Treatment As Usual Group Research Articles

Randomized controlled trial investigating web-based, therapist delivered eye movement desensitization and reprocessing for adults with suicidal ideation.

Promising preliminary evidence suggests that EMDR may reduce suicidal ideation (SI) when used to treat Major Depressive Disorder, Posttraumatic Stress Disorder, and trauma symptoms in the context of acute mental health crises. EMDR has never been tested specifically for treating SI, and there is a lack of data regarding the safety and effectiveness of web-based, therapist-delivered EMDR in populations with known SI. The primary objective of this study was to investigate the impact of web-based, therapist-delivered EMDR, targeting experiences associated with suicidal thinking. Secondary objectives included examining the effect of EMDR treatment on symptoms of depression, anxiety, posttraumatic stress, emotional dysregulation, and dissociation, as well as safety and attrition. This randomized control trial (ClinicalTrials.gov ID number: NCT04181047) assigned adult outpatients reporting SI to either a web-based EMDR intervention or a treatment as usual (TAU) group. TAU included primary and mental health services available within the Canadian public health system. Participants in the EMDR group received up to 12 web-based EMDR desensitization sessions, delivered twice weekly during the COVID-19 pandemic (2021-2023). The Health Research Ethics Board at the University of Alberta approved the protocol prior to initiation of data collection for this study (protocol ID number: Pro00090989). Forty-two adult outpatients received either EMDR (n=20) or TAU (n=22). Participants reported a high prevalence of early onset and chronic SI, and there was a high rate of psychiatric comorbidity. In the EMDR group, median SI, depression, anxiety, and posttraumatic symptom scale scores decreased from baseline to the four month follow-up. In the TAU group, only the median SI and posttraumatic symptom scale scores decreased from baseline to four month follow up. Although sample size precludes direct comparison, there were numerically fewer adverse events and fewer dropouts in the EMDR group relative to the TAU group. Study results provide promising preliminary evidence that web-based EMDR may be a viable delivery approach to address SI. In this complex population, a short treatment course was associated with reductions of SI and other symptoms across multiple diagnostic categories. Further investigation is warranted to verify and extend these results. https://clinicaltrials.gov/study/NCT04181047?id=NCT04181047&rank=1, identifier NCT04181047.

Pilot study of career mentoring program for juveniles.

This article describes an innovative career-mentoring program for court-ordered juveniles that targets risk factors of recidivism and incorporates elements of effective career intervention. Youth were randomly assigned to a mentoring group or a treatment-as-usual (TAU) group. The mentoring group received nine sessions of a structured career-mentoring program from students at a university. The TAU group received other programs provided by the court. Results at posttest indicated that the mentoring group exhibited more pro-social motivations for work, more realistic attitudes toward work, and more professional job interests than the TAU group. Persons in the mentoring group enjoyed their mentoring experience with their university student mentors. Results have implications for cost-effective programs for court-ordered youth at a crucial time in their development. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Cue-exposure treatment influences resting-state functional connectivity—a randomized controlled fMRI study in alcohol use disorder

RationaleCue-exposure therapy (CET) consists of exposing patients to the cause of their affliction in a controlled environment and after psychological preparation. Ever since it was conceived, it has been suggested as a treatment for different types of behavioural impairments, from anxiety disorders to substance abuse. In the field of addictive behaviour, many different findings have been shown regarding the effectiveness of this therapy.ObjectivesThis study aims to examine the underlying neurobiological mechanisms of the effects of CET in patients with alcohol use disorder using resting-state functional magnetic resonance imaging (rs-fMRI).MethodsIn a randomized, controlled study, we examined patients after inpatient detoxification as well as healthy controls. Patients underwent nine sessions of CET spaced over 3 weeks. Rs-fMRI was conducted before treatment and 3 weeks after treatment onset in patients, healthy controls received only one rs-fMRI measurement. The final participant sample with complete data included 35 patients in the CET group, 17 patients in the treatment-as-usual group, and 43 HCs.ResultsOur results show differences in the Salience Network when comparing the CET group to the treatment-as-usual group (TAU). Functional connectivity between the anterior cingulate Cortex (ACC) and the insula was increased after CET, whereas it was decreased from ACC to the putamen and globus pallidus. Further, increased connectivity with the precuneus was found in the dorsal attention network after cue exposure treatment.ConclusionsThese findings suggest that cue exposure therapy changes the resting-state brain connectivity with additional effects to the standard psychotherapy treatment. Hence, our study results suggest why including CET in standard therapies might improve the preparation of patients in front of daily situations.

First-episode psychosis intervention programme versus standard care for the clinical management of early phases of psychosis: cost analysis.

Early intervention programmes (EIPs) in psychosis have gained attention as specialised interventions to improve health-related and societal impacts for people with psychotic disorders. Previous studies have presented evidence in favour of EIPs over the first year of intervention, despite none considering the critical period before psychosis onset (5 years). To compare the associated costs of the First Episode Psychosis Intervention Program (CRUPEP) and treatment as usual (TAU) in a real-world cohort in a non-specialised psychiatric community setting. Direct and indirect mental health-related costs were calculated over 1 year and up to 7 years. Healthcare and societal costs were calculated from economic data related to the consumption of all healthcare resources, including emergency department attendances, hospital admissions, psychotropic medication prescriptions and societal costs. From a healthcare perspective, the intervention (CRUPEP) group initially showed a marginally higher cost per patient than the TAU group (€7621 TAU group v. €11 904 CRUPEP group) over the first year of follow-up. However, this difference was reversed between the groups on considering the entire follow-up, with the TAU group showing considerably higher associated costs per patient (€77 026 TAU v. €25 247 CRUPEP). The EIP (CRUPEP) showed clinical benefits and minimised the direct and indirect health-related costs of the management of psychosis. Although the CRUPEP intervention initially reported increased costs over 1 year, TAU surpassed the global costs over the entire follow-up.

Integrative group psychotherapy for patients with somatic symptom disorder: A randomized controlled trial

The study aimed to determine whether specific integrative group psychotherapy (IGPT), based on CBT, combined with techniques of psychodynamic therapy and mindful body and emotional awareness is more effective than non-specific supportive group psychotherapy (SGPT) and treatment as usual (TAU) alone. A total of 120 SSD patients were randomly assigned to IGPT, SGPT or TAU groups. Both IGPT and SGPT showed significantly lower SSD-12 scores at the 4, 8, and 12-week follow-ups compared to TAU. No significant differences were observed between IGPT and SGPT at any follow-up point. These findings highlight the potential benefits of group psychotherapy in SSD treatment.

Circadian Reinforcement Therapy in Combination With Electronic Self-Monitoring to Facilitate a Safe Postdischarge Period for Patients With Major Depression: Randomized Controlled Trial.

Patients with major depression exhibit circadian disturbance of sleep and mood, and when they are discharged from inpatient wards, this disturbance poses a risk of relapse. We developed a circadian reinforcement therapy (CRT) intervention to facilitate the transition from the inpatient ward to the home for these patients. CRT focuses on increasing the zeitgeber strength for the circadian clock through social contact, physical activity, diet, daylight exposure, and sleep timing. In this study, we aimed to prevent the worsening of depression after discharge by using CRT, supported by an electronic self-monitoring system, to advance and stabilize sleep and improve mood. The primary outcome, which was assessed by a blinded rater, was the change in the Hamilton Depression Rating Scale scores from baseline to the end point. Participants were contacted while in the inpatient ward and randomized 1:1 to the CRT or the treatment-as-usual (TAU) group. For 4 weeks, participants in both groups electronically self-monitored their daily mood, physical activity, sleep, and medication using the Monsenso Daybuilder (MDB) system. The MDB allowed investigators and participants to simultaneously view a graphical display of registrations. An investigator phoned all participants weekly to coinspect data entry. In the CRT group, participants were additionally phoned between the scheduled calls if specific predefined trigger points for mood and sleep were observed during the daily inspection. Participants in the CRT group were provided with specialized CRT psychoeducation sessions immediately after inclusion, focusing on increasing the zeitgeber input to the circadian system; a PowerPoint presentation was presented; paper-based informative materials and leaflets were reviewed with the participants; and the CRT principles were used during all telephone consultations. In the TAU group, phone calls focused on data entry in the MDB system. When discharged, all patients were treated at a specialized affective disorders service. Overall, 103 participants were included. Participants in the CRT group had a significantly larger reduction in Hamilton Depression Scale score (P=.04) than those in the TAU group. The self-monitored MDB data showed significantly improved evening mood (P=.02) and sleep quality (P=.04), earlier sleep onset (P=.009), and longer sleep duration (P=.005) in the CRT group than in the TAU group. The day-to-day variability of the daily and evening mood, sleep offset, sleep onset, and sleep quality were significantly lower in the CRT group (all P<.001) than in the TAU group. The user evaluation was positive for the CRT method and the MDB system. We found significantly lower depression levels and improved sleep quality in the CRT group than in the TAU group. We also found significantly lower day-to-day variability in daily sleep, mood parameters, and activity parameters in the CRT group than in the TAU group. The delivery of the CRT intervention should be further refined and tested. ClinicalTrials.gov NCT02679768; https://clinicaltrials.gov/study/NCT02679768. RR2-10.1186/s12888-019-2101-z.

Modifying diet and exercise in multiple sclerosis (MoDEMS): A randomized controlled trial for behavioral weight loss in adults with multiple sclerosis and obesity

Background: Obesity is a risk factor for developing multiple sclerosis (MS) and MS-related disability. The efficacy of behavioral weight loss interventions among people with MS (pwMS) remains largely unknown. Objective: Examine whether a group-based telehealth weight loss intervention produces clinically significant weight loss in pwMS and obesity. Methods: Seventy-one pwMS were randomized to the weight loss intervention or treatment-as-usual (TAU). The 6-month program promoted established guidelines for calorie reduction and increased physical activity. Anthropometric measurements, mobility tasks, self-report questionnaires, and accelerometry were used to assess changes at follow-up. Results: Mean percent weight loss in the treatment group was 8.6% compared to 0.7% in the TAU group (p < .001). Sixty-five percent of participants in the intervention achieved clinically meaningful weight loss (⩾ 5%). Participants in the treatment group engaged in 46.2 minutes/week more moderate-to-vigorous physical activity than TAU participants (p = .017) and showed improvements in quality of life (p = .012). Weight loss was associated with improved mobility (p = .003) and reduced fatiguability (p = .008). Conclusion: Findings demonstrate the efficacy of a behavioral intervention for pwMS and obesity, with clinically significant weight loss for two-thirds of participants in the treatment condition. Weight loss may also lead to improved mobility and quality of life.

A pragmatic randomized controlled exploratory trial of the effectiveness of Eye Movement Desensitization and Reprocessing therapy for psychotic disorder

BackgroundPeople with severe mental illness are often excluded from trials related to Eye Movement Desensitization and Reprocessing (EMDR) therapy. Principal concerns are that they may not tolerate treatment, might risk relapse or that psychotic symptoms may worsen. There is however building evidence of a traumatogenic etiology of psychotic disorder that may benefit therapeutically from EMDR. However, EMDR in this role is done mainly in specialist tertiary settings. AimTo conduct a randomized exploratory trial of prospective treatment of EMDR for people with psychotic disorder and a history of trauma in an adult community mental health service. MethodsA randomized exploratory trial with a controlled pilot design was employed to conduct a prospective treatment and six-month follow-up study with an interim 10-week analysis in a rural county in the UK (population 538,000). We recruited participants with psychotic disorder who had a reported history of trauma and were interested in receiving trauma therapy. They were then randomized to either receive EMDR or treatment as usual (TAU). The primary instrument used was the Impact of Events Scale (IES) with secondary instruments of Positive and Negative Symptoms of Psychotic Disorder (PANSS), PTSD Checklist (PCL-C), and subjective Quality of Life (MANSA). ResultsIES scores showed significant improvements in the EMDR group (n = 24, age 42.0 SD (14.5), 42% male) compared to the TAU group (n = 12, age 34.4 SD (11.3), 50% male) at 10 weeks and at six months (p < 0.05). There were significant improvements in PCL-C and PANSS negative symptoms scores associated with treatment (p < 0.05). All other scales showed positive trends. ConclusionsThis study demonstrates that EMDR can reduce the impact of traumatic events for patients with a psychotic disorder in a clinical setting in the UK. The improvements in psychotic disorder persisted for six months after treatment. Trial registrationISRCTN43816889.

Efficacy of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction for Depression Symptoms and Sleep-Wake Disruption in Older and Younger Adults: Secondary Age-Stratified Analysis of a Randomized Controlled Trial

ObjectivePerform a secondary analysis examining the efficacy of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for depression symptom responses, and explore changes in potential target mechanisms. DesignSecondary analysis of a randomized controlled trial with convenience age subsamples (younger (20–49 year; n = 52) versus and older (50–71 years; n = 35)). SettingCommunity mental health clinics. ParticipantsEighty-seven adults with serious mental illness. InterventionTranS-C versus treatment as usual (TAU). MeasurementsOutcomes were depression symptoms (Quick Inventory of Depression Symptoms), insomnia symptoms (Insomnia Severity Index), and objective sleep-wake rhythm measures (interdaily stability and relative amplitude). ResultsDepression response rates (≥50% symptom reductions) were higher in the TranS-C (35.0%) than the TAU (8.8%) group 6-months postintervention (χ2 = 10.3, p = 0.001). There was a medium effect of TranS-C versus TAU on depression symptoms 6-months postintervention (Cohen's d = −0.40, 95% confidence interval (CI): −0.81, 0.01). In both age groups, there were large treatment effects on insomnia symptoms post-treatment (Cohen's d >0.90). In the older subsample, there were additionally medium treatment effects on post-treatment interdaily stability (Cohen's d = 0.60, 95% CI: −0.11, 1.61). Post-treatment reductions in insomnia symptoms correlated with depression symptom reduction 6-months later in the younger subsample (Spearman rho = 0.59, n = 20, p = 0.008). In older adults, postintervention increases in interdaily stability correlated with depression symptom reductions 6-months later (Spearman rho = −0.52, n = 15, p = 0.049). ConclusionConfirmatory trials are needed, given the low age-specific sample sizes here, to determine if TranS -C's produces durable depression responses by increasing sleep-wake rhythm stability in older adults and improving insomnia symptoms in younger adults. Brief article summaryThe authors evaluated preliminary efficacy of a behavioral intervention that targets sleep/sleep-wake rhythms, the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C), for depression symptoms in people with serious mental illness. TranS-C was associated with higher depression response rates than treatment as usual 6-months postintervention. The degree of depression symptom response 6-months later was related to the degree of treatment phase improvements in interdaily stability (in older adults) and reduction in insomnia severity (in younger adults).A pragmatic nonpharmacologic intervention, the Transdiagnostic Intervention for Sleep and Circadian Dysfunction, has preliminary efficacy for improving sleep-wake factors and depression symptoms.

Outpatient care for adolescents' and young adults' mental health: promoting self- and others' understanding through a metacognitive interpersonal therapy-informed psychological intervention.

Psychological distress may result in impairment and difficulty understanding oneself and others. Thus, addressing metacognitive issues in psychotherapy may improve psychopathology in adolescents and young adults (AYAs). We aimed to compare metacognitive interpersonal therapy (MIT)-informed psychotherapy with other treatment-as-usual (TAU) therapies. We administered the Global Assessment of Functioning (GAF) scale, the Clinical Global Impressions-Severity (CGI-S) scale, and the Brief Psychiatric Rating Scale (BPRS) at baseline (BL) and at treatment termination (the endpoint was at 6 months and any last results obtained before that term were carried forward in analyzes). Patients received concomitant psychiatric and psychological treatment. Sixty AYAs were involved in the study. There was a significant reduction in symptomatology after the intervention. Twelve patients (17%) dropped out; treatment adherence was 83%. In the MIT group, 2 patients dropped out (11%), and in the TAU group, 9 patients dropped out (19%). All scales showed a significant reduction in symptoms between baseline (BL) and the 6-month endpoint: GAF (χ2 = 6.61, p < 0.001), BPRS (χ2 = 6.77, p < 0.001), and CGI (χ2 = 7.20, p < 0.001). There was a greater efficacy for the MIT group in terms of symptom reduction on the BPRS (t = 2.31; p < 0.05). The study confirmed the efficacy of early and integrated care in adolescence and suggested greater symptom reduction for a psychotherapeutic intervention focused on stimulating mentalization skills. The study indicates the usefulness of this type of approach in the treatment of adolescent psychopathology. Due to the small sample size, the results need replication.

Home-administered transcranial direct current stimulation with asynchronous remote supervision in the treatment of depression: feasibility, tolerability, and clinical effectiveness.

Depression is an often chronic condition, characterized by wide-ranging physical, cognitive and psychosocial symptoms that can lead to disability, premature mortality or suicide. It affects 350 million people globally, yet up to 30% do not respond to traditional treatment, creating an urgent need for novel non-pharmacological treatments. This open-label naturalistic study assesses the practical feasibility, tolerability, and clinical effectiveness of home-administered transcranial direct current stimulation (tDCS) with asynchronous remote supervision, in the treatment of depression. Over the course of 3 weeks, 40 patients with depression received psychotherapy and half of this group also received daily bi-frontal tDCS stimulation of the dorsolateral prefrontal cortex. These patients received tDCS for 30 min per session with the anode placed over F3 and the cathode over F4, at an intensity of 2 mA for 21 consecutive days. We measured patients' level of depression symptoms at four time points using the Beck Depression Inventory, before treatment and at 1-week intervals throughout the treatment period. We monitored practical feasibility such as daily protocol compliance and tolerability including side effects, with the PlatoScience cloud-based remote supervision platform. Of the 20 patients in the tDCS group, 90% were able to comply with the protocol by not missing more than three of their assigned sessions, and none dropped out of the study. No serious adverse events were reported, with only 14 instances of mild to moderate side effects and two instances of scalp pain rated as severe, out of a total of 420 stimulation sessions. Patients in the tDCS group showed a significantly greater reduction in depression symptoms after 3 weeks of treatment, compared to the treatment as usual (TAU) group [t(57.2) = 2.268, p = 0.027]. The tDCS group also showed greater treatment response (50%) and depression remission rates (75%) compared to the TAU group (5 and 30%, respectively). These findings provide a possible indication of the clinical effectiveness of home-administered tDCS for the treatment of depression, and its feasibility and tolerability in combination with asynchronous supervision.

A randomized controlled trial to evaluate the efficacy of metacognitive training for older adults with depression (MCT-Silver) in Portugal: study protocol.

Depression is one of the most common psychological disorders in later life. Although psychological interventions are recommended by treatment guidelines, most older adults with depression remain untreated. The aim of this study is to evaluate the efficacy of the Portuguese version of Metacognitive Training for Depression in later life (MCT-Silver). This is a study protocol of an observer-blind, parallel-group, randomized controlled trial to compare the efficacy of MCT-Silver with a treatment as usual (TAU) control group among older adults (age 65 years and older) with depressive symptoms according to the Montgomery-Asberg Depression Scale. Participants will be tested at three assessment time points (baseline, immediately following the intervention [8 weeks], and 3 months after the intervention). The primary outcome is change in self-rated depression symptoms assessed by the Beck Depression Inventory (BDI-II). Secondary outcomes include clinician-rated depression, self-esteem, dysfunctional beliefs, metacognitive beliefs, ruminations, attitudes toward aging and quality of life. A self-designed subjective appraisal rating scale consisting of 21-items will be used to assess participant acceptance of MCT-Silver. MCT-Silver is an innovative intervention, which aims to reduce dysfunctional thoughts as well as depression-related behaviors and coping strategies through the metacognitive perspective. Until now, the training has only been tested in Germany. It is expected that after 8 weeks of treatment and 3 months later, the experimental group will demonstrate significant reductions in depressive symptoms, metacognitive beliefs, dysfunctional attitudes and ruminative responses compared to the TAU group. Moreover, quality of life, self-esteem, and attitudes towards aging will be significantly improved in MCT-Silver compared to the TAU group. ClinicalTrials.gov, NCT05640492.

A multivariate cognitive approach to predict social functioning in recent onset psychosis in response to computerized cognitive training

Clinical and neuroimaging data has been increasingly used in recent years to disentangle heterogeneity of treatment response to cognitive training (CT) and predict which individuals may achieve the highest benefits. CT has small to medium effects on improving cognitive and social functioning in recent onset psychosis (ROP) patients, who show the most profound cognitive and social functioning deficits among psychiatric patients. We employed multivariate pattern analysis (MVPA) to investigate the potential of cognitive data to predict social functioning improvement in response to 10 h of CT in patients with ROP. A support vector machine (SVM) classifier was trained on the naturalistic data of the Personalized Prognostic Tools for Early Psychosis Management (PRONIA) study sample to predict functioning in an independent sample of 70 ROP patients using baseline cognitive data. PRONIA is a part of a FP7 EU grant program that involved 7 sites across 5 European countries, designed and conducted with the main aim of identifying (bio)markers associated with an enhanced risk of developing psychosis in order to improve early detection and prognosis. Social functioning was predicted with a balanced accuracy (BAC) of 66.4% (Sensitivity 78.8%; Specificity 54.1%; PPV 60.5%; NPV 74.1%; AUC 0.64; P = 0.01). The most frequently selected cognitive features (mean feature weights > ± 0.2) included the (1) correct number of symbol matchings within the Digit Symbol Substitution Test, (2) the number of distracting stimuli leading to an error within 300 and 200 trials in the Continuous Performance Test and (3) the dynamics of verbal fluency between 15 and 30 s within the Verbal Fluency Test, phonetic part. Next, the SVM classifier generated on the PRONIA sample was applied to the intervention sample, that obtained 54 ROP patients who were randomly assigned to a social cognitive training (SCT) or treatment as usual (TAU) group and dichotomized into good (GF-S ≥ 7) and poor (GF-S < 7) functioning patients based on their level of Global Functioning-Social (GF-S) score at follow-up (FU). By applying the initial PRONIA classifier, using out-of-sample cross-validation (OOCV) to the sample of ROP patients who have undergone the CT intervention, a BAC of 59.3% (Sensitivity 70.4%; Specificity 48.1%; PPV 57.6%; NPV 61.9%; AUC 0.63) was achieved at T0 and a BAC of 64.8% (Sensitivity 66.7%; Specificity 63.0%; PPV 64.3%; NPV 65.4%; AUC 0.66) at FU. After SCT intervention, a significant improvement in predicted social functioning values was observed in the SCT compared to TAU group (P ≤0.05; ES[Cohens' d] = 0.18). Due to a small sample size and modest variance of social functioning of the intervention sample it was not feasible to predict individual response to SCT in the current study. Our findings suggest that the use of baseline cognitive data could provide a robust individual estimate of future social functioning, while prediction of individual response to SCT using cognitive data that can be generated in the routine patient care remains to be addressed in large-scale cognitive training trials.

O.1.1-7 As we were and as we should be, concurrent exercise training in adults with schizophrenia: CORTEX-SP study

Abstract Purpose People with schizophrenia (SP) in addition to presenting an unhealthy lifestyle, psychosocial determinants, such as decreased self-esteem and social stigma, and the presence of psychiatric symptoms, have a profound impact on the health-related quality of life (HRQoL). Thus, people with SP have reported greater disability than those healthy control (HC) in HRQoL, assessed by the 36-Item Short-Form Health Survey questionnaire (SF-36). Therefore, the promotion of a healthy lifestyle and interventions aiming to increase physical activity (i.e., aerobic and resistance training) should be a priority given the health benefits. It is well known that regular physical activity improves HRQoL contributing to perceived well-being, with greater improvements in interventions supervised by exercise specialists. Methods This research was carried out to analyze the HRQoL measurements in an SP population (n = 112, 20.4% women, 41.3±10.4 yr old) in comparison to an HC sample (n = 30), and to determine in the SP sample the changes in QoL following 20-week supervised concurrent exercise training program (EX) compared to a Treatment-As-Usual (TAU). The SF-36 questionnaire was used to assess HRQoL. Results At baseline, the SP population showed lower scores (P &amp;lt; 0.05) in physical function, role-physical, bodily pain, general health, vitality, social functioning, mental health, and physical and mental component summaries compared to HC. After 20-week intervention, physical functioning (↑12.9%), general health (↑15.3%), mental health (↑8.3%), and physical component summary (↑5.1%), increased (P &amp;lt; 0.05) in EX group. In contrast, no significant changes were seen in the TAU for any of the domains studied. Following the Bonferroni correction, there were between-group significant differences. Thus, the EX group showed significant (P &amp;lt; 0.05) improvements (i.e., higher values) compared with the TAU group in physical functioning (difference = 14.3; 95% CI, 5.8-22.8), general health (difference = 11.7; 95% CI, 5.0-18.5) and physical component summary (difference = 4.6; 95% CI, 1.1-8.2), and no significant between-group differences were found in any other domains. Conclusions These results highlight the important role of supervised exercise in improving physical and psychological health.

Moderated Online Social Therapy for Carers of Early Psychosis Clients in Real-World Settings: Cluster Randomized Controlled Trial.

Family carers of youth recovering from early psychosis experience significant stress; however, access to effective family interventions is poor. Digital interventions provide a promising solution. Our objective was to evaluate across multiple Australian early psychosis services the effectiveness of a novel, web-based early psychosis intervention for carers. In this cluster randomized controlled trial conducted across multiple Australian early psychosis services, our digital moderated online social therapy for carers (Altitudes) plus enhanced family treatment as usual (TAU) was compared with TAU alone on the primary outcome of perceived stress and secondary outcomes including mental health symptoms and family variables at the 6-month follow-up. Eighty-six caregivers were randomized and data were available for 74 young people in their care. Our primary hypothesis that carers randomized to Altitudes+TAU would report greater improvements in perceived stress at follow-up compared with carers randomized to TAU alone was not supported, with the TAU alone group showing more improvement. For secondary outcomes, the TAU alone group showed improved mindfulness over time. Regardless of group assignment, we observed improvements in satisfaction with life, quality of life, emotional overinvolvement, and burden of care. In contrast, hair cortisol concentration increased. Post hoc analyses revealed more contact with early psychosis services in the intervention group compared to TAU alone and that improvements in perceived stress and social support were associated with use of the intervention in the Altitudes+TAU group. In this study, 80% (12/15) reported a positive experience with Altitudes and 93% (14/15) would recommend it to others. Our trial did not show a treatment effect for Altitudes in perceived stress. However, our post hoc analysis indicated that the amount of use of Altitudes related to improvements in stress and social support. Additional design work is indicated to continue users' engagement and to significantly improve outcomes in problem-solving, communication, and self-care. Australian and New Zealand Clinical Trials Registry ACTRN12617000942358; https://trialsearch.who.int/Trial2.aspx?TrialID=ACTRN12617000942358.

Rates of Preterm Birth and Low Birth Weight in an Adolescent Obstetric Clinic: Achieving Health Equity Through Trauma-Informed Care.

Adolescents who are pregnant and identify as Black are exposed to more societal harms that increase their and their offspring's risk for poor health outcomes. The Colorado Adolescent Maternity Program (CAMP) offers comprehensive, multidisciplinary (medical, behavioral health, nutrition, case management), trauma-informed obstetric care to pregnant adolescents to ensure the healthiest pregnancy and birth possible and pursue health equity. The present study aimed to examine ethnic and racial disparities in preterm birth and low birth weight before and after implementation of a trauma-informed model of care. Participants were 847 pregnant adolescents (ages 12-22 years; 41% self-identified as Hispanic, 32% as non-Hispanic Black, 21% as non-Hispanic white) who received prenatal treatment-as-usual (TAU) or trauma-informed treatment. Demographic information, mental health symptoms, and birth outcomes were abstracted from medical records. Overall, findings provided support that implementation of a trauma-informed model of prenatal care led to equitable birth outcomes across racial and ethnic groups. Specifically, Black adolescents in the TAU group were more than twice as likely to deliver preterm or low birth weight infants compared with white and Hispanic adolescents. In the trauma-informed group, however, there were no statistical differences in birth outcomes across racial/ethnic groups, indicating an elimination of disparities in both preterm birth and low birth weight in this population. These more equitable birth outcomes occurred even in the context of adolescents of color having reported more severe depression symptoms postimplementation. These findings provide evidence that a health system-level intervention, herein trauma-informed obstetric care for adolescents, can play a meaningful role in the reduction of racial disparities in birth outcomes.

As we were and as we Should Be, Combined Exercise Training in Adults with Schizophrenia: CORTEX-SP Study Part I.

Given the health benefits and the role of exercise as an anti-inflammatory adjuvant program, this study aimed to determine the effectiveness of a combined exercise program on cardiorespiratory fitness (CRF), body composition, and biochemical levels in adults with schizophrenia (SZ) characterized at baseline as metabolically unhealthy overweight with low CRF. Participants diagnosed with SZ (n = 112, 41.3 ± 10.4 yr, 28.7% women) were randomly assigned into a Treatment-As-Usual (TAU) control group (n = 53) or a supervised exercise group (n = 59, 3 days/week). Each combined exercise session consisted of both a low-volume high-intensity interval training (less than 10 min of high-intensity time per session) and a resistance circuit-training program. All variables were assessed pre-and post-intervention (20 weeks). For the assessment of CRF, a peak cardiopulmonary exercise test on a cycle ergometer was used. Following the intervention, participants from the exercise group (n = 51) showed increases in CRF (P < 0.001) through peak oxygen uptake (L·min-1; Δ = 17.6%; mL·kg.1·min-1, Δ = 19.6%) and the metabolic equivalent of task (Δ = 19%), with no significant changes (P > 0.05) in body composition and biochemical variables. However, the TAU group (n = 38) did not show any significant change in the study variables (P > 0.05). Between-group significant differences (P ≤ 0.05) were observed in CRF, first ventilatory threshold, and heart rate peak after the intervention period favoring the exercise group. This study demonstrated that a supervised combined exercise program in people with SZ helps to maintain body composition values and improve CRF levels. This could lead to an important clinical change in the characterization from metabolically unhealthy overweight to a metabolically healthy overweight population. Hence, exercise should be considered a co-adjuvant program in the treatment of the SZ population.

Comprehensive geriatric assessment delivered by advanced nursing practitioners within primary care setting: a mixed-methods pilot feasibility randomised controlled trial

BackgroundComprehensive Geriatric Assessment (CGA)is a widely accepted intervention for frailty and can be cost-effective within a primary care setting.ObjectiveTo explore the feasibility of identifying older adults with frailty and assess the subsequent implementation of a tailored CGA with care and support plan by Advanced Nursing Practitioners (ANPs).MethodsA mixed-method parallel randomised controlled trial was conducted. Participants were recruited from two General Practice (GP) centres between January and June 2019. Older adults with confirmed frailty, as assessed by practice nurses, were randomised, using a web service, to the intervention or treatment-as-usual (TAU) groups for six months with an interim and a final review. Data were collected on feasibility, health service usage, function, quality of life, loneliness, and participants' experience and perception of the intervention. Non-parametric tests were used to analyse within and between-group differences. P-values were adjusted to account for type I error. Thematic analysis of qualitative data was conducted.ResultsOne hundred sixty four older adults were invited to participate, of which 44.5% (n = 72) were randomised to either the TAU (n = 37) or intervention (n = 35) groups. All participants in the intervention group were given the baseline, interim and final reviews. Eight participants in each group were lost to post-intervention outcome assessment. The health service use (i.e. hospital admissions, GP/emergency calls and GP/Accident Emergency attendance) was slightly higher in the TAU group; however, none of the outcome data showed statistical significance between-group differences. The TAU group showed a deterioration in the total functional independence and its motor and cognition components post-intervention (p < .05), though the role limitation due to physical function and pain outcomes improved (p < .05). The qualitative findings indicate that participants appreciated the consistency of care provided by ANPs, experienced positive therapeutic relationship and were connected to wider services.DiscussionFrailty identification and intervention delivery in the community by ANPs were feasible. The study shows that older adults with frailty living in the community might benefit from intervention delivered by ANPs. It is suggested to examine the cost-effectiveness of the intervention in sufficiently powered future research.Trial registrationsThe protocol is available at clinicaltirals.gov, ID: NCT03394534; 09/01/2018.

Testing pathways to scale: study protocol for a three-arm randomized controlled trial of a centralized and a decentralized (“Train the Trainers”) dissemination of a mental health program for Kenyan adolescents

BackgroundProviding care in Kenya to all youth in need is difficult because of a shortage of professional providers and societal stigma. Previous trials of the Anansi model, which involves delivering low-touch mental health interventions through a tiered caregiving model (including lay-providers, supervisors, and clinical experts), have shown its effectiveness for reducing depression and anxiety symptoms in school-going Kenyan adolescents. In this trial, we aim to assess two different scale-up strategies by comparing centralized implementation (i.e., by the organization that designed the Anansi model) against implementation through an implementing partner.MethodsIn this three-arm trial, 1600 adolescents aged 13 to 20 years will be randomized to receive the Shamiri intervention from either the Shamiri Institute or an implementation partner or to be placed in the treatment as usual (TAU) control group. The implementation partner will be trained and supplied with protocols to ensure that the same procedures are followed by both implementors. Implementation activities will run concurrently for both implementors. The Shamiri intervention will be delivered by trained lay providers to groups of 10–15 adolescents over four weekly sessions which will take place in secondary schools in Machakos and Makueni counties in Kenya. The TAU group will receive the usual care offered by their respective schools. Outcomes will be assessed at baseline, midpoint (2 weeks), endpoint (4 weeks), and 1 month follow-up. The analysis will be based on an intent-to-treat approach. Mixed effects models will be used to assess trajectories over time of the primary outcomes (anxiety and depressive symptoms, mental well-being, perceived social support, and academic performance) and secondary outcomes for the intervention groups and the control group. Effect sizes will be computed for the mean differences of the intervention and control arms at midpoint, endpoint, and follow-up.DiscussionThis trial will provide insight into the comparative effectiveness of different strategies for scaling a school-based mental health care model. Findings will also indicate areas for improved efficiency of the model to enhance its replicability by other implementors.Trial registrationPan African Clinical Trials Registry (PACTR) (ID: PACTR202305589854478, Approved: 02/05/2023).

Dance/movement therapy for improving balance ability and bone mineral density in long-term patients with schizophrenia: a randomized controlled trial

Fractures are common accidents for long-term hospitalized patients with schizophrenia (SZ) in psychiatric hospitals, and once they occur, patients usually endure the pain of fractures for a long time. Accumulating evidence has supported the implementation of dance/movement therapy (DMT) as a promising intervention for patients with SZ. However, no research has been conducted to investigate its role in balance ability in SZ. This study was designed to investigate the efficacy of a 12-week DMT intervention in bone mineral density and balance ability in patients with SZ using a randomized, controlled trial design. A total of 58 veterans with SZ were randomly assigned to the DMT intervention group (n = 29) and the treatment-as-usual (TAU) group (n = 29). Bone mineral density (BMD) and balance ability were measured in both groups at two measurement points (at baseline and at the end of Week 12). We found that patients in the DMT intervention group had significant improvements in BMD and balance ability compared with the TAU group by using repeated measures analysis of variance. Treatment with DMT demonstrated a significant improvement in BMD from baseline to week 12 (0.03, 95% CI: 0.01–0.05). For the Berg total score and static and dynamic balance, the mean changes in the DMT group were 7.3 (95% CI: 5.6–9.0), 4.0 (95% CI: 0.9–7.1), and 3.7 (95% CI: 2.6–4.8), respectively. Regression analysis showed that baseline BMD was a significant predictor of improvement in BMD from baseline to week 12 in the DMT group (β = 0.58, p < 0.001). Our results suggest for the first time that DMT intervention may be effective in beneficially regulating BMD and balance ability in SZ patients.