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Effects of prenatal individualized mixed management on breastfeeding and maternal health at three days postpartum: A randomized controlled trial.
Zhao, Y, Lin, Q, Wang, J, Bao, J
Early human development. 2020;:104944
Abstract
BACKGROUND Pregnant women with antenatal depression are more prone to postpartum depression and failure in breastfeeding than women without antenatal depression. The purpose of this study was to evaluate the effectiveness of a prenatal individualized mixed management intervention on breastfeeding and maternal physical and psychological status at three days postpartum. METHODS This randomized single-blind controlled trial was conducted from December 2017 to August 2018 with 182 primiparous women in Shanghai, China. Participants with Edinburgh Postnatal Depression Scale (EPDS) scores ≥9 were randomly allocated to the intervention group (n = 91) or control group (n = 91). The intervention group underwent a 4-session individualized mixed management intervention and the control group received usual care. Feeding patterns, Breastfeeding Self-Efficacy Scale (BSES), Infant Breastfeeding Assessment Scale (IBAS), and EPDS were used to measure the main outcomes. Two-tailed p-values of p < .05 were considered statistically significant. RESULTS The intervention group had significantly more effective breastfeeding behavior, better breastfeeding self-efficacy, more successful breastfeeding initiation, lower EPDS scores, more sleep time, and better appetite than the control group. CONCLUSION The prenatal individualized mixed management intervention demonstrated significant short-term improvement in breastfeeding and maternal physical and psychological health at three days postpartum. TRIAL REGISTRATION ChiCTR-IOR-17013761; December 7, 2017.
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Effectiveness of Chinese herbal medicine granules and traditional Chinese medicine-based psychotherapy for perimenopausal depression in Chinese women: a randomized controlled trial.
Cao, XJ, Huang, XC, Wang, X
Menopause (New York, N.Y.). 2019;(10):1193-1203
Abstract
OBJECTIVE The aim of the study was to assess the effectiveness of Chinese herbal medicine combined with traditional Chinese medicine (TCM)-based psychotherapy (TBP) on perimenopausal depression (PMD). METHODS This multicenter, randomized, placebo-controlled clinical trial was conducted in nine hospitals in China between August 2015 and June 2017. The study included 307 women with PMD who were divided randomly into two treatment groups: the Bushen Tiaogan formula (BSTG) plus TBP (n = 156) and placebo plus TBP (n = 151). All participants underwent treatment for 8 weeks and were followed up for 4 weeks. The primary outcome measures included scores of the Greene Climacteric Scale (GCS), Self-Rating Depression Scale (SDS), and Self-Rating Anxiety Scale (SAS). Secondary outcomes included serum levels of sex hormones and lipids, as well as adverse events. RESULTS The average GCS, SDS, and SAS scores after treatment were significantly lower in the BSTG-plus-TBP group than those in the placebo-plus-TBP group, and the differences were greatest at the end of the 12th week: the average GCS scores were 10.8 in the BSTG-plus-TBP group versus 18.5 in the placebo-plus-TBP group (P < 0.001); the average SDS scores were 30.7 in the BSTG-plus-TBP group versus 45.4 in the placebo-plus-TBP group (P < 0.001); the SAS scores were 28.6 in the BSTG-plus-TBP group versus 42.6 in the placebo-plus-TBP group (P < 0.001). In addition, treatments with BSTG plus TBP significantly reduced the levels of basal follicle-stimulating hormone (P = 0.045) and triglycerides (P = 0.039) and increased the level of high-density lipoprotein cholesterol (P < 0.001) compared to placebo treatments with TBP. No serious adverse events occurred, and the safety indices of complete blood counts, renal function, and liver function were within normal ranges, before and after treatments. CONCLUSIONS Treatment with BSTG formula plus TBP was more effective than TBP alone for improving PMD symptoms, sexual hormone levels, and blood lipid conditions in women with mild PMD.
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Assessment of Alimentación Normal con Ajuste de Insulina (ANAIS), a Spanish version of the DAFNE programme, in people with Type 1 diabetes: a randomized controlled parallel trial.
Sánchez-Hernández, RM, Alvarado-Martel, D, López-Plasencia, Y, Carrillo-Domínguez, A, Jiménez-Rodríguez, A, Rodríguez-Cordero, J, Vera-Elzo, T, Santana Del Pino, Á, Nóvoa-Mogollón, FJ, Wägner, AM
Diabetic medicine : a journal of the British Diabetic Association. 2019;(8):1037-1045
Abstract
AIM: To evaluate the effects of Alimentación Normal con Ajuste de Insulina (ANAIS), a group-based, therapeutic education programme for Type 1 diabetes based on a flexible insulin regimen adjusted to the individual's food intake. METHODS Participants with Type 1 diabetes and HbA1c levels of 53-86 mmol/mol (7-10%) were recruited from outpatient clinics at a tertiary care centre. They were randomized (using opaque, sealed envelopes, with a 2:1 treatment allocation ratio) to attend the training course immediately (immediate ANAIS; intervention group) or a year later (delayed ANAIS; control group). The main outcome was HbA1c level at 1 year. Secondary outcomes included lipid levels, weight, hypoglycaemic events, insulin dose, treatment satisfaction, self-perceived dietary freedom, quality of life and participant-defined goals. RESULTS A total of 48 participants were assigned to the intervention group and 32 to the control group. Twelve months after completing the training, adjusted HbA1c was not significantly different in the intervention group [64 ± 1.3 vs 68 ± 1.6 mmol/mol (8.0 ±0.1% vs 8.4 ±0.1%); P=0.081]. Treatment satisfaction was significantly higher in the intervention group, but no differences were found in hypoglycaemic events, weight, insulin dose or changes in dietary freedom. At 1 year after the intervention, 72% of the participants (vs 33% in the control group; P=0.046) reported exceeding their expectations regarding achievement of their main personal goal. CONCLUSION Promoting dietary freedom and empowering people with Type 1 diabetes through structured education programmes, such as ANAIS, improves treatment satisfaction and self-defined goals. No significant improvement in HbA1c level was achieved.
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Omega-3 polyunsaturated fatty acids and psychological intervention for workers with mild to moderate depression: A double-blind randomized controlled trial.
Tayama, J, Ogawa, S, Nakaya, N, Sone, T, Hamaguchi, T, Takeoka, A, Hamazaki, K, Okamura, H, Yajima, J, Kobayashi, M, et al
Journal of affective disorders. 2019;:364-370
Abstract
BACKGROUND This study assessed whether a combined intervention of omega-3 polyunsaturated fatty acids (PUFAs) and psychoeducation better improved mild to moderate depression in workers compared to psychoeducation alone. METHODS This study was a double-blinded, parallel group, randomized controlled trial that compared the intervention group, receiving omega-3 fatty acids, with a control group, receiving a placebo supplement. Participants receiving omega-3 fatty acids took 15 × 300 mg capsules per day for 12 weeks. The total daily dose of omega-3 PUFAs was 500 mg docosahexaenoic acid and 1000 mg eicosapentaenoic acid (EPA). The Beck Depression Inventory®-II (BDI-II) was used to assess the severity of depression after treatment. RESULTS After 12 weeks of treatment, BDI-II scores were significantly lower in the placebo and omega-3 group, when compared to their respective baseline scores (Placebo: t = - 4.6, p < 0.01; Omega-3: t = - 7.3, p < 0.01). However, after 12 weeks of treatment, we found no significant difference between both groups with respect to changes in the BDI-II scores (0.7; 95% CI, - 0.7 to 2.1; p = 0.30). LIMITATIONS This study did not measure blood omega-3 fatty acid concentration and presented a high-dropout rate. Moreover, our results may not be generalizable to other regions. CONCLUSIONS The results show that a combination of omega-3 fatty acids and psychoeducation and psychoeducation alone can contribute to an improvement in symptoms in people with mild to moderate depression. However, there is no difference between the interventions in ameliorating symptoms of depression.
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Protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies.
Mira, A, Díaz-García, A, Castilla, D, Campos, D, Romero, S, Bretón-López, J, García-Palacios, A, Baños, R, Botella, C
BMC psychiatry. 2019;(1):133
Abstract
BACKGROUND There are evidence-based interventions for depression that include different components. However, the efficacy of their therapeutic components is unknown. Another important issue related to depression interventions is that, up to now, their therapeutic components have only focused on reducing negative symptoms rather than on improving positive affect and well-being. Because the low levels of positive affect are more strongly linked to depression than to other emotional disorders, it is important to include this variable as an important treatment target. Positive psychotherapeutic strategies (PPs) could help in this issue. The results obtained so far are consistent and promising, showing that Internet-based interventions are effective in treating depression. However, most of them are also multi-component, and it is important to make progress in investigating what each component contributes to the intervention. METHODS The current study will be a three-armed, simple-blinded, randomized controlled clinical trial with a dismantling design. 192 participants will be randomly assigned to: a) an Internet-based Global Protocol condition, which includes traditional therapeutic components of evidence-based treatments for depression (Motivation for change, Psychoeducation, Cognitive Therapy, Behavioral Activation (BA), Relapse Prevention) and PPs component, offering strategies to enhance positive mood and promote psychological strengths; b) an Internet-based BA Protocol condition (without the PPs component), and c) an Internet-based PPs Protocol condition (without the BA component). Primary outcome measures will be the BDI-II and PANAS. Secondary outcomes will include other variables such as depression, anxiety and stress, quality of life, resilience, and wellbeing related measures. Treatment acceptance and usability will also be measured. Participants will be assessed at pre-, post-treatment, 3-, 6- and 12- month follow- ups. The data will be analyzed based on the Intention-to-treat principle. Per protocol analyses will also be performed. DISCUSSION To the best of our knowledge, this is the first randomized dismantling intervention study for depression with the aim of exploring the contribution of a PPs component and the BA component in an Internet-based intervention. The three protocols are online interventions, helping to reach many people who need psychological treatments and otherwise would not have access to them. TRIAL REGISTRATION Clinicalstrials.gov as NCT03159715 . Registered 19 May 2017.
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Ageing as a mindset: a study protocol to rejuvenate older adults with a counterclockwise psychological intervention.
Pagnini, F, Cavalera, C, Volpato, E, Comazzi, B, Vailati Riboni, F, Valota, C, Bercovitz, K, Molinari, E, Banfi, P, Phillips, D, et al
BMJ open. 2019;(7):e030411
Abstract
INTRODUCTION Although ageing is generally perceived as a biologically determined process, the literature increasingly points to the importance of psychological factors in the ageing process, specifically age-related stereotypes or cognitive mindsets. Such stereotypes reflect self-perceptions and others' perceptions about the ageing process and can have a strong influence on health and life satisfaction, specifically through self-fulfilling prophecy mechanisms. This study aimed to investigate whether changes in mindsets can change the ageing process. METHODS AND ANALYSIS This study replicates in large part the original 1979 'Counterclockwise' experiment by Ellen Langer and will involve a group of older adults (aged 75+) taking part of a 1-week retreat outside of Milan, Italy. Participants will be instructed and helped to relive their younger selves, acting as if they are living in the year 1989. The week-long residential programme is designed to prime this perception by incorporating a completely retrofitted physical environment, as well as providing opportunities to engage in social activities that would have been common in the late 1980s. This 'counterclockwise' intervention will be tested as a randomised control trial comprised of the experimental ('counterclockwise') group, an active control group (same activities, no time manipulation) and a no-treatment group. Ninety participants will be randomly allocated to one of these three conditions. Every participant will be assessed for medical, cognitive, psychological and age appearance at four time points: at the time of recruitment, after the intervention (ie, after a week for the no-treatment group) and again after 6 and 12 months. ETHICS AND DISSEMINATION The study has been approved by the Ethics Committees of the Department of Psychology of Università Cattolica del Sacro Cuore and Don Gnocchi Foundation. Results will be disseminated through peer-reviewed journals, scientific meetings and direct presentation to the general population. TRIAL REGISTRATION NUMBER NCT03552042; Pre-results.
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An online growth mindset intervention in a sample of rural adolescent girls.
Burnette, JL, Russell, MV, Hoyt, CL, Orvidas, K, Widman, L
The British journal of educational psychology. 2018;(3):428-445
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Abstract
BACKGROUND Students living in rural areas of the United States exhibit lower levels of educational attainment than their suburban counterparts. Innovative interventions are needed to close this educational achievement gap. AIMS We investigated whether an online growth mindset intervention could be leveraged to promote academic outcomes. SAMPLE We tested the mindset intervention in a sample of 222 10th-grade adolescent girls (M age = 15.2; 38% White, 25% Black, 29% Hispanic) from four rural, low-income high schools in the Southeastern United States. METHODS We conducted a randomized controlled trial to test the efficacy of the growth mindset intervention, relative to a sexual health programme. We used random sampling and allocation procedures to assign girls to either the mindset intervention (n = 115) or an attention-matched control programme (n = 107). We assessed participants at pre-test, immediate post-test, and 4-month follow-up. RESULTS Relative to the control condition, students assigned to the mindset intervention reported stronger growth mindsets at immediate post-test and 4-month follow-up. Although the intervention did not have a total effect on academic attitudes or grades, it indirectly increased motivation to learn, learning efficacy and grades via the shifts in growth mindsets. CONCLUSIONS Results indicate that this intervention is a promising method to encourage growth mindsets in rural adolescent girls.
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Using dolls for therapeutic purposes: A study on nursing home residents with severe dementia.
Cantarella, A, Borella, E, Faggian, S, Navuzzi, A, De Beni, R
International journal of geriatric psychiatry. 2018;(7):915-925
Abstract
OBJECTIVES Among the psychosocial interventions intended to reduce the behavioral and psychological symptoms of dementia (BPSD), doll therapy (DT) is increasingly used in clinical practice. Few studies on DT have been based on empirical data obtained with an adequate procedure; however, none have assessed its efficacy using an active control group, and the scales used to assess changes in BPSD are usually unreliable. The aim of the present study was to measure the impact of DT on people with severe dementia with a reliable, commonly used scale for assessing their BPSD, and the related distress in formal caregivers. Effects of DT on the former's everyday abilities (ie, eating behavior) were also examined. METHOD Twenty-nine nursing home residents aged from 76 to 96 years old, with severe dementia (Alzheimer's or vascular dementia), took part in the experiment. They were randomly assigned to an experimental group that used dolls or an active control group that used hand warmers with sensory characteristics equivalent to the dolls. Benefits of DT on BPSD and related formal caregiver distress were examined with the Neuropsychiatric Inventory. The effects of DT on eating behavior were examined with the Eating Behavior Scale. RESULTS Only the DT group showed a reduction in BPSD scores and related caregiver distress. DT did not benefit eating behavior, however. CONCLUSIONS This study suggests that DT is a promising approach for reducing BPSD in people with dementia, supporting evidence emerging from previous anecdotal studies.
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Excess weight gain prevention in adolescents: Three-year outcome following a randomized controlled trial.
Tanofsky-Kraff, M, Shomaker, LB, Wilfley, DE, Young, JF, Sbrocco, T, Stephens, M, Brady, SM, Galescu, O, Demidowich, A, Olsen, CH, et al
Journal of consulting and clinical psychology. 2017;(3):218-227
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OBJECTIVE Interpersonal psychotherapy (IPT) prevents weight gain in adults with obesity and binge-eating-disorder, and is especially effective among those with increased psychosocial problems. However, IPT was not superior to health education (HE) to prevent excess weight gain at 1-year follow-up in 113 adolescent girls at high-risk for excess weight gain because of loss-of-control eating and high body mass index (BMI; kg/m2; Tanofsky-Kraff et al., 2014). METHOD Participants from the original trial were recontacted 3 years later for assessment. At baseline, adolescent- and parent-reported social-adjustment problems and trait anxiety were evaluated. At baseline and follow-ups, BMIz and adiposity by dual-energy x-ray absorptiometry were obtained. RESULTS Nearly 60% were reassessed at 3 years, with no group differences in participation (ps ≥ .70). Consistent with 1 year, there was no main effect of group on change in BMIz/adiposity (ps ≥ .18). In exploratory analyses, baseline social-adjustment problems and trait-anxiety moderated outcome (ps < .01). Among girls with high self-reported baseline social-adjustment problems or anxiety, IPT, compared to HE, was associated with the steepest declines in BMIz (p < .001). For adiposity, girls with high or low anxiety in HE and girls with low anxiety in IPT experienced gains (ps ≤ .03), while girls in IPT with high anxiety stabilized. Parent-reports yielded complementary findings. CONCLUSION In obesity-prone adolescent girls, IPT was not superior to HE in preventing excess weight gain at 3 years. Consistent with theory, exploratory analyses suggested that IPT was associated with improvements in BMIz over 3 years among youth with high social-adjustment problems or trait anxiety. Future studies should test the efficacy of IPT for obesity prevention among at-risk girls with social-adjustment problems and/or anxiety. (PsycINFO Database Record
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Fostering Self-Compassion and Loving-Kindness in Patients With Borderline Personality Disorder: A Randomized Pilot Study.
Feliu-Soler, A, Pascual, JC, Elices, M, Martín-Blanco, A, Carmona, C, Cebolla, A, Simón, V, Soler, J
Clinical psychology & psychotherapy. 2017;(1):278-286
Abstract
UNLABELLED The aim of this randomized pilot study is to investigate the effects of a short training programme in loving-kindness and compassion meditation (LKM/CM) in patients with borderline personality disorder. Patients were allocated to LKM/CM or mindfulness continuation training (control group). Patients in the LKM/CM group showed greater changes in Acceptance compared with the control group. Remarkable changes in borderline symptomatology, self-criticism and self-kindness were also observed in the LKM/CM group. Mechanistic explanations and therapeutic implications of the findings are discussed. HIGHLIGHTS Three weeks of loving-kindness and compassion meditations increased acceptance of the present-moment experience in patients with borderline personality disorder. Significant improvements in the severity of borderline symptoms, self-criticism, mindfulness, acceptance and self-kindness were observed after the LKM/CM intervention. LKM/CM is a promising complementary strategy for inclusion in mindfulness-based interventions and Dialectical Behavioural Therapy for treating core symptoms in borderline personality disorder. Copyright © 2016 John Wiley & Sons, Ltd.