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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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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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Effect of adapted interpersonal psychotherapy versus health education on mood and eating in the laboratory among adolescent girls with loss of control eating.
Tanofsky-Kraff, M, Crosby, RD, Vannucci, A, Kozlosky, M, Shomaker, LB, Brady, SM, Sbrocco, T, Pickworth, CK, Stephens, M, Young, JF, et al
The International journal of eating disorders. 2016;(5):490-8
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OBJECTIVE Interpersonal psychotherapy (IPT) is aimed at improving negative affect that is purported to contribute to the development and maintenance of loss-of-control (LOC) eating. Although youth who report LOC over eating tend to consume more snack-foods than those without LOC, it is unknown if IPT impacts objective energy intake. METHODS To test if IPT improves mood and eating in the laboratory, we examined a sample of 88 girls with LOC eating who were randomized to either IPT (n = 46) or a standard-of-care health education (HE) group program. At baseline, and 6-month (follow-up 1) and 1-year (follow-up 2) following the initiation of the groups, girls consumed lunch from a multi-item meal with an instruction designed to model a LOC episode. Girls also reported mood state immediately before each meal. RESULTS Girls in IPT experienced no significant changes in pre-meal state depressive affect, while girls in HE experienced a non-significant improvement by follow-up 1 and then returned to baseline by follow-up 2 (p < .04). We found no significant group difference for changes in total intake relative to girls' daily energy needs (p's ≥ .25). However, IPT reduced, while HE increased, the percentage of daily energy needs consumed from snack-foods by follow-up 2 (p = .04). Within-groups, HE increased their snack food intake from follow-up 1 to follow-up 2 (p = .01). CONCLUSIONS In adolescent girls with LOC, IPT did not change total intake at the test meal and was associated with reduced snack-food intake. Data are required to determine if IPT effectively prevents excess weight gain in the longer-term. © 2015 Wiley Periodicals, Inc. (Int J Eat Disord 2016; 49:490-498).
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Effect of Psychotherapy on Health Care Utilization in Children With Inflammatory Bowel Disease and Depression.
Keerthy, D, Youk, A, Srinath, AI, Malas, N, Bujoreanu, S, Bousvaros, A, Keljo, D, DeMaso, DR, Szigethy, EM
Journal of pediatric gastroenterology and nutrition. 2016;(6):658-664
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OBJECTIVES Pediatric patients with inflammatory bowel disease (IBD) are at an increased risk of developing depression compared with community controls. Depression often negatively influences illness behaviors such as resource utilization. We sought to investigate the effects of treating depression on utilization of medical resources in depressed pediatric patients with IBD by comparing rates of health care utilization 1 year before and after psychotherapy. METHOD Two hundred seventeen subjects ages 9 to 17 years with IBD and depression received 3 months of psychotherapy for depression as part of a multicenter randomized controlled trial. Of these 217 subjects, 70 had utilization data available 1 year prior and 1 year after receiving 3 months of psychotherapy. Primary outcomes included frequency of hospitalizations, inpatient hospital days, outpatient gastrointestinal visits, and number of emergency room visits, radiological examinations, and endoscopies. Within subject analyses were completed comparing health care utilization 12 months before psychotherapy compared with the 12 months after the conclusion of psychotherapy. RESULTS Fifty-one and 19 patients had CD and UC, respectively. A total of 55.7% of patients had major depression and 44.3% had minor depression. Overall, all study measures of health care utilization were significantly reduced after psychotherapy (P < 0.01)-including gastrointestinal-related (mean values) hospitalization frequency, inpatient days, outpatient visit, emergency room visits, radiological examinations, and endoscopies. CONCLUSIONS Psychotherapy for comorbid depression in pediatric patients with IBD is associated with decreased GI-related health care utilization. The present study highlights the importance of screening for depression in a pediatric population with IBD, and that psychotherapy may be a reasonable adjunctive treatment for pediatric patients with IBD and comorbid depression.
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Efficacy of low-intensity psychological intervention applied by ICTs for the treatment of depression in primary care: a controlled trial.
Castro, A, García-Palacios, A, García-Campayo, J, Mayoral, F, Botella, C, García-Herrera, JM, Pérez-Yus, MC, Vives, M, Baños, RM, Roca, M, et al
BMC psychiatry. 2015;:106
Abstract
BACKGROUND Depression is one of the most common disorders in Psychiatric and Primary Care settings and is associated with significant disability and economic costs. Low-intensity psychological interventions applied by Information and Communication Technologies (ICTs) could be an efficacious and cost-effective therapeutic option for the treatment of depression. The aim of this study is to assess 3 low-intensity psychological interventions applied by ICTs (healthy lifestyle, positive affect and mindfulness) in Primary Care; significant efficacy for depression treatment has previously showed in specialized clinical settings by those interventions, but ICTs were not used. METHOD Multicenter controlled randomized clinical trial in 4 parallel groups. Interventions have been designed and on-line device adaptation has been carried out. Subsequently, the randomized controlled clinical trial will be conducted. A sample of N = 240 mild and moderate depressed patients will be recruited and assessed in Primary Care settings. Patients will be randomly assigned to a) healthy lifestyle psychoeducational program + improved primary care usual treatment (ITAU), b) focused program on positive affect promotion + ITAU c) mindfulness + ITAU or d) ITAU. The intervention format will be one face to face session and four ICTs on-line modules. Patients will be diagnosed with MINI psychiatric interview. Main outcome will be PHQ-9 score. They will be also assessed by SF-12 Health Survey, Client Service Receipt Inventory, EuroQoL-5D questionnaire, Positive and Negative Affect Scale, Five Facet Mindfulness Questionnaire and the Pemberton Happiness Index. Patients will be assessed at baseline, post, 6 and 12 post-treatment months. An intention to treat and per protocol analysis will be performed. DISCUSSION Low-intensity psychological interventions applied by Information and Communication Technologies have been not used before in Spain and could be an efficacious and cost-effective therapeutic option for depression treatment. The strength of the study is that it is the first multicenter controlled randomized clinical trial of three low intensity and self-guided interventions applied by ICTs (healthy lifestyle psychoeducational program; focused program on positive affect promotion and brief intervention based on mindfulness) in Primary Care settings. TRIAL REGISTRATION Current Controlled Trials ISRCTN82388279 . Registered 16 April 2014.
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Effectiveness of a transdiagnostic internet-based protocol for the treatment of emotional disorders versus treatment as usual in specialized care: study protocol for a randomized controlled trial.
González-Robles, A, García-Palacios, A, Baños, R, Riera, A, Llorca, G, Traver, F, Haro, G, Palop, V, Lera, G, Romeu, JE, et al
Trials. 2015;:488
Abstract
BACKGROUND Emotional disorders (depression and anxiety disorders) are highly prevalent mental health problems. Although evidence showing the effectiveness of disorder-specific treatments exists, high comorbidity rates among emotional disorders limit the utility of these protocols. This has led some researchers to focus their interest on transdiagnostic interventions, a treatment perspective that might be more widely effective across these disorders. Also, the current way of delivering treatments makes it difficult provide assistance to all of the population in need. The use of the Internet in the delivery of evidence-based treatments may help to disseminate treatments among the population. In this study, we aim to test the effectiveness of EmotionRegulation, a new transdiagnostic Internet-based protocol for unipolar mood disorders, five anxiety disorders (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder and anxiety disorder not otherwise specified), and obsessive-compulsive disorder in comparison to treatment as usual as provided in Spanish public specialized mental health care. We will also study its potential impact on basic temperament dimensions (neuroticism/behavioral inhibition and extraversion/behavioral activation). Expectations and opinions of patients about this protocol will also be studied. METHODS/DESIGN The study is a randomized controlled trial. 200 participants recruited in specialized care will be allocated to one of two treatment conditions: a) EmotionRegulation or b) treatment as usual. Primary outcome measures will be the BAI and the BDI-II. Secondary outcomes will include a specific measure of the principal disorder, and measures of neuroticism/behavioral inhibition and extraversion/behavioral activation. Patients will be assessed at baseline, post-treatment, and 3- and 12-month follow-ups. Intention to treat and per protocol analyses will be performed. DISCUSSION Although the effectiveness of face-to-face transdiagnostic protocols has been investigated in previous studies, the number of published transdiagnostic Internet-based programs is still quite low. To our knowledge, this is the first randomized controlled trial studying the effectiveness of a transdiagnostic Internet-based treatment for several emotional disorders in public specialized care. Combining both a transdiagnostic approach with an Internet-based therapy format may help to decrease the burden of mental disorders, reducing the difficulties associated with disorder-specific treatments and facilitating access to people in need of treatment. Strengths and limitations are discussed. TRIAL REGISTRATION ClinicalTrials.gov NCT02345668 . Registered 27 July 2015.
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Study Protocol for a randomized controlled trial of mentalization based therapy against specialist supportive clinical management in patients with both eating disorders and symptoms of borderline personality disorder.
Robinson, P, Barrett, B, Bateman, A, Hakeem, A, Hellier, J, Lemonsky, F, Rutterford, C, Schmidt, U, Fonagy, P
BMC psychiatry. 2014;:51
Abstract
BACKGROUND The NOURISHED study: Nice OUtcomes for Referrals with Impulsivity, Self Harm and Eating Disorders.Eating Disorders (ED) and Borderline Personality Disorder (BPD) are both difficult to treat and the combination presents particular challenges. Both are associated with vulnerability to loss of mentalization (awareness of one's own and others' emotional state). In BPD, Mentalization Based therapy (MBT) has been found effective in reducing symptoms. In this trial we investigate the effectiveness and cost-effectiveness of MBT adapted for Eating disorders (Mentalization Based Therapy for Eating Disorders (MBT-ED)) compared to a standard comparison treatment, Specialist Supportive Clinical Management (SSCM-ED) in patients with a combination of an Eating Disorder and either a diagnosis of BPD or a history of self-harm and impulsivity in the previous 12 months. METHODS/DESIGN We will complete a multi-site single-blind randomized controlled trial (RCT) of MBT-ED vs SSCM-ED. Participants will be recruited from three Eating Disorder Services and two Borderline Personality Disorder Services in London. Participants allocated to MBT-ED will receive one year of weekly group and individual therapy and participants allocated to SSCM-ED will receive 20 sessions of individual therapy over 1 year. In addition, participants in both groups will have access to up to 5 hours of dietetic advice. The primary outcome measure is the global score on the Eating Disorders Examination. Secondary outcome measures include total score on the Zanarini BPD scale, the Object Relations Inventory, the Depression Anxiety Stress Scales, quality of life and cost-effectiveness. Measures are taken at recruitment and at 6 month intervals up to 18 months. DISCUSSION This is the first Randomised Controlled Trial of MBT-ED in patients with eating disorders and symptoms of BPD and will provide evidence to inform therapy decisions in this group of patients. During MBT-ED mentalization is encouraged, while in SSCM-ED it is not overtly addressed. This study will help elucidate mechanisms of change in the two therapies and analysis of therapy and interview transcripts will provide qualitative information about the conduct of therapy and changes in mentalization and object relations. TRIAL REGISTRATION ISRCTN51304415.
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An exploratory randomized controlled study of a healthy living intervention in early intervention services for psychosis: the INTERvention to encourage ACTivity, improve diet, and reduce weight gain (INTERACT) study.
Lovell, K, Wearden, A, Bradshaw, T, Tomenson, B, Pedley, R, Davies, LM, Husain, N, Woodham, A, Escott, D, Swarbrick, CM, et al
The Journal of clinical psychiatry. 2014;(5):498-505
Abstract
BACKGROUND People with psychosis often experience weight gain, which places them at risk of cardiovascular disease, diabetes, and early death. OBJECTIVE To determine the uptake, adherence, and clinical effectiveness of a healthy living intervention designed to reduce weight gain. METHOD An exploratory randomized controlled trial, comparing the intervention with treatment as usual (TAU) in 2 early intervention services for psychosis in England. DSM-IV classification was the diagnostic criteria used to assign the psychiatric diagnoses. The primary outcome was change in body mass index (BMI) from baseline to 12-month follow-up. The study was conducted between February 2009 and October 2012. RESULTS 105 service users, with a BMI of ≥ 25 (≥ 24 in South Asians), were randomized to intervention (n = 54) or TAU (n = 51) after stratification by recent commencement of antipsychotic medication. Ninety-three service users (89%) were followed up at 12 months. Between-group difference in change in BMI was not significant (effect size = 0.11). The effect of the intervention was larger (effect size = 0.54, not significant) in 15 intervention (28%) and 10 TAU (20%) participants who were taking olanzapine or clozapine at randomization. CONCLUSIONS The healthy living intervention did not show a significant difference in BMI reduction compared to the TAU group. TRIAL REGISTRATION www.isrctn.org identifier: ISRCTN22581937.
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Using problem solving therapy to treat veterans with subsyndromal depression: a pilot study.
Kasckow, J, Klaus, J, Morse, J, Oslin, D, Luther, J, Fox, L, Reynolds, C, Haas, GL
International journal of geriatric psychiatry. 2014;(12):1255-61
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OBJECTIVE We conducted a pilot study comparing problem solving therapy for primary care (PST-PC) to a dietary education control condition in middle-aged and older veterans with symptoms of emotional distress and subsyndromal depression. METHODS This was a two-site study at the VA Pittsburgh Healthcare System and Philadelphia VA Medical Center. Participants included veterans >50 years of age referred from primary care clinics who were eligible if they obtained a pre-screen score >11 on the Centers for Epidemiologic Studies Depression (CES-D) scale. Exclusions were a DSM-IV Major Depressive Episode within the past year, active substance abuse/dependence within 1 month, current antidepressant therapy, and a Mini mental status exam score <24. Participants were randomized to receive one of two interventions--either PST-PC or an attention control condition consisting of dietary education (DIET)--each consisting of six to eight sessions within a 4-month period. RESULTS Of 45 individuals randomized, 23 (11 PST-PC and 12 DIET) completed treatment. Using regression models in completers that examined outcomes at end of treatment while controlling for baseline scores, there were significant differences between treatment groups in SF-36 mental health component scores but not in depressive symptoms (as assessed with either the 17-item Hamilton Rating Scale for Depression or the Beck Depression Inventory), social problem solving skills, or physical health status (SF-36 physical health component score). CONCLUSIONS These pilot study findings suggest that a six-to-eight session version of PST-PC may lead to improvements in mental health functioning in primary care veterans with subsyndromal depressive symptoms.