Effects of a Guided Web-Based Smoking Cessation Program With Telephone Counseling: A Cluster Randomized Controlled Trial

Background

Preliminary findings suggest that Web-based interventions may be effective in achieving significant smoking cessation. To date, very few findings are available for primary care patients, and especially for the involvement of general practitioners.

Objective

Our goal was to examine the short-term effectiveness of a fully automated Web-based coaching program in combination with accompanied telephone counseling in smoking cessation in a primary care setting.

Methods

The study was an unblinded cluster-randomized trial with an observation period of 12 weeks. Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education, motivation, exercise guidance, daily short message service (SMS) reminding, weekly feedback through Internet, and active monitoring by general practitioners. All components of the program are fully automated. Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program. The main outcome was the biochemically confirmed smoking status after 12 weeks.

Results

We recruited 168 participants (86 intervention group, 82 control group) into the study. For 51 participants from the intervention group and 70 participants from the control group, follow-up data were available both at baseline and 12 weeks. Very few patients (9.8%, 5/51) from the intervention group and from the control group (8.6%, 6/70) successfully managed smoking cessation (OR 0.86, 95% CI 0.25-3.0; P=.816). Similar results were found within the intent-to-treat analysis: 5.8% (5/86) of the intervention group and 7.3% (6/82) of the control group (OR 1.28, 95% CI 0.38-4.36; P=.694). The number of smoked cigarettes per day decreased on average by 9.3 in the intervention group and by 6.6 in the control group (2.7 mean difference; 95% CI -5.33 to -0.58; P=.045). After adjustment for the baseline value, age, gender, and height, this significance decreases (mean difference 2.2; 95% CI -4.7 to 0.3; P=.080).

Conclusions

This trial did not show that the tested Web-based intervention was effective for achieving smoking cessation compared to usual care. The limited statistical power and the high drop-out rate may have reduced the study’s ability to detect significant differences between the groups. Further randomized controlled trials are needed in larger populations and to investigate the long-term outcome.

Trial Registration

German Register for Clinical Trials, registration number DRKS00003067; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ ID=DRKS00003067 (Archived by WebCite at http://www.webcitation.org/6Sff1YZpx).     

Diagnosing depression in primary care using self-completed instruments: UK validation of PHQ-9 and CORE-OM.

There is increased emphasis on routine assessment of depression in primary care. This report is the first UK validation of two self-completed measures: the Patient Health Questionnaire (PHQ-9) and the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM). Optimum cut-off points were established against a diagnostic gold standard in 93 patients. PHQ-9 sensitivity = 91.7% (95% confidence interval [CI] = 77.5 to 98.3%) and specificity 78.3% (95% CI = 65.8 to 87.9%). CORE-OM sensitivity = 91.7% (95% CI = 77.5 to 98.2%) and specificity = 76.7% (95% CI = 64.0 to 86.6%). Brief self-rated questionnaires are as good as clinician-administered instruments in detecting depression in UK primary care.     

A cluster randomized controlled trial to assess the effectiveness of an intervention to educate students about depression

BACKGROUND: Depression is an important cause of disability worldwide, with many people experiencing their first depressive episode before the age of 18. University students are particularly vulnerable to depression. Depression can be treated successfully in most patients. However, for treatment to be successful, depressed people need to recognize their symptoms as illness, present to medical care, and be aware that effective treatment is available. A thoughtful health campaign might therefore increase the likelihood of successful treatment. METHOD: A cluster randomized controlled trial was conducted to determine the effectiveness of an educational intervention. A total of 3313 undergraduate students participated in the study. The intervention consisted of postcards and posters on depression and its treatment. The primary outcome was student awareness that depression can be treated effectively. Secondary outcomes included the proportion of students reading the postcards, recognition of symptoms and knowledge of treatments. RESULTS: The postcards were read by 69% of students. Less than half of participants reported that depression could be treated effectively, and there was no evidence of a difference between the intervention and control groups [341 (49.1%) v. 379 (49.7%), difference -0.7, p=0.8, 95% confidence interval (CI) -5.1 to 3.7]. However, intervention group participants were more likely than control group participants to recognize depressive symptoms and to report that antidepressants are not addictive. CONCLUSIONS: Many university students lack knowledge about depression and its treatment. Simple and cheap media, such as postcards and posters, might help to improve awareness in areas where current knowledge is low.     

Case management to improve major depression in primary health care: a systematic review

BACKGROUND: Deficits in the care of depression lead to poor medication adherence, which increases the risk of an unfavourable outcome for this care. This review evaluates effects on symptoms and medication adherence of case management in primary health care. METHOD: A systematic literature search was performed. The quality of the studies was rated according to the Cochrane Effective Practice and Organization of Care Group (EPOC) criteria. To conduct a subgroup analysis interventions were classified as either 'standard' or 'complex' case management. RESULTS: Thirteen studies met the inclusion criteria. In a meta-analysis we calculated a standard mean difference/effect size on symptom severity after 6-12 months of -0.40 (95% CI -0.60 to -0.20). Patients in the intervention groups were more likely to achieve remission after 6-12 months [relative risk (RR) 1.39, 95% CI 1.30-1.48]. The relative risk for clinical response was 1.82 (95% CI 1.68-2.05). Patients in intervention groups had better medication adherence than the control group (RR 1.5, 95% CI 1.28-1.86). We found heterogeneous results when assessing effects of different types of intervention. CONCLUSIONS: We conclude that case management improves management of major depression in primary health-care settings.     

Effectiveness of a web-based self-help intervention for symptoms of depression, anxiety, and stress: randomized controlled trial

Background

Self-help therapies are often effective in reducing mental health problems. We developed a new Web-based self-help intervention based on problem-solving therapy, which may be used for people with different types of comorbid problems: depression, anxiety, and work-related stress.

Objective

The aim was to study whether a Web-based self-help intervention is effective in reducing depression, anxiety, and work-related stress (burnout).

Methods

A total of 213 participants were recruited through mass media and randomized to the intervention (n = 107) or a waiting list control group (n = 106). The Web-based course took 4 weeks. Every week an automated email was sent to the participants to explain the contents and exercises for the coming week. In addition, participants were supported by trained psychology students who offered feedback by email on the completed exercises. The core element of the intervention is a procedure in which the participants learn to approach solvable problems in a structured way. At pre-test and post-test, we measured the following primary outcomes: depression (CES-D and MDI), anxiety (SCL-A and HADS), and work-related stress (MBI). Quality of life (EQ-5D) was measured as a secondary outcome. Intention-to-treat analyses were performed.

Results

Of the 213 participants, 177 (83.1%) completed the baseline and follow-up questionnaires; missing data were statistically imputed. Of all 107 participants in the intervention group, 9% (n = 10) dropped out before the course started and 55% (n = 59) completed the whole course. Among all participants, the intervention was effective in reducing symptoms of depression (CES-D: Cohen’s d = 0.50, 95% confidence interval (CI) 0.22-0.79; MDI: d = 0.33, 95% CI 0.03-0.63) and anxiety (SCL-A: d = 0.42, 95% CI 0.14-0.70; HADS: d = 0.33, 95% CI 0.04-0.61) as well as in enhancing quality of life (d = 0.31, 95% CI 0.03-0.60). Moreover, a higher percentage of patients in the intervention group experienced a significant improvement in symptoms (CES-D: odds ratio [OR] = 3.5, 95% CI 1.9-6.7; MDI: OR = 3.7, 95% CI 1.4-10.0; SCL-A: OR = 2.1, 95% CI 1.0-4.6; HADS: OR = 3.1, 95% CI 1.6-6.0). Patients in the intervention group also recovered more often (MDI: OR = 2.2; SCL-A: OR = 2.0; HADS < 8), although these results were not statistically significant. The course was less effective for work-related stress, but participants in the intervention group recovered more often from burnout than those in the control group (OR = 4.0, 95% CI 1.2-13.5).

Conclusions

We demonstrated statistically and clinically significant effects on symptoms of depression and anxiety. These effects were even more pronounced among participants with more severe baseline problems and for participants who fully completed the course. The effects on work-related stress and quality of life were less clear. To our knowledge, this is the first trial of a Web-based, problem-solving intervention for people with different types of (comorbid) emotional problems. The results are promising, especially for symptoms of depression and anxiety. Further research is needed to enhance the effectiveness for work-related stress.

Trial Registration

International Standard Randomized Controlled Trial Number (ISRCTN) 14881571     

Incremental cost-effectiveness of a collaborative care intervention for panic disorder

BACKGROUND: Panic disorder is a prevalent, often disabling, disorder among primary-care patients, but there are large gaps in quality of treatment in primary care. This study describes the incremental cost-effectiveness of a combined cognitive behavioral therapy (CBT) and pharmacotherapy intervention for patients with panic disorder versus usual primary-care treatment. METHOD: This randomized control trial recruited 232 primary-care patients meeting DSM-IV criteria for panic disorder from March 2000 to March 2002 from six primary-care clinics from university-affiliated clinics at the University of Washington (Seattle) and University of California (Los Angeles and San Diego). Patients were randomly assigned to receive either treatment as usual or a combined CBT and pharmacotherapy intervention for panic disorder delivered in primary care by a mental health therapist. Intervention patients had up to six sessions of CBT modified for the primary-care setting in the first 12 weeks, and up to six telephone follow-ups over the next 9 months. The primary outcome variables were total out-patient costs, anxiety-free days (AFDs) and quality adjusted life-years (QALYs). RESULTS: Relative to usual care, intervention patients experienced 60.4 [95% confidence interval (CI) 42.9-77.9] more AFDs over a 12-month period. Total incremental out-patient costs were 492 US dollars higher (95% CI 236-747 US dollars ) in intervention versus usual care patients with a cost per additional AFD of 8.40 US dollars (95% CI 2.80-14.0 US dollars ) and a cost per QALY ranging from 14,158 US dollars (95% CI 6,791-21,496 US dollars ) to 24,776 US dollars (95% CI 11,885-37,618 US dollars ). The cost per QALY estimate is well within the range of other commonly accepted medical interventions such as statin use and treatment of hypertension. CONCLUSIONS: The combined CBT and pharmacotherapy intervention was associated with a robust clinical improvement compared to usual care with a moderate increase in ambulatory costs.     

Computerised patient-specific guidelines for management of common mental disorders in primary care: a randomised controlled trial.

BACKGROUND: A large proportion of people with depression and anxiety go unrecognised by their general practitioner (GP). Case-finding does not appear to be effective on its own. AIM: To compare the effectiveness of case-finding followed by computer-generated patient-specific guidelines with usual care for the management of common mental disorders in primary care.Design of study: Individual patient randomised controlled trial. SETTING: Five general practices in Bristol and Cardiff.METHOD: 762 individuals aged >/= 16 years scoring >/= 12 on the Clinical Interview Schedule Revised were randomised. The experimental intervention required participants to complete a computerised psychosocial assessment that generated a report for the GP including patient-specific treatment recommendations. The control patients were treated as usual with access to locally agreed guidelines.RESULTS: Participants' 12-item General Health Questionnaire (GHQ) score dropped irrespective of treatment allocation. The experimental group had a significantly lower GHQ score at 6 weeks, but not at 6 months. Recovery at 6 months was 3% greater among those receiving the experimental intervention (95% confidence interval [CI] = -4 to 10). Treatment was not significantly associated with quality of life or patient satisfaction.CONCLUSION: Only small benefits are likely from using case-finding followed by patient-specific guidelines to improve clinical management of common mental disorders in primary care. However, depression and anxiety are important public health problems so the utility of such systems should be further investigated.     

Effect of antiseptic bathing with chlorhexidine or octenidine on central line–associated bloodstream infections in intensive care patients: a cluster-randomized controlled trial

ObjectivesOur study aimed to compare the effect of daily bathing with chlorhexidine, octenidine, or water and soap (routine care = control) on central line (CL)–associated bloodstream infection (CLABSI) rates in intensive care units (ICUs).MethodsA multicentre cluster-randomized controlled trial was done with a 12-month intervention period from February 1, 2017 to January 31, 2018 (octenidine and routine care group) or from June 1, 2017 to May 31, 2018 (chlorhexidine group). Wards were randomly assigned to one of two decolonization regimes or routine care (control). Intervention included daily bathing with 2% chlorhexidine-impregnated cloths or 0.08% octenidine wash mitts for 12 months, whereas the control group used water and soap (routine care). The primary outcome was incidence density of CLABSI per 1000 CL days. Poisson regression and generalized estimating equation models were applied.ResultsA total of 72 ICUs with 76 815 patients (22 897 patients in the chlorhexidine group, 25 127 in the octenidine group, and 28 791 in the routine care group) were included. Incidence densities were 0.90 CLABSI per 1000 CL days (95% CI 0.67–1.19) in the chlorhexidine group, 1.47 (95% CI 1.17–1.81) in the octenidine group, and 1.17 (95% CI 0.93–1.45) in the routine care group. Adjusted incidence rate ratios of CLABSI were 0.69 (95% CI 0.37–1.22, p = 0.28) in the chlorhexidine group and 1.22 (95% CI 0.54–2.75, p = 0.65) in the octenidine group (compared with routine care).DiscussionAntiseptic bathing with 2% chlorhexidine-impregnated cloths and 0.08% octenidine wash mitts lacks a significant preventive effect on CLABSI rates in ICUs. However, our trial has a high likelihood of being underpowered because CLABSI rates in the routine care group were approximately 40% lower than initially assumed.     

A multi-faceted strategy to improve the use of national fertility guidelines; a cluster-randomized controlled trial

BACKGROUND Proper use of clinical practice guidelines can decrease variation in care between settings. However, actual use of fertility guidelines is suboptimal and in need of improvement. Hence, a cluster-randomized controlled trial was designed to study the effects of two strategies to implement national Dutch guidelines on comprehensive fertility care. METHODS Sixteen fertility clinics participated in the trial. A minimal, professional-oriented implementation strategy of audit and feedback was tested versus a maximal multi-faceted strategy that was both professional and patient oriented. The extent of adherence to guideline recommendations, reflected in quality indicator scores, was the primary outcome measure. To gain an insight into unwanted side effects, patient anxiety and depression scores were gathered as secondary outcomes. Data collection encompassed medical record search, patient and professional questionnaires. RESULTS A total of 1499 couples were included at baseline and 1396 at the after-measurement. No overall significant improvement in indicator scores was found for either strategy [odds ratios ranging from 0.23 (95% confidence interval (CI): 0.06-0.95) to 6.66 (95% CI: 0.33-132.8]. Secondary outcomes did not differ significantly for both groups, although selected anxiety scores appeared lower in the maximal intervention group. Process evaluation of the trial revealed positive patient experiences with the intervention material [e.g. an increased understanding of their doctor's treatment policy (61%), an increased ability to ask questions about the treatment (61%)]. Professionals' appreciation of intervention elements varied, and execution of the multi-faceted strategy appeared incomplete. DISCUSSION Absence of an intervention effect may be due to the nature of the strategies, incomplete execution or flaws in study design. Process evaluation data raise the question of whether professionals should be the only stakeholder responsible for guideline implementation. This study therefore contributes to an increased understanding of fertility guideline implementation in general, and the role of patients in particular.     

A pragmatic randomized controlled trial of a guided self-help intervention versus a waiting list control in a routine primary care mental health service

OBJECTIVES. To evaluate the effectiveness of a two session guided self-help (GSH) intervention provided by primary care graduate mental health workers (PCGMHWs) in a primary care mental health service. DESIGN. Pragmatic randomized trial, with a wait list control design. METHOD. Patients presenting with significant anxiety and depression problems were given one or more self-help booklets at screening and randomly allocated to an immediate (ITG) or delayed treatment group (DTG). Following this, a two-session GSH intervention was provided by one of two PCGMHWs, with a review session to decide on the need for further intervention. The DTG began the intervention 8 weeks after the screening and the primary outcome was Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) scores after 8 weeks. RESULTS. A total of 63 patients were allocated to the ITG, 59 to the DTG. Analysis of covariance, carried out on an intention to treat basis, showed a significant treatment effect, F(1,98) = 15, p < .001, and a comparison of means at 8 weeks showed a significant difference, t(116) = 2.1 (95% CI [1.1, 5.9]), p= .042 with an effect size, d= 0.375. Taking the two groups together, CORE-OM scores for patients who completed the intervention reduced between screening and the review session by an average of 7.9 (95% CI [6.3, 9.5]), effect size of 1.2. Between screening and the review session, 47% showed a reliable and clinically significant improvement. CONCLUSIONS. The study provides some support for the effectiveness of a two-session GSH intervention and a stepped-care service model.     

Concordance between the PHQ-9 and the HSCL-20 in depressed primary care patients

BACKGROUND: Two instruments commonly used in primary care research to measure depressive severity are the Patient Health Questionnaire-9 (PHQ-9) and the Hopkins Symptom Checklist-20 (HSCL-20). However, there is little information regarding the relationship between clinical information derived from these scales. The present study investigates the psychometric properties of the PHQ-9 and HSCL-20, determines the degree of instrument concordance, and describes the factor structure of the HSCL-20. METHODS: A secondary data analysis from a randomized controlled trial was performed. A total of 405 primary care patients with major depressive disorder and/or dysthymia were administered the PHQ-9 and the HSCL-20 when recruited for the study. RESULTS: Good internal consistency reliability estimates were obtained for both scales (PHQ-9 alpha=0.803; HSCL-20 alpha=0.837). All PHQ-9 inter-item and corrected item-total correlations showed that no item detracted from overall scale functioning. HSCL-20 items assessing overeating, poor appetite, and sexual interest were poorly correlated with other items and with the total scale score. A positive, moderate strength relationship was found between the instruments (r=0.54, p<0.0001). Exploratory factor analysis of the HSCL-20 yielded a six-factor structure, which accounted for almost 63% of the variance in total score. The largest contribution to common variance in the scale was provided by an "anxiety and self-reproach" factor. CONCLUSIONS: PHQ-9 and HSCL-20 total scores were moderately correlated. Although the HSCL-20 is utilized as a measure of depression severity, it may lack sufficient specificity to be an accurate reflection of depression status per se.     

A randomised controlled trial to test the feasibility of a collaborative care model for the management of depression in older people

BACKGROUND: Depression is the most common mental health disorder in people aged over 65 years. Late-life depression is associated with chronic illness and disability. AIM: To investigate the feasibility of a collaborative care model for depression in older people in a primary care setting. DESIGN OF STUDY: Randomised controlled trial with 16-weeks follow up. SETTING: A primary care trust in Manchester. METHOD: Participants were 105 people aged 60 years or older who scored 5 or more on the Geriatric Depression Scale; 53 were randomly allocated to an intervention group and 52 to a usual care group. The intervention group received care managed by a community psychiatric nurse who delivered an intervention comprising a facilitated self-help programme with close liaison with primary care professionals and old-age psychiatry according to a defined protocol. The usual care group received usual GP care. A nested qualitative study explored the views of the health professionals and patients regarding the acceptability and effectiveness of the intervention. RESULTS: The main outcome measure was recovery from depression. Patients in the intervention group were less likely to suffer from major depressive disorder at follow up compared with usual care (0.32, 95% confidence = interval = 0.11 to 0.93, P = 0.036). The qualitative component of the study demonstrated the acceptability of the intervention to patients. CONCLUSION: A model of collaborative care for older people with depression, used in a primary care setting with a facilitated self-help intervention is more effective than usual GP care. This study demonstrates that the implementation of a collaborative care model is feasible in UK primary care and that the intervention is effective and acceptable to patients.     

How important are Phase 1 interventions for complex interpersonal trauma? A pilot randomized control trial of a group psychoeducational intervention

Although psychoeducational interventions are recommended as Phase 1 interventions for complex trauma, there is limited evidence on their efficacy. This pilot randomized control trial (RCT) investigated the efficacy of a pure psychoeducational intervention for complex trauma. A brief 10‐session intervention was delivered to n = 44 female prisoners in a compressed format to accommodate short sentence lengths and was compared with usual care (n = 42). Results from an intent‐to‐treat (ITT) analysis indicated that there were no statistically significant differences between the two arms across the three assessment time points (including 1‐month postintervention) for the main outcomes (Behavioural Assessment Checklist‐Revised, β = 4.60, 95% CI [?1.60, 10.88], p = .148; posttraumatic stress disorder [PTSD] Checklist, β = ?1.47, 95% CI [?4.30, 1.36], p = .303). Post hoc reliable change analyses suggested twice the number of adequate dose participants made progress in addressing PTSD symptoms compared with usual care (30.3% vs. 17.6%, OR 2.03, 95% CI [.64, 6.43]). Although further work in this area is required, initial results, overall, suggest that psychoeducational group‐based treatment modalities achieve only small effect sizes in comparison with usual care.     

Successful GP intervention with frequent attenders in primary care: randomised controlled trial.

BACKGROUND: Frequent attenders to GP clinics can place an unnecessary burden on primary care. Interventions to reduce frequent attendance have had mixed results. AIM: To assess the effectiveness of a GP intervention to reduce frequent-attender consultations. DESIGN OF STUDY: Randomised controlled trial with frequent attenders divided into an intervention group and two control groups (one control group was seen by GPs also providing care to patients undergoing the intervention). SETTING: A health centre in southern Spain. METHOD: Six GPs and 209 randomly-selected frequent attenders participated. Three GPs were randomly allocated to perform the new intervention: of the 137 frequent attenders registered with these three GPs, 66 were randomly allocated to receive the intervention (IG) and 71 to a usual care control group (CG2). The other three GPs offered usual care to the other 72 frequent attenders (CG1). The main outcome measure was the total number of consultations 1 year post-intervention. Baseline measurements were recorded of sociodemographic characteristics, provider-user interface, chronic illnesses, and psychosocial variables. GPs allocated to the new intervention received 15 hours' training which incorporated biopsychosocial, organisational, and relational approaches. After 1 year of follow-up frequent attenders were contacted. An intention-to-treat analysis was used. RESULTS: A multilevel model was built with three factors: time, patient, and doctor. After adjusting for covariates, the mean number of visits at 1 year in IG was 13.10 (95% confidence interval [CI]=11.39 to 14.94); in the CG1 group was 19.37 (95% CI=17.31 to 21.55); and in the CG2 group this was 16.72 (95% CI=4.84 to 18.72). CONCLUSION: The new intervention with GPs resulted in a significant and relevant reduction in frequent-attender consultations. Although further trials are needed, this intervention is recommended to GPs interested in reducing consultations by their frequent attenders.     

A Web-Based Program Improves Physical Activity Outcomes in a Primary Care Angina Population: Randomized Controlled Trial

Background

Angina affects more than 50 million people worldwide. Secondary prevention interventions such as cardiac rehabilitation are not widely available for this population. An Internet-based version could offer a feasible alternative.

Objective

Our aim was to examine the effectiveness of a Web-based cardiac rehabilitation program for those with angina.

Methods

We conducted a randomized controlled trial, recruiting those diagnosed with angina from general practitioners (GPs) in primary care to an intervention or control group. Intervention group participants were offered a 6-week Web-based rehabilitation program (“ActivateYourHeart”). The program was introduced during a face-to-face appointment and then delivered via the Internet (no further face-to-face contact). The program contained information about the secondary prevention of coronary heart disease (CHD) and set each user goals around physical activity, diet, managing emotions, and smoking. Performance against goals was reviewed throughout the program and goals were then reset/modified. Participants completed an online exercise diary and communicated with rehabilitation specialists through an email link/synchronized chat room. Participants in the control group continued with GP treatment as usual, which consisted of being placed on a CHD register and attending an annual review. Outcomes were measured at 6-week and 6-month follow-ups during face-to-face assessments. The primary outcome measure was change in daily steps at 6 weeks, measured using an accelerometer. Secondary outcome measures were energy expenditure (EE), duration of sedentary activity (DSA), duration of moderate activity (DMA), weight, diastolic/systolic blood pressure, and body fat percentage. Self-assessed questionnaire outcomes included fat/fiber intake, anxiety/depression, self-efficacy, and quality of life (QOL).

Results

A total of 94 participants were recruited and randomized to the intervention (n=48) or the usual care (n=46) group; 84 and 73 participants completed the 6-week and 6-month follow-ups, respectively. The mean number of log-ins to the program was 18.68 (SD 13.13, range 1-51), an average of 3 log-ins per week per participant. Change in daily steps walked at the 6-week follow-up was +497 (SD 2171) in the intervention group and –861 (SD 2534) in the control group (95% CI 263-2451, P=.02). Significant intervention effects were observed at the 6-week follow-up in EE (+43.94 kcal, 95% CI 43.93-309.98, P=.01), DSA (–7.79 minutes, 95% CI –55.01 to –7.01, P=.01), DMA (+6.31 minutes, 95% CI 6.01-51.20, P=.01), weight (–0.56 kg, 95% CI –1.78 to –0.15, P=.02), self-efficacy (95% CI 0.30-4.79, P=.03), emotional QOL score (95% CI 0.01-0.54, P=.04), and angina frequency (95% CI 8.57-35.05, P=.002). Significant benefits in angina frequency (95% CI 1.89-29.41, P=.02) and social QOL score (95% CI 0.05-0.54, P=.02) were also observed at the 6-month follow-up.

Conclusions

An Internet-based secondary prevention intervention could be offered to those with angina. A larger pragmatic trial is required to provide definitive evidence of effectiveness and cost-effectiveness.

Trial Registration

International Standard Randomized Controlled Trial Number (ISRCTN): 90110503; http://www.controlled-trials.com/ISRCTN90110503/ISRCTN90110503 (Archived by WebCite at http://www.webcitation.org/6RYVOQFKM).     

Comparing the effectiveness of home visiting paraprofessionals and mental health professionals delivering a postpartum depression preventive intervention: a cluster-randomized non-inferiority clinical trial

To determine whether pregnant women receiving the Mothers and Babies group–based intervention exhibited greater depressive symptom reductions and fewer new cases of major depression than women receiving usual community-based services, and to examine whether groups run by paraprofessional home visitors and mental health professionals yielded similar depressive symptom reductions and prevention of major depression. Using a cluster-randomized design, 37 home visiting programs were randomized to usual home visiting, Mothers and Babies delivered via home visiting paraprofessionals, or Mothers and Babies delivered via mental health professionals. Baseline assessments were conducted prenatally with follow-up extending to 24 weeks postpartum. Eligibility criteria were ≥ 16 years old, ≤ 33 gestation upon referral, and Spanish/English speaking. Depressive symptoms at 24 weeks postpartum was the primary outcome. Eight hundred seventy-four women were enrolled. Neither intervention arm was superior to usual care in decreasing depressive symptoms across the sample (p = 0.401 home visiting paraprofessional vs. control; p = 0.430 mental health professional vs. control). Post hoc analyses suggest a positive intervention effect for women exhibiting mild depressive symptoms at baseline. We have evidence of non-inferiority, as the model-estimated mean difference in depressive symptoms between intervention arms (0.01 points, 95% CI: −0.79, 0.78) did not surpass our pre-specified margin of non-inferiority of two points. Although we did not find statistically significant differences between intervention and control arms, non-inferiority analyses found paraprofessional home visitors generated similar reductions in depressive symptoms as mental health professionals. Additionally, Mothers and Babies appears to reduce depressive symptoms among women with mild depressive symptoms when delivered by mental health professionals. This trial is registered on ClinicalTrials.gov (initial post: December 1, 2016; identifier: NCT02979444).

     

PHASE: a randomised, controlled trial of supervised self-help cognitive behavioural therapy in primary care.

BACKGROUND: Common mental health problems account for up to 40% of all general practitioner (GP) consultations. Patients have limited access to evidence-based psychological therapies. Cognitive behavioural therapy self-help strategies offer one potential solution. AIM: To determine differences in clinical outcome, patient satisfaction and costs, between a cognitive behavioural-based self-help package facilitated by practice nurses compared to ordinary care by GPs for mild to moderate anxiety and depression. DESIGN OF STUDY: Randomised controlled trial. SETTING: Seventeen primary healthcare teams. METHOD: Patients presenting to their GP with mild to moderate anxiety and/or depression were recruited to the study and randomised to receive either a self-help intervention facilitated by practice nurses or ordinary care. The self-help intervention consisted of up to three appointments: two 1 week apart and a third 3 months later. There were no restrictions on ordinary care. RESULTS: Intention-to-treat analysis showed that patients treated with practice nurse-supported cognitive behavioural therapy self-help attained similar clinical outcomes for similar costs and were more satisfied than patients treated by GPs with ordinary care. On-treatment analysis showed patients receiving the facilitated cognitive behavioural therapy self-help were more likely to be below clinical threshold at 1 month compared to the ordinary care group (odds ratio [OR] = 3.65, 95% confidence interval [CI] = 1.87 to 4.37). This difference was less well marked at 3 months (OR = 1.36, 95% CI = 0.52 to 3.56). CONCLUSION: Facilitated cognitive behavioural self-help may provide a short-term cost-effective clinical benefit for patients with mild to moderate anxiety and depression. This has the potential to help primary care provide a choice of effective psychological as well as pharmacological treatments for mental health problems.     

Cluster randomised controlled trial of an educational outreach visit to improve influenza and pneumococcal immunisation rates in primary care.

BACKGROUND: Improvement in the delivery of influenza and pneumococcal vaccinations to high-risk groups is an important aspect of preventive care for primary healthcare teams. AIM: To investigate the effect of an educational outreach visit to primary healthcare teams on influenza and pneumococcal vaccination uptake in high-risk patients. DESIGN: Cluster randomised controlled trial. SETTING: Thirty general practices in the Trent region, UK. METHODS: Fifteen practices were randomised to intervention and 15 to the control group after stratifying for baseline vaccination rate. All intervention practices were offered and received an educational outreach visit to primary healthcare teams, in addition to audit and feedback directed at improving influenza and pneumococcal vaccination rates in high-risk groups. Control practices received audit and feedback alone. All practices measured influenza and pneumococcal vaccination rates in high-risk groups. Primary outcomes were improvements in vaccination rates in patients aged 65 years and over, and patients with coronary heart disease (CHD), diabetes and a history of splenectomy. RESULTS: Improvements in pneumococcal vaccination rates in the intervention practices were significantly greater compared with controls in patients with CHD, 14.8% versus 6.5% (odds ratio [OR] = 1.23, 95% confidence interval [CI] = 1.13 to 1.34) and diabetes, 15.5% versus 6.8% (OR = 1.18, 95% CI = 1.08 to 1.29) but not splenectomy, 6.5% versus 4.7% (OR = 0.96, 95% CI = 0.65 to 1.42). Improvements for influenza vaccination were also usually greater in intervention practices but did not reach statistical significance. The increases for influenza vaccination in intervention versus control practices were for CHD, 18.1% versus 13.1% (OR = 1.06, 95% CI = 0.99 to 1.12); diabetes, 15.5% versus 12.0% (OR = 1.07, 95% CI = 0.99 to 1.16), splenectomy 16.1% versus 2.9% (OR = 1.22, 95% CI = 0.78 to 1.93); and those over 65 years 20.7% versus 25.4% (OR = 0.99, 95% CI = 0.96 to 1.02). CONCLUSION: Practices where primary care teams received an educational outreach visit demonstrated a significantly greater improvement in uptake in high-risk groups for pneumococcal but not influenza vaccine.     

Enhanced treatment for depression in primary care: long-term outcomes of a psycho-educational prevention program alone and enriched with psychiatric consultation or cognitive behavioral therapy

BACKGROUND: The long-term outcome of major depression is often unfavorable, and because most cases of depression are managed by general practitioners (GPs), this places stress on the need to improve treatment in primary care. This study evaluated the long-term effects of enhancing the GP's usual care (UC) with three experimental interventions. METHOD: A randomized controlled trial was conducted from 1998 to 2003. The main inclusion criterion was receiving GP treatment for a depressive episode. We compared: (1) UC (n=72) with UC enhanced with: (2) a psycho-educational prevention (PEP) program (n=112); (3) psychiatrist-enhanced PEP (n=37); and (4) brief cognitive behavioral therapy followed by PEP (CBT-enhanced PEP) (n=44). We assessed depression status quarterly during a 3-year follow-up. RESULTS: Pooled across groups, depressive disorder-free and symptom-free times during follow-up were 83% and 17% respectively. Almost 64% of the patients had a relapse or recurrence, the median time to recurrence was 96 weeks, and the mean Beck Depression Inventory (BDI) score over 12 follow-up assessments was 9.6. Unexpectedly, PEP patients had no better outcomes than UC patients. However, psychiatrist-enhanced PEP and CBT-enhanced PEP patients reported lower BDI severity during follow-up than UC patients [mean difference 2.07 (95% confidence interval (CI) 1.13-3.00) and 1.62 (95% CI 0.70-2.55) respectively] and PEP patients [2.37 (95% CI 1.35-3.39) and 1.93 (95% CI 0.92-2.94) respectively]. CONCLUSIONS: The PEP program had no extra benefit compared to UC and may even worsen outcome in severely depressed patients. Enhancing treatment of depression in primary care with psychiatric consultation or brief CBT seems to improve the long-term outcome, but findings need replication as the interventions were combined with the ineffective PEP program.