Dominic Trépel

Screening for anxiety disorders with the GAD-7 and GAD-2: a systematic review and diagnostic metaanalysis

OBJECTIVE To systematically review the accuracy of the GAD-7 and GAD-2 questionnaires for identifying anxiety disorders. METHODS A systematic review of the literature was conducted to identify studies that validated the GAD-7 or GAD-2 against a recognized gold standard diagnosis. Pooled estimates of diagnostic test accuracy were produced using random-effects bivariate metaanalysis. Heterogeneity was explored using the I(2) statistic. RESULTS A total of 12 samples were identified involving 5223 participants; 11 samples provided data on the accuracy of the GAD-7 for identifying generalized anxiety disorder (GAD). Pooled sensitivity and specificity values appeared acceptable at a cutoff point of 8 [sensitivity: 0.83 (95% CI 0.71-0.91), specificity: 0.84 (95% CI 0.70-0.92)] although cutoff scores 7-10 also had similar pooled estimates of sensitivity/specificity. Six samples provided data on the accuracy of the GAD-2 for identifying GAD. Pooled sensitivity and specificity values appeared acceptable at a cutoff of 3 [sensitivity: 0.76 (95% CI 0.55-0.89), specificity: 0.81 (95% CI 0.60-0.92)]. Four studies looked at the accuracy of the questionnaires for identifying any anxiety disorder. CONCLUSIONS The GAD-7 had acceptable properties for identifying GAD at cutoff scores 7-10. The GAD-2 had acceptable properties for identifying GAD at a cutoff score of 3. Further validation studies are needed.

PROMISE : first-trimester progesterone therapy in women with a history of unexplained recurrent miscarriages - a randomised, double-blind, placebo-controlled, international multicentre trial and economic evaluation

BACKGROUND AND OBJECTIVES Progesterone is essential to maintain a healthy pregnancy. Guidance from the Royal College of Obstetricians and Gynaecologists and a Cochrane review called for a definitive trial to test whether or not progesterone therapy in the first trimester could reduce the risk of miscarriage in women with a history of unexplained recurrent miscarriage (RM). The PROMISE trial was conducted to answer this question. A concurrent cost-effectiveness analysis was conducted. DESIGN AND SETTING A randomised, double-blind, placebo-controlled, international multicentre study, with economic evaluation, conducted in hospital settings across the UK (36 sites) and in the Netherlands (nine sites). PARTICIPANTS AND INTERVENTIONS Women with unexplained RM (three or more first-trimester losses), aged between 18 and 39 years at randomisation, conceiving naturally and giving informed consent, received either micronised progesterone (Utrogestan(®), Besins Healthcare) at a dose of 400 mg (two vaginal capsules of 200 mg) or placebo vaginal capsules twice daily, administered vaginally from soon after a positive urinary pregnancy test (and no later than 6 weeks of gestation) until 12 completed weeks of gestation (or earlier if the pregnancy ended before 12 weeks). MAIN OUTCOME MEASURES Live birth beyond 24 completed weeks of gestation (primary outcome), clinical pregnancy at 6-8 weeks, ongoing pregnancy at 12 weeks, miscarriage, gestation at delivery, neonatal survival at 28 days of life, congenital abnormalities and resource use. METHODS Participants were randomised after confirmation of pregnancy. Randomisation was performed online via a secure internet facility. Data were collected on four occasions of outcome assessment after randomisation, up to 28 days after birth. RESULTS A total of 1568 participants were screened for eligibility. Of the 836 women randomised between 2010 and 2013, 404 received progesterone and 432 received placebo. The baseline data (age, body mass index, maternal ethnicity, smoking status and parity) of the participants were comparable in the two arms of the trial. The follow-up rate to primary outcome was 826 out of 836 (98.8%). The live birth rate in the progesterone group was 65.8% (262/398) and in the placebo group it was 63.3% (271/428), giving a relative risk of 1.04 (95% confidence interval 0.94 to 1.15; p = 0.45). There was no evidence of a significant difference between the groups for any of the secondary outcomes. Economic analysis suggested a favourable incremental cost-effectiveness ratio for decision-making but wide confidence intervals indicated a high level of uncertainty in the health benefits. Additional sensitivity analysis suggested the probability that progesterone would fall within the National Institute for Health and Care Excellences threshold of £20,000-30,000 per quality-adjusted life-year as between 0.7145 and 0.7341. CONCLUSIONS There is no evidence that first-trimester progesterone therapy improves outcomes in women with a history of unexplained RM. LIMITATIONS This study did not explore the effect of treatment with other progesterone preparations or treatment during the luteal phase of the menstrual cycle. FUTURE WORK Future research could explore the efficacy of progesterone supplementation administered during the luteal phase of the menstrual cycle in women attempting natural conception despite a history of RM. TRIAL REGISTRATION Current Controlled Trials ISRCTN92644181; EudraCT 2009-011208-42; Research Ethics Committee 09/H1208/44. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 41. See the NIHR Journals Library website for further project information.

Self-hypnosis for intrapartum pain management in pregnant nulliparous women: a randomised controlled trial of clinical effectiveness

(Primary) To establish the effect of antenatal group self‐hypnosis for nulliparous women on intra‐partum epidural use.

Effect of Collaborative Care vs Usual Care on Depressive Symptoms in Older Adults With Subthreshold Depression: The CASPER Randomized Clinical Trial

Importance There is little evidence to guide management of depressive symptoms in older people. Objective To evaluate whether a collaborative care intervention can reduce depressive symptoms and prevent more severe depression in older people. Design, Setting, and Participants Randomized clinical trial conducted from May 24, 2011, to November 14, 2014, in 32 primary care centers in the United Kingdom among 705 participants aged 65 years or older with Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) subthreshold depression; participants were followed up for 12 months. Interventions Collaborative care (n=344) was coordinated by a case manager who assessed functional impairments relating to mood symptoms. Participants were offered behavioral activation and completed an average of 6 weekly sessions. The control group received usual primary care (n=361). Main Outcomes and Measures The primary outcome was self-reported depression severity at 4-month follow-up on the 9-item Patient Health Questionnaire (PHQ-9; score range, 0-27). Included among 10 prespecified secondary outcomes were the PHQ-9 score at 12-month follow-up and the proportion meeting criteria for depressive disorder (PHQ-9 score ≥10) at 4- and 12-month follow-up. Results The 705 participants were 58% female with a mean age of 77 (SD, 7.1) years. Four-month retention was 83%, with higher loss to follow-up in collaborative care (82/344 [24%]) vs usual care (37/361 [10%]). Collaborative care resulted in lower PHQ-9 scores vs usual care at 4-month follow-up (mean score with collaborative care, 5.36 vs with usual care, 6.67; mean difference, −1.31; 95% CI, −1.95 to −0.67; P < .001). Treatment differences remained at 12 months (mean PHQ-9 score with collaborative care, 5.93 vs with usual care, 7.25; mean difference, −1.33; 95% CI, −2.10 to −0.55). The proportions of participants meeting criteria for depression at 4-month follow-up were 17.2% (45/262) vs 23.5% (76/324), respectively (difference, −6.3% [95% CI, −12.8% to 0.2%]; relative risk, 0.83 [95% CI, 0.61-1.27]; P = .25) and at 12-month follow-up were 15.7% (37/235) vs 27.8% (79/284) (difference, −12.1% [95% CI, −19.1% to −5.1%]; relative risk, 0.65 [95% CI, 0.46-0.91]; P = .01). Conclusions and Relevance Among older adults with subthreshold depression, collaborative care compared with usual care resulted in a statistically significant difference in depressive symptoms at 4-month follow-up, of uncertain clinical importance. Although differences persisted through 12 months, findings are limited by attrition, and further research is needed to assess longer-term efficacy. Trial Registration isrctn.org Identifier: ISRCTN02202951

Computerised cognitive behaviour therapy for depression in adolescents: study protocol for a feasibility randomised controlled trial

Introduction The 1 year prevalence of depression in adolescents is about 2%. Treatment with antidepressant medication is not recommended for initial treatment in young people due to concerns over high side effects, poor efficacy and addictive potential. Evidence suggests that cognitive behaviour therapy (CBT) is an effective treatment for depression and is currently one of the main treatment options recommended in adolescents. Given the affinity young people have with information technology they may be treated effectively, more widely and earlier in their illness evolution using computer-administered CBT (CCBT). Currently little is known about the clinical and resource implications of implementing CCBT within the National Health Service for adolescents with low mood/depression. We aim to establish the feasibility of running a fully powered randomised controlled trial (RCT). Methods and analysis Adolescents aged 12–18 with low mood/depression, (scoring ≥20 on the Mood and Feelings Questionnaire (MFQ)), will be approached to participate. Consenting participants will be randomised to either a CCBT programme (Stressbusters) or accessing selected websites providing information about low mood/depression. The primary outcome measure will be the Beck Depression Inventory (BDI). Participants will also complete generic health measures (EQ5D-Y, HUI2) and resource use questionnaires to examine the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline, 4 and 12-month follow-ups. Progress and risk will be monitored via the MFQ administered at each treatment session. The acceptability of a CCBT programme to adolescents; and the willingness of clinicians to recruit participants and of participants to be randomised, recruitment rates, attrition rates and questionnaire completion rates will be collected for feasibility analysis. We will estimate ‘numbers needed’ to plan a fully powered RCT of clinical and cost-effectiveness. Ethics and dissemination The current trial protocol received a favourable ethical opinion from Leeds (West) Research and Ethics Committee. (Reference: 10/H1307/137). Trial registration number ISRCTN31219579.

Screening for psychological and mental health difficulties in young people who offend: a systematic review and decision model

BACKGROUND There is policy interest in the screening and treatment of mental health problems in young people who offend, but the value of such screening is not yet known. OBJECTIVES To assess the diagnostic test accuracy of screening measures for mental health problems in young people who offend; to evaluate the clinical effectiveness and cost-effectiveness of screening and treatment; to model estimates of cost; to assess the evidence base for screening against UK National Screening Committee criteria; and to identify future research priorities. DATA SOURCES In total, 25 electronic databases including MEDLINE, PsycINFO, EMBASE and The Cochrane Library were searched from inception until April 2011. Reverse citation searches of included studies were undertaken and reference list of included studies were examined. REVIEW METHODS Two reviewers independently examined titles and abstracts and extracted data from included studies using a standardised form. The inclusion criteria for the review were (1) population - young offenders (aged 10-21 years); (2) intervention/instrument - screening instruments for mental health problems, implementation of a screening programme or a psychological or pharmacological intervention as part of a clinical trial; (3) comparator - for diagnostic test accuracy studies, any standardised diagnostic interview; for trials, any comparator; (4) outcomes - details of diagnostic test accuracy, mental health outcomes over the short or longer term or measurement of cost data; and (5) study design - for diagnostic test accuracy studies, any design; for screening programmes, randomised controlled trials or controlled trials; for clinical effectiveness studies, randomised controlled trials; for economic studies, economic evaluations of screening strategies or interventions. RESULTS Of 13,580 studies identified, nine, including eight independent samples, met the inclusion criteria for the diagnostic test accuracy and validity of screening measures review. Screening accuracy was typically modest. No studies examined the clinical effectiveness of screening, although 10 studies were identified that examined the clinical effectiveness of interventions for mental health problems. There were too few studies to make firm conclusions about the clinical effectiveness of treatments in this population. No studies met the inclusion criteria for the assessment of the cost-effectiveness of screening or treatment. An exemplar decision model was developed for depression, which identified a number of the likely key drivers of uncertainty, including the prevalence of unidentified mental health problems, the severity of mental health problems and their relationship to generic measures of outcome and the impact of treatment on recidivism. The information evaluated as part of the review was relevant to five of the UK National Screening Committee criteria. On the basis of the above results, none of the five criteria was met. LIMITATIONS The conclusions of the review are based on limited evidence. Conclusions are tentative and the decision model should be treated as an exemplar. CONCLUSIONS Evidence on the clinical effectiveness and cost-effectiveness of screening for mental health problems in young people who offend is currently lacking. Future research should consider feasibility trials of clinical interventions to establish important parameters ahead of conducting definitive trials. Future diagnostic studies should compare the diagnostic test accuracy of a range of screening instruments, including those recommended for use in the UK in this population. These studies should be designed to reduce the decision uncertainty identified by the exemplar decision model. REGISTRATION This study is registered as PROSPERO CRD42011001466. FUNDING The National Institute for Health Research Health Technology Assessment programme.

Social Stories™ to alleviate challenging behaviour and social difficulties exhibited by children with autism spectrum disorder in mainstream schools: design of a manualised training toolkit and feasibility study for a cluster randomised controlled trial with nested qualitative and cost-effectiveness components.

BACKGROUND A Social Story™ (Carol Gray) is a child-friendly intervention that is used to give children with autism spectrum disorders (ASDs) social information in situations where they have social difficulties. Limited evidence mainly using single-case designs suggests that they can reduce anxiety and challenging behaviour. OBJECTIVES The objectives were to conduct a systematic review, use this to develop a manualised intervention and run a feasibility trial to inform a fully powered randomised controlled trial (RCT) on their clinical effectiveness and cost-effectiveness in schools. DESIGN This is a three-stage study following the Medical Research Council framework for complex interventions. Specifically, it involved a theoretical phase, a qualitative stage and a feasibility trial stage. SETTING Qualitative interviews and focus groups took place in Child and Adolescent Mental Health Service and primary care settings. The feasibility study took place in 37 local mainstream schools. PARTICIPANTS Fifty children (aged 5-15 years) in mainstream school settings with a diagnosis of ASD were entered into the trial. For each child, an associated teacher and parent was also recruited. INTERVENTIONS The intervention was a goal-setting session followed by a manualised toolkit (including a training session) for creating Social Stories™ for use with school-aged children. The comparator treatment was a goal-setting session followed by an attention control. Both arms received treatment as usual. MAIN OUTCOME MEASURES Outcomes tested as part of the feasibility study included child- and proxy-completed questionnaires for mental health, quality of life and goal-based outcome measures. Adults additionally completed behaviour diaries and the parental stress index. RESULTS The review found that the research into social stories is predominantly based in the USA, carried out in under-12-year-olds and using single-case designs. Most studies either did not follow established Social Story criteria or did not report if they did. The assessment of effectiveness presents a largely positive picture but is limited by methodological issues. There were no adequate RCTs and insufficient information to assess a number of important sources of potential bias in most studies. A manualised intervention was produced using an iterative process between user focus groups and a writing team, and assessed in the feasibility study. All 50 participant groups were recruited within the study time frame. Two outcome measures, the Social Responsiveness Scale-2 and the custom-made goal-based measure, showed high levels of completion rates and appeared to be capturing social and behaviour skills targeted by the use of Social Stories. Detailed recommendations for a full trial are provided. LIMITATIONS Blinding of participants was not feasible. Treatment fidelity was not assessed because of low levels of story return rates. CONCLUSIONS The study showed that a fully powered RCT is feasible with an extended geographical footprint. A large amount of data and information has helped to inform the design of this RCT, which will be the subject of a future research grant application. Future work could focus on developing an appropriate blinded outcome measure for this population. STUDY REGISTRATION This study is registered as PROSPERO CRD42011001440. TRIAL REGISTRATION Current Controlled Trials ISRCTN96286707. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 6. See the NIHR Journals Library website for further project information.

A comparison of physical activity, physical fitness levels, BMI, and blood pressure of adults with intellectual disability, who do and do not take part in Special Olympics Ireland programmes.

People with an intellectual disability are less physically active, live more sedentary lives, have lower fitness levels and are more likely to be overweight or obese than the general population. No evidence exists on the impact of participation in Special Olympics Ireland (SOI) on physical activity and physical fitness levels. Adults with intellectual disabilities (16–64 years) were recruited from services and SOI clubs. Physical measures included waist circumference, height, weight, blood pressure, heart rate and 6-min walking test. Self-report questionnaires gathered data on physical activity levels. Actigraph (GT3X) accelerometers were used to gain an objective measure of physical activity. SOI participants accumulated more moderate to vigorous physical activity per day, had higher fitness levels and more positive health profile scores than those not taking part in SOI. SOI has the potential to make a positive difference to people’s physical health and subsequently their overall health and well-being.

Computerised cognitive–behavioural therapy for depression in adolescents: feasibility results and 4-month outcomes of a UK randomised controlled trial

Objectives Computer-administered cognitive–behavioural therapy (CCBT) may be a promising treatment for adolescents with depression, particularly due to its increased availability and accessibility. The feasibility of delivering a randomised controlled trial (RCT) comparing a CCBT program (Stressbusters) with an attention control (self-help websites) for adolescent depression was evaluated. Design Single centre RCT feasibility study. Setting The trial was run within community and clinical settings in York, UK. Participants Adolescents (aged 12–18) with low mood/depression were assessed for eligibility, 91 of whom met the inclusion criteria and were consented and randomised to Stressbusters (n=45) or websites (n=46) using remote computerised single allocation. Those with comorbid physical illness were included but those with psychosis, active suicidality or postnatal depression were not. Interventions An eight-session CCBT program (Stressbusters) designed for use with adolescents with low mood/depression was compared with an attention control (accessing low mood self-help websites). Primary and secondary outcome measures Participants completed mood and quality of life measures and a service Use Questionnaire throughout completion of the trial and 4 months post intervention. Measures included the Beck Depression Inventory (BDI) (primary outcome measure), Mood and Feelings Questionnaire (MFQ), Spence Childrens Anxiety Scale (SCAS), the EuroQol five dimensions questionnaire (youth) (EQ-5D-Y) and Health Utility Index Mark 2 (HUI-2). Changes in self-reported measures and completion rates were assessed by treatment group. Results From baseline to 4 months post intervention, BDI scores and MFQ scores decreased for the Stressbusters group but increased in the website group. Quality of life, as measured by the EQ-5D-Y, increased for both groups while costs at 4 months were similar to baseline. Good feasibility outcomes were found, suggesting the trial process to be feasible and acceptable for adolescents with depression. Conclusions With modifications, a fully powered RCT is achievable to investigate a promising treatment for adolescent depression in a climate where child mental health service resources are limited. Trial registration number ISRCTN31219579.

People with intellectual disability and their families' perspectives of Special Olympics Ireland: Qualitative findings from the SOPHIE study.

Previous research has highlighted that while involvement in Special Olympics can have benefits for athletes and their families, there can also be many barriers to participation. This qualitative study, which was part of a large mixed-method study, examined the experiences and perspectives of people with intellectual disability, their families and staff who work with them, about Special Olympics Ireland (SOI). A total of 47 participants (15 athletes, 6 non-athletes, 18 family members and 8 staff members) participated in focus group and individual interviews. Supplemental data, gathered as part of the larger study extracted from open-ended survey questions completed by 97 family members also informed this element. Findings revealed four main themes: impact of participation on athletes, impact of involvement on families, barriers to participation and how to enhance participation rates. Involvement in Special Olympics impacted positively on the quality of life of athletes and families. Enhanced availability of user-friendly information and service accessibility were important drivers identified for enhancing participation rates in Special Olympics.