intentional group compared with the incidental group. Memory for target and contextual information was unrelated to factors of nonepisodic cognition, irrespective of encoding intentionality. In addition, memory for target information was unrelated to factors of episodic cognition. However, memory for wider contextual information was related to some factors of episodic cognition, and these relationships differed between the intentional and incidental groups. Our results lead us to propose the hypothesis that intentional encoding of episodic information increases the coherence of the representation of the context in which the episode took place. This hypothesis remains to be tested.

No Significant Effect of Prefrontal tDCS on Working Memory Performance in Older Adults.

Transcranial direct current stimulation (tDCS) has been put forward as a non-pharmacological alternative for alleviating cognitive decline in old age. Although results have shown some promise, little is known about the optimal stimulation parameters for modulation in the cognitive domain. In this study, the effects of tDCS over the dorsolateral prefrontal cortex (dlPFC) on working memory performance were investigated in thirty older adults. An N-back task assessed working memory before, during and after anodal tDCS at a current strength of 1 mA and 2 mA, in addition to sham stimulation. The study used a single-blind, cross-over design. The results revealed no significant effect of tDCS on accuracy or response times during or after stimulation, for any of the current strengths. These results suggest that a single session of tDCS over the dlPFC is unlikely to improve working memory, as assessed by an N-back task, in old age.

Lessons from a pilot and feasibility randomised trial in depression (Blood pressure Rapid Intensive Lowering And Normal Treatment for Mood and cognition in persistent depression (BRILiANT mood study)).

BACKGROUND: The blood pressure rapid intensive lowering and normal treatment for mood and cognition in persistent depression (BRILiANT mood study) was devised as a pilot study to investigate the feasibility and safety of intensive blood pressure lowering as treatment for persistent mood and cognitive symptoms in older adults with major depressive disorder and to assess the availability of this population for recruitment. In addition, the relationship between reduced blood pressure and the change in cerebral blood flow and mood was to be investigated. METHODS: A single centre pilot randomised controlled trial (RCT), with two parallel groups of intensive or normal treatment for hypertension, recruiting from primary and secondary care and newspaper advert, with an aim of recruiting 66 participants, was observed in this study. At the end of the recruitment period, in order to explore the reasons for failure to recruit to target, surveys were developed and issued to those involved in recruitment. RESULTS: Recruitment rates were lower than expected which led to the study being expanded to further areas and opened to self-referral via advertisement. However, because of better management of hypertension due to changes in the UK Quality and Outcomes Framework guidelines for blood pressure treatment, few eligible patients were identified and the study closed at the end of the recruitment period, with 13 participants consenting, but 12 failing screening resulting in one recruited participant. CONCLUSIONS: Overall, the BRILiANT mood study was found not to be feasible, and results suggest that the expected patient population no longer exists. To overcome such recruitment difficulties, a prompt commencement of a study after funding so no relevant care changes occur might help prevent similar problems in future studies. In addition, self-referral, in this case via advertisement in papers, may be a useful tool to increase response rate. When recruiting in primary care, direct access to primary care databases, in a secure and anonymised way, may enable more effective screening. Ultimately, the BRILiANT mood study was shown not to be feasible; this was a useful conclusion from this pilot study. TRIAL REGISTRATION: ISRCTN 64524251; UKCRN Portfolio No: 13284.