Effectiveness of a brief group behavioral intervention for common mental disorders in Syrian refugees in Jordan: A randomized controlled trial

BackgroundCommon mental disorders are frequently experienced by refugees. This study evaluates the impact of a brief, lay provider delivered group-based psychological intervention [Group Problem Management Plus (gPM+)] on the mental health of refugees in a camp, as well as on parenting behavior and children’s mental health.Methods and findingsIn this single-blind, parallel, randomized controlled trial, 410 adult Syrian refugees (300 females, 110 males) in Azraq Refugee Camp (Jordan) were identified through screening of psychological distress (≥16 on the Kessler Psychological Distress Scale) and impaired functioning (≥17 on the WHO Disability Assessment Schedule). Participants were randomly allocated to gPM+ or enhanced usual care (EUC) involving referral information for psychosocial services on a 1:1 ratio. Participants were aware of treatment allocation, but assessors were blinded to treatment condition. Primary outcomes were scores on the Hopkins Symptom Checklist-25 (HSCL; depression and anxiety scales) assessed at baseline, 6 weeks, and 3 months follow-up as the primary outcome time point. It was hypothesized that gPM+ would result in greater reductions of scores on the HSCL than EUC. Secondary outcomes were disability, posttraumatic stress, personally identified problems, prolonged grief, prodromal psychotic symptoms, parenting behavior, and children’s mental health. Between October 15, 2019 and March 2, 2020, 624 refugees were screened for eligibility, 462 (74.0%) screened positive, of whom 204 were assigned to gPM+ and 206 to EUC. There were 168 (82.4%) participants in gPM+ and 189 (91.7%) in EUC assessed at follow-up. Intent-to-treat analyses indicated that at follow-up, participants in gPM+ showed greater reduction on HSCL depression scale than those receiving EUC (mean difference, 3.69 [95% CI 1.90 to 5.48], p = .001; effect size, 0.40). There was no difference between conditions in anxiety (mean difference −0.56, 95% CI −2.09 to 0.96; p = .47; effect size, −0.03). Relative to EUC, participants in gPM+ had greater reductions in severity of personally identified problems (mean difference 0.88, 95% CI 0.07 to 1.69; p = .03), and inconsistent disciplinary parenting (mean difference 1.54, 95% CI 1.03 to 2.05; p < .001). There were no significant differences between conditions for changes in PTSD, disability, grief, prodromal symptoms, or childhood mental health outcomes. Mediation analysis indicated the change in inconsistent disciplinary parenting was associated with reduced attentional (β = 0.11, SE .07; 95% CI .003 to .274) and internalizing (β = 0.08, SE .05; 95% CI .003 to 0.19) problems in children. No adverse events were attributable to the interventions or the trial. Major limitations included only one-quarter of participants being male, and measures of personally identified problems, grief, prodromal psychotic symptoms, inconsistent parenting behavior, and children’s mental health have not been validated with Syrians.ConclusionsIn camp-based Syrian refugees, a brief group behavioral intervention led to reduced depressive symptoms, personally identified problems, and disciplinary parenting compared to usual care, and this may have indirect benefits for refugees’ children. The limited capacity of the intervention to reduce PTSD, disability, or children’s psychological problems points to the need for development of more effective treatments for refugees in camp settings.Trial registrationProspectively registered at Australian and New Zealand Clinical Trials Registry: ACTRN12619001386123.

Richard A. Bryant and colleagues evaluate effects of a lay provider-delivered intervention on adult Syrian refugees’ mental health, parenting behavior, and their children’s mental health.     

Effectiveness of a WHO self‐help psychological intervention for preventing mental disorders among Syrian refugees in Turkey: a randomized controlled trial

Refugees are at high risk of developing mental disorders. There is no evidence from randomized controlled trials (RCTs) that psychological interventions can prevent the onset of mental disorders in this group. We assessed the effectiveness of a self‐help psychological intervention developed by the World Health Organization, called Self‐Help Plus, in preventing the development of mental disorders among Syrian refugees experiencing psychological distress in Turkey. A two‐arm, assessor‐masked RCT was conducted in two Turkish areas. Eligible participants were adult Syrian refugees experiencing psychological distress (General Health Questionnaire ≥3), but without a diagnosis of mental disorder. They were randomly assigned either to the Self‐Help Plus arm (consisting of Self‐Help Plus combined with Enhanced Care as Usual, ECAU) or to ECAU only in a 1:1 ratio. Self‐Help Plus was delivered in a group format by two facilitators over five sessions. The primary outcome measure was the presence of any mental disorder assessed by the Mini International Neuropsychiatric Interview at six‐month follow‐up. Secondary outcome measures were the presence of mental disorders at post‐intervention, and psychological distress, symptoms of post‐traumatic stress disorder and depression, personally identified psychological outcomes, functional impairment, subjective well‐being, and quality of life at post‐intervention and six‐month follow‐up. Between October 1, 2018 and November 30, 2019, 1,186 refugees were assessed for inclusion. Five hundred forty‐four people were ineligible, and 642 participants were enrolled and randomly assigned to either Self‐Help Plus (N=322) or ECAU (N=320). Self‐Help Plus participants were significantly less likely to have any mental disorders at six‐month follow‐up compared to the ECAU group (21.69% vs. 40.73%; Cramer''s V = 0.205, p<0.001, risk ratio: 0.533, 95% CI: 0.408‐0.696). Analysis of secondary outcomes suggested that Self‐Help Plus was not effective immediately post‐intervention, but was associated with beneficial effects at six‐month follow‐up in terms of symptoms of depression, personally identified psychological outcomes, and quality of life. This is the first prevention RCT ever conducted among refugees experiencing psychological distress but without a mental disorder. Self‐Help Plus was found to be an effective strategy for preventing the onset of mental disorders. Based on these findings, this low‐intensity self‐help psychological intervention could be scaled up as a public health strategy to prevent mental disorders in refugee populations exposed to ongoing adversities.     

Effectiveness of a brief group behavioural intervention on psychological distress in young adolescent Syrian refugees: A randomised controlled trial

BackgroundMillions of young adolescents in low- and middle-income countries (LMICs) affected by humanitarian crises experience elevated rates of poor mental health. There is a need for scalable programs that can improve the mental health of young adolescents. This study evaluated the effectiveness of a nonspecialist delivered group-based intervention (Early Adolescent Skills for Emotions (EASE)) to improve young adolescents’ mental health.Methods and findingsIn this single-blind, parallel, controlled trial, Syrian refugees aged 10 to 14 years in Jordan were identified through screening of psychological distress as defined by scores ≥15 on the Paediatric Symptom Scale. Participants were randomised to either EASE or enhanced usual care (EUC) involving referral to local psychosocial services (on a 1:1.6 ratio). Participants were aware of treatment allocation but assessors were blinded. Primary outcomes were scores on the Paediatric Symptom Checklist (PSC; internalising, externalising, and attentional difficulty scales) assessed at week 0, 9 weeks, and 3 months after treatment (primary outcome time point). It was hypothesised that EASE would result in greater reductions on internalising symptoms than EUC. Secondary outcomes were depression, posttraumatic stress, well-being, functioning, school belongingness, and caregivers’ parenting and mental health. Between June 2019 and January 2020, 1,842 young adolescent refugees were screened for eligibility on the basis of psychological distress. There were 520 adolescents (28.2%) who screened positive, of whom 471 (90.6%) agreed to enter the trial. Overall, 185 were assigned to EASE and 286 to EUC, and 169 and 254 were retained at 3 months for EASE and EUC, respectively. Intent-to-treat analyses indicated that at 3 months, EASE resulted in greater reduction on the PSC-internalising scale than EUC (estimated mean difference 0.69, 95% CI 0.19 to 1.19; p = 0.007; effect size, 0.38) but there were no differences for PSC-externalising (estimated mean difference 0.24, 95% CI −0.43 to 0.91; p = 0.49; effect size, −0.10), PSC-attentional problem (estimated mean difference −0.01, 95% CI −0.51 to 0.54; p = 0.97; effect size, −0.01) scores, or on depression, posttraumatic stress, well-being, functioning, or school belongingness. Relative to EUC, caregivers in EASE had less psychological distress (estimated mean difference 1.95, 95% CI 0.71 to 3.19; p = 0.002) and inconsistent disciplinary parenting (mean difference 1.54, 95% CI 1.03 to 2.05; p < 0.001). Secondary analyses that (a) focused on adolescents with probable internalising disorders; (b) completed the 3-month assessment; and (c) controlled for trauma exposure did not alter the primary results. Mediation analysis indicated that for caregivers in the EASE condition, reduction in inconsistent disciplinary parenting was associated with reduced attentional (β = 0.11, SE 0.07; 95% CI 0.003, 0.274) and internalising (β = 0.11, SE 0.07; 95% CI 0.003, 0.274) problems in their children. No adverse events were attributable to the intervention. A limitation was that EUC was not matched to EASE in terms of facilitator attention or group involvement.ConclusionsEASE led to reduced internalising problems in young refugee adolescents and was associated with reduced distress and less inconsistent disciplinary parenting in caregivers. This intervention has the potential as a scalable intervention to mitigate young adolescents’ emotional difficulties in LMIC.Trial registrationProspectively registered at Australian and New Zealand Clinical Trials Registry: ACTRN12619000341123.

In a randomized controlled trial, Richard A. Bryant and colleagues study the effectiveness of the Early Adolescent Skills for Emotions (EASE) intervention to improve the mental health of Syrian refugees aged 10-14 years living in Jordan.     

A randomized controlled trial of a personalized feedback intervention for problem gamblers

Background

Personalized feedback is a promising self-help for problem gamblers. Such interventions have shown consistently positive results with other addictive behaviours, and our own pilot test of personalized normative feedback materials for gamblers yielded positive findings. The current randomized controlled trial evaluated the effectiveness, and the sustained efficacy, of the personalized feedback intervention materials for problem gamblers.

Methodology/Principal Findings

Respondents recruited by a general population telephone screener of Ontario adults included gamblers with moderate and severe gambling problems. Those who agreed to participate were randomly assigned to receive: 1) the full personalized normative feedback intervention; 2) a partial feedback that contained all the feedback information provided to those in condition 1 but without the normative feedback content (i.e., no comparisons provided to general population gambling norms); or 3) a waiting list control condition. The primary hypothesis was that problem gamblers who received the personalized normative feedback intervention would reduce their gambling more than problem gamblers who did not receive any intervention (waiting list control condition) by the six-month follow-up.

Conclusions/Significance

The study found no evidence for the impact of normative personalized feedback. However, participants who received, the partial feedback (without norms) reduced the number of days they gambled compared to participants who did not receive the intervention. We concluded that personalized feedback interventions were well received and the materials may be helpful at reducing gambling. Realistically, it can be expected that the personalized feedback intervention may have a limited, short term impact on the severity of participants'' problem gambling because the intervention is just a brief screener. An Internet-based version of the personalized feedback intervention tool, however, may offer an easy to access and non-threatening portal that can be used to motivate participants to seek further help online or in person.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00578357","term_id":"NCT00578357"}}NCT00578357     

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

ABSTRACT: 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.     

Effects of internet-based guided self-help problem-solving therapy for adolescents with depression and anxiety: a randomized controlled trial

Background

Symptoms of depression and anxiety are highly prevalent in adolescence and they are the cause of considerable suffering. Even so, adolescents are not inclined to seek professional help for emotional problems. Internet-based preventive interventions have been suggested as a feasible method of providing appropriate care to adolescents with internalizing symptoms. The objective of this study was to evaluate the effects of preventive Internet-based (guided) self-help problem-solving therapy (PST) for adolescents reporting mild to moderate symptoms of depression and/or anxiety as compared to a waiting list control group (WL).

Methodology/Principal Findings

A total of 45 participants were randomized to the 2 conditions. PST consisted of 5 weekly lessons. Participants were supported by e-mail. Self-report measures of depression and anxiety were filled in at baseline and after 3 weeks, 5 weeks, and 4 months. Of the 45 participants, 28 (62.2%) completed questionnaires after 3 weeks, 28 (62.2%) after 5 weeks, and 27 (60%) after 4 months. Hierarchical linear modeling analyses revealed overall improvement over time for both groups on depressive and anxiety symptoms. However, no significant group x time interactions were found. No differences were found between completers and non-completers.

Conclusions/Significance

Results show that depressive and anxiety symptoms declined in both groups. No support was found, however, for the assumption that Internet-based PST was efficacious in reducing depression and anxiety in comparison to the waiting list control group. This finding could represent lack of power.

Trial Registration

Netherlands Trial Register NTR1322     

Effects of an educational intervention for general practitioners in adolescent health care principles: a randomized controlled study

Objective To evaluate the effectiveness of an educational intervention in adolescent health designed for general practitioners, in accordance with evidence-based practice in continuing medical education. Design Randomized, controlled trial with baseline testing and 7- and 13-month follow-ups. Setting The intervention was delivered in local community settings to general practitioners in metropolitan Melbourne, Australia. Participants A total of 108 self-selected general practitioners. Intervention A multifaceted educational program (2.5 hours per week for 6 weeks) in the principles of adolescent health care, followed 6 weeks later by a 2-hour session of case discussion and debriefing. Outcome measures Objective ratings of videotaped consultations with standardized adolescent patients and self-completion questionnaires were used to measure general practitioners' knowledge, skill, and self-perceived competency; satisfaction with the program; and self-reported change in practice. Results 103 of 108 physicians (95%) completed all phases of the intervention and evaluation protocol. The intervention group showed significantly greater improvements than the control group in all outcomes at the 7-month follow-up (all subjects P<0.03), except for the standardized patients' rating of rapport and satisfaction (P=0.12). 104 participants (96%) found the program appropriate and relevant. At the 13-month follow-up, most improvements were sustained, the standardized patients' rating of confidentiality fell slightly, and the objective assessment of competence further improved. 106 physicians (98%) reported a change in practice attributable to the intervention. Conclusions General practitioners were willing to complete continuing medical education in adolescent health and its evaluation. The design of the intervention, using evidence-based educational strategies, proved effective and expeditious in achieving sustainable and large improvements in knowledge, skill, and self-perceived competency.     

Telephone cognitive-behavioral therapy for subthreshold depression and presenteeism in workplace: a randomized controlled trial

Background

Subthreshold depression is highly prevalent in the general population and causes great loss to society especially in the form of reduced productivity while at work (presenteeism). We developed a highly-structured manualized eight-session cognitive-behavioral program with a focus on subthreshold depression in the workplace and to be administered via telephone by trained psychotherapists (tCBT).

Methods

We conducted a parallel-group, non-blinded randomized controlled trial of tCBT in addition to the pre-existing Employee Assistance Program (EAP) versus EAP alone among workers with subthreshold depression at a large manufacturing company in Japan. The primary outcomes were depression severity as measured with Beck Depression Inventory-II (BDI-II) and presenteeism as measured with World Health Organization Health and Work Productivity Questionnaire (HPQ). In the course of the trial the follow-up period was shortened in order to increase acceptability of the study.

Results

The planned sample size was 108 per arm but the trial was stopped early due to low accrual. Altogether 118 subjects were randomized to tCBT+EAP (n = 58) and to EAP alone (n = 60). The BDI-II scores fell from the mean of 17.3 at baseline to 11.0 in the intervention group and to 15.7 in the control group after 4 months (p<0.001, Effect size = 0.69, 95%CI: 0.32 to 1.05). However, there was no statistically significant decrease in absolute and relative presenteeism (p = 0.44, ES = 0.15, −0.21 to 0.52, and p = 0.50, ES = 0.02, −0.34 to 0.39, respectively).

Conclusion

Remote CBT, including tCBT, may provide easy access to quality-assured effective psychotherapy for people in the work force who present with subthreshold depression. Further studies are needed to evaluate the effectiveness of this approach in longer terms. The study was funded by Sekisui Chemicals Co. Ltd.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00885014","term_id":"NCT00885014"}}NCT00885014     

Psychoanalytic and cognitive-behavior therapy of chronic depression: study protocol for a randomized controlled trial

ABSTRACT: BACKGROUND: Despite limited effectiveness of short-term psychotherapy for chronic depression, there is a lack of trials of long-term psychotherapy. Our study is the first to determine the effectiveness of controlled long-term psychodynamic and cognitive-behavioral (CBT) treatments and to assess the effects of preferential vs. randomized assessment. Methods / Design: Patients are assigned to treatment according to their preference or randomized (if they have no clear preference). Up to 80 sessions of psychodynamic or psychoanalytically oriented treatments (PAT) or up to 45 sessions of CBT are offered during the first year in the study. After the first year, PAT can be continued according to the "naturalistic", usual way of treating such patients within the system of German health care system (normally 240 up to 300 sessions), CBT therapists may extend their treatment up to 80 sessions, but focus mainly on maintenance and relapse prevention. We plan to recruit a total of 240 patients (60 per arm). A total of 11 assessments are conducted throughout treatment and up to 3 years after initiation of treatment. The primary outcome measures are the QIDS (independent clinician rating) and the BDI after year 1, 2 and 3. DISCUSSION: We combine an RCT and a naturalistic approach in order to investigate, how effectively chronic depression can be treated on an outpatient basis by the two forms of treatment reimbursed in the German health care system and we will determine the effects of treatment preference vs. randomization.     

Alzheimer's disease multiple intervention trial (ADMIT): study protocol for a randomized controlled clinical trial

ABSTRACT: BACKGROUND: Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer's disease reduces patients' neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects' functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged [greater than or equal to]45 years who are diagnosed with possible or probable Alzheimer's disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study.Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer's disease compared to subjects treated in the control group. Outcomes The primary outcome is the Alzheimer's Disease Cooperative Studies Group Activities of Daily Living Scale; secondary outcome measures are two performance-based measures including the Short Physical Performance Battery and Short Portable Sarcopenia Measure. Outcome assessments for both the caregiver-reported scale and subjects' physical performance scales are completed in the subject's home. Randomization Eligible patient-care giver dyads will be stratified by clinic type and block randomized with a computer developed randomization scheme using a 1:1 allocation ratio. Blinding Single blinded. Research assistants completing the outcome assessments were blinded to the subjects' treatment group. Trial status Ongoing ClinicalTrial.Gov identifier NCT01314950; date of completed registration 10 March 2011; date first patient randomized 9 March 2011.     

Effects of preconception lifestyle intervention in infertile women with obesity: The FIT-PLESE randomized controlled trial

BackgroundWomen with obesity and infertility are counseled to lose weight prior to conception and infertility treatment to improve pregnancy rates and birth outcomes, although confirmatory evidence from randomized trials is lacking. We assessed whether a preconception intensive lifestyle intervention with acute weight loss is superior to a weight neutral intervention at achieving a healthy live birth.Methods and findingsIn this open-label, randomized controlled study (FIT-PLESE), 379 women with obesity (BMI ≥ 30 kg/m²) and unexplained infertility were randomly assigned in a 1:1 ratio to 2 preconception lifestyle modification groups lasting 16 weeks, between July 2015 and July 2018 (final follow-up September 2019) followed by infertility therapy. The primary outcome was the healthy live birth (term infant of normal weight without major anomalies) incidence. This was conducted at 9 academic health centers across the United States. The intensive group underwent increased physical activity and weight loss (target 7%) through meal replacements and medication (Orlistat) compared to a standard group with increased physical activity alone without weight loss. This was followed by standardized empiric infertility treatment consisting of 3 cycles of ovarian stimulation/intrauterine insemination. Outcomes of any resulting pregnancy were tracked. Among 191 women randomized to standard lifestyle group, 40 dropped out of the study before conception; among 188 women randomized to intensive lifestyle group, 31 dropped out of the study before conception. All the randomized women were included in the intent-to-treat analysis for primary outcome of a healthy live birth. There were no significant differences in the incidence of healthy live births [standard 29/191(15.2%), intensive 23/188(12.2%), rate ratio 0.81 (0.48 to 1.34), P = 0.40]. Intensive had significant weight loss compared to standard (−6.6 ± 5.4% versus −0.3 ± 3.2%, P < 0.001). There were improvements in metabolic health, including a marked decrease in incidence of the metabolic syndrome (baseline to 16 weeks: standard: 53.6% to 49.4%, intensive 52.8% to 32.2%, P = 0.003). Gastrointestinal side effects were significantly more common in intensive. There was a higher, but nonsignificant, first trimester pregnancy loss in the intensive group (33.3% versus 23.7% in standard, 95% rate ratio 1.40, 95% confidence interval [CI]: 0.79 to 2.50). The main limitations of the study are the limited power of the study to detect rare complications and the design difficulty in finding an adequate time matched control intervention, as the standard exercise intervention may have potentially been helpful or harmful.ConclusionsA preconception intensive lifestyle intervention for weight loss did not improve fertility or birth outcomes compared to an exercise intervention without targeted weight loss. Improvement in metabolic health may not translate into improved female fecundity.Trial registrationClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT02432209","term_id":"NCT02432209"}}NCT02432209.

Richard Legro and colleagues investigate the impact of a preconception weight loss intervention on healthy live birth rates in women with obesity and unexplained infertility.     

A therapeutic application of the experience sampling method in the treatment of depression: a randomized controlled trial

In depression, the ability to experience daily life positive affect predicts recovery and reduces relapse rates. Interventions based on the experience sampling method (ESM-I) are ideally suited to provide insight in personal, contextualized patterns of positive affect. The aim of this study was to examine whether add-on ESM-derived feedback on personalized patterns of positive affect is feasible and useful to patients, and results in a reduction of depressive symptomatology. Depressed outpatients (n=102) receiving pharmacological treatment participated in a randomized controlled trial with three arms: an experimental group receiving add-on ESM-derived feedback, a pseudo-experimental group participating in ESM but receiving no feedback, and a control group. The experimental group participated in an ESM procedure (three days per week over a 6-week period) using a palmtop. This group received weekly standardized feedback on personalized patterns of positive affect. Hamilton Depression Rating Scale – 17 (HDRS) and Inventory of Depressive Symptoms (IDS) scores were obtained before and after the intervention. During a 6-month follow-up period, five HDRS and IDS assessments were completed. Add-on ESM-derived feedback resulted in a significant and clinically relevant stronger decrease in HDRS score relative to the control group (p<0.01; −5.5 point reduction in HDRS at 6 months). Compared to the pseudo-experimental group, a clinically relevant decrease in HDRS score was apparent at 6 months (B=−3.6, p=0.053). Self-reported depressive complaints (IDS) yielded the same pattern over time. The use of ESM-I was deemed acceptable and the provided feedback easy to understand. Patients attempted to apply suggestions from ESM-derived feedback to daily life. These data suggest that the efficacy of traditional passive pharmacological approach to treatment of major depression can be enhanced by using person-tailored daily life information regarding positive affect.     

A benefit-finding intervention for family caregivers of persons with Alzheimer disease: study protocol of a randomized controlled trial

Background

Patients with ST-elevation myocardial infarction (STEMI) not treated with primary or rescue percutaneous coronary intervention (PCI) are at risk for recurrent ischemia, especially when viability in the infarct-area is present. Therefore, an invasive strategy with PCI of the infarct-related coronary artery in patients with viability would reduce the occurrence of a composite end point of death, reinfarction, or unstable angina (UA).

Methods

Patients admitted with an (sub)acute myocardial infarction, who were not treated by primary or rescue PCI, and who were stable during the first 48 hours after the acute event, were screened for the study. Eventually, we randomly assigned 216 patients with viability (demonstrated with low-dose dobutamine echocardiography) to an invasive or a conservative strategy. In the invasive strategy stenting of the infarct-related coronary artery was intended with abciximab as adjunct treatment. Seventy-five (75) patients without viability served as registry group. The primary endpoint was the composite of death from any cause, recurrent myocardial infarction (MI) and unstable angina at one year. As secondary endpoint the need for (repeat) revascularization procedures and anginal status were recorded.

Results

The primary combined endpoint of death, recurrent MI and unstable angina was 7.5% (8/106) in the invasive group and 17.3% (19/110) in the conservative group (Hazard ratio 0.42; 95% confidence interval [CI] 0.18-0.96; p = 0.032). During follow up revascularization-procedures were performed in 6.6% (7/106) in the invasive group and 31.8% (35/110) in the conservative group (Hazard ratio 0.18; 95% CI 0.13-0.43; p < 0.0001). A low rate of recurrent ischemia was found in the non-viable group (5.4%) in comparison to the viable-conservative group (14.5%). (Hazard-ratio 0.35; 95% CI 0.17-1.00; p = 0.051).

Conclusion

We demonstrated that after acute MI (treated with thrombolysis or without reperfusion therapy) patients with viability in the infarct-area benefit from a strategy of early in-hospital stenting of the infarct-related coronary artery. This treatment results in a long-term uneventful clinical course. The study confirmed the low risk of recurrent ischemia in patients without viability.

Trial registration

ClinicalTrials.gov: NCT00149591.     

Effect of educational intervention on medication timing in Parkinson's disease: a randomized controlled trial

Background  

Medicine usage in Parkinson's disease patients is often imperfect, in particular irregular timing of medication. The effect of informing Parkinson's disease patients about the continuous dopaminergic hypothesis (to encourage regular medicine intake) on medication adherence and motor control was tested.     

Acupuncture for migraine prophylaxis: a randomized controlled trial

Background:

Acupuncture is commonly used to treat migraine. We assessed the efficacy of acupuncture at migraine-specific acupuncture points compared with other acupuncture points and sham acupuncture.

Methods:

We performed a multicentre, single-blind randomized controlled trial. In total, 480 patients with migraine were randomly assigned to one of four groups (Shaoyang-specific acupuncture, Shaoyang-nonspecific acupuncture, Yangming-specific acupuncture or sham acupuncture [control]). All groups received 20 treatments, which included electrical stimulation, over a period of four weeks. The primary outcome was the number of days with a migraine experienced during weeks 5–8 after randomization. Our secondary outcomes included the frequency of migraine attack, migraine intensity and migraine-specific quality of life.

Results:

Compared with patients in the control group, patients in the acupuncture groups reported fewer days with a migraine during weeks 5–8, however the differences between treatments were not significant (p > 0.05). There was a significant reduction in the number of days with a migraine during weeks 13–16 in all acupuncture groups compared with control (Shaoyang-specific acupuncture v. control: difference –1.06 [95% confidence interval (CI) –1.77 to –0.5], p = 0.003; Shaoyang-nonspecific acupuncture v. control: difference –1.22 [95% CI –1.92 to –0.52], p < 0.001; Yangming-specific acupuncture v. control: difference –0.91 [95% CI –1.61 to –0.21], p = 0.011). We found that there was a significant, but not clinically relevant, benefit for almost all secondary outcomes in the three acupuncture groups compared with the control group. We found no relevant differences between the three acupuncture groups.

Interpretation:

Acupuncture tested appeared to have a clinically minor effect on migraine prophylaxis compared with sham acupuncture.

Trial Registration:

Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00599586","term_id":"NCT00599586"}}NCT00599586About 6%–8% of men and 16%–18% of women in the United States and England experience migraines, with or without an aura.^1,2 A prevalence of 1% has been reported in mainland China,³ compared with 4.7% in Hong Kong and 9.1% in Taiwan.^4,5 A recent Cochrane meta-analysis suggests that acupuncture as migraine prophylaxis is safe and effective and should be considered as a treatment option for willing patients.⁶Although the specific effects acupuncture are controversial, acupuncture, as it is currently practised, clearly differentiates between real acupuncture points and nonacupuncture points. The Chinese Government launched the National Basic Research Program to obtain more data about the specificity of acupuncture points.⁷Trials from Italy and Brazil^8,9 showed that acupuncture was more effective than sham acupuncture in preventing migraines, but other trials have reported no differences.^10–13 There is no evidence that one acupuncture strategy is more effective than another for treating migraines. According to acupuncture theory, a headache on the lateral side is usually defined as a Shaoyang headache. In Jinkuiyi,¹⁴ migraines are said to affect the yang meridians (including the Taiyang, Yangming and Shaoyang meridians). In Lingshu,¹⁵ the Shaoyang meridians are said to go through the lateral side of the body, therefore the Shaoyang meridians are thought to be superior for treating migraines. Some points on the Shaoyang meridians are regarded as being more specific for migraines than other points.¹⁶Our aim was to investigate whether acupuncture at specific acupuncture points was more efficacious in preventing migraine than sham acupuncture at nonacupuncture points. We also investigated whether the efficacy varied when acupuncture points along different meridians or points along the same meridian were used.     

Preoperative lifestyle intervention in bariatric surgery: Initial results from a randomized,controlled trial

Objective:

To document preoperative outcomes of a behavioral lifestyle intervention delivered to patients prior to bariatric surgery in comparison to treatment as usual (insurance‐mandated physician supervised diet).

Design and Methods:

After completing a baseline assessment, candidates for surgery were randomized to a 6‐month, evidence‐informed, manualized lifestyle intervention (LIFESTYLE, n = 121) or to preoperative care as usual (USUAL CARE, n = 119). At 6 months, 187 participants remained candidates for bariatric surgery and were included in the analyses.

Results:

LIFESTYLE participants lost significantly more weight than those receiving USUAL CARE [8.3 ± 7.8 kg vs. 3.3 ± 5.5 kg, F(1,183) = 23.6, P < 0.0001], with an effect size of 0.72. Additionally, logistic regression modeling indicated that LIFESTYLE patients were significantly more likely to lose at least 5% of initial body weight than those in USUAL CARE [OR (95% CI) = 2.94 (1.253, 6.903)], as were participants who were heavier [OR (95% CI) = 1.07 (1.001‐1.14) for each unit increase in BMI] or with larger improvements in eating behaviors [OR (95% CI) = 1.1 (1.049, 1.145) for each unit increase on the Eating Behavior Inventory).

Conclusions:

A behavioral lifestyle intervention for severely overweight individuals leads to clinically significant weight loss prior to bariatric surgery. Post‐surgery follow‐up will allow us to examine the impact of the preoperative intervention on postoperative outcomes.