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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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Current and Future Treatments in Alzheimer's Disease.
Atri, A
Seminars in neurology. 2019;(2):227-240
Abstract
The foundation of current Alzheimer's disease (AD) treatment involves pharmacological and nonpharmacological management and care planning predicated on patient-centered psychoeducation, shared goal-setting, and decision-making forged by a strong triadic relationship between clinician and the patient-caregiver dyad. Food and Drug Administration (FDA) approved AD medications, cholinesterase-inhibitors (ChEIs), and the N-methyl-d-aspartate (NMDA) antagonist memantine, when utilized as part of a comprehensive care plan, while generally considered symptomatic medications, can provide modest "disease course-modifying" effects by enhancing cognition, and reducing loss of independence. When combined, pharmacologic and nonpharmacologic treatments can meaningfully mitigate symptoms and reduce clinical progression and care burden. AD pharmacotherapy first involves identification and elimination of potentially harmful medications and supplements. First line treatment for neuropsychiatric symptoms and problem behaviors is nonpharmacological and involves psychoeducation, trigger identification, and implementation, iterative evaluation, and adjustment of behavioral and environmental interventions. Intensive research efforts are underway to develop more accurate and practical AD diagnostic biomarkers and clinical tools and better therapeutics. Ongoing research studies for primary and secondary prevention of AD and clinical trials evaluating symptomatic and disease-modifying treatments in symptomatic AD are directed at diverse therapeutic targets including neurochemicals, amyloid and tau pathological processes, mitochondria, inflammatory pathways, neuroglia, and multimodal lifestyle interventions.
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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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Psychological therapies for chronic widespread pain and fibromyalgia syndrome.
Häuser, W, Jones, G
Best practice & research. Clinical rheumatology. 2019;(3):101416
Abstract
Psychological factors such as adverse childhood experiences, traumatic life events, interpersonal conflicts and psychological distress play an important role in the predisposition, onset and severity of chronic widespread pain (CWP) and fibromyalgia syndrome (FMS). Therefore, psychological therapies might have the potential to reduce disability as well as symptom and economic burden in patients with CWP and FMS. Recent interdisciplinary guidelines have suggested different strengths of recommendation for psychological therapies for FMS. The aims of this narrative review are to summarise: • Mechanisms of actions. • Evidence on efficacy, tolerability and safety. • Knowledge gaps and needs for future research of psychological therapies for CWP and FMS for non-mental health professionals.
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[Implicit Self-Regulation of Food-Intake: Consequences for Psychotherapy].
Paslakis, G, de Zwaan, M
Psychotherapie, Psychosomatik, medizinische Psychologie. 2019;(11):453-461
Abstract
Explicit processes of self-regulation require insight and control during implementation and are therefore often experienced as being strenuous, while implicit processes of steering behavior are automatic, rapid and effortless. However, self-regulation is not always either explicit or implicit; all variants ranging from those that are entirely automatic to those being entirely under control are present. As individuals are not aware of their underlying implicit modes of self-regulation, it is necessary to create an approach that is proximal to affective processing, by-passing the cognitive, verbal level. Promising approaches of this kind are such including embodied experiences or such shifting the body to a state, in which the apperception of implicit mechanisms is facilitated. Given that therapeutic work of self-regulation is in many cases carried out on an explicit level of processing, the need for novel, neurobiologically founded strategies intervening on the implicit (pre-verbal) level are called for. Correspondent paradigms, e. g. the approach-avoidance task (AAT) for the assessment of implicit processes are presented here with regard to food-intake regulation. This work is a narrative (qualitative) review aiming at illustrating the field of implicit bias research as well as the development of new implicit bias training paradigms to be used as add-on in future psychotherapeutic treatments. Therefore, a selection of relevant studies based on subjective criteria was made. Thus, this work is not a systematic review and does not claim to be an exhaustive description of studies of this kind.
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Psychedelic-Assisted Group Therapy: A Systematic Review.
Trope, A, Anderson, BT, Hooker, AR, Glick, G, Stauffer, C, Woolley, JD
Journal of psychoactive drugs. 2019;(2):174-188
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Abstract
Contemporary research with classic psychedelic drugs (e.g., lysergic acid diethylamide (LSD) and psilocybin) is indebted to the twentieth-century researchers and clinicians who generated valuable clinical knowledge of these substances through experimentation. Several recent reviews that highlight the contributions of this early literature have focused on psychedelic-assisted individual psychotherapy modalities. None have attempted to systematically identify and compile experimental studies of psychedelic-assisted group therapy. In therapeutic settings, psychedelics were often used to enhance group therapy for a variety of populations and clinical indications. We report on the results of a systematic review of the published literature in English and Spanish on psychedelic-assisted group therapies. Publications are characterized by their clinical approach, experimental method, and clinical outcomes. Given the renewed interest in the clinical use of psychedelic medicines, this review aims to stimulate hypotheses to be tested in future research on psychedelic-assisted psychotherapy, group process, and interpersonal functioning.
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Pharmacological and non-pharmacological treatments for irritable bowel syndrome: Protocol for a systematic review and network meta-analysis.
Zhou, S, Liu, X, Wang, X, Xi, F, Luo, X, Yao, L, Tang, H
Medicine. 2019;(30):e16446
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Abstract
BACKGROUND The global prevalence of Irritable bowel syndrome (IBS) is estimated to be as high as 15% and a number of different non-pharmacological and pharmacological treatments have been used to manage IBS in clinical practice, which poses great challenges for clinicians to make appropriate decisions. Hence, a systematic review and network meta-analysis on all available pharmacological and non-pharmacological treatments for IBS is needed to provide reliable evidence. METHODS We will search the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane IBD Group Specialized Trials Register, MEDLINE, EMBASE, and Chinese Biomedical medicine (CBM) from inception to 31, May 2019. Randomized controlled trials of pharmacological and nonpharmacological interventions for IBS will be included. Study quality will be assessed on the basis of the methodology and categories described in the Cochrane Collaboration Handbook. Primary outcomes are global or clinical improvement and quality of life. A Bayesian network meta-analysis would be performed, and relative ranking of agents would be assessed. A node splitting method will be used to examine the inconsistency between direct and indirect comparisons when a loop connecting 3 arms exists. RESULTS Researchers will rank the effectiveness and safety of the potentials interventions for IBS according the characteristics of patients by conducting an advanced network meta-analysis based on Bayesian statistical model, and interpret the results by using GRADE approach. CONCLUSION The conclusion of our study will provide updated evidence to rank the effectiveness and safety of pharmacological and non-pharmacological interventions for IBS. ETHICS AND DISSEMINATION Ethical approval is not applicable since this study is a network meta-analysis based on published trials. PROTOCOL REGISTRATION NUMBER CRD42018083844.
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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.