6-month Follow-up Assessment Research Articles

Effect of Clinician Training in the Modular Approach to Therapy for Children vs Usual Care on Clinical Outcomes and Use of Empirically Supported Treatments

The Modular Approach to Therapy for Children (MATCH) was developed to address the comorbidities common among clinically referred youth, with beneficial outcomes shown in 2 US randomized clinical trials, where it outperformed both usual clinical care and single disorder-specific treatments. To determine whether MATCH training of clinicians would result in more use of empirically supported treatment (EST) and better clinical outcomes than usual care (UC) in the publicly funded, multidisciplinary context of New Zealand. This multisite, single-blind, computer-randomized clinical effectiveness trial compared MATCH with UC in child and adolescent mental health services in 5 regions of New Zealand. Recruitment occurred from March 2014 to July 2015, and a 3-month follow-up assessment was completed by May 2016. Clinicians at participating child and adolescent mental health services were randomized (1:1) to undertake training in MATCH or to deliver UC, and young people with anxiety, depression, trauma-related symptoms, or disruptive behavior seeking treatment at child and adolescent mental health services were randomized (1:1) to receive MATCH or UC. Participants and research assistants were blind to allocation. Data analysis was performed from April 2016 to July 2017. MATCH comprises EST components for flexible management of common mental health problems. UC includes case management and psychological therapies. Both can include pharmacotherapy. There were 3 primary outcomes: trajectory of change of clinical severity, as measured by weekly ratings on the Brief Problem Monitor (BPM); fidelity to EST content, as measured by audio recordings of therapy sessions coded using the Therapy Integrity in Evidence Based Interventions: Observational Coding System; and efficiency of service delivery, as measured by duration of therapy (days) and clinician time (minutes). The study included 65 clinicians (mean age, 38.7 years; range, 23.0-64.0 years; 54 female [83%]; MATCH, 32 clinicians; UC, 33 clinicians) and 206 young people (mean age, 11.2 years; range 7.0-14.0 years; 122 female [61%]; MATCH, 102 patients; UC, 104 patients). For the BPM total ratings for parents, there was a mean (SE) slope of -1.04 (0.14) (1-year change, -6.12) in the MATCH group vs -1.04 (0.10) (1-year change, -6.17) in the UC group (effect size, 0.00; 95% CI, -0.27 to 0.28; P = .96). For the BPM total for youths, the mean (SE) slope was -0.74 (0.15) (1-year change, -4.35) in the MATCH group vs -0.73 (0.10) (1-year change, -4.32) in the UC group (effect size, -0.02; 95% CI, -0.30 to 0.26; P = .97). Primary analyses (intention-to-treat) showed no difference in clinical outcomes or efficiency despite significantly higher fidelity to EST content in the MATCH group (58 coded sessions; mean [SD], 80.0% [20.0%]) than the UC group (51 coded sessions; mean [SD], 57.0% [32.0%]; F(1,108) = 23.0; P < .001). With regard to efficiency of service delivery, there were no differences in total face-to-face clinician time between the MATCH group (mean [SD], 806 [527] minutes) and the UC group (mean [SD], 677 [539] minutes) or the overall duration of therapy between the MATCH group (mean [SD], 167 [107 days]) and the UC group (mean [SD], 159 [107] days). MATCH significantly increased adherence to EST practices but did not improve outcomes or efficiency. The nonsuperiority of MATCH may be attributable to high levels of EST use in UC in New Zealand. Australian New Zealand Clinical Trials Registry Identifier: ACTRN12614000297628.

Development of a brief online intervention to address aggression in the context of emotion-related impulsivity: Evidence from a wait-list controlled trial

Trait-like tendencies to respond impulsively to emotion, labelled emotion-related impulsivity, are robustly related to aggression. We developed and tested an online intervention to address emotion-related impulsivity and aggression. The 6-session intervention focused on behavioral techniques shown to decrease arousal and aggression, supplemented with implementation intentions and smartphone prompts to facilitate skills transfer into daily life. First, we piloted the intervention in-person with 4 people. Then, 235 participants were randomly assigned to take the online intervention immediately or after a wait-list period; those in the waitlist were then invited to take part in the intervention. Participants completed the self-rated Feelings Trigger Action Scale to assess emotion-related impulsivity, the interview-based Modified Overt Aggression Scale and the self-rated Buss Perry Aggression Questionnaire. Participants who took part in the treatment completed daily anger logs. Attrition, as with other online programs, was high; however, treatment completers reported high satisfaction, and outcomes changed more rapidly during treatment than waitlist across all key outcome indices. In analyses including all participants who took part in the treatment (immediate or delayed), we observed moderate-to-large treatment gains, which were maintained as of the 3-month follow-up assessment. This work supports the usefulness of an intervention for addressing emotion-related impulsivity and aggression.

Family involvement moderates the relationship between perceived recovery orientation of services and personal narratives among Chinese with schizophrenia in Hong Kong: a 1-year longitudinal investigation.

Family has been found to have an influential role on clinical and recovery outcomes of people with schizophrenia. While recovery-oriented services can facilitate service users to develop a rich and positive identity, it is unclear how different levels of family involvement may interact with recovery-oriented services in affecting personal recovery. The present study aimed to examine how family involvement moderates the relationship between perceived recovery-orientation of services and personal narratives of Chinese people in Hong Kong who had recent onset of schizophrenia spectrum disorder longitudinally. Multi-method approach (semi-structured interview, researcher ratings, self-report measures) was adopted. 167 participants completed assessments at baseline; 93 and 68 of them were retained at 6-month and 12-month follow-up assessment, respectively. Baseline perceived recovery orientation of services significantly predicted richer personal narratives at 6-month follow-up when baseline family involvement was optimal (B = 0.26, p = 0.03, 95% CI [0.02-0.48]). As to 12-month assessment, baseline perceived recovery orientation of services significantly predicted poorer personal narratives when family was perceived as under-involved at baseline (B = -0.45, p = 0.02, 95% CI [-0.88 to -0.07]). Without proper family involvement, recovery-oriented services could be ineffectual in facilitating the development of rich personal narratives for Chinese people in Hong Kong.

Improving abnormal gait patterns by using a gait exercise assist robot (GEAR) in chronic stroke subjects: A randomized, controlled, pilot trial

BackgroundAlthough the Gait Exercise Assist Robot (GEAR) has been reported to effectively improve gait of hemiplegic patients, no study has investigated its use in chronic stroke patients. It is possible to facilitate gait reorganization by gait training with less compensation using the GEAR even in chronic stroke patients. Research questionWhat are the effects of GEAR training on the abnormal gait patterns of chronic stroke subjects? MethodsSubjects were randomly assigned to either the GEAR group (n = 8) or the treadmill group (n = 11). Each group underwent 20 sessions (40 min/day, 5 days/week). The changes in the 10 types of abnormal gait patterns were evaluated using a three-dimensional motion analysis system and the Global Rating of Change (GRC) scale before and after the intervention, and at 1-month and 3-month follow-up assessment. ResultsIn the GEAR group, hip hiking at a 1-month follow-up assessment was markedly lesser than that before the intervention, and the excessive hip external rotation at 3-month follow-up assessment was notably lesser than that after the intervention, but the change in excessive hip external rotation was in the normal range. In the treadmill group, knee extensor thrust at a 1-month follow-up assessment was strikingly lesser than that before the intervention, but the difference was in the normal range. In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention. But, in the treadmill group, only the GRC scale score at a 1-month follow-up assessment was visibly higher than that before the intervention. SignificanceGait training using the GEAR may be more effective than treadmill-training in improving the swing phase in chronic stroke subjects.

Kiss and Makeup? Examining the Co-occurrence of Conflict and Sex.

Although conflict and sex frequently occur in relationships, little research has examined their interconnectedness. Some evidence suggests their co-occurrence can benefit relationships, whereas other evidence suggests the opposite. We sought to clarify such contrasting evidence by conducting a dyadic daily-diary study of 107 newlywed couples that included a 6-month follow-up assessment. Although conflict (operationalized as one partner doing something the other did not like) was unassociated with the likelihood of sex on a given day, it predicted a lower likelihood the following day. Moreover, despite the fact that sex co-occurring with (vs. occurring independent of) conflict was less enjoyable, it partially reduced the negative effects of conflict on both spouses' daily relationship quality. The extent to which sex and conflict co-occurred was unassociated with intimates' changes in marital satisfaction 6months later. The implications of engaging in post-conflict sex are nuanced: although such sex is less enjoyable, it temporarily buffers relationship quality in that moment.

Evaluating Girls on the Run in Promoting Positive Youth Development: Group Comparisons on Life Skills Transfer and Social Processes

Girls on the Run (GOTR), a physical activity-based positive youth development program, uses running as a platform to teach life skills and promote healthy behaviors. In this companion paper of our comprehensive project, the authors evaluated program impact on positive youth development by comparing GOTR participants to youth in other organized activities (Sport and physical education [PE]) on life skills transfer and social processes. Qualitative methods complemented quantitative data through interviews with GOTR stakeholders. The participants included 215 girls in GOTR and 692 girls in the same grades and schools who did not participate in GOTR (Sport = 485; PE = 207). They completed self-report measures of life skills transfer, peer and coach relatedness, and coach autonomy support at the season's end. GOTR subsamples of girls, coaches, caregivers, and school personnel participated in focus groups. Girls in GOTR compared favorably to the Sport and PE girls on all life skills-managing emotions, resolving conflicts, helping others, and making intentional decisions-and to the PE girls for all 3 social processes. The GOTR and Sport girls did not differ on coach relatedness and autonomy support, but the Sport girls rated teammate relatedness higher. The GOTR girls' scores on life skills transfer remained stable at a 3-month follow-up assessment. Stakeholders in the focus groups shared corroborating evidence that, through participating in GOTR, girls learn skills that generalize to school and home contexts. Using comparison groups, a retention assessment, and mixed methods, the findings provide evidence that GOTR is effective in teaching skills and strategies that generalize to broader life domains. The processes that explain group differences on life skills transfer include GOTR's intentional curriculum of skill-building activities delivered by coaches within a caring and autonomy-supportive climate.

EXERCISE-RELATED SELF-MONITORING AND CHANGE IN MUSCULAR STRENGTH IN PROSTATE CANCER PATIENTS UNDERGOING ANDROGEN DEPRIVATION THERAPY

Self-monitoring is associated with successful health behavior change and improvements in relevant fitness outcomes accompanying lifestyle interventions. Although exercise consistently results in meaningful improvements in muscular strength and physical function among prostate cancer patients (PCa) undergoing androgen deprivation therapy (ADT), the extent to which exercise-related self-monitoring is linked with improvements in clinically relevant outcomes among PCa patients remains unclear. PURPOSE: The purpose of the single-blind, randomized controlled Individualized Diet and Exercise Adherence-Pilot (IDEA-P) trial is to evaluate the preliminary efficacy of a combined exercise and dietary (EX+D) intervention, implementing a group-mediated cognitive behavioral (GMCB) approach, relative to standard of care (SC) treatment among PCa patients undergoing ADT. In the current study, we conducted an exploratory analysis to evaluate the relationship between exercise-related self-monitoring in the EX+D intervention and change in muscular strength at 3-months post intervention. METHODS: A total of 32 PCa patients (M age = 65 years) on ADT were randomly assigned to the EX+D (n = 16) or SC (n = 16) interventions. Measures of 1RM chest and leg extension strength were obtained at baseline and 3-month follow-up assessments. RESULTS: Results from a linear regression analysis revealed that frequency of self-monitoring was not significantly associated with increased 1RM chest strength (b = 0.52; SEb = 0.551; r2 = .083; p = 0.364) or 1RM leg extension strength (b = 0.234; SEb = 0.716; r2 = .083; p = 0.751). CONCLUSION: Findings suggest that exercise-related self-monitoring was not significantly associated with change in upper or lower body muscular strength observed following the EX+D intervention in the IDEA-P trial. Given the importance of exercise and preservation of muscular strength for PCa patients undergoing ADT, exploring the role of exercise-related self-monitoring in future optimally-power lifestyle intervention trials is warranted.

Progestin-only pill use over 6 months postpartum

ObjectivesTo determine progestin-only pill (POP) use at 3 and 6 months postpartum among women who chose POPs at the postpartum visit. Study DesignSecondary data analysis of a prospective observational study with telephone interviews at 3 and 6 months postpartum to assess contraceptive use. ResultsOf 440 women who attended the postpartum visit, 92 (20.9%) chose POPs. Current POP use was 44/84 (52.4%) at 3 months, 33/76 (43.4%) at 6 months, and 32/76 (42.1%) at both 3- and 6-month follow-up assessments. ConclusionAbout half of women who plan POP use at the postpartum visit are not using this method at 3 months after delivery. ImplicationsAbout half of women with a prescription for progestin-only pills will be not using this method at 3 months postpartum; further understanding of continued sexual activity and breastfeeding may clarify pregnancy risk for those not reporting modern contraception use during the postpartum period.

Anxiety symptoms in first-episode psychosis.

Anxiety disorders and symptoms are common in people with psychotic disorders, having a negative impact on clinical status, function level and overall prognosis. However, research on the significance of anxiety in predicting remission and long-term functioning in first-episode psychosis (FEP) is still scarce. This study investigated the effects of anxiety and obsessive-compulsive symptoms (OCS) on clinical and functional improvement in individuals with FEP. FEP patients (N = 97) aged 18-40 years were recruited from the University Hospital District of Helsinki and the City of Helsinki. Psychotic and anxiety symptoms were measured using the Brief Psychiatric Rating Scale. Obsessive-compulsive symptoms were assessed using the Obsessive-Compulsive Inventory (OCI-R), and functioning was evaluated using the Social and Occupational Functioning Assessment Scale (SOFAS). Follow-up measurements were performed at 2 and 12 months. We specifically studied whether anxiety and obsessive-compulsive symptoms at the 2-month follow-up assessment, at a time when the initial treatment response had been achieved, would predict outcomes at 12 months. Symptoms of anxiety and OCS correlated moderately with each other and psychotic symptoms, but at the 12-month follow-up, OCS no longer correlated significantly with psychotic and anxiety symptoms. When the level of psychotic symptoms was adjusted for, more severe OCS at the 2-month follow-up was associated with a lower rate of remission at 12 months, whereas a higher level of anxiety symptoms at 2 months was associated with better functioning at 12 months. OCS may be predictive of poorer clinical outcomes, whereas anxiety symptoms may predict better functional outcomes.

Prednisolone versus placebo addition in the treatment of patients with recent-onset psychotic disorder: a trial design

BackgroundThe symptom severity of a substantial group of schizophrenia patients (30–40%) does not improve through pharmacotherapy with antipsychotic medication, indicating a clear need for new treatment options to improve schizophrenia outcome. Meta-analyses, genetic studies, randomized controlled trials, and post-mortem studies suggest that immune dysregulation plays a role in the pathophysiology of schizophrenia. Some anti-inflammatory drugs have shown beneficial effects on the symptom severity of schizophrenia patients. Corticosteroids are effective in various chronic inflammatory and autoimmune disorders. Prednisolone, a potent glucocorticosteroid, has minor mineral-corticosteroid potencies and can adequately pass the blood–brain barrier and its side effects and safety profile are well known. Therefore, the effect of prednisolone can be studied as a proof of concept for immune modulation as a treatment for schizophrenia.Methods/designIn total, 90 subjects aged 18–70 years and diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder (Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) 295.x) or psychosis not otherwise specified (NOS; 298.9) will be included. The time interval between the onset of psychosis and study entry should not exceed 7 years. Patients will be randomized 1:1 to either prednisolone or placebo daily for a period of 6 weeks in addition to a stable dose of antipsychotic medication. Study medication will be initiated at 40 mg for 3 days, after which it will be tapered down within 6 weeks after initiation, following inflammatory bowel diseases treatment guidelines. Primary outcome is change in symptom severity, expressed as change in total score on the Positive and Negative Symptom Scale (PANSS) from baseline to end of treatment. Cognitive functioning (measured through the Brief Assessment of Cognition in Schizophrenia (BACS)) and change in Global Assessment Functioning (GAF) and depressive symptoms as measured with the Calgary Depression Scale for Schizophrenia (CDS) will be assessed, in addition to various immunological biomarkers. Secondary outcomes are a 4- and 6-month follow-up assessment of PANSS, BACS, and GAF scores and immunological biomarkers. Additionally, a subgroup of patients will be included in the magnetic resonance imaging (MRI) part of the study where MR spectroscopy and structural, functional, and diffusion MRI will be conducted.DiscussionIt is expected that prednisolone addition to current antipsychotic medication use will reduce symptom severity and will improve cognition when compared to placebo.Trial registrationClinicalTrials.gov, NCT02949232 and NCT03340909. Registered 31 October 2016 and 14 November 2017. EudraCT-number 2014–000520-14 and 2017–000163-32.

A Randomized Controlled Trial of Brief Skills Training in Affective and Interpersonal Regulation (STAIR) for Veterans in Primary Care.

This randomized controlled trial assessed the efficacy of a five-session version of Skills Training in Affective and Interpersonal Regulation (STAIR) among veterans obtaining treatment in primary care. Veterans who screened positive for either posttraumatic stress disorder (PTSD) or depression (N = 26) were enrolled and randomized into either five-session STAIR or treatment as usual (TAU). Assessments of PTSD symptoms (PTSD Checklist for DSM-5; PCL-5), depression (Beck Depression Inventory-II; BDI-II), emotion regulation (Difficulties in Emotion Regulation Scale; DERS), and social engagement difficulties (World Health Organization Disability Assessment 2.0; WHODAS-2) were assessed at pretreatment, posttreatment, and 3-month follow-up assessments. Participants assigned to the five-session STAIR condition reported significant improvements on all measures, whereas those assigned to TAU showed no change. Group × Treatment interactions were significant for all outcomes, and effect sizes for the interactions ranged from moderate to large, Hedge's gs = 0.81 for the PCL-5, 1.15 for the BDI-II, 0.75 for the DERS, and 0.81 for the WHODAS-2. The results indicate that five-session STAIR, a brief, skills-focused treatment, may be effective in reducing a range of symptoms and in improving social functioning among veterans treated in primary care settings.

Randomized Trial Comparing Preliminary Results of Radialization and Centralization Procedures in Bayne Types 3 and 4 Radial Longitudinal Deficiency

The choice of surgical procedure in severe (Bayne and Klug types 3 and 4) radial longitudinal deficiency (RLD) is contentious. Existing studies have reported varying results with both centralization and radialization procedures. The purpose of this study was to compare the clinical and radiologic outcome of radialization and centralization procedures at a short-to-intermediate-term follow-up for the treatment of types 3 and 4 RLD. Fourteen patients with 17 affected limbs having types 3 or 4 RLD were recruited in this prospective, randomized, controlled trial. After initial application of successive casts for soft tissue distraction, patients were randomized to 2 wrist alignment procedures-centralization and radialization. Clinical and radiologic parameters recorded at stipulated intervals until a final follow-up of 24 months included hand-forearm angle, ulnar bow, forearm length, arm length, total angulation, and range of motion at elbow, wrist, and fingers. Centralization was performed in 9 affected limbs, whereas radialization was performed in 8 affected limbs. Nine affected limbs had type 4 RLD, and 8 affected limbs had type 3 RLD. There was no significant difference in the hand-forearm angle in the immediate postoperative period. At 3 months, the radiologic hand-forearm angle increased to 19 degrees in the centralization group, while the radialization group showed an average increase to 4 degrees. This increase in the hand-forearm angle continued at 6-, 12-, and 24-month follow-up assessments. Worsening of the deformity was more in the centralization group, as compared with the radialization group. The forearm length also significantly differed in the 2 groups at 6-, 12-, and 24-month follow-up; however, when adjusted for preoperative lengths, the difference was significant only at 12- and 24-month follow-up. At a short-to-intermediate-term follow-up, radialization fares better than centralization in terms of recurrence of deformity and in terms of affecting the forearm length. Longer follow-up with a larger sample size is needed to draw definitive conclusions. Level I.

An Integrative Neuro-Psychotherapy Treatment to Foster the Adjustment in Acquired Brain Injury Patients-A Randomized Controlled Study.

Adjustment disorders (AjD) with depressive symptoms following an acquired brain injury (ABI) is a common phenomenon. Although brain injuries are increasing more and more, research on psychological therapies is comparably scarce. The present study compared, by means of a randomized controlled trial (RCT), a newly developed integrative treatment (Standard PLUS) to a standard neuropsychological treatment (Standard). Primary outcomes were depressive symptoms assessed with the Beck Depression Inventory (BDI-II) at post-treatment and 6-month follow-up assessment. In total, 25 patients (80% after a stroke) were randomized to one of the two conditions. Intention-to-treat analyses showed that the two groups did not significantly differ either at post-treatment nor at follow-up assessment regarding depressive symptoms. Both treatments showed large within-group effect sizes on depressive symptoms. Regarding secondary outcomes, patients in the Standard PLUS condition reported more emotion regulation skills at post-assessment than in the control condition. However, this difference was not present anymore at follow-up assessment. Both treatments showed medium to large within-group effects sizes on most measures for patients suffering from an AjD after ABI. More research with larger samples is needed to investigate who profits from which intervention.

Knowledge acquisition and retention after a high flow training programme in Peru: a quasi-experimental single group pre–post design

ObjectiveRespiratory infections remain the leading infectious cause of death in children under 5 and disproportionately affect children in resource-limited settings. Implementing non-invasive respiratory support can reduce respiratory-related mortality. However, maintaining...

Testing the efficacy of a minimal-guidance online self-help intervention for alcohol misuse in Estonia: study protocol of a randomized controlled trial

BackgroundDespite an initial steep decrease in alcohol misuse among Estonians through structural intervention means and the scaling up of alcohol counselling in the mid-2000’s, most of the country’s alcohol misuse indicators remain clearly higher than European averages. Consequently, an online self-help program was launched as part of an initial behavioral intervention initiative to foster progress in alcohol prevention on a population level.MethodsA two-arm randomized controlled trial (RCT) has been designed to compare the efficacy of a culturally-adapted minimal-guidance online self-help program, the 8-week “Selge” online program against a control condition that consists of a self-administered test of alcohol use and advice regarding usual treatment in Estonia. A target sample of 600 individuals will be recruited and randomly assigned to either condition. The program will contain 10 modules based on principles of cognitive behavioural therapy (CBT) and motivational interviewing (MI). Participants in the control group will have access to the full treatment after they complete their final follow-up assessment. The primary outcome will be change in the Alcohol Use Disorders Identification Test (AUDIT) score between the 6-month follow-up and baseline assessments. Secondary outcomes will include the number of standard drinks consumed and alcohol-free days, drinking motives and motivation for change, as well as changes in mental health. Assessments will be completed at baseline, at the end of treatment, and at 6 months follow-up. Data analysis will follow the intention-to-treat principle and employ (generalised) linear mixed models.DiscussionThe “Selge” program is the first and only internet program for the intervention of alcohol misuse in Estonia. If proven effective, it will foster progress in the intervention of alcohol misuse in the Estonian population and be implemented as a standard program amidst the continuum of intervention and care.Trial registrationCurrent Controlled Trials ISRCTN48753339 registered 04/06/2019 retrospectively.

The effect of co-morbid anxiety on remission from depression for people participating in a randomised controlled trial of the Friendship Bench intervention in Zimbabwe

BackgroundThere is a lack of data from low- and middle-income countries on whether anxiety independently predicts a more chronic course for depression. MethodsWe undertook secondary data analysis of a cluster randomised controlled trial in Zimbabwe which had tested the effectiveness of the Friendship Bench intervention for common mental disorders compared to enhanced usual care. Inclusion for the current study was participants from the trial who had probable major depression at baseline, defined as scoring => 11 on the locally validated Patient Health Questionnaire (PHQ9). This emerged to be 354 of the original 573 (61.78%) of the original trial sample. Anxiety was measured using the locally validated cut-point on the Generalised Anxiety Disorder scale (GAD-7). Persistent depression was defined as scoring => 11 on the PHQ-9 at six-months follow-up. Analysis in Stata 15 used random-effects logistic regression to adjust for clustering by clinic. OutcomesOf the 354 participants who were eligible for treatment, 329 (92·9%) completed 6-month follow-up assessment. 37% of the trial sample had persistent depression at 6-months follow-up; 59% in the control arm and 17% in the intervention arm. Co-morbid anxiety present at trial baseline was independently associated with persistent depression after adjusting for age, gender and baseline depression severity (adjusted OR = 2·83, 95% CI 1·32–6·07). There was no evidence of effect modification by trial arm. Baseline depression severity also predicted persistent depression. Interpretation Treatment for depression in low and middle-income countries (LMIC) should be directed towards those with greatest need. This includes people with co-morbid anxiety and greater depression severity at initial assessment who are less likely to remit at six months. Advice on coping with anxiety, psychological treatments which target common anxiety symptoms such as fear, avoidance, excessive worry and intrusive thoughts, and Selective Serotonin Reuptake Inhibitors (SSRIs) should be made more widely available in LMIC and offered to those with persistent mixed depression and anxiety.

Combining Web-Based Attentional Bias Modification and Approach Bias Modification as a Self-Help Smoking Intervention for Adult Smokers Seeking Online Help: Double-Blind Randomized Controlled Trial.

BackgroundAutomatically activated cognitive motivational processes such as the tendency to attend to or approach smoking-related stimuli (ie, attentional and approach bias) have been related to smoking behaviors. Therefore, these cognitive biases are thought to play a role in maintaining smoking behaviors. Cognitive biases can be modified with cognitive bias modification (CBM), which holds promise as an easy-access and low-cost online intervention. However, little is known about the effectiveness of online interventions combining two varieties of CBM. Targeting multiple cognitive biases may improve treatment outcomes because these biases have been shown to be relatively independent.ObjectiveThis study aimed to test the individual and combined effects of two web-based CBM varieties—attentional bias modification (AtBM) and approach bias modification (ApBM)—in a double-blind randomized controlled trial (RCT) with a 2 (AtBM: active versus sham) × 2 (ApBM: active versus sham) factorial design.MethodsA total of 504 adult smokers seeking online help to quit smoking were randomly assigned to 1 of 4 experimental conditions to receive 11 fully automated CBM training sessions. To increase participants’ intrinsic motivation to change their smoking behaviors, all participants first received brief, automated, tailored feedback. The primary outcome was point prevalence abstinence during the study period. Secondary outcomes included daily cigarette use and attentional and approach bias. All outcomes were repeatedly self-assessed online from baseline to the 3-month follow-up. For the examination of training effects on outcome changes, an intention-to-treat analysis with a multilevel modeling (MLM) approach was adopted.ResultsOnly 10.7% (54/504) of the participants completed all 11 training sessions, and 8.3% (42/504) of the participants reached the 3-month follow-up assessment. MLM showed that over time, neither AtBM or ApBM nor a combination of both differed from their respective sham training in point prevalence abstinence rates (P=.17, P=.56, and P=.14, respectively), and in changes in daily cigarette use (P=.26, P=.08, and P=.13, respectively), attentional bias (P=.07, P=.81, and P=.15, respectively), and approach bias (P=.57, P=.22, and P=.40, respectively), while daily cigarette use decreased over time across conditions for all participants (P<.001).ConclusionsThis RCT provides no support for the effectiveness of combining AtBM and ApBM in a self-help web-based smoking cessation intervention. However, this study had a very high dropout rate and a very low frequency of training usage, indicating an overall low acceptability of the intervention, which precludes any definite conclusion on its efficacy. We discuss how this study can inform future designs and settings of online CBM interventions.Trial RegistrationNetherlands Trial Register NTR4678; https://www.trialregister.nl/trial/4678

Correcting exaggerated drinking norms with a mobile message delivery system: Selective prevention with heavy-drinking first-year college students.

Many efficacious interventions designed to reduce college student drinking aim to correct misperceptions of peers' drinking behavior. The present study tested the efficacy of a novel delivery strategy, namely text messages, for promoting promoderation descriptive and injunctive drinking norms. Participants included 121 college students who were randomly assigned to receive daily text messages containing accurate drinking norms (experimental group, n = 61) or historical facts (control group, n = 60) for 10 weeks following a baseline assessment. Participants completed 3-month postbaseline and 6-month postbaseline follow-up assessments. The 3-month assessment revealed that promoderation text messages were effective for reducing peak consumption and alcohol consequences. Changes in descriptive norms and injunctive norms aligned with these two behavioral outcomes. The intervention group reported perceiving others as drinking less on their heaviest drinking day and perceived others as being less approving of alcohol-related consequences than the control group. The intervention group also reported more peer approval of using protective behavioral strategies. Yet intervention effects were not maintained. None of the outcome measures differed by condition at the 6-month postbaseline assessment. Thus, the intervention had short-term effects on self-reported drinking behavior as well as on perceptions of drinking norms. However, the behavioral changes were not maintained when participants were assessed in the second semester after the daily text messages intervention had stopped. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

A prospective study of pessary use for severe pelvic organ prolapse: 3-year follow-up outcomes

To estimate the optimal definition of successful pessary use and the long-term success rate of the pessary as well as the complications and factors associated with continued pessary use. Consecutive patients who had symptomatic stage III/IV POP were enrolled. The degrees of POP were assessed by POP-Q. All patients completed the PFIQ-7 questionnaire before pessary use. For the 1-week, 1-month, 3-month, 6-month, 1-year and 3-year follow-up assessments, patients visited the clinic for an examination and to complete the questionnaire. SPSS 18.0 was used for the data analysis. Wilcoxon's signed-rank test was performed to estimate the change in PFIQ-7 scores before and after pessary use. Logistic regression was performed to identify the factors associated with the duration of pessary use. A total of 60 subjects (average age 68.93 ± 8.98years) were enrolled. The 3-year success rate of the pessary was 63.33%. The PFIQ-7 score in the 1-month follow-up was significantly decreased (16.22 ± 12.81 vs 1.39 ± 3.39, P = 0.000). During the follow-up, none of the patients experienced any severe complications, and the rate of vaginal erosion was 20% (12/60). The PFIQ-7 score in the 1-month follow-up decreased more than 50% and was associated with continuous pessary use [OR 20.75, P = 0.027, 95% CI (2.28, 189.27)]. Successful pessary use can be defined as fitting for longer than 3months. The PFIQ-7 scores should be focused on during the follow-up. The treatment should be changed if the scores decrease less than 50% in the 1-month follow-up.

Use of an activity tracker as a measurement tool in a knee osteoarthritis clinical trial (active-oa trial)

Purpose: In osteoarthritis (OA) clinical trials, reliable and responsive outcome measures to document improvements in function are limited. Current measures predominately rely on self-reported function tests, but they are poorly responsive, subject to misreporting and the placebo response. Functional measures such as observed timed-up-and-go test (TUG) and six-minute walk test (6MWT) are advocated, but their relevance may be limited in the context of a patient’s real-world functional capabilities. Using physical activity tracking devices/wearables as a way to measure improvements in function in day-to-day life is potentially an attractive and easily available alternative to conventional OA trial outcome measures. Consumer-level activity monitors have shown high validity for measurement of steps when compared with research-grade devices. The aim of this study is to assess if the use of an activity tracker in an OA clinical trial is a responsive measurement tool. Secondary objectives include the assessment of the feasibility of an activity tracker use and validity of an activity tracker in an OA clinical trial. Methods: This was a prospective cohort study nested in the Platelet-rich Plasma as a Symptom and Disease-Modifying Treatment for Knee Osteoarthritis - the RESTORE trial (ACTRN12617000853347). Consecutive participants recruited to the RESTORE trial were invited to join this study. Participants ≥ 50 years old with painful knee OA and Kellgren and Lawrence (KL) grade 2-3 were included. Participants were asked to wear an activity tracker (Fitbit Flex (2), Fitbit Inc, San Francisco, CA, USA) for seven consecutive days at the time of baseline assessment (week 0, before their injection therapies), and at the 2-month follow-up assessment. The primary outcome was mean steps per day calculated from a seven-day wear of an activity tracker. To determine the responsiveness of the activity tracker, the standardised response mean (SRM) was calculated for mean steps per day between baseline and 2 months; dividing the mean change scores by the standard deviation of the mean change scores. To investigate validity, correlation coefficient (r) was used to examine the relationship between change in the mean steps per day between baseline and 2 months and participant-perceived global ratings of change (global improvement in function) at 2 months. The relationship of change in mean steps per day and change in secondary outcomes between baseline and 2 months was examined: global improvement (pain and overall improvement), 6MWT, TUG, numeric rating scale (NRS) for pain, knee osteoarthritis outcome score (KOOS), and the Western Ontario and McMaster Universities Osteoarthritis index (WOMAC). Correlation coefficients were estimated for continuous variables. The activity tracker wear was deemed feasible if >70% of patients comply with wearing the trackers at least six out of seven days for each measurement period. Results: 65 participants were recruited (mean age = 61.3 years; 46% female; mean BMI 28.7 kg/m2; 41.5% KLG 2 and 58.5% KLG 3). 8 participants dropped out or had activity tracker misuse/failure at the 2-month follow-up. The SRM was -0.02 (95% CI -0.38 to 0.35) for mean steps per day between baseline and 2 months. The proportion of participants who wore the trackers for six out of seven days was 98% at baseline and 100% at 2-months follow-up. The correlation with change in mean steps per day at baseline and 2 months and outcome measures are detailed in table 1. Conclusions: The use of an activity tracker in a real-world OA clinical trial demonstrated small correlations between change in steps at baseline and 2 months follow-up with global improvement overall and WOMAC function. The use of a tracker is a feasible option with demonstration of good compliance amongst the trial participants. This study has not shown significant responsiveness or validity of the activity trackers in comparison with other regularly utilised outcome measures in OA clinical trials. However, the main challenge of this study is the lack of a gold standard outcome measure to validate against. Due to the complex nature of pain, perceived quality of life, and the interplay between these factors and measured function, a lack of correlation does not necessarily represent a failed validation in this context.