Trials Of Psychological Interventions Research Articles

Cognitive behavioral therapy program for cannabis use cessation in first-episode psychosis patients: study protocol for a randomized controlled trial.

BackgroundThe high rate of cannabis use among patients with first-episode psychosis (FEP), as well as the associated negative impact on illness course and treatment outcomes, underlines the need for effective interventions in these populations. However, to date, there have been few clinical treatment trials (of pharmacological or psychological interventions) that have specifically focused on addressing comorbid cannabis use among these patients. The aim of this paper is to describe the design of a study protocol for a randomized controlled trial in which the objective is to assess the efficacy of a specific cognitive behavioral therapy program for cannabis cessation in patients with FEP compared to standard treatment (psychoeducation).Methods/designThis is a single-blind randomized study with 1 year of follow-up. Patients are to be randomly assigned to one of two treatments: (1) specific cognitive behavioral therapy for cannabis cessation composed of 1-hour sessions once a week for 16 weeks, in addition to pharmacological treatment scheduled by the psychiatrist, or (2) a control group (psychoeducation + pharmacological treatment) following the same format as the experimental group. Participants in both groups will be evaluated at baseline (pre-treatment), at 16 weeks (post-treatment), and at 3 and 6 months and 1 year of follow-up. The primary outcome will be that patients in the experimental group will have greater cannabis cessation than patients in the control group at post-treatment. The secondary outcome will be that the experimental group will have better clinical and functional outcomes than the control group.DiscussionThis study provides the description of a clinical trial design based on specific cognitive behavioral therapy for cannabis cessation in FEP patients, aiming to improve clinical and functional outcome, as well as tackling the addictive disorder.Trial registrationNCT02319746 ClinicalTrials.gov Identifier. ClinicalTrials.gov Protocol and Results Registration System (PRS) Receipt Release Date: 15 December 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1507-x) contains supplementary material, which is available to authorized users.

Associations between personality disorder characteristics and treatment outcomes in people with co-occurring alcohol misuse and depression.

BackgroundPersonality disorders are highly comorbid with alcohol misuse and depressive symptomatology; however, few studies have investigated treatment outcomes in this population. The aim of this study was to examine relationships between baseline personality disorder cluster profiles and overall and treatment-related changes for those with co-occurring alcohol misuse and depression.MethodsSecondary analysis was conducted using a subset of data (N = 290) from two randomised controlled trials of psychological interventions for co-occurring alcohol misuse and depression, which did not specifically target personality disorders. Baseline dimensional personality disorder cluster scores were derived from the International Personality Disorder Examination Questionnaire (IPDEQ). Four treatment conditions were compared: a brief integrated intervention, followed by no further treatment, or nine further sessions of integrated-, alcohol-, or depression-focused treatment. Associations between IPDEQ scores and changes in alcohol use, depressive symptoms and functioning from baseline to the 6- and the 12-month follow-ups were of primary interest.ResultsPersonality disorder cluster scores moderately negatively impacted on overall change (primarily Cluster C), as well as treatment-related outcomes (primarily Cluster A), particularly changes in depressive symptoms and psychosocial functioning. Longer interventions appeared to be more effective in the longer-term (e.g., at 12-month follow-up), with integrated interventions relatively more effective than single-focused ones for individuals with higher personality disorder cluster scores.ConclusionsGreater attention needs to be paid to particular personality disorder clusters during the assessment and treatment of individuals with co-occurring alcohol misuse and depression. Integrated interventions, incorporating motivational interviewing and cognitive behaviour therapy, may provide a useful therapeutic framework. Integrated interventions also provide opportunities for adjunctive components focussing on other issues and coping strategies (e.g., to offset negative affective states), potentially tailored to the characteristics and needs of individual participants.

Psychological and Behavioral Interventions for Managing Insomnia Disorder: An Evidence Report for a Clinical Practice Guideline by the American College of Physicians

Psychological and behavioral interventions are frequently used for insomnia disorder. To assess benefits and harms of psychological and behavioral interventions for insomnia disorder in adults. Ovid MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and PsycINFO through September 2015, supplemented with hand-searching. Randomized, controlled trials of psychological or behavioral interventions that were published in English and enrolled adults with insomnia disorder lasting 4 or more weeks. Data extraction by single investigator confirmed by a second reviewer; dual investigator assessment of risk of bias; consensus determination of strength of evidence. Sixty trials with low to moderate risk of bias compared psychological and behavioral interventions with inactive controls or other psychological and behavioral interventions. Cognitive behavioral therapy for insomnia (CBT-I) improved posttreatment global and most sleep outcomes, often compared with information or waitlist controls (moderate-strength evidence). Use of CBT-I improved several sleep outcomes in older adults (low- to moderate-strength evidence). Multicomponent behavioral therapy improved several sleep outcomes in older adults (low- to moderate-strength evidence). Stimulus control improved 1 or 2 sleep outcomes (low-strength evidence). Evidence for other comparisons and for harms was insufficient to permit conclusions. A wide variety of comparisons limited the ability to pool data. Trials did not always report global outcomes and infrequently conducted remitter or responder analysis. Comparisons were often information or waitlist groups, and publication bias was possible. Use of CBT-I improves most outcomes compared with inactive controls. Multicomponent behavioral therapy and stimulus control may improve some sleep outcomes. Evidence on other outcomes, comparisons, and long-term efficacy were limited. Agency for Healthcare Research and Quality. ( CRD42014009908).

Dimensions of dependence and their influence on the outcome of cognitive behaviour therapy for health anxiety: randomized controlled trial.

The personality trait of dependence is common in health-seeking behaviour. We therefore examined its impact in a large randomized controlled trial of psychological treatment for health anxiety. To test whether dependent personality traits were positive or negative in determining the outcome of an adapted form of cognitive behaviour therapy for health anxiety (CBT-HA) over the course of 5 years and whether dependent personality dysfunction could be viewed dimensionally in a similar way to the new ICD-11 diagnostic system for general personality disorder. Dependent personality dysfunction was assessed using a self-rated questionnaire, the Dependent Personality Questionnaire, at baseline in a randomized controlled trial of 444 patients from medical clinics with pathological health anxiety treated with a modified form of CBT-HA or standard treatment in the medical clinics, with assessment on five occasions over 5 years. Dependent personality dysfunction was assessed using four severity groups. Patients with mild and moderate dependent personality disorder treated with CBT-HA showed the greatest reduction in health anxiety compared with standard care, and those with no dependent dysfunction showed the least benefit. Patients with higher dependent traits received significantly more treatment sessions (8.6) than those with low trait levels (5.4) (p < 0.01). The results suggest that patients treated with cognitive behaviour therapy for health anxiety respond better if they have moderate dependent personality. The reasons for this may be related to better adherence to psychological treatment and greater negative effects of frequent reassurance and excessive consultation in those treated in standard care. Copyright © 2016 John Wiley & Sons, Ltd.

Psychological and educational interventions for subfertile men and women.

Approximately one-fifth of all subfertile couples seeking fertility treatment show clinically relevant levels of anxiety, depression, or distress. Psychological and educational interventions are frequently offered to subfertile couples, but their effectiveness, both in improving mental health and pregnancy rates, is unclear. To assess the effectiveness of psychological and educational interventions for subfertile couples on psychological and fertility treatment outcomes. We searched (from inception to 2 April 2015) the Cochrane Gynaecology and Fertility Group Specialised Register of Controlled Trials, the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 2, 2015), MEDLINE, EMBASE, PsycINFO, EBSCO CINAHL, DARE, Web of Science, OpenGrey, LILACS, PubMed, and ongoing trials registers. We handsearched reference lists and contacted experts in the field. We included published and unpublished randomised controlled trials (RCTs), cluster randomised trials, and cross-over trials (first phase) evaluating the effectiveness of psychological and educational interventions on psychological and fertility treatment outcomes in subfertile couples. Two review authors independently assessed trial risk of bias and extracted data. We contacted study authors for additional information. Our primary outcomes were psychological measures (anxiety and depression) and fertility rates (live birth or ongoing pregnancy). We assessed the overall quality of the evidence using GRADE criteria.As we did not consider the included studies to be sufficiently similar to permit meaningful pooling, we summarised the results of the individual studies by presenting the median and interquartile range (IQR) of effects as well as the minimum and maximum values. We calculated standardised mean differences (SMDs) for continuous variables and odds ratios (ORs) for dichotomous outcomes. We included 39 studies involving 4925 participants undergoing assisted reproductive technology. Studies were heterogeneous with respect to a number of factors, including nature and duration of interventions, participants, and comparator groups. As a result, we judged that pooling results would not result in a clinically meaningful estimate of a treatment effect. There were substantial methodological weaknesses in the studies, all of which were judged to be at high risk of bias for one or more quality assessment domains. There was concern about attrition bias (24 studies), performance bias for psychological outcomes (27 studies) and fertility outcomes (18 studies), and detection bias for psychological outcomes (26 studies). We therefore considered study-specific estimates of intervention effects to be unreliable. Thirty-three studies reported the outcome mental health. Only two studies reported the outcome live birth, and both of these had substantial attrition. One study reported ongoing pregnancy, again with substantial attrition. We have combined live birth and ongoing pregnancy in one outcome. Psychological outcomesStudies utilised a variety of measures of anxiety and depression. In all cases a low score denoted benefit from the intervention.SMDs for anxiety were as follows: psychological interventions versus attentional control or usual care: median (IQR) = -0.30 (-0.84 to 0.00), minimum value -5.13; maximum value 0.84, 17 RCTs, 2042 participants; educational interventions versus attentional control or usual care: median = 0.03, minimum value -0.38; maximum value 0.23, 4 RCTs, 330 participants.SMDs for depression were as follows: psychological interventions versus attentional control or usual care: median (IQR) = -0.45 (-0.68 to -0.08), minimum value -3.01; maximum value 1.23, 12 RCTs, 1160 participants; educational interventions versus attentional control or usual care: median = -0.33, minimum value -0.46; maximum value 0.17, 3 RCTs, 304 participants. Fertility outcomesWhen psychological interventions were compared with attentional control or usual care, ORs for live birth or ongoing pregnancy ranged from minimum value 1.13 to maximum value 10.05. No studies of educational interventions reported this outcome. The effects of psychological and educational interventions on mental health including distress, and live birth or ongoing pregnancy rates is uncertain due to the very low quality of the evidence. Existing trials of psychological and educational interventions for subfertility were generally poorly designed and executed, resulting in very serious risk of bias and serious inconsistency in study findings. There is a need for studies employing appropriate methodological techniques to investigate the benefits of these treatments for this population. In particular, attentional control groups should be employed, that is groups receiving a treatment that mimics the amount of time and attention received by the treatment group but is not thought to have a specific effect upon the participants, in order to distinguish between therapeutic and non-specific effects of interventions. Where attrition cannot be minimised, appropriate statistical techniques for handling drop-out must be applied. Failure to address these issues in study design has resulted in studies that do not provide a valid basis for answering questions about the effectiveness of these interventions.

Exploratory randomized controlled trial of a group psychological intervention for postnatal depression in British mothers of South Asian origin

IntroductionThe rates of postnatal depression (PND) in British South Asian (BSA) women are higher than the general population. PND is known to cause disability and suffering in women and negative consequences for their infants and their family with huge costs to society. Due to linguistic and cultural barriers, BSA women do not access health care services.ObjectivesTo conduct an exploratory trial to test the feasibility and acceptability of a culturally adapted group Cognitive Behavioural Therapy (CBT) intervention (Positive Health Programme (PHP).AimWe aimed to determine if depressed BSA women receiving the PHP intervention will show significant improvements in terms of severity of depression, marital support, and social support as compared to the control group.MethodsWe used a two-arm pragmatic single-blind randomised controlled design. Women meeting the inclusion criteria were randomised either to the experimental group receiving PHP or treatment as usual (TAU) that is standard care usually provided by the GP.ResultsA total of 615 mothers were screened for participation in the trial, of these 137 were assessed further to determine eligibility. Eighty-three mothers were randomized to receive either PHP (n = 42) or treatment as usual (TAU) (n = 41). Mothers found the intervention to be acceptable and felt an overall positive change in their attitudes, behaviour and confidence level.ConclusionThe recruitment and retention figures (70%) highlight the ability of the research team to engage with the population. The findings suggest the acceptability of the culturally adapted PHP intervention for British South Asian women with postnatal depression.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Trends in Methodological Quality in Controlled Trials of Psychological and Social Interventions

Objective: There is substantial evidence that poorly designed and reported research can mislead decision making in clinical care. This review investigates the methodological quality of Swedish trials of a wide array of psychological and social interventions. Method: The review includes 302 articles published in peer-reviewed journals during 1990–2014, which evaluated a psychological or social intervention; included a randomized or nonrandomized control group with a pre–post- or pre-follow-up design; and targeted individuals in order to prevent or rehabilitate from physical, psychological, or social problems. The results are based on the information reported in the articles. Results: Overall, methodological quality increased with time. However, more recent studies contained methodological deficits. For example, few had used blinded data collectors, reported power analyses, or searched for adverse events. Conclusion: The results indicate a potential risk of biased results in both older and newer trials. Possible implications for practice and research are discussed.

Interventions to improve patients' compliance with therapies aimed at lowering glycated hemoglobin (HbA1c) in type 1 diabetes: systematic review and meta-analyses of randomized controlled clinical trials of psychological, telecare, and educational interventions.

BackgroundBrazilian records on glycemic control in patients with type 1 diabetes show treatment efficacy. Poor patient adherence to therapeutic proposals influences these results and can be associated with social, psychological, and economic aspects, besides others factors. The aim of this study was to evaluate the efficacy of psychological, telecare, and educational interventions to improve treatment compliance among patients with type 1 diabetes. Compliance was assessed indirectly using reduction of glycated hemoglobin (HbA1c) as the principal outcome measure.MethodsSystematic review and meta-analyses of randomized controlled clinical trials (RCTs) were performed using Medline, Embase, Cochrane and Scopus databases up to April 2015. The following medical subject headings were used: Diabetes Mellitus, Type 1, Patient Compliance or Adherence, Hemoglobin A, glycated, and Randomized Controlled Trial. The principal outcome was change in HbA1c between baseline and follow-up. Where appropriate, trials were combined in meta-analysis using fixed effects models.ResultsFrom 191 articles initially identified, 57 were full text reviewed, and 19 articles met the inclusion criteria providing data from 1782 patients (49.4 % males, age 18 years). The RCTs (2 to 24 months in duration) were divided into four groups according to type of intervention: psychology (seven studies; 818 patients), telecare (six studies; 494 patients); education (five studies; 349 patients), and psychoeducation (one study; 153 patients). All studies reported some type of adherence measurement of the interventions. Decrease in HbA1c was observed after psychology (MD −0.310; 95 % CI, −0.599 to −0.0210, P = 0.035) but not after telecare (MD −0.124 %; 95 % CI, −0.268, 0.020; P = 0.090) or educational (MD −0.001; 95 % CI, −0.202, 0.200; P = 0.990) interventions.ConclusionPsychological approaches to improve adherence to diabetes care treatment modestly reduced HbA1c in patients with type 1 diabetes; telecare and education interventions did not change glycemic control. However, the limited number of studies included as well as their methodological quality should be taken into account.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1207-6) contains supplementary material, which is available to authorized users.

Interventions for sexual dysfunction following treatments for cancer in women.

The proportion of people living with and surviving cancer is growing. This has led to increased awareness of the importance of quality of life, including sexual function, in those affected by cancer. Sexual dysfunction is a potential long-term complication of many cancer treatments. This includes treatments that have a direct impact on the pelvic area and genitals, and also treatments that have a more generalised (systemic) impact on sexual function.This is an update of the original Cochrane review published in Issue 4, 2007, on interventions for treating sexual dysfunction following treatments for cancer for men and women. Since publication in 2007, there has been an increase in the number of trials for both men and women and this current review critiques only those for women. A review in press will present those for men. To evaluate the effectiveness of interventions for treating sexual dysfunction in women following treatments for cancer. To assess adverse events associated with interventions. We searched the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 9), MEDLINE, EMBASE, PsycINFO, AMED, CINAHL, Dissertation Abstracts and the NHS Research Register. The searches were originally run in January 2007 and we updated these to September 2015. We included randomised controlled trials (RCTs) that assessed the effectiveness of a treatment for sexual dysfunction. The trial participants were women who had developed sexual dysfunction as a consequence of a cancer treatment. We sought evaluations of interventions that were pharmaceutical, mechanical, psychotherapeutic, complementary or that involved physical exercise. Two review authors independently extracted the data and assessed trial quality. We considered meta-analysis for trials with comparable key characteristics. Since the original version of this review we have identified 11 new studies in women. The one study identified in the earlier version of this review was excluded in this update as it did not meet our narrower inclusion criteria to include only interventions for the treatment, not prevention, of sexual dysfunction.In total 1509 female participants were randomised across 11 trials. All trials explored interventions following treatment either for gynaecological or breast cancer. Eight trials evaluated a psychotherapeutic or psycho-educational intervention. Two trials evaluated a pharmaceutical intervention and one pelvic floor exercises. All involved heterosexual women. Eight studies were at a high risk of bias as they involved a sample of fewer than 50 participants per trial arm. The trials varied not only in intervention content but in outcome measurements, thereby restricting combined analysis. In the trials evaluating a psychotherapeutic intervention the effect on sexual dysfunction was mixed; in three trials benefit was found for some measures of sexual function and in five trials no benefit was found. Evidence from the other three trials, two on different pharmaceutical applications and one on exercise, differed and was limited by small sample sizes. Only the trial of a pH-balanced vaginal gel found significant improvements in sexual function. The trials of pharmaceutical interventions measured harm: neither reported any. Only one psychological intervention trial reported that no harm occurred because of the intervention; the other trials of psychological support did not measure harm. Since the last version of this review, the new studies do not provide clear information on the impact of interventions for sexual dysfunction following treatments for cancer in women. The sexual dysfunction interventions in this review are not representative of the range that is available for women, or of the wider range of cancers in which treatments are known to increase the risk of sexual problems. Further evaluations are needed.

Psychological Treatment Trials for Hypoactive Sexual Desire Disorder: A Sexual Medicine Critique and Perspective.

Publications claim efficacy for treatment of hypoactive sexual desire disorder (HSDD) in women with cognitive behavior therapy (CBT) and mindfulness meditation training (MMT). However, no review has evaluated the evidence for these therapies from the rigorous perspective of sexual medicine. The aim of this study was to evaluate the published controlled trials of CBT and MMT for disorders of sexual desire from the perspective of sexual medicine standards of control paradigms, risk/benefit ratios, and clinical significance. MEDLINE was reviewed from the last 10 years. Evaluated study quality via 10 metrics and efficacy as mean change, and proportion of responders and remitters. Three controlled trials support CBT and two controlled trials support MMT. The reports of the trials each lacked several scientific requirements: a hierarchy of endpoints with a planned primary endpoint, sufficient information on the intervention to reproduce it, randomization, adequate control, accepted measures of benefits and harms, compliance data, and/or outcomes of clinical relevance. Psychological treatments for HSDD are not yet supported by adequate clinical trials. The current scientific and regulatory standards for drug treatment trials should also be applicable to psychological treatment trials.

Response and Rebuttal to Editorial Comment on “Psychological Treatment Trials for Hypoactive Sexual Desire Disorder: A Sexual Medicine Critique and Perspective”

Endpoints have been established by the Food and Drug Administration to demonstrate efficacy in medication treatments of female sexual dysfunction, and treatment must be statistically superior to placebo. All studies of hypoactive sexual desire disorder (HSDD) require partnered sexual activity; without a partner to approach the woman with HSDD, she would likely never participate in non-partnered sexual activity. Psychological treatments/psychotherapy cannot demonstrate efficacy when investigators fail to use a control paradigm that is equivalent to placebo, that is, the subject believes the control condition might be the study intervention. Although we might wish to believe that the combination of an approved medication for HSDD and psychotherapy would produce a better outcome than either intervention alone, no published studies have demonstrated such. If we can’t prove that psychotherapy alone is superior to an adequate control paradigm, we will not be able to prove the combination is effective. Study subjects, and patients for that matter, are not authorities on therapy and have few expectations about potential interventions. Supportive psychotherapy is not an effective treatment for major depressive disorder, a potentially comparable model for study design. Thus, supportive psychotherapy is a reasonable control vs. cognitive behavior therapy or mindfulness-based psychotherapy for HSDD as it would require a similar level/duration of investigator contact, and is easily provided, and while it gives the impression of real treatment, is ineffective for HSDD. A randomized, controlled trial is level 1 evidence to support a treatment; failure to use an adequate control is insufficient science, no matter how difficult or costly, and claims of effectiveness of psychotherapy vs. a waitlist control group must be met with skepticism.

Barriers to psychological care among primary caregivers of children undergoing hematopoietic stem cell transplantation.

This substudy of an intervention trial aimed to describe barriers to participation in psychological care among primary caregivers of children who were about to undergo a hematopoietic stem cell transplantation (HSCT), including demographic and medical correlates. Three hundred and twelve primary caregivers of children undergoing HSCT who were approached to participate in a psychological intervention trial (n = 218 enrollees and 94 decliners) completed a measure of barriers to psychological care. The most frequently endorsed barriers to care were focusing on the child as priority, not wanting to leave the child's bedside, and already having adequate psychosocial support. The least frequently endorsed barriers were location, wait times, and stigma around seeking psychological care. Results suggest that explaining how psychological care for a primary caregiver can positively affect their ill child may reduce barriers to seeking needed support services. Certain practical barriers to care may be irrelevant in inpatient settings where psychological support is offered.

The PROblem Gambling RESearch Study (PROGRESS) research protocol: a pragmatic randomised controlled trial of psychological interventions for problem gambling

IntroductionInternational prevalence rates for problem gambling are estimated at 2.3%. Problem gambling is a serious global public health concern due to adverse personal and social consequences. Previous research evaluating the...

The Role of Mobile Phone Technology in Understanding and Preventing Suicidal Behavior.

In this editorial, we discuss how mobile phone technology has the potential to move the field forward in terms of understanding suicide risk as well as laying foundations for the development of effective treatments/interventions. We have focused on mobile health technology given the rapid growth of mobile health approaches in suicide prevention (De Jaegere & Portzky, 2014; Mishara & Kerkhof, 2013) and psychological research more generally (Myin-Germeys et al., 2009; Nock, Prinstein, & Sterba, 2009; Palmier-Claus et al., 2011) and because mobile phone use is ubiquitous, with 75% of the world having access to a mobile phone (Kay, 2011). (aut. ref.)

Does It Matter Who Provides Psychological Interventions for Medically Unexplained Symptoms? A Meta-Analysis

Background: Patients with medically unexplained symptoms (MUS) are difficult to treat and cause high health-care costs. Psychological interventions might be a beneficial option for treating patients with MUS, but evidence is inconsistent. This meta-analysis compares the effectiveness of psychological interventions for MUS - delivered either by psychotherapists (PTs) or by general practitioners (GPs) - with that of usual care. Method: We conducted a systematic review and meta-analysis on randomised controlled trials of psychological interventions for MUS. Physical symptoms were the primary outcome, and physical functioning and psychological symptoms were the secondary outcomes. We pooled between-group effect sizes (ESs) after the treatment and at the follow-up in random-effects meta-regressions and stratified meta-analyses. We repeated these analyses with the intervention provider, intervention dose, MUS severity and methodological quality as predictors of relative intervention effects. Results: A total of 3,225 patients in 20 studies were analysed. After the treatment, small and significant ESs were found for all 3 outcome domains (ES range: 0.13-0.19, all p < 0.05). Psychological interventions were more beneficial for physical symptoms when delivered by PTs than by GPs (p = 0.02). There was no difference between PTs and GPs in terms of physical functioning and psychological symptoms. Conclusion: Psychological interventions are effective for patients with MUS, but the effects are small and most likely of short duration. Interventions that are delivered by PTs appear to have larger effects on unexplained physical symptoms than those delivered by GPs. Whether this superiority is due to a larger number of sessions of PT interventions remains unclear from our findings.

Psychological interventions for parents of children and adolescents with chronic illness.

Psychological interventions for parents of children and adolescents with chronic illness.

A randomized controlled trial of a 10 week group psychotherapeutic treatment added to standard medical treatment in patients with functional dyspepsia

ObjectiveEpidemiological evidence suggests an association between psychological factors and functional dyspepsia (FD). Yet few randomized controlled trials (RCTs) of psychological interventions have been conducted for FD. We conducted an RCT to evaluate the efficacy of psychotherapy among chronic FD. MethodsOne hundred fifty-eight consecutive patients with FD were randomized to medical therapy plus psychotherapy consisted in 8 group and 2 individual sessions focused on teaching techniques for coping with FD (intensive treatment (IT); n=76) or medical therapy alone (conventional treatment (CT); n=82). Patients completed validated self-reported questionnaires before and after the 10-week treatment and 6months later. Linear mixed-effects models were used, in intention-to-treat analysis. ResultsAt the end of treatment period, statistically significant improvements were observed for IT compared with CT for dyspepsia-related quality of life (DRQoL). DRQoL mean changes of 6.09 and 3.54 were obtained in IT and CT patients, respectively (p=<0.0001); and SS mean changes of 11.55 and 4.57 were obtained in IT and CT patients, respectively (p=0.0013). Those improvements, measured by minimum clinically important difference (MCID), were clinically significant (DRQoL: 77% of the IT patients exceeded the MCID vs the 45% of the CT; SS: 75% vs 48%). Six months after treatment, those statistically significant improvements persisted for DRQoL (p=0.0067) and for SS (p=0.0405). Clinical improvements persisted for SS (63% vs 41%). ConclusionsThese findings suggest that adding psychotherapy to standard medical therapy improves short-term outcomes in patients with FD and may have long-term effects as well. The cost-effectiveness of intensive therapy needs to be evaluated.Registration number and name of trial registry: NCT01802710

Efficacy and safety of pharmacological and psychological interventions for the treatment of psychosis and schizophrenia in children, adolescents and young adults: a systematic review and meta-analysis.

BackgroundStudies report contrasting results regarding the efficacy and safety of pharmacological, psychological, and combined interventions in psychosis and schizophrenia in children, adolescents and young adults.MethodsSystematic review and meta-analysis. Embase, Medline, PreMedline, PsycINFO, and CENTRAL were searched to July 2013 without restriction to publication status. Randomised trials comparing any pharmacological, psychological, or combined intervention for psychosis and schizophrenia in children, adolescents and young adults were included. Studies were assessed for bias, and GRADE criteria were used to describe the quality of the results.ResultsTwenty-seven trials including 3067 participants were identified. Meta-analyses were performed for 12 comparisons: symptoms, relapse, global state, psychosocial functioning, depression, weight and discontinuation. Low quality evidence demonstrated that antipsychotics have small beneficial effects on psychotic symptoms (SMD = -0.42, 95% CI -0.58 to -0.26), and a medium adverse effect on weight gain (WMD = 1.61, 95% CI 0.61 to 2.60) and discontinuation due to side effects (RR = 2.44, 95% CI, 1.12 to 5.31). There were no trials of psychological treatments in under-18 year olds. There was no evidence of an effect of psychological interventions on psychotic symptoms in an acute episode, or relapse rate, but low quality evidence of a large effect for family plus individual CBT on the number of days to relapse (WMD = 32.25, 95% CI -36.52 to -27.98).ConclusionsFor children, adolescents and young adults, the balance of risk and benefit of antipsychotics appears less favourable than in adults. Research is needed to establish the potential for psychological treatments, alone and in combination with antipsychotics, in this population.

Randomized trial of psychological interventions to preventing postpartum depression among Iranian first-time mothers

Background:The current study was conducted to examine the effect of cognitive behavior therapy on the reduction postpartum mood disorder and increasing the self-esteem of at-risk Iranian mothers.Methods:In this quasi-experimental study, 135 at-risk mothers were selected from the population by means of cluster sampling and randomly assigned into one of two groups: Intervention (n = 64), or control (n = 71). The control group received usual medical care, and the intervention group received an eight sessions’ cognitive behavior program during pregnancy. Assessments were administered at two time points (pretest at the beginning of the third trimester and posttest at 2 weeks postpartum). Beck anxiety, beck depression, Edinburgh postpartum depression, (PPD) Coopersmith self-esteem, and religious attitude questionnaire were used to collect data.Results:The mean age of participants was 25.8 ± 3.7 years. One-third of them had either bachelor or higher degrees in education (33%). About two-third of participants were unemployment with similar distribution in both the groups (intervention = 80%, control = 83%). The majority (70%) of the participants had cesarean section deliveries. There were no statistically significant differences respects to sociodemographic characteristics between the control and intervention groups (P > 0.05). The multivariate analysis of covariance results showed that the average scores of PPD were reduced significantly in the intervention group (P < 0.001). Also while the mean score of anxiety in the intervention group decreased from 23.31 (standard error [SE] =12.11) to 16.64 (SE = 8.33) and self-esteem increased from 29.09 (SE = 3.51) to 31.81 (SE = 2.76), no change was statistically significant in comparison to the control group.Conclusions:According to the findings of the present study, cognitive behavior intervention is effective in reducing PPD in at-risk mothers.

European clinical network: autism spectrum disorder assessments and patient characterisation.

The United Nations and World Health Organisation have identified autism spectrum disorder (ASD) as an important public health issue across global mental health services. Although a range of tools exist to identify and quantify ASD symptoms, there is a lack of information about which ASD measures are used in different services worldwide. This paper presents data from a large survey of measures used for patient characterisation in major ASD research and clinical centres across Europe collected between June 2013 and January 2014. The objective was to map the use of different instruments used to characterise ASD, comorbid psychopathology and cognitive and adaptive ability for patient diagnostic and characterisation purposes across Europe. Sixty-six clinical research sites diagnosing 14,844 patients per year contributed data. The majority of sites use the well-established Autism Diagnostic Observation Schedule (ADOS) and the Autism Diagnostic Interview (ADI) instruments, though the proportion of sites in Western Europe using the ADI was almost double the rate in Eastern Europe. Approximately half the sites also used the Social Communication Questionnaire (SCQ) and Social Responsiveness Scale (SRS), although use of the SRS was over three times higher in Western Europe compared with Eastern Europe. The use of free/open access measures was lower than commercially available tools across all regions. There are clinical and scientific benefits in encouraging further convergence of clinical characterisation measures across ASD research and clinical centres in Europe to facilitate large-scale data sharing and collaboration, including clinical trials of novel medications and psychological interventions.