Stepped Care Research Articles

Patient perspectives of care pathways for people with low back pain: A qualitative study

BackgroundLow back pain (LBP) care pathways aim to enhance health outcomes through patient-clinician mutual decision-making and care coordination. However, challenges to successful translation into practice include patients' understanding, expectation, and acceptance of treatment and management strategies for LBP. This study explored patients’ perspectives and/or experience of care pathways and their involvement in decision-making in primary care. MethodsA qualitative descriptive design was adopted. Semi-structured interviews were conducted with 14 participants with LBP recruited from the community. Inductive thematic analysis of the qualitative data was conducted within the design framework to enable a systematic comparison of experiences across participants and within individual cases. ResultsFive themes described participant perspectives and understanding of care pathways: i) care pathways can guide decision-making; ii) familiarity with no and/or stepped care pathway, but preference for matched or blend of care pathways; iii) engaging in shared decision-making; iv) patient-related barriers to implementation; v) patient-related facilitators to implementation. ConclusionsParticipants felt that existing care pathways did not meet their needs when pain persisted. Participants preferred matched or hybrid care pathways and suggested that implementation of such pathways should focus on addressing an individual's needs. Adopting a holistic approach, and clarity in shared decision-making, were deemed crucial for effective implementation of LBP pathways in practice. Consumer (patient) engagement in the design of LBP care pathways is recommended.

Preliminary results of adapting the stepped care model for depression management in Vietnam.

BackgroundDepression is the leading burden of mental disease, especially in low-and-middle-income countries like Vietnam. The Stepped Care Model is a promising approach to managing depression in the community with low resources. This is the first study that implemented the adapted Stepped Care Model for depression management in the Vietnamese context and evaluated the initial effectiveness of this community-based intervention in the Thai Nguyen community.Materials and methodsA quasi-experimental study with a 3-month follow-up was conducted in 10 selected communes in Thai Nguyen province. The most important modifications in the Stepped Care Model for depression management were the screening focused on the high-risk individuals living in the community; the combination of 8-session group psychotherapy with animation activities at commune health stations (CHS); and using psychotherapy as first-line treatment. From August 2020 to January 2021, quantitative data were collected using the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7, and the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form. The descriptive analyses were performed to describe the demographic characteristics and the change in the questionnaires' mean score at the baseline and 3-month follow-up.ResultsA total of 1,891 people were approached in the community, of which 359 voluntary people met the study criteria and attended group psychotherapy. During group psychotherapy, the average PHQ-9 scores gradually decreased, and after the 8th session, this figure dropped by 2.65 times compared to the beginning. After 3 months, the percentage of the group with mild-moderate depression shrank from 95.5 to 9.3%, and there were no more severe cases. Moreover, life satisfaction increased by 32% and the anxiety level significantly dropped according to Q-LES-Q-SF and GAD-7 accordingly.ConclusionThe preliminary results after 3-month follow-up showed that the Stepped Care Model with group psychotherapy at the CHS was promising to manage the depression in the community. This task shifting approach with limited resources should be further disseminated and studied for long-term effectiveness in low-and-middle-income countries like Vietnam.

Effectiveness of the SMART Sex Ed program among 13-18 year old English and Spanish speaking adolescent men who have sex with men.

Adolescent men who have sex with men (AMSM) have a high HIV incidence and low utilization of testing and prevention services. However, very few HIV prevention programs exist that focus on the unique sexual health needs of AMSM. SMART is a stepped care package of eHealth interventions that comprehensively address the sexual and HIV prevention needs of AMSM. This study examines the impact of the first step of SMART, "SMART Sex Ed," on 13- to 18-year-old AMSM (n = 983) from baseline to three-month follow-up across 18 separate outcomes measuring HIV prevention attitudes, skills, and behaviors. We observed significant change from baseline to three-month post-intervention in nine HIV-related outcomes (e.g., receipt of HIV and STI test, HIV knowledge), as well as largely consistent effects across demographic subgroups (e.g., race, age, rural, low SES). Analyses observed no effects on condom use behaviors. SMART Sex Ed shows promise as an effective sexual health education program for diverse AMSM.

Referral to aftercare following inpatient withdrawal treatment and readmission: retrospective chart review of patients with substance use disorders.

Aftercare following inpatient withdrawal treatment improves the prognosis and prevents future readmissions in patients with substance use disorders. According to the stepped care approach, the setting and intensity of aftercare should be adjusted to the patients' specific needs and resources. This study evaluated the real-life referral to different types of aftercare in Switzerland and the rate of inpatient readmission within a 1-year follow-up. All substance use disorder patients admitted for inpatient withdrawal treatment in a Swiss psychiatric hospital between January and December 2016 (n = 497) were included in this retrospective study. Clinical and sociodemographic characteristics were extracted from the electronic medical records and their impact on the likelihood of being referred to a particular type of aftercare (general practitioner, psychiatric outpatient care, psychiatric day clinic, inpatient rehabilitation programme) was evaluated. For each type of referral, we determined the readmission rate within one year after discharge. In the sample of substance use disorder patients (mean age 41 years; 69% male), alcohol use disorder was by far the most frequent substance use disorder. Most patients were referred to psychiatric outpatient care (39.8%), followed by a general practitioner (31.0%), inpatient rehabilitation (19.3%) and psychiatric day clinic (9.9%). Patient characteristics that point to an unfavourable course of disease, including higher symptom severity, history of more than two previous admissions, compulsory admission and treatment discontinuation, were associated with a higher likelihood to be referred to lower-level aftercare (general practitioner, psychiatric outpatient care), whereas patients with lower symptom severity, fewer than two previous admissions, voluntary admission and regular discharge were more likely to be referred to high-intensity aftercare (psychiatric day clinic, inpatient rehabilitation). The readmission rate after one year did not differ between the different settings of aftercare (range 40.4-42.9%). The findings of this study suggest that patients suffering from severe substance use disorders and/or from an unfavourable course of disease who would benefit from a more intensive aftercare setting, such as psychiatric day clinics or inpatient rehabilitation programs, might be under-treated, whereas patients with a rather favourable prognosis might similarly benefit from a less intensive treatment setting, such as psychiatric outpatient care. Regarding the comparable readmission rates, we recommend considering more efficient resource management by promoting stepped care approaches for substance use disorders and establishing standardised placement criteria in Switzerland.

Adapting stepped care: Changes to service delivery format in the context of high demand.

Given the ongoing dilemma for college counseling centers to meet steady increases in demand for services, this study outlines the implementation of an adapted stepped care model in a university counseling center. Our adapted model focused, as do other stepped care models, on treatment planning and lower-intensity interventions, with the addition of the intensive therapy option being provided on a weekly basis. We adopted our stepped care model across a large center and hypothesized that after implementation we would be able to serve a similar number of clients as our previous model and that treatment outcomes for these clients would improve. Descriptive data and regression analyses demonstrated support for our hypotheses, including an increased likelihood of clinically significant improvement for clients postimplementation. Implications for adapting service delivery models using practice-based evidence are discussed. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Stepped Care Versus Standard Care for Children After Trauma: A Randomized Non-Inferiority Clinical Trial.

Trauma-focused cognitive-behavioral therapy (TF-CBT) is an evidence-based therapist-led treatment for children after trauma. Parents often experience barriers to treatment engagement, including cost. Stepped care TF-CBT (SC-TF-CBT) was developed as an alternative delivery system. Step One is a parent-led therapist-assisted treatment. Step Two provides therapist-led TF-CBT for children who did not benefit from Step One and require more intensive treatment. This study compared SC-TF-CBT to standard TF-CBT in a community-based non-inferiority trial. A total of 183 children (aged 4-12 years) experiencing posttraumatic stress symptoms (PTSS) and their caregivers were randomly assigned to SC-TF-CBT or standard TF-CBT within 6 community clinics. Assessments occurred at baseline, mid- and posttreatment, and 6 and 12 months. Primary outcomes included PTSS and impairment. Secondary outcomes included severity, diagnostic status, remission, and response. Treatment cost, acceptability, and satisfaction were measured. Difference and non-inferiority tests were applied. SC-TF-CBT participants changed at rates comparable to participants in TF-CBT for primary and secondary measures. SC-TF-CBT was non-inferior to TF-CBT for PTSS, impairment, and severity at all time points except for impairment at the 6-month assessment. Attrition did not differ between treatment arms (132 participants were completers). Baseline treatment acceptability was lower for SC-TF-CBT parents, although there was no difference in expected treatment improvements or treatment satisfaction at posttreatment. Based on regression estimates, total costs were 38.4% lower for SC-TF-CBT compared to TF-CBT, whereas recurring costs were 53.7% lower. Stepped Care TF-CBT provides an alternative way to deliver treatment for some children and parents, with reduced cost for providers and parents. Stepped Care for Children after Trauma: Optimizing Treatment; https://clinicaltrials.gov; NCT02537678.

Comparative effectiveness of three versions of a stepped care model for insomnia differing in the amount of therapist support in internet-delivered treatment: study protocol for a pragmatic cluster randomised controlled trial (GET Sleep)

IntroductionIt is unclear how internet-delivered cognitive-behavioural therapy for insomnia (CBT-I) can be integrated into healthcare systems, and little is known about the optimal level of therapist guidance. The aim of...

Sequential Interventions for Major Depression and Heart Failure Self-Care: A Randomized Clinical Trial.

Major depression and inadequate self-care are common in patients with heart failure (HF). Little is known about how to intervene when both problems are present. This study examined the efficacy of a sequential approach to treating these problems. Stepped Care for Depression in HF was a single-site, single-blind, randomized controlled trial of cognitive behavior therapy (CBT) versus usual care (UC) for major depression in patients with HF. The intensive phase of the CBT intervention lasted between 8 and 16 weeks, depending upon the rate of improvement in depression. All participants received a tailored HF self-care intervention that began 8 weeks after randomization. The intensive phase of the self-care intervention ended at 16 weeks post-randomization. The coprimary outcome measures were the Beck Depression Inventory (version 2) and the Maintenance scale of the Self-Care of HF Index (v6.2) at week 16. One hundred thirty-nine patients with HF and major depression were enrolled; 70 were randomized to UC and 69 to CBT. At week 16, the patients in the CBT arm scored 4.0 points ([95% CI, -7.3 to -0.8]; P=0.02) lower on the Beck Depression Inventory, version 2 than those in the usual care arm. Mean scores on the Self-Care of HF Index Maintenance scale were not significantly different between the groups ([95% CI, -6.5 to 1.5]; P=0.22). CBT is more effective than usual care for major depression in patients with HF. However, initiating CBT before starting a tailored HF self-care intervention does not increase the benefit of the self-care intervention. URL: https://www. gov; Unique identifier: NCT02997865.

Mitigating the mental health consequences of mass shootings: An in-silico experiment.

SummaryBackgroundThere is emerging evidence that mass shootings are associated with adverse mental health outcomes at the community level. Data from other mass-traumatic events examined the effectiveness of usual care (UC), (i.e., psychological first aid approaches without triage), and stepped care (SC) approaches, with triage, in reducing the burden of post-traumatic stress disorder (PTSD) in a community.MethodsWe built an agent-based model of 118,000 people that was demographically comparable to the population of Parkland and Coral Springs, Florida, US. We parametrized the model with data from other traumatic events. Using simulations, we then estimated the community prevalence of PTSD one month following the Stoneman Douglas High School (Florida, US) shooting and reported the potential reach, effectiveness, and cost effectiveness of different what-if treatment scenarios (SC or UC) over a two-year period.FindingsOne month following the mass shooting, PTSD prevalence in the community was 11.3% (95% CI: 11.1–11.5%). The reach of SC was 3461 (95% CI: 3573–3736) per 10,000 and the reach of UC was 2457 (95% CI: 2401–2510) per 10,000. SC was superior to UC in reducing PTSD prevalence, yielding, after two years, a risk difference of −0.044 (95% CI, −0.046 to −0.042) and a risk ratio of 0.452 (95% CI, 0.437–0.468). SC was also superior to UC in reducing the persistence of PTSD, yielding, after two years, a risk difference of −0.39 (95% CI, −0.401 to −0.379) and a risk ratio of 0.452 (95% CI, 0.439–0.465). The incremental cost-effectiveness of SC compared to UC was $2718.49 per DALYs saved, and $0.47 per PTSD-free day.InterpretationThis simulation demonstrated the potential benefits of different community-level approaches in mitigating the burden of PTSD following a mass shooting. These results warrant further research on community-based interventions to mitigate the mental health consequences of mass shootings.FundingNone.

Digital and remote behavioral therapies for treating tic disorders: Recent advances and next steps.

The rapid expansion of access to and engagement with digital technology over the past 15 years has transformed the potential for remote delivery of evidence-based digital health interventions (DHIs). Digital and remote behavioral interventions have the potential to address current gaps in the provision of evidence-based therapies in healthcare services. As the lack of access to behavioral treatments for people with tic disorders is a pressing issue across the world, there is great potential for DHIs to close this treatment gap. Here, we present a critical synthesis of the recent key advances in the field of digitally delivered, remote therapy for tics, outlining the research evidence for the clinical and cost-effectiveness and acceptability of digital or remotely delivered therapy. We found five trials aimed at reducing tic severity in children and young people and one trial for adults. The evidence supports the clinical utility of DHIs to deliver tic therapies, which shows promise in being clinically efficacious compared to an active control. Furthermore, DHIs in trials show good adherence and engagement and are acceptable to patients. The role of human support (including therapists and parents for young people) is likely to be important to encourage adherence. DHIs, where the main therapeutic content is delivered via web-based chapters, are likely to reduce clinical time, and maintain intervention fidelity, but further research is required to understand cost-effectiveness. Despite utilizing randomized controlled trials, only two trials were sufficiently powered to address efficacy and only one trial explored contextual factors that may influence engagement. Moreover, only one trial followed patients for >12 months, thus further long-term follow-ups are required. Specifically, we note that despite an emerging evidence base, DHIs for tics are yet to be routinely implemented in healthcare provision in any country. Drawing on the existing evidence, we conclude by proposing a stepped care model, in which digital therapy is implemented as a widely accessible first-line treatment using a purely online or therapist-supported approach.

Mindfulness-Based Interventions for Perioperative Pain Management and Opioid Risk Reduction Following Surgery: A Stepped Care Approach.

Surgical procedures often improve health and function but can sometimes also result in iatrogenic effects, including chronic pain and opioid misuse. Due to the known risks of opioids and the physical, emotional, and financial suffering that often accompanies chronic pain, there has been a call for greater use of complementary non-pharmacological treatments like mindfulness-based interventions. Mindfulness can be broadly described as an attentional state involving moment-by-moment meta-awareness of thoughts, emotions, and body sensations. An expanding number of randomized clinical trials have found strong evidence for the value of mindfulness techniques in alleviating clinical symptomology relevant to surgical contexts. The purpose of this review is to examine the empirical evidence for the perioperative use of mindfulness interventions. We present a mindfulness-based stepped care approach that first involves brief mindfulness to treat preoperative pain and anxiety and prevent development of postoperative chronic pain or opioid misuse. More extensive mindfulness-based interventions are then provided to patients who continue to experience high pain levels or prolonged opioid use after surgery. Finally, we review psychophysiological mechanisms of action that may be integral to the analgesic and opioid sparing effects of mindfulness.

Stepped care to optimize pre-exposure prophylaxis (PrEP) effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa: a randomized control trial

BackgroundHIV incidence among pregnant and postpartum women remains high in South Africa. Pre-exposure prophylaxis (PrEP) use remains suboptimal in this population, particularly during the postpartum period when women’s engagement with routine clinic visits outside PrEP decreases. Key barriers to sustained PrEP use include the need for ongoing contact with the health facility and suboptimal counseling around effective PrEP use.MethodsStepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum women (SCOPE-PP), is a two-stepped unblinded, individually randomized controlled trial (RCT) that aims to optimize peripartum and postpartum PrEP use by providing a stepped package of evidence-based interventions. We will enroll 650 pregnant women (> 25 weeks pregnant) who access PrEP at a busy antenatal clinic in Cape Town at the time of recruitment and follow them for 15 months. We will enroll and individually randomize pregnant women > 16 years who are not living with HIV who are either on PrEP or interested in starting PrEP during pregnancy. In step 1, we will evaluate the impact of enhanced adherence counselling and biofeedback (using urine tenofovir tests for biofeedback) and rapid PrEP collection (to reduce time required) on PrEP use in early peripartum compared to standard of care (SOC) (n = 325 per arm). The primary outcome is PrEP persistence per urine tenofovir levels and dried blood spots of tenofovir diphosphate (TFV-DP) after 6-months. The second step will enroll and individually randomize participants from Step 1 who discontinue taking PrEP or have poor persistence in Step 1 but want to continue PrEP. Step 2 will test the impact of enhanced counseling and biofeedback plus rapid PrEP collection compared to community PrEP delivery with HIV self-testing on PrEP use (n = up to 325 postpartum women). The primary outcome is PrEP continuation and persistence 6-months following second randomization (~ 9-months postpartum). Finally, we will estimate the cost effectiveness of SCOPE-PP vs. SOC per primary outcomes and disability-adjusted life-years (DALYs) averted in both Step 1 and 2 using micro-costing with trial- and model-based economic evaluation.DiscussionThis study will provide novel insights into optimal strategies for delivering PrEP to peripartum and postpartum women in this high-incidence setting.Trial registrationNCT05322629: Date of registration: April 12, 2022.

Interprofessional collaboration to support patients with social problems in general practice—a qualitative focus group study

BackgroundSocial problems of patients such as family or work-related conflicts as well as financial difficulties affect the individual health situation and the treatment of diseases in general practice. General practitioners (GPs) would like to have direct access to professionals in social care services. In Germany, there are many different social care facilities for people with a wide range of social problems. As the social and health care systems hardly interact collaborations between social professionals (SPs) and GPs are rare exceptions.This study explored perspectives of GPs regarding their patients with social problems in combination with the perspectives of SPs. Aim of this study was to explore how a systematic interprofessional collaboration between GPs and SPs could be realised.MethodsWe carried out a participatory sequential qualitative study design consisting of two focus groups with GPs, two with SPs and two mixed-professional focus groups with GPs and SPs. The focus groups were conducted with semi-structured moderating guidelines and analysed with a qualitative content analysis approach using inductive and deductive categories.ResultsGPs view themselves as the first point of contact for their patients' social problems. For persistent social problems, they expressed a desire for support and SPs were willing to provide this. We developed a stepped care implementation model for a systematic cooperation consisting of nine collaboration strategies. These strategies included: index or website of social care services, referrals to the social care system, using flyers and posters of social care services, direct contact/hotline to local social care services, participation in meetings of social care facilities, involving physician assistants, external social care advice service in GP rooms, implementation in education and training and access to volunteers.ConclusionsOur stepped care implementation model for a systematic cooperation of GPs and SPs could be a feasible need- and resource-oriented approach for the collaborative care of patients with social problems to improve their medical treatment in most western healthcare systems. GPs and SPs are ready to generate the necessary evidence for policy makers in high quality RCTs.

A273 Step into Health: Monitoring and Addressing Weight Management Utilizing a Stepped Care Treatment Program

A273 Step into Health: Monitoring and Addressing Weight Management Utilizing a Stepped Care Treatment Program

Effectiveness of distance-based suicide interventions: multi-level meta-analysis and systematic review

The use of distance-based interventions (DBIs) to reduce suicidal ideation and behaviours are an increasingly relevant form of intervention. DBIs are more affordable, scalable and available than traditional face-to-face interventions, helping to narrow the gap between needed and provided care. To evaluate the overall effectiveness of DBIs against suicidal ideation and behaviours. We systematically searched Web of Science, Scopus and PubMed for all DBIs primarily aimed at reducing suicidal ideation and behaviours. Data were analysed with a robust variance estimation corrected, multi-level meta-analysis. We found 38 studies, reporting 110 outcomes. Effectiveness in reducing suicidal ideation was low (standardised mean difference -0.174, 95% CI -0.238 to -0.110). DBIs were significantly less effective against suicidal behaviours than against suicidal ideation, although still effective (standardised mean difference -0.059, 95% CI -0.087 to -0.032). Human involvement had no significant effect on effectiveness. Despite low effectiveness, DBIs might play a role in large-scale prevention efforts against suicidal ideation within a stepped care approach. Further, DBIs may be helpful in expanding mental health services in low- and middle-income countries with otherwise limited access to mental healthcare. Although the evidence for DBIs efficacy is well grounded, the technical and scientific evaluation of DBIs regarding their set up, functionality and components needs to be addressed in future studies.

The clinical effectiveness and cost-effectiveness of a ‘stepping into day treatment’ approach versus inpatient treatment as usual for anorexia nervosa in adult specialist eating disorder services (DAISIES trial): a study protocol of a randomised controlled multi-centre open-label parallel group non-inferiority trial

BackgroundAnorexia nervosa (AN) is a serious and disabling mental disorder with a high disease burden. In a proportion of cases, intensive hospital-based treatments, i.e. inpatient or day patient treatment, are required, with day patient treatment often being used as a ‘step-down’ treatment after a period of inpatient treatment. Demand for such treatment approaches has seen a sharp rise. Despite this, the relative merits of these approaches for patients, their families, and the NHS and wider society are relatively unknown. This paper describes the rationale for, and protocol of, a two-arm multi-centre open-label parallel group non-inferiority randomised controlled trial, evaluating the effectiveness and cost-effectiveness of these two intensive treatments for adults with severe AN: inpatient treatment as usual and a stepped care day patient approach (the combination of day patient treatment with the option of initial inpatient treatment for medical stabilisation). The main aim of this trial is to establish whether, in adults with severe AN, a stepped care day patient approach is non-inferior to inpatient treatment as usual in relation to improving body mass index (BMI) at 12 months post-randomisation.Methods386 patients with a Diagnostic and Statistical Manual 5th edition diagnosis of severe AN or related disorder, with a BMI of ≤16 kg/m2 and in need of intensive treatment will be randomly allocated to either inpatient treatment as usual or a stepped care day patient approach. Patients in both groups will receive treatment until they reach a healthy weight or get as close to this point as possible. Assessments will be conducted at baseline (prior to randomisation), and at 6 and 12 months post-randomisation, with additional monthly symptom monitoring. The primary outcome will be BMI at the 12-month post-randomisation assessment. Other outcomes will include psychosocial adjustment; treatment motivation, expectations and experiences; cost-effectiveness; and carer burden.DiscussionThe results of this study will provide a rigorous evaluation of two intensive treatment approaches which will inform future national and international treatment guidelines and service provision.Trial registrationISRCTN ISRCTN10166784. Registered 28 February 2020. ISRCTN is a primary registry of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) network and includes all items from the WHO Trial Registration Data Set.

Preventative Care in First Responder Mental Health: Focusing on Access and Utilization via Stepped Telehealth Care.

First responders are at high risk for disorders that arise from repeat exposure to stress and trauma (Post Traumatic Stress Disorder, depression, and problematic alcohol use). Although mental health treatments are available, first responders often do not access them, anchored by barriers that include: lack of knowledge, stigma, negative experience with mental health providers, and time-based burdens. In this study, we designed an intervention to address these barriers, extending a Planned-Action framework. Step 1 involved self-report screening for four mental health risks (PTSD, depression, anxiety, and alcohol use risk), delivered to all personnel electronically, who were free to either consent and participate or opt-out. The detection of risk(s) in Step 1 led to scheduling a Step 2 telehealth appointment with a trained clinician. We report descriptive statistics for participation/attrition/utilization in Steps 1 and 2, rates of risk on four mental health variables, and rate of adherence to follow-up treatment recommendations. Step 1: In total, 53.3% of personnel [229 of 429 full-time employees (221 males; eight females; 95% White; 48% paramedic or Emergency Medical Technician; 25% captain; 19% engineer; 7% other)] initially opted-in by consenting and completing the brief remote screening survey. Among those who opted-in and completed (n = 229), 43% screened positive for one or more of the following mental health risks: PTSD (7.9%); depression (9.6%); anxiety (13.5%); alcohol use (36.7%). Step 2: A maximum of three attempts were made to schedule "at risk" individuals into Step 2 (n = 99). Among the 99 who demonstrated a need for mental health treatment (by screening positive for one or more risk), 56 (56.6%) engaged in the telehealth appointment. Of the 56 who participated in Step 2 clinical appointments, 38 were recommended for further intervention (16.6% of full-time personnel who participated). Among the 38 firefighters who were recommended to seek further mental health services, 29 were adherent/followed through (76.3% of those who received recommendations for further services). Taken together, evidence-based, culturally conscious, stepped care models delivered via the virtual/telehealth medium can promote access, utilization, and cost-effective mental health services for first responders. Implications are for informing larger, more rigorous dissemination and implementation efforts.

Effectiveness and cost-effectiveness for the treatment of depressive symptoms in refugees and asylum seekers: A multi-centred randomized controlled trial.

SummaryBackgroundCurrent evidence points towards a high prevalence of psychological distress in refugee populations, contrasting with a scarcity of resources and amplified by linguistic, institutional, financial, and cultural barriers. The objective of the study is to investigate the overall effectiveness and cost-effectiveness of a Stepped Care and Collaborative Model (SCCM) at reducing depressive symptoms in refugees, compared with the overall routine care practices within Germany's mental healthcare system (treatment-as-usual, TAU).MethodsA multicentre, clinician-blinded, randomised, controlled trial was conducted across seven university sites in Germany. Asylum seekers and refugees with relevant depressive symptoms with a Patient Health Questionnaires score of ≥ 5 and a Refugee Health Screener score of ≥ 12. Participants were randomly allocated to one of two treatment arms (SCCM or TAU) for an intervention period of three months between April 2018 and March 2020. In the SCCM, participants were allocated to interventions tailored to their symptom severity, including watchful waiting, peer-to-peer- or smartphone intervention, psychological group therapies or mental health expert treatment. The primary endpoint was defined as the change in depressive symptoms (Patient Health Questionnaire-9, PHQ-9) after 12 weeks. The secondary outcome was the change in Montgomery Åsberg Depression Rating Scale (MADRS) from baseline to post-intervention.FindingsThe intention-to-treat sample included 584 participants who were randomized to the SCCM (n= 294) or TAU (n=290). Using a mixed-effects general linear model with time, and the interaction of time by randomisation group as fixed effects and study site as random effect, we found significant effects for time (p < .001) and time by group interaction (p < .05) for intention-to-treat and per-protocol analysis. Estimated marginal means of the PHQ-9 scores after 12 weeks were significantly lower in SCCM than in TAU (for intention-to-treat: PHQ-9 mean difference at T1 1.30, 95% CI 1.12 to 1.48, p < .001; Cohen's d=.23; baseline-adjusted PHQ-9 mean difference at T1 0.57, 95% CI 0.40 to 0.74, p < .001). Cost-effectiveness and net monetary benefit analyses provided evidence of cost-effectiveness for the primary outcome and quality-adjusted life years. Robustness of results were confirmed by sensitivity analyses.InterpretationThe SSCM resulted in a more effective and cost-effective reduction of depressive symptoms compared with TAU. Findings suggest a suitable model to provide mental health services in circumstances where resources are limited, particularly in the context of forced migration and pandemics.FundingThis project is funded by the Innovationsfond and German Ministry of Health [grant number 01VSF16061]. The present trial is registered under Clinical-Trials.gov under the registration number: NCT03109028. https://clinicaltrials.gov/ct2/show/NCT03109028

Developing a New Neuromodulation Treatment Pathway for the Treatment of Depression

AimsTo ensure an appropriate treatment pathway is available to patients diagnosed with Depression a STEPPED care model where different types of intervention are offered depending on the patient's experienced severity of Depression. However, a great percentage of patients continue to experience disabling symptoms and fall into the Treatment Resistant Depression (TRD) category. There was a need to review the options available within local Mental Health Services (MHS) for the treatment of patients with depression and TRD.MethodsA new clinical pathway was designed to provide access to patients to emerging treatments, such as EsKetamine, Vagal Nerve Stimulation (VNS) and repetitive Transcranial Magnetic Stimulation (rTMS). After calculating the local impact of depression to patients, trust resources and society we extrapolated our calculations to neighbouring Trusts covering the South West. A newly developed business plan demonstrating the need for new treatment options and the benefits, financial and otherwise, was presented and underwent various approvals levels by the Trust Governance and Executive Committees and local commissioning groups, before being able to proceed. Within the original business plan, rTMS and VNS were offered in addition to the existing ECT as parts of a new treatment pathway. We are now in the process of incorporating EsKetamine and Transcranial Direct Current Stimulation (tDCS). The clinic was set up in March 2020, just at the beginning of the pandemic, which halted operations for quite a few months before being able to resume recentlyResultsWe have managed to treat patients with both VNS and rTMS from our Trust, as well from surrounding areas. Patients have already experienced benefits in the recovery from symptoms. The new service has provided another line of support for colleagues in offering bespoke treatment plans to their patients and patients have appreciated having access to new non-traditional treatment options.ConclusionAlthough there has been a primary result in improving patient care, income generation is also possible by positioning the Trust in the forefront of new therapeutics and allowing the provision of service to expand to neighbouring Trusts and private patients. Other benefits are associated with the Trust's reputations and kudos being enhanced and include the forging of new pathways within the developing alliance with General Hospitals, increased ‘visibility’ for training and research opportunities, improved patient satisfaction and improved CQC standing.

Stepped Care Models for Chronic Pain

&#x0D; CADTH included 6 reports describing the potential clinical benefits of 5 stepped care models for chronic pain in this review.&#x0D; &#x0D; The randomized controlled trial of the stepped care model for patients who are overweight or obese with chronic pain due medial tibiofemoral osteoarthritis described the impact on pain remission, pain intensity, and function.&#x0D; The before-after and retrospective cohort study of the Stepped Care Model of Pain Management described the effects on pain, quality of chronic pain care, pharmacotherapy use, and health care utilization in US veterans.&#x0D; The before-after study of the biopsychosocial stepped care model for non-cardiac chest pain described the potential benefits on chest pain, depression, anxiety, quality of life, and health care use.&#x0D; The prospective cohort study of the Stepped Care Strategy compared a cohort of patients who received stepped care strategy-consistent care for hip or knee pain due to osteoarthritis with a cohort who received stepped care strategy-inconsistent care and described the results on pain physical function, self-efficacy, active pain coping, and health care use.&#x0D; The Evaluation of Stepped Care for Chronic Pain randomized controlled trial described the effects on pain, disability, and pharmacotherapy use in US veterans.&#x0D; &#x0D; &#x0D; CADTH included 1 cost-effectiveness analysis that described the cost implications of a stepped care pathway for treating sciatica pain.&#x0D; While all included models used a stepped care approach to chronic pain management, the models were customized, and the evaluation methods were heterogeneous.&#x0D;