Study protocol for a multisite randomized controlled trial of an internet and mobile‐based intervention for preventing and reducing perinatal depressive symptoms

Nearly 20% of women in the United States experience clinically significant depressive symptoms during pregnancy or the postpartum period. These women may benefit from easily accessible, nonpharmacologic, and inexpensive self‐management approaches, such as via internet and mobile‐based interventions, to prevent development of symptoms and/or intervene with current symptoms. This paper summarizes the research protocol of a nationally‐funded large‐scale randomized controlled study to evaluate “Mamma Mia,” a self‐guided program with 44 modules that women use throughout pregnancy to 6 months postpartum. The program contains a novel combination of components designed to enable women to enhance self‐efficacy, emotional self‐regulation, and perceived social support. The overall goal of this three‐arm longitudinal randomized controlled trial is to evaluate the effects and mechanisms of this self‐management approach in diverse women in the U.S. (n = 1950). Enrolled pregnant women will be randomly assigned to one of three groups: (1) “Mamma Mia” alone, which is self‐guided; (2) “Mamma Mia Plus” in which participants engage in the “Mamma Mia” modules plus receive brief guided support from a registered nurse; or (3) usual prenatal/postpartum care. The first specific aim is to evaluate effects by group on the primary outcome of interest, depressive symptoms, over time. The second aim is to evaluate effects by group on subjective well‐being, anxiety, and stress. Using a conceptual framework based upon Individual and Family Self‐Management Theory, the third aim is to evaluate possible mediators (self‐efficacy, emotion self‐regulation, perceived support) and possible moderators (e.g., race/ethnicity, type of healthcare clinician) of this self‐management approach.     

A preoperative education intervention to reduce anxiety and improve recovery among Chinese cardiac patients: a randomized controlled trial

BackgroundPatients awaiting cardiac surgery typically experience significant physical and psychological stress. However, although there is evidence that preoperative education interventions can lead to positive postoperative outcomes for surgical patients in general, less is known about the effectiveness among patients undergoing cardiac surgery, especially Chinese cardiac patients.ObjectivesTo determine whether a preoperative education intervention designed for Chinese cardiac patients can reduce anxiety and improve recovery.DesignRandomized controlled trial.SettingsCardiac surgical wards of two public hospitals in Luoyang, China.Methods153 adult patients undergoing cardiac surgery were randomized into the trial, 77 to a usual care control group and 76 to preoperative education group comprising usual care plus an information leaflet and verbal advice. Measurement was conducted before randomization and at seven days following surgery. The primary outcome was change in anxiety measured by the Hospital Anxiety and Depression Scale (HADS). Secondary outcomes were change in depression (HADS), change in pain as measured by subscales of the Brief Pain Inventory-short form (BPI-sf), length of Intensive Care Unit stay and postoperative hospital stay.ResultsOf 153 participants randomized, 135 (88.2%) completed the trial. Participants who received preoperative education experienced a greater decrease in anxiety score (mean difference ?3.6 points, 95% confidence interval ?4.62 to ?2.57; P < 0.001) and a greater decrease in depression score (mean difference ?2.1 points, 95% CI ?3.19 to ?0.92; P < 0.001) compared with those who did not. There was no difference between groups in average pain, current pain, and interference in general activity, mood and walking ability. Patients randomized to the preoperative education group reported less interference from pain in sleeping (mean difference ?0.9 points, 95% CI ?1.63 to ?0.16; P = 0.02). There was some evidence to suggest a reduced number of hours spent in the Intensive Care Unit among preoperative education patients (P = 0.05) but no difference in length of postoperative hospital stay (P = 0.17).ConclusionsThis form of preoperative education is effective in reducing anxiety and depression among Chinese cardiac surgery patients. Based upon existing evidence and international practice, preoperative education should be incorporated into routine practice to prepare Chinese cardiac patients for surgery.     

Treating persistent depressive symptoms in post-ACS patients: the project COPES phase-I randomized controlled trial

Depression and sub-syndromal depressive symptoms are important predictors of morbidity and mortality after acute coronary syndrome (ACS). Prior trials of depression treatment in post-ACS patients have demonstrated no improvement for event-free survival, and only modest improvement in depression symptoms. These trials have raised a number of important issues regarding timing of depression intervention, acceptability of depression treatment to ACS patients, and safety for subsets of the treated population. This article describes Project COPES (Coronary Psychosocial Evaluation Studies), a multi-center Phase-I randomized clinical trial. Project COPES uses a patient preference depression treatment that has previously been found acceptable to medical patients, and a 3-month pre-randomization observation period to insure depression status. The study sample will include 200 post-ACS patients. The primary outcome is patient satisfaction with depression care. Secondary, exploratory aims include the acceptability of depression treatment, reduction in depressive symptoms, and the effects of treatment on two key pathways--medication adherence and inflammation--hypothesized to link depression to post-ACS prognosis. These analyses will provide important data to inform subsequent clinical trials with this population.     

A longitudinal study of family conflicts, social support, and antenatal depressive symptoms among Chinese women

Little is known about the causal factors of antenatal depressive symptomatology in the Chinese population. A total of 1,527 pregnant women were recruited to investigate the predictors of antenatal depressive symptoms using a stress process model in a prospective longitudinal study. The Edinburgh Postnatal Depression Scale, the Dyadic Adjustment Scale, the Stryker Adjustment Checklist, and the Interpersonal Support Evaluation List were used. Multiple linear regression analysis revealed that marital conflict, parent-in-law conflict, and social support predicted antenatal depressive symptoms. Psychiatric nurses can identify predictors to help initiate preventive intervention.     

A randomized controlled trial to reduce delay in older adults seeking help for symptoms of acute myocardial infarction

Older adults with symptoms of acute myocardial infarction (AMI) have longer pre-treatment delay times than their younger counterparts. A 2-group, randomized controlled sample consisted of 115 adults, 65 years of age or older with a self-reported history of coronary artery disease. A pre-test was given to all participants followed by a structured education and counseling intervention to those in the experimental group. Data were re-collected at 3 months. There was a statistically significant increase in knowledge, beliefs, and perceived control without an increase in anxiety in the intervention group. There was no significant difference in attitudes. Older adults at risk for AMI should be targeted for individualized education and counseling in clinics, physician offices, and community centers.     

A technology-augmented intervention to prevent peer violence and depressive symptoms among at-risk emergency department adolescents: Protocol for a randomized control trial

BackgroundPeer violence and depressive symptoms are increasingly prevalent among adolescents, and for many, use the emergency department (ED) as their primary source of healthcare. Brief in-person interventions and longitudinal text-message-based interventions are feasible, acceptable, and may be effective in reducing peer violence and depressive symptoms when delivered in the ED setting. This paper presents the study design and protocol for an in-ED brief intervention (BI) and text messaging program (Text).MethodsThis study will be conducted in a pediatric ED which serves over 50,000 pediatric patients per year. Recruitment of study participants began in August 2018 and anticipated to continue until October 2021. The study will enroll 800 adolescents (ages13–17) presenting to the ED for any reason who self-report past-year physical peer violence and past-two week mild-to-moderate depressive symptoms. The study will use a factorial randomized trial to test both overall intervention efficacy and determine the optimal combination of intervention components. A full 2 × 2 factorial design randomizes patients at baseline to 1) BI or no BI; and 2) Text or no Text. Peer violence and depressive symptoms improvements will be measured at 2, 4, and 8 months through self-report and medical record review.DiscussionThis study has important implications for the progress of the greater field of mobile health interventions, as well as for adolescent violence and depression prevention in general. This proposal has high clinical and public health significance with high potential scalability, acceptability, and impact.     

Effect of life review writing on depressive symptoms in older adults: a randomized controlled trial

OBJECTIVE. We examined the effects of engaging in the occupation-based intervention of life review through writing on expressed depressive symptoms as measured with the Geriatric Depression Scale in older adults residing in senior residences.METHOD. The study design was a randomized controlled trial that took place in four senior residences in New York City. Forty-five participants (23 treatment, 22 wait-list control) ≥65 yr old participated in the 8-wk, once-weekly autobiographical writing workshop, Share Your Life Story (Sierpina, 2002).RESULTS. Depressive symptoms were significantly less prevalent for the treatment group than for the control group after the 8-wk life review program (repeated-measures analysis of variance p = .03).CONCLUSION. The results suggest that the Share Your Life Story writing workshop is an effective occupation-based intervention for occupational therapists to use with older adults who reside in senior residences.     

Autogenic training to reduce anxiety in nursing students: randomized controlled trial

AIM: This paper reports a study to determine the effectiveness of autogenic training in reducing anxiety in nursing students. BACKGROUND: Nursing is stressful, and nursing students also have the additional pressures and uncertainties shared with all academic students. Autogenic training is a relaxation technique consisting of six mental exercises and is aimed at relieving tension, anger and stress. Meta-analysis has found large effect sizes for autogenic trainings intervention comparisons, medium effect sizes against control groups, and no effects when compared with other psychological therapies. A controlled trial with 50 nursing students found that the number of certified days off sick was reduced by autogenic training compared with no treatment, and a second trial with only 18 students reported greater improvement in Trait Anxiety, but not State Anxiety, compared with untreated controls. METHODS: A randomized controlled trial with three parallel arms was completed in 1998 with 93 nursing students aged 19-49 years. The setting was a university college in the United Kingdom. The treatment group received eight weekly sessions of autogenic training, the attention control group received eight weekly sessions of laughter therapy, and the time control group received no intervention. The outcome measures were the State-Trait Anxiety Inventory, the Maslach Burnout Inventory, blood pressure and pulse rate completed at baseline, 2 months (end of treatment), and 5, 8, and 11 months from randomization. RESULTS: There was a statistically significantly greater reduction of State (P<0.001) and Trait (P<0.001) Anxiety in the autogenic training group than in both other groups immediately after treatment. There were no differences between the groups for the Maslach Burnout Inventory. The autogenic training group also showed statistically significantly greater reduction immediately after treatment in systolic (P<0.01) and diastolic (P<0.05) blood pressure, and pulse rate (P<0.002), than the other two groups. CONCLUSION. Autogenic training has at least a short-term effect in alleviating stress in nursing students.     

A family intervention to reduce delirium in hospitalised ICU patients: A feasibility randomised controlled trial

BackgroundFamily members could play an important role in preventing and reducing the development of delirium in Intensive Care Units (ICU) patients. This study sought to assess the feasibility of design and recruitment, and acceptability for family members and nurses of a family delivered intervention to reduce delirium in ICU patients.MethodA single centre randomised controlled trial in an Australian medical/surgical ICU was conducted. Sixty-one family members were randomised (29 in intervention and 32 in non-intervention group). Following instructions, the intervention comprised the family members providing orientation or memory clues (family photographs, orientation to surroundings) to their relative each day. In addition, family members conducted sensory checks (vision and hearing with glasses and hearing aids); and therapeutic or cognitive stimulation (discussing family life, reminiscing) daily. Eleven ICU nurses were interviewed to gain insight into the feasibility and acceptability of implementing the intervention from their perspective.ResultsRecruitment rate was 28% of eligible patients (recruited n = 90, attrition n = 1). Following instruction by the research nurse the family member delivered the intervention which was assessed to be feasible and acceptable by family members and nurses. Protocol adherence could be improved with alternative data collection methods. Nurses considered the activities acceptable.ConclusionThe study was able to recruit, randomise and retain family member participants. Further strategies are required to assess intervention fidelity and improve data collection.     

Pilot randomized controlled trial of a mindfulness-based group intervention in adolescent girls at risk for type 2 diabetes with depressive symptoms

Objective(1) Evaluate feasibility and acceptability of a mindfulness-based group in adolescent girls at-risk for type 2 diabetes (T2D) with depressive symptoms, and (2) compare efficacy of a mindfulness-based versus cognitive-behavioral group for decreasing depressive symptoms and improving insulin resistance.Design and settingParallel-group, randomized controlled pilot trial conducted at a university.ParticipantsThirty-three girls 12–17y with overweight/obesity, family history of diabetes, and elevated depressive symptoms were randomized to a six-week mindfulness-based (n = 17) or cognitive-behavioral program (n = 16).InterventionsBoth interventions included six, one-hour weekly group sessions. The mindfulness-based program included guided mindfulness awareness practices. The cognitive-behavioral program involved cognitive restructuring and behavioral activation.Main outcome measuresAdolescents were evaluated at baseline, post-intervention, and six-months. Feasibility/acceptability were measured by attendance and program ratings. Depressive symptoms were assessed by validated survey. Insulin resistance was determined from fasting insulin and glucose, and dual energy x-ray absorptiometry was used to assess body composition.ResultsMost adolescents attended ≥80% sessions (mindfulness: 92% versus cognitive-behavioral: 87%, p = 1.00). Acceptability ratings were strong. At post-treatment and six-months, adolescents in the mindfulness condition had greater decreases in depressive symptoms than adolescents in the cognitive-behavioral condition (ps < .05). Compared to the cognitive-behavioral condition, adolescents in the mindfulness-based intervention also had greater decreases in insulin resistance and fasting insulin at post-treatment, adjusting for fat mass and other covariates (ps < .05).ConclusionsA mindfulness-based intervention shows feasibility and acceptability in girls at-risk for T2D with depressive symptoms. Compared to a cognitive-behavioral program, after the intervention, adolescents who received mindfulness showed greater reductions in depressive symptoms and better insulin resistance.ClinicalTrials.gov identifier: NCT02218138 clinicaltrials.gov     

The effects of exercise and social support on mothers reporting depressive symptoms: a pilot randomized controlled trial

A 12-week randomized controlled trial was conducted (n = 20) investigating the effects of a multi-intervention programme of exercise and social support compared to a control group. Both groups had given birth in the past 12 months and were experiencing depressive symptomatology. Pretest data of physical fitness and structured questionnaires were compared to post-test data. The results from the study showed that mothers who were in the multi-intervention group improved their fitness levels and depressive symptomatology significantly more than the control group. However, there were no significant changes to either group's social support levels. These results are encouraging and suggest that a pram push walking intervention might be an effective treatment for mothers suffering postnatal distress.     

Effectiveness of a multifactorial intervention program to reduce falls incidence among community-living older adults: a randomized controlled trial

Pérula LA, Varas-Fabra F, Rodríguez V, Ruiz-Moral R, Fernández JA, González J, Pérula CJ, Roldán AM, de Dios C, and the EPICA Study Collaborative Group. Effectiveness of a multifactorial intervention program to reduce falls incidence among community-living older adults: a randomized controlled trial.ObjectiveTo determine the effectiveness of a multifactorial intervention program to prevent falls among older adults as compared with a brief intervention.DesignRandomized controlled trial.SettingEleven health centers located in Córdoba, Spain.ParticipantsPeople over 70 years old (N=404), who are residents in the community.InterventionsThe centers were randomized to either 1 of the 2 groups: intervention group (IG), of a multifactorial nature (individual advice, information leaflet, physical exercise workshop, and home visits), or control group (CG) (brief individual advice and information leaflet).Main Outcome MeasuresFall rates and time until the fall; estimates of the relative and absolute risk of falls; and survival analysis and Cox regression.ResultsOf the patients recruited, 133 were in the IG and 271 were in the CG. Around 33% in the IG and 30.25% in the CG had had a fall in the previous year (P=.56). After 12 months, the fall incidence rate was 17.29% in the IG and 23.61% in the CG (relative risk=0.73; 95% confidence interval [CI], 0.48–1.12; P=.146). Around 60% of the IG patients said they had increased the time spent on physical activity. In the IG, the incidence of falls at home was 27.5% compared with 49.3% in the CG (P=.04). Being a woman (odds ratio [OR]=1.62; 95% CI, 1.03–2.54), having a history of falls (OR=1.15; 95% CI, 1.05–1.26), suffering acute health problems (OR=2.19; 95% CI, 1.09–4.40), and doing moderate exercise (OR=1.91; 95% CI, 1.08–3.38) were found as factors associated with a higher risk of falls.ConclusionsAlthough the reduction of falls in the IG was nearly halved, and after the intervention there was a significant reduction in the number of falls at these patients' homes, the multifactorial intervention program is no more effective than the brief intervention to reduce the overall risk of falls.     

Usefulness of a run-in period to reduce drop-outs in a randomized controlled trial of a behavioral intervention

ObjectivesWe evaluated the usefulness of a simple run-in period to reduce drop-outs in a behavioral intervention to improve blood pressure (BP). In a pilot study where a run-in period was not used, we had a 25% drop-out rate.MethodsA prospective evaluation was performed in the context of a blinded 3-arm randomized trial. Participants are eligible if they have uncontrolled BP on 2 consecutive visits. Potential participants are approached during a routine visit, informed, consented and enrolled. After a 1-month run-in period during which all participants receive a phone call to: i) verify phone availability, ii) get basic information on treatment, and iii) confirm the baseline visit, participants return for a baseline visit. They are then randomized to one of the three treatment arms: usual care, non-tailored counseling, or tailored counseling. Participants make return visits at 3, 6 and 12 months.ResultsOf the 1275 potential participants who received detailed study information, 301 consented to participate, of whom 226 were enrolled. During the run-in period, 73 withdrew consent and 153 participants were randomized; 7 subsequently dropped out. There were no differences (p > .1) between the 73 cancelled and the 153 randomized patients. There were fewer drop-outs than in the pilot study (5% vs. 25%, p < .0001).ConclusionsThe run-in period reduces the number of drop-outs after randomization and improves statistical power. In order to retain external validity, it is important to compare participants who remain in the study and those that cancel, and incorporate that in generalizing from the study.     

Flavonoids to reduce bleeding and pain after stapled hemorrhoidopexy: a randomized controlled trial

INTRODUCTION: Control of postoperative symptoms is of paramount importance in ambulatory surgery. This trial was conducted to evaluate whether a micronized purified flavonoid fraction (MPFF) (Detralex((R))) reduces postoperative bleeding, pain and consumption of analgesics after ambulatory stapled hemorrhoidopexy, as reported in trials after classic hemorrhoidectomy. Phlebotropic activity, protective effect on the capillaries and anti-inflammatory properties of this drug have been reported in several studies. METHODS: Sixty-three patients with third-degree hemorrhoids had ambulatory stapled hemorrhoidopexy under spinal anesthesia in the period of one year. The patients were randomized, with 30 receiving Detralex 500 mg (2 tablets 3 times daily for 5 days after the operation) and 33 forming the control group. The patients were asked to daily self-assess the presence of blood on defecation, degree of pain and consumption of analgesics for the first week after the operation. RESULTS: There was no significant difference between the two groups in duration of presence of blood, degree of pain or analgesics requirement. No major complications, such as bleeding requiring transfusion or hospitalization, sepsis, anal stenosis or urgent defecation, were noted in the follow-up period. There were no side effects from Detralex treatment. DISCUSSION: In our study we could not demonstrate any positive effect of prescribing flavonoids after stapler hemorrhoidopexy. This procedure may not be sufficiently aggressive and is associated with too few postoperative complications to show any protective influence of flavonoids.     

Peer-led alcohol intervention for college students: A pilot randomized controlled trial

This study aims to assess the preliminary efficacy and feasibility of a brief, peer-led alcohol intervention to reduce alcohol consumption in binge-drinking Spanish nursing students. A pilot randomized controlled trial was conducted with 50 first-year nursing students who were randomly assigned either a 50-min peer-led motivational intervention with individual feedback or a control condition. Primary outcomes for testing the preliminary efficacy were alcohol use and alcohol-related consequences. Quantitative and content analyses of open-ended survey questions were performed. Participants in the intervention condition significantly reduced binge-drinking episodes, peak blood alcohol content, and consequences compared to the control group. Principal facilitators were completing the questionnaire during the academic schedule and providing tailored feedback through a graphic report. The main barrier was the unreliability of students' initial commitment. The findings suggest that a brief motivational intervention could be effective for reducing alcohol consumption and alcohol-related consequences in Spanish college students. Peer counselors and participants reported high satisfaction, indicating that the intervention is feasible. However, a full trial should be conducted taking into account the identified barriers and facilitators.     

精神分裂症恢复期综合式家庭心理干预的前瞻、随机、对照研究

目的以精神分裂症恢复期患者为主要研究对象,采用前瞻性随机对照研究,探讨综合式家庭心理干预对患者的近期效果。方法80例患者抽答法被随机分配到干预组40例和对照组40例,干预组除药物治疗外接受系统的综合式家庭心理干预,对照组只有药物维持治疗。结果在1年末,干预组患者的简明精神病量表(BPRS)、社会功能缺陷量表(SDSS)、症状自评量表(SCL-90)、与对照组比较均有显著性差异(t=3.62～3.68,P<0.001),服药依从率、年复发率(u=3.48,3.52,P<0.001),说明干预组患者的精神症状、社会功能、心理状况明显改善,服药依从率明显提高,年复发率明显降低。结论综合式家庭心理干预对精神分裂症恢复期具有良好的效果。     

A nursing intervention to reduce prehospital delay in acute coronary syndrome: a randomized clinical trial

Prehospital delay in patients experiencing symptoms of acute coronary syndrome (ACS) has proved to be a significant and intractable public health problem, with minimal change in delay time over the past 2 decades despite numerous community education programs designed to reduce delay. With each 30-minute increment of delay, 1-year mortality increases by 7.5%, thus reinforcing the importance of helping patients label symptoms correctly and take appropriate action steps to seek definitive treatment. We therefore are conducting a multicenter, international clinical trial in 3,500 patients with documented coronary heart disease to determine whether a brief education and counseling intervention delivered by a nurse can reduce prehospital delay in the face of symptoms of ACS. The main outcome being studied is time from ACS symptom onset to arrival at the emergency department. Secondary outcomes include use of the emergency medical system; aspirin use; and knowledge, attitudes, and beliefs about heart attack symptoms. Patients are being followed for 2 years from the time of enrollment. The purpose of this article is to describe the intervention and its theoretical framework, and to outline the design of this randomized controlled trial.