A Randomized Depression Prevention Trial Comparing Interpersonal Psychotherapy—Adolescent Skills Training to Group Counseling in Schools

Given the rise in depression disorders in adolescence, it is important to develop and study depression prevention programs for this age group. The current study examined the efficacy of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), a group prevention program for adolescent depression, in comparison to group programs that are typically delivered in school settings. In this indicated prevention trial, 186 adolescents with elevated depression symptoms were randomized to receive IPT-AST delivered by research staff or group counseling (GC) delivered by school counselors. Hierarchical linear modeling examined differences in rates of change in depressive symptoms and overall functioning from baseline to the 6-month follow-up assessment. Cox regression compared rates of depression diagnoses. Adolescents in IPT-AST showed significantly greater improvements in self-reported depressive symptoms and evaluator-rated overall functioning than GC adolescents from baseline to the 6-month follow-up. However, there were no significant differences between the two conditions in onset of depression diagnoses. Although both intervention conditions demonstrated significant improvements in depressive symptoms and overall functioning, results indicate that IPT-AST has modest benefits over groups run by school counselors which were matched on frequency and duration of sessions. In particular, IPT-AST outperformed GC in reduction of depressive symptoms and improvements in overall functioning. These findings point to the clinical utility of this depression prevention program, at least in the short-term. Additional follow-up is needed to determine the long-term effects of IPT-AST, relative to GC, particularly in preventing depression onset.     

Effects of Combined Physical and Cognitive Exercises on Cognition and Mobility in Patients With Mild Cognitive Impairment: A Randomized Clinical Trial

Importance

Although participation in physical and cognitive activities is encouraged to reduce the risk of dementia, the preventive efficacy of these activities for patients with mild cognitive impairment is unestablished.

Home-Based Activity Program for Older People With Depressive Symptoms: DeLLITE–A Randomized Controlled Trial

PURPOSE We wanted to assess the effectiveness of a home-based physical activity program, the Depression in Late Life Intervention Trial of Exercise (DeLLITE), in improving function, quality of life, and mood in older people with depressive symptoms.METHODS We undertook a randomized controlled trial involving 193 people aged 75 years and older with depressive symptoms at enrollment who were recruited from primary health care practices in Auckland, New Zealand. Participants received either an individualized physical activity program or social visits to control for the contact time of the activity intervention delivered over 6 months. Primary outcome measures were function, a short physical performance battery comprising balance and mobility, and the Nottingham Extended Activities of Daily Living scale. Secondary outcome measures were quality of life, the Medical Outcomes Study 36-item short form, mood, Geriatric Depression Scale (GDS-15), physical activity, Auckland Heart Study Physical Activity Questionnaire, and self-report of falls. Repeated measures analyses tested the differential impact on outcomes over 12 months’ follow-up.RESULTS The mean age of the participants was 81 years, and 59% were women. All participants scored in the at–risk category on the depression screen, 53% had a Diagnostic and Statistical Manual of Mental Disorders or International Classification of Diseases, Tenth Revision diagnosis of major depression or scored more than 4 on the GDS-15 at baseline, indicating moderate or severe depression. Almost all participants, 187 (97%), completed the trial. Overall there were no differences in the impact of the 2 interventions on outcomes. Mood and mental health related quality of life improved for both groups.CONCLUSION The DeLLITE activity program improved mood and quality of life for older people with depressive symptoms as much as the effect of social visits. Future social and activity interventions should be tested against a true usual care control.     

Health Messaging and African–American Infant Sleep Location: A Randomized Controlled Trial

Infant-parent bedsharing increases the risk of SIDS and other sleep-related deaths. Despite AAP recommendations to avoid bedsharing, public health efforts have been unsuccessful in changing behaviors. African–American infants are more than twice as likely to die from SIDS and other sleep-related deaths, and are also twice as likely to bedshare with their parents. Further, African–American parents have a high degree of self-efficacy with regards to preventing infant suffocation, but low self-efficacy with regards to SIDS risk reduction. It is unclear whether messages emphasizing suffocation prevention will decrease bedsharing. To evaluate the impact of specific health messages on African–American parental decisions regarding infant sleep location. We conducted a randomized, controlled trial of African–American mothers of infants. The control group received standard messaging emphasizing AAP-recommended safe sleep practices, including avoidance of bedsharing, for the purposes of SIDS risk reduction. The intervention group received enhanced messaging emphasizing safe sleep practices, including avoidance of bedsharing, for both SIDS risk reduction and suffocation prevention. Participants completed interviews at 2–3 weeks, 2–3 months, and 5–6 months after the infant’s birth. 1194 mothers were enrolled in the study, and 637 completed all interviews. Bedsharing, both usually (aOR 1.005 [95 % CI 1.003, 1.006]) and last night (aOR 1.004 [95 % CI 1.002, 1.007]) increased slightly but statistically significantly with infant age (p < 0.001). Receipt of the enhanced message did not impact on sleep location. Maternal belief that bedsharing increased the risk of SIDS or suffocation declined over 6 months (p < 0.001) and did not differ by group assignment. African–American mothers who received an enhanced message about SIDS risk reduction and suffocation prevention were no less likely to bedshare with their infants. Clinical Trials Registration: Clinical Trials.gov identifier NCT01361880     

Effect of Protein Supplementation on Physical Performance in Older People With Sarcopenia–A Randomized Controlled Trial

ObjectivesTo test the long-term effects of whey-enriched protein supplementation on muscle and physical performance.DesignA 12-month randomized controlled double blind trial with a 43-month of post-trial follow-up.SettingPorvoo, Finland.ParticipantsA total of 218 older (>74 years of age) community-dwelling people with sarcopenia.Intervention(1) Control with no supplementation; (2) isocaloric placebo; and (3) 20 g × 2 whey-enriched protein supplementation. All participants were given instructions on home-based exercise, dietary protein, and vitamin D supplementation of 20 μg/d.MeasurementsPhysical performance was assessed by short physical performance battery and continuous summary physical performance scores. Hand grip strength and calf intracellular resistance based skeletal muscle index were measured by bioimpedance spectroscopy. The measurements were performed at 0, 6, and 12 months. The post-trial follow-up was performed by a postal questionnaire and national census record data.ResultsThe participants were older (75-96 years of age) and mostly women (68%). The test supplements had no significant effects on physical performance; the 12-month changes for short physical performance battery were −0.55, −.05, and 0.03 points in control, isocaloric, and protein groups (P = .17), respectively. The changes in continuous summary physical performance scores were similar between the intervention groups (P = .76). The hand grip strength decreased significantly in all intervention groups, and the 12-month changes in calf intracellular resistance-based skeletal muscle index were minor and there were no differences between the intervention groups. One-half of the patients (56%) in both supplement groups reported mild gastrointestinal adverse effects. Differences were found neither in the all-cause mortality nor physical functioning in the post-trial follow-up.ConclusionsThe whey-enriched protein supplementation in combination with low intensity home-based physical exercise did not attenuate the deterioration of muscle and physical performance in community-dwelling older people with sarcopenia.     

The Impact of Written Emotional Disclosure on Cancer Caregivers’ Perceptions of Burden,Stress, and Depression: A Randomized Controlled Trial

Spousal cancer caregivers’ emotional and relational health can become compromised over time due to ongoing challenges related to the cancer experience. This warrants a call for the assessment of interventions aimed at improving aspects of caregiver well-being. The current study employed a randomized controlled trial to determine whether emotional disclosure via the use of expressive writing improved spousal cancer caregivers’ perceived caregiver burden, stress, and depression. Participants (N = 64) were assigned to one of the two disclosure conditions: expressive disclosure or benefit finding—or to a time-management control condition. Participants completed three at-home writing sessions at one-week intervals. Results indicated that written forms of emotional disclosure might improve burden, stress, and depression contingent on writing condition. Specifically, both forms of emotional disclosure outperformed the control condition in reducing caregivers’ depression. The control condition outperformed treatments in reducing caregiver stress. Finally, posttest caregiver burden was significantly lower than pretest burden across all writing conditions.

This trial was registered with clinicaltrials.gov, ID: NCT02339870     

The Study of Mental and Resistance Training (SMART) Study—Resistance Training and/or Cognitive Training in Mild Cognitive Impairment: A Randomized,Double-Blind,Double-Sham Controlled Trial

BackgroundMild cognitive impairment (MCI) increases dementia risk with no pharmacologic treatment available.MethodsThe Study of Mental and Resistance Training was a randomized, double-blind, double-sham controlled trial of adults with MCI. Participants were randomized to 2 supervised interventions: active or sham physical training (high intensity progressive resistance training vs seated calisthenics) plus active or sham cognitive training (computerized, multidomain cognitive training vs watching videos/quizzes), 2–3 days/week for 6 months with 18-month follow-up. Primary outcomes were global cognitive function (Alzheimer's Disease Assessment Scale-cognitive subscale; ADAS-Cog) and functional independence (Bayer Activities of Daily Living). Secondary outcomes included executive function, memory, and speed/attention tests, and cognitive domain scores.ResultsOne hundred adults with MCI [70.1 (6.7) years; 68% women] were enrolled and analyzed. Resistance training significantly improved the primary outcome ADAS-Cog; [relative effect size (95% confidence interval) −0.33 (−0.73, 0.06); P < .05] at 6 months and executive function (Wechsler Adult Intelligence Scale Matrices; P = .016) across 18 months. Normal ADAS-Cog scores occurred in 48% (24/49) after resistance training vs 27% (14/51) without resistance training [P < .03; odds ratio (95% confidence interval) 3.50 (1.18, 10.48)]. Cognitive training only attenuated decline in Memory Domain at 6 months (P < .02). Resistance training 18-month benefit was 74% higher (P = .02) for Executive Domain compared with combined training [z-score change = 0.42 (0.22, 0.63) resistance training vs 0.11 (−0.60, 0.28) combined] and 48% higher (P < .04) for Global Domain [z-score change = .0.45 (0.29, 0.61) resistance training vs 0.23 (0.10, 0.36) combined].ConclusionsResistance training significantly improved global cognitive function, with maintenance of executive and global benefits over 18 months.     

Early and Intensive Dietary Counseling in Lung Cancer Patients Receiving (Chemo)Radiotherapy—A Pilot Randomized Controlled Trial

Malnutrition is prevalent in patients undergoing (chemo)radiotherapy (RT) for lung cancer. This pilot study tested the feasibility and acceptability of delivering an intensive nutrition intervention for lung cancer patients receiving RT. Twenty-four patients with lung cancer were randomized to receive the intervention which employed a care pathway to guide intensive dietary counseling from pretreatment until 6-wk posttreatment or usual care. Nutritional, fatigue, and functional outcomes were assessed using valid and reliable questionnaires before randomization, at the start and end of RT and 1- and 3-mo post-RT. Consent rate was 57% with an overall attrition of 37%. Subject compliance with the completion of study questionnaires was 100%. A clinically important mean difference indicated greater overall satisfaction with nutritional care in the intervention group (5.00, interquartile range [IQR] 4.50–5.00; 4.00, IQR 4.00–4.00). Clinically important differences favoring the intervention were observed for weight (3.0 kg; 95% confidence interval [CI] ?0.8, 6.8), fat-free mass (0.6 kg; 95% CI ?2.1, 3.3), physical well-being (2.1; 95% CI ?2.3, 6.5), and functional well-being (5.1; 95% CI 1.6, 8.6), but all 95% CIs were wide and most included zero. Recruitment feasibility and acceptability of the intervention were demonstrated, which suggest larger trials using an intensive nutrition intervention would be achievable.     

Influence of Shared Decision Making on Decisional Conflict and Regret in Postpartum Mother–Infant Care: A Randomized Controlled Trial

ObjectivesAlthough postpartum rooming-in is encouraged by the World Health Organization, independent separated nursery care is still widely adopted in Eastern countries. Our aim is to evaluate the effect of shared decision making (SDM) assisted by patient decision aids on subjective decisional conflict and regret among women who are required to make choices regarding postpartum infant care.MethodsA total of 196 pregnant women who came for routine checkups 1 month before delivery were randomly assigned to the SDM group or the classic group. Before the mothers were discharged after delivery, their decision-making difficulties were evaluated. The primary outcome was the decisional conflict, which was assessed using the SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) scale. The secondary outcome was the decisional regret, which was measured using the Decision Regret scale.ResultsCompared with the classic group, SDM group had surer feelings about the choice (P＜.001), felt more confident about knowing the benefits and risks of each option (P＜.001), had a clearer understanding of the benefits and risks (P＜.001), and felt sufficiently supported with enough advice to make a suitable choice (P＜.001). No significant difference was noted in the Decision Regret scores between groups. The choice of 24-hour rooming-in, 12-hour rooming-in, and separated nursery care was not significantly different between groups.ConclusionsSDM reduced the decisional conflict and uncertainty of the mothers. Available choices of postpartum mother–infant care should be provided to mothers through SDM that includes individual values, health goals, and clear knowledge and transparency.     

Does Resistance Training Improve the Functional Capacity and Well Being of Very Young Anorexic Patients? A Randomized Controlled Trial

PurposeWe determined the effects of a 3-month low–moderate-intensity strength training program (2 sessions/week) on functional capacity, muscular strength, body composition, and quality of life (QOL) in 22 young (12–16 yrs) anorexic outpatients.MethodsPatients were randomly assigned to a training or control group (n = 11 [10 females] each). Training sessions were of low intensity (loads for large muscle groups ranging between 20%–30% and 50%–60% of six repetitions maximum [6RM] at the end of the program). We measured functional capacity by the time up and go and the timed up and down stairs tests. Muscular strength was assessed by 6RM measures for seated bench and leg presses. We estimated percent body fat and muscle mass. We assessed patients' QOL with the Short Form-36 items.ResultsThe intervention was well tolerated and did not have any deleterious effect on patients' health, and did not induce significant losses in their body mass. The only studied variable for which a significant interaction (group × time) effect was found (p = .009) was the 6RM seated lateral row test.ConclusionsLow–moderate-intensity strength training does not seem to add major benefits to conventional psychotherapy and refeeding treatments in young anorexic patients.     

Effects of Elastic Resistance Training on Functional Performance and Myokines in Older Women—A Randomized Controlled Trial

ObjectivesTo investigate the short- and long-term effects of elastic resistance training (ERT) on physical performance, inflammatory markers, and myokines in older women living in a nursing home.DesignA randomized controlled trial, with 12 weeks of ERT intervention.Setting and participantsNursing home. Twenty female nursing home residents (mean age = 84 ± 8 years) were randomized into 2 groups: the training group (n = 11), and the control group (n = 9).MeasuresMuscle mass was estimated with bioelectrical impedance, and the functional test Short Physical Performance Battery (SPPB) was performed, whereas handgrip strength and plasma concentration of myokines and inflammatory markers were measured before and after the intervention period. Additional blood samples were also taken after the fourth ERT session. A mixed model (group × time) analysis of variance was applied to determine the effect on primary and secondary outcomes.ResultsAfter 1 exercise session, the training group showed a significant increase in brain-derived neurotrophic factor (BDNF) (P = .04) and a decrease in interleukin (IL)-8 (P = .01) plasma concentration. After 12 weeks of intervention, the results showed a significant group × time effects for the SPPB total score (P < .01), as well as gait speed (P = .04), chair rise (P < .01), and BDNF concentration (P = .02). However, there were no significant interactions for grip strength, IL-15, IL-8, resistin, glucose, and C-reactive protein (P ≥ .06).Conclusions/ImplicationsThe present study emphasizes the clinical impact of moderate-intensity ERT on mobility and functional performance in older women. The results indicate that an increase in exercise-induced peripheral BDNF may have a protective role in the preservation of muscular function in older women. Incorporating ERT into nursing homes could be a feasible preventive strategy to counteract functional deterioration.     

The Effects of Supplementation with a Vitamin and Mineral Complex with Guaraná Prior to Fasted Exercise on Affect,Exertion, Cognitive Performance,and Substrate Metabolism: A Randomized Controlled Trial

Exercise undertaken in a fasted state can lead to higher post-exercise mental fatigue. The administration of a vitamin and mineral complex with guaraná (MVM + G) has been shown to attenuate mental fatigue and improve performance during cognitively demanding tasks. This placebo-controlled, double-blind, randomized, balanced cross-over study examined the effect of MVM + G consumed prior to morning exercise on cognitive performance, affect, exertion, and substrate metabolism. Forty active males (age 21.4 ± 3.0 year; body mass index (BMI) 24.0 ± 2.4 kg/m²; maximal oxygen consumption (V̇O_2max) 57.6 ± 7.3 mL/min/kg) completed two main trials, consuming either MVM + G or placebo prior to a 30-min run at 60% V̇O_2max. Supplementation prior to exercise led to a small but significant reduction in Rating of Perceived Exertion (RPE) during exercise compared to the placebo. The MVM + G combination also led to significantly increased accuracy of numeric working memory and increased speed of picture recognition, compared to the placebo. There were no significant effects of supplementation on any other cognitive or mood measures or on substrate metabolism during exercise. These findings demonstrate that consuming a vitamin and mineral complex containing guaraná, prior to exercise, can positively impact subsequent memory performance and reduce perceived exertion during a moderate-intensity run in active males.     

Effects of ω-3 Fatty Acids and Catechins on Fatty Acid Synthase in the Prostate: A Randomized Controlled Trial

Animal and human studies suggest fish oil and green tea may have protective effect on prostate cancer. Fatty acid synthase (FAS) has been hypothesized to be linked to chemoprotective effects of both compounds. This study evaluated the independent and joint effects of fish oil (FO) and green tea supplement (epigallocatechin-3-gallate, EGCG) on FAS and Ki-67 levels in prostate tissue. Through a double-blinded, randomized controlled trial with 2 × 2 factorial design, 89 men scheduled for repeat prostate biopsy following an initial negative prostate biopsy were randomized into either FO alone (1.9 g DHA + EPA/day), EGCG alone (600 mg/day), a combination of FO and EGCG, or placebo. We used linear mixed-effects models to test the differences of prostate tissue FAS and Ki-67 by immunohistochemistry between pre- and post-intervention within each group, as well as between treatment groups. Results did not show significant difference among treatment groups in pre-to-post-intervention changes of FAS (P = 0.69) or Ki-67 (P = 0.26). Comparing placebo group with any of the treatment groups, we did not find significant difference in FAS or Ki-67 changes (all P > 0.05). Results indicate FO or EGCG supplementation for a short duration may not be sufficient to produce biologically meaningful changes in FAS or Ki-67 levels in prostate tissue.     

Effects of the Caregiver Interaction Profile Training on Caregiver–Child Interactions in Dutch Child Care Centers: A Randomized Controlled Trial

Background

Previous studies underscore the need to improve caregiver–child interactions in early child care centers.

Objective

In this study we used a randomized controlled trial to examine whether a 5-week video feedback training can improve six key interactive skills of caregivers in early child care centers: Sensitive responsiveness, respect for autonomy, structuring and limit setting, verbal communication, developmental stimulation, and fostering positive peer interactions.

Method

A total of 139 caregivers from 68 early child care groups for 0- to 4-year-old children in Dutch child care centers participated in this RCT, 69 in the intervention condition and 70 in the control condition. Caregiver interactive skills during everyday interactions with the children were rated from videotape using the Caregiver Interaction Profile (CIP) scales at pretest, posttest, and follow-up 3 months after the posttest.

Results

Results at posttest indicate a significant positive training effect on all six caregiver interactive skills. Effect sizes of the CIP training range between d = 0.35 and d = 0.79. Three months after the posttest, caregivers in the intervention group still scored significantly higher on sensitive responsiveness, respect for autonomy, verbal communication, and fostering positive peer interactions than caregivers in the control group with effect sizes ranging between d = 0.47 and d = 0.70.

Conclusions

This study shows that the quality of caregiver–child interactions can be improved for all six important caregiver skills, with a relatively short training program. Possible ways to further improve the training and to implement it in practice and education are discussed.

     

Non-Diagnosis Decisions and Non-Treatment Decisions in Elderly Patients With Cardiovascular Diseases,Do They Differ? – A Systematic Review

The growth in the number of possible medical interventions in the past decennia necessitates physicians to consider whether to use them. Contrary to decisions to withhold treatment, little is known about "non-diagnosis decisions" (NDD) although their consequences seem to be more uncertain. Hence, we hypothesized that "determinants" and "reasons" for NDD are different from those that are associated with non-treatment decisions (NTD). We performed a systematic review on research on physicians' decisions to withhold or withdraw diagnostic or therapeutic interventions. A total of 11,773 unique citations published either in Medline, Embase, or the Cochrane databases were screened, of which 45 articles, -including 4 articles describing NDD in elderly patients suspected of cardiovascular diseases, were considered relevant and analysed in detail. "Determinants" and "reasons" for NDD and NTD were extracted, categorized into predefined categories, and compared with each other. Besides several similarities, we found various differences between NDD and NTD. The proportionality of an intervention (ie, the risk or burden of an intervention opposed to that of no intervention) was associated with NTD but not with NDD. Physician and care institution related characteristics, such as age of the physician or the employment of physician extenders, were more frequently associated with NDD than with NTD. Furthermore, the presence of non-resuscitate directives was correlated with NDD but not with NTD. This systematic review shows that there is little information on NDD in the current literature. Yet, there is not enough evidence to conclude whether NDD can be seen as a separate entity distinct from NTD. More research focusing on NDD seems needed.