Democratic therapeutic community treatment for personality disorder: randomised controlled trial.

BACKGROUND: Democratic therapeutic community (DTC) treatment has been used for many years in an effort to help people with personality disorder. High-quality evidence from randomised controlled trials (RCTs) is absent. AIMS: To test whether DTC treatment reduces use of in-patient services and improves the mental health of people with personality disorder. METHOD: An RCT of 70 people meeting DSM-IV criteria for personality disorder (trial registration: ISRCTN57363317). The intervention was DTC and the control condition was crisis planning plus treatment as usual (TAU). The primary outcome was days of in-patient psychiatric treatment. Secondary outcomes were social function, mental health status, self-harm and aggression, attendance at emergency departments and primary care, and satisfaction with care. All outcomes were measured at 12 and 24 months after randomisation. RESULTS: Number of in-patient days at follow-up was low among all participants and there was no difference between groups. At 24 months, self- and other directed aggression and satisfaction with care were significantly improved in the DTC compared with the TAU group. CONCLUSIONS: DTC is more effective than TAU in improving outcomes in personality disorder. Further studies are required to confirm this conclusion.

The Experience of Caring For or Living with an Individual with an Eating Disorder: A Meta-Synthesis of Qualitative Studies.

Eating disorders (ED) has the highest mortality rate of psychiatric disorders and a high incidence of comorbidity. Because of the average age of onset, care typically befalls family members. However, despite the severity of the disorder and the burden placed on the family, research into the caregiving experience is still developing. Studies have shown caregivers of individuals with ED to experience high levels of distress, burden and expressed emotion. Recent theoretical models have underscored the importance of caregivers' responses as a maintenance factor for the ED, and family therapy has proved efficacious. However, the literature pertaining to the experience of family members living with or caring for an individual with an ED has not been systematically reviewed. This review aimed to synthesize qualitative studies relating to the caring experience and its impact, thereby gaining an understanding from the perspective of the individuals themselves. Relevant search terms were utilized to systematically search key databases. Twenty studies, with a total sample of 239 participants, met the inclusion criteria. Nine core themes emerged from the synthesis, forming the basis of an explanatory theory. The ED was found to have a pervasive impact upon family members, mediated by a number of factors. Cognitive appraisals affected the caregiving experience and responses to the individual. The experience of caregiving was continually reappraised leading to a process of adaptation. The majority of studies identified unmet carer needs. The implications of the findings are discussed with reference to existing theoretical models and in terms of clinical practice. Copyright © 2015 John Wiley & Sons, Ltd. KEY PRACTITIONER MESSAGES: Carers experience a significant amount of guilt and distress once they have found out about their loved one's eating disorder. Across the studies, there were many themes of unmet need for carers. Siblings have often been overlooked by both clinicians and researchers. Interventions for people with eating disorders should also acknowledge carers and close family members.

The clinical and cost-effectiveness of brief advice for excessive alcohol consumption among people attending sexual health clinics: a randomised controlled trial.

OBJECTIVES: To examine the clinical and cost-effectiveness of brief advice for excessive alcohol consumption among people who attend sexual health clinics. METHODS: Two-arm, parallel group, assessor blind, pragmatic, randomised controlled trial. 802 people aged 19 years or over who attended one of three sexual health clinics and were drinking excessively were randomised to either brief advice or control treatment. Brief advice consisted of feedback on alcohol and health, written information and an offer of an appointment with an Alcohol Health Worker. Control participants received a leaflet on health and lifestyle. The primary outcome was mean weekly alcohol consumption during the previous 90 days measured 6 months after randomisation. The main secondary outcome was unprotected sex during this period. RESULTS: Among the 402 randomised to brief advice, 397 (99%) received it. The adjusted mean difference in alcohol consumption at 6 months was -2.33 units per week (95% CI -4.69 to 0.03, p=0.053) among those in the active compared to the control arm of the trial. Unprotected sex was reported by 154 (53%) of those who received brief advice, and 178 (59%) controls (adjusted OR=0.89, 95% CI 0.63 to 1.25, p=0.496). There were no significant differences in costs between study groups at 6 months. CONCLUSIONS: Introduction of universal screening and brief advice for excessive alcohol use among people attending sexual health clinics does not result in clinically important reductions in alcohol consumption or provide a cost-effective use of resources. TRIAL REGISTRATION NUMBER: Current Controlled Trials ISRCTN 99963322.

The clinical effectiveness and cost-effectiveness of brief intervention for excessive alcohol consumption among people attending sexual health clinics: a randomised controlled trial (SHEAR).

BACKGROUND: Excessive use of alcohol is associated with poor sexual health, but the clinical effectiveness and cost-effectiveness of brief alcohol intervention in this setting has not been investigated. OBJECTIVE: To examine the effects and cost-effectiveness of brief intervention for excessive alcohol consumption among people who attend sexual health clinics. DESIGN: A two-arm, parallel-group, single-blind, pragmatic, randomised controlled trial. Participants were randomised via an independent and remote telephone randomisation service using permuted blocks, stratified by clinic. SETTING: Study participants were recruited from three sexual health clinics in central and west London. PARTICIPANTS: For inclusion, potential participants had to be aged ≥ 19 years, drink excessive alcohol according to the Modified-Single Alcohol Screening Question, and be willing to provide written informed consent. We excluded those who were unable to communicate in English sufficiently well to complete the baseline assessment and those who could not provide contact details for the follow-up assessment. INTERVENTIONS: Brief advice was delivered by the treating clinician and comprised feedback on the possible health consequences of excessive drinking, a discussion of whether the participant's clinic attendance was linked to current alcohol use, written information on alcohol and health and an offer of an appointment with an alcohol health worker (AHW). Appointments with AHWs took place either in person or by telephone, lasted up to 30 minutes, and used the 'FRAMES' (Feedback about the adverse effects of alcohol, an emphasis on personal Responsibility for changing drinking behaviour, Advice about alcohol consumption, a Menu of options for further help and advice, an Empathic stance towards the patient and an emphasis on Self-efficacy) approach. Those in the control arm of the trial were offered a copy of a leaflet providing general information on health and lifestyle. MAIN OUTCOME MEASURES: Outcomes were assessed 6 months after randomisation. The primary outcome was mean weekly alcohol consumption during the previous 90 days. The main secondary outcome was unprotected sex during this period. RESULTS: Eight hundred and two people were recruited to the study of whom 592 (74%) were followed up 6 months later. Among 402 participants who were randomised to brief intervention, 397 (99%) received brief advice from the treating clinician and 81 (20%) also received input from an AHW. The adjusted mean difference in alcohol consumption after 6 months was -2.33 units per week [95% confidence interval (CI) -4.69 to 0.03 units per week, p = 0.053] for those in the active arm compared with the control arm. Unprotected sex was reported by 154 (53%) of those who received brief intervention and by 178 (59%) of controls (adjusted odds ratio 0.89, 95% CI 0.63 to 1.25, p = 0.496). Participants randomised to brief intervention reported drinking a mean of 10.4 units of alcohol per drinking day compared with 9.3 units among control participants (difference 1.10, 95% CI 0.29 to 1.96, p = 0.009). We found no statistically significant differences in other outcomes. Brief intervention (brief advice and input from an AHW) cost on average £12.60 per person to deliver and did not appear to provide a cost-effective use of resources. CONCLUSIONS: Introduction of universal screening and brief intervention for excessive alcohol use among people who attend sexual health clinics does not result in clinically important reductions in alcohol consumption or provide a cost-effective use of resources. While people attending sexual health clinics may want to achieve better sexual health, attempts to reduce alcohol consumption may not be seen by them as a necessary means of trying to achieve this aim. TRIAL REGISTRATION: This trial is registered as ISRCTN 99963322. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 30. See the NIHR Journals Library website for further project information.

Activity groups for people with schizophrenia: a randomized controlled trial.

BACKGROUND: UK guidelines recommend that patients with schizophrenia are offered access to social activities, however, the impact of such interventions have not been examined in a large randomized trial. AIMS: To investigate the effect of an activity group intervention on mental health and global functioning 12 months after randomization compared to standard care alone. METHODS: Secondary analysis of data from the MATISSE study. Primary outcomes were global functioning, assessed using the Global Assessment of Functioning (GAF), and mental health symptoms measured using the Positive and Negative Syndrome Scale (PANSS). RESULTS: About 140 participants were randomized to activity groups and 137 to standard care alone. Follow-up data were collected from 242 (87%) participants. Mental health improved significantly among those offered activity groups (change in PANSS score = -6.0, 95% CI -2.3 to -9.8) but global functioning did not (change in GAF score = 0.8, 95% CI -1.7 to 3.3). No significant differences were found between treatment arms. CONCLUSIONS: Offering activity groups to patients with schizophrenia was not associated with any additional clinical benefits. There was poor uptake and attendance at activity groups. Interventions that aim to improve negative symptoms may be useful in enabling engagement in psychosocial interventions.

Brief intervention for alcohol misuse in people attending sexual health clinics: study protocol for a randomized controlled trial.

BACKGROUND: Over the last 30 years the number of people who drink alcohol at harmful levels has increased in many countries. There have also been large increases in rates of sexually transmitted infections. Available evidence suggests that excessive alcohol consumption and poor sexual health may be linked. The prevalence of harmful alcohol use is higher among people attending sexual health clinics than in the general population, and a third of those attending clinics state that alcohol use affects whether they have unprotected sex. Previous research has demonstrated that brief intervention for alcohol misuse in other medical settings can lead to behavioral change, but the clinical- and cost-effectiveness of this intervention on sexual behavior have not been examined. METHODS: We will conduct a two parallel-arm, randomized trial. A consecutive sample of people attending three sexual health clinics in London and willing to participate in the study will be screened for excessive alcohol consumption. Participants identified as drinking excessively will then be allocated to either active treatment (Brief Advice and referral for Brief Intervention) or control treatment (a leaflet on healthy living). Randomization will be via an independent and remote telephone randomization service and will be stratified by study clinic. Brief Advice will comprise feedback on the possible health consequences of excessive alcohol consumption, written information about alcohol and the offer of an appointment for further assessment and Brief Intervention. Follow-up data on alcohol use, sexual behavior, health related quality of life and service use will be collected by a researcher masked to allocation status six months later. The primary outcome for the study is mean weekly alcohol consumption during the previous three months, and the main secondary outcome is the proportion of participants who report unprotected sex during this period. DISCUSSION: Opportunistic intervention for excessive alcohol use has been shown to be effective in a range of medical settings. The SHEAR study will examine whether delivering such interventions in sexual health clinics results in reductions in alcohol consumption and will explore whether this is associated with changes in sexual behavior.