Preliminary Outcome Data Research Articles

Change in Depression Severity Among Depressed Older Crime Victims.

The crime rates in urban centers are rising. The psychological impact of crime can range from distress to longstanding mental health impairment. Despite the rising crime rates and psychological impact on victims, little research has been conducted on older adult crime victims' mental health. In this manuscript we describe the profile of older adult crime victims in New York City referred for mental health services, their rates of depression, and the preliminary outcome data from a brief therapy intervention (PROTECT) targeting depression among victims. Building on prior research demonstrating the efficacy of PROTECT for depressive symptom reduction in elder abuse victims, the present study hypothesized elder crime victims who completed PROTECT therapy would demonstrate clinically meaningful depression symptom reduction as measured by the Patient Health Questionnaire-9 (PHQ-9). Additionally, it was hypothesized that these clinically significant depression symptom reductions would be demonstrated regardless of sex, gender, victimization type, victimization frequency, or living status. The results demonstrate that 67.7% (21/31) of participants had a clinically significant reduction in PHQ-9 scores (≥5 points) upon completion of PROTECT. There were no significant group differences in clinically significant depression symptom reduction, suggesting that PROTECT is an effective intervention for a diverse sample of elder crime victims. Future research should focus on the mental health impact of crime against older adults and explore reductions in anxiety and PTSD symptoms among crime victims. Through our partnerships we aim to bridge the divide between victim service providers, and mental health service providers to assist victims to recover, heal, and thrive.

Telehealth Engaged Music for Pain Outcomes: A Music and Imagery Proof-of-concept Study with Veterans.

Music therapy interventions target biopsychosocial outcomes and are a non-pharmacological option for integrated pain management. To date, most music and pain studies have focused on acute pain, passive music experiences, and in-person delivery. The purpose of this study was to examine feasibility and acceptability and determine proof-of-concept for a newly developed telehealth music imagery (MI) intervention for Veterans with chronic pain. A single-group proof-of-concept pilot study was conducted with Veterans with chronic pain (n = 8). Feasibility was assessed through examination of recruitment, retention, and session/measure completion rates; acceptability through participant interviews; and whether the intervention resulted in clinically meaningful change scores (pre- to post-intervention) on measures of pain, anxiety, and depression at the individual level. For Veterans who passed eligibility screening, we had an enrollment rate of 89%, with good retention (75%). Overall, participating Veterans found the intervention acceptable, identified specific challenges with technology, and recommended an increased number of sessions. Preliminary outcome data for pain, anxiety, and depression were mixed, with some Veterans reporting clinically meaningful improvements and others reporting no change or worsening symptoms. Findings informed modifications to the telehealth MI intervention and the design of a larger pilot randomized controlled trial to assess feasibility and acceptability of the modified intervention in a larger population of Veterans with chronic pain using additional measures and a control condition.

Promoting Diversity in the Biomedical Sciences with the Teen Science Ambassador Program.

Mental health and substance use fields suffer from underrepresentation of racially and ethnically minoritized, first-generation college student, and female members. The homogeny of the current workforce can impede scientific productivity, creativity, and problem-solving in addressing health-related issues. Our team developed the Teen Science Ambassador Program (TSAP) to provide underrepresented minoritized (URM) high school students with science-focused education, research opportunities, and mentoring within their community. The goals of the current study were to describe the logic model and structure of TSAP, provide access to a resource bank to facilitate replication across communities, and present preliminary mixed-methods outcome data to guide development of the program. Qualitative and quantitative results from our first two cohorts (N = 18; 89% girls; 72% Black or African American; 22% Hispanic or Latino; 40% of parents did not have a college degree) indicated TSAP contributed to sustained interest, increased confidence, and enhanced sense of belonging in science-related fields, especially those pertaining to mental health and substance use. These findings highlight the program's promise to facilitate entry and sustainment of URM and female youth within the biomedical sciences. Given the urgent need to promote diversity in the mental health and biomedical workforce, we provide readers with a resource bank to facilitate replication across communities.

Multimodal agility-based exercise training (MAT) versus strength and endurance training (SET) to improve multiple sclerosis-related fatigue and fatigability during inpatient rehabilitation: a randomized controlled pilot and feasibility study [ReFEx

BackgroundMultimodal agility-based exercise training (MAT) is a group-based exercise training framework for persons with multiple sclerosis (pwMS) with a potential to impact fatigue and fatigability. In a mixed-methods design, this study evaluated the feasibility of implementing MAT in an inpatient rehabilitation setting and the feasibility of a randomized controlled trial (RCT) study protocol with ‘traditional’ strength and endurance training (SET) as an active control condition. Secondarily, preliminary outcome data was acquired.MethodsPwMS with low to moderate disability and self-reported fatigue were randomly allocated to either MAT or SET when starting inpatient rehabilitation (4–6 weeks). The MAT-participants exercised in a group following a MAT-manual (sessions were gym- (5x/week) and pool-based (3x/week)). SET-participants exercised individually 5x/week on a cycle ergometer, and 3x/week on strength training machines. Feasibility assessments focused on processes, resources, management, time, and scientific domains. Assessed clinical outcomes at admission and discharge included perceived fatigue, motor and cognitive fatigability, cognitive performance, motor function, and balance confidence. Perceived fatigue was reassessed 1, 4, and 12 weeks after discharge. Feasibility was determined regarding predetermined progression criteria.ResultsTwenty-two participants were randomized. Both groups performed the minimum number of sessions (> 18), and retention was adequate (73–91%). SET-participants performed more sessions than MAT-participants (30.8 vs. 22.7) and stayed longer in the facility (34.2 vs. 31.6 days). Non-eligibility of admitted pwMS was high (74% non-eligible), mainly due to high EDSS and inability to attend pool-based sessions. Consequently, recruitment (1.8/month) was slower than the predetermined progression criterium. Baseline assessments took longer than required (only 50% completed within 3 days). Short-term fatigue reduction was similar for both groups. Motor fatigability also improved in both groups, whereas cognitive fatigability deteriorated. In MAT, average improvement in walking endurance (43.9 m) exceeded minimal important change values for individuals (> 26.9 m).ConclusionsProgressing to a definitive RCT necessitates adaptation of eligibility criteria. In the present design it will also be difficult to attain similar dosing of interventions. A multicenter RCT focused only on gym-based MAT might be another option to assess the effect of MAT. The primary outcome measure should be able to measure change in perceived fatigue more robustly.Trial registrationGerman Clinical Trials Register: DRKS00023943, date of registration: 23 September 2021.

Acceptability, feasibility and short-term outcomes of temperament based therapy with support (TBT-S): a novel 5-day treatment for eating disorders

BackgroundTemperament Based Therapy with Support (TBT-S) aims to target the mechanisms underlying the aetiology and maintenance of eating disorders, and was developed as an adjunct to treatment as usual. There is limited research investigating acceptability, feasibility and possible benefits of TBT-S. Therefore, the primary aim of the current study was to assess treatment feasibility and acceptability at a tertiary specialized eating disorders service in Norway, with a secondary aim to explore possible benefits in clinical outcome.MethodsForty-one patients (mean age 25.3, range 18–43) and 58 supports were assessed pre- and post TBT-S. The majority of the patients were diagnosed with either anorexia nervosa or atypical anorexia nervosa. Participants completed an 18-item Patient and Support Satisfaction Questionnaire, in addition to a questionnaire assessing the usefulness of the different intervention components and strategies utilised in TBT-S, as well as a 4-item treatment satisfaction questionnaire. Measures of treatment efficacy were completed at both time-points, whereas treatment acceptability was only assessed post-treatment.ResultsFindings reveal that TBT-S is a feasible treatment with high client satisfaction. Preliminary outcome data were also encouraging, and in line with previous studies. There were no voluntary drop-outs. All participants, both patients and supports, reported that TBT-S helped them deal more effectively with their challenges. After completing treatment, there was a significant decrease in patients’ self-reported eating disorder psychopathology, psychosocial impairment and state anxiety, while trait anxiety remained unchanged. Patients also reported significantly improved social relationships, whereas supports reported a significant increase in (own) psychological health. There were no differences in family functioning.ConclusionsTBT-S is a promising new treatment for eating disorders with high acceptability scores and low treatment attrition. Future studies should aim to explore methods which can most appropriately measure the effect of TBT-S and the usefulness of the different components of this treatment. Randomised controlled trials are needed to assess treatment efficacy of TBT-S.

Understanding institutionally supported free college programs

AbstractThis chapter examines institutionally funded free community college programs that address specific community workforce needs. Within the article, the authors showcase “Rediscover LCCC,” a foundation‐funded scholarship program at Laramie County Community College in Wyoming that pays students’ tuition and fees for up to three years in specific, high‐demand degree and certificate programs, such as information technology, healthcare, and the trades. Preliminary outcome data is shared. The article concludes by encouraging community college leaders to support such programs as a way for students to attain work‐ready degrees and certificates needed by the local community, without incurring student debt.

Pilot feasibility and acceptability study evaluating use of group CBT-I in improving sleep and fatigue in older adults.

This paper describes a pilot study, in a small sample of older adults, designed to ascertain the feasibility, acceptability and potential effectiveness of group Cognitive Behavioural Therapy For Insomnia (CBT-I). Eleven older adults participated in a 3-week group CBT-I intervention with pre- and post-intervention outcome measures of sleep and fatigue. Acceptability was measured via post-intervention focus groups. Feasibility was measured via recruitment, retention and completion data. Subjective sleep outcomes were measured pre- and post-intervention using the Pittsburgh Sleep Quality Index. Fatigue was measured using the Fatigue Severity Index. Objective sleep outcome measures were obtained via pre- and post-intervention wrist actigraphy. Feasibility and acceptability were confirmed in the pilot study. Retention and completion levels were high, with participants largely positive in the focus group feedback. Preliminary sleep outcome data supported the potential effectiveness of the intervention in significantly improving several measures of sleep and fatigue including a three-point reduction in the Global PSQI scores, an increase in total sleep time of almost an hour per night and these results were mirrored by a significant reduction of nine points in the overall measure of fatigue severity. A group CBT-I intervention is a low-cost, low-risk intervention which improves subjective and objective measures of sleep in older adults. These positive sleep outcomes are translated into significantly decreased levels of fatigue. Future research should focus on a larger sample size with a randomised controlled trial design.

Building a Restorative Justice Diversion Program for Youth in Rural Areas

Restorative Justice (RJ) models of diversion from the criminal justice system have been used successfully with adults and youth charged with minor offenses. Professionally mediated RJ conferences bring together the offender and the person(s) harmed to discuss the impact of their actions and develop a plan to restore community safety and make amends. An RJ model aimed at diverting youth from the juvenile justice system for minor offenses has successfully worked in an urban region in Kentucky for over a decade. The same RJ model was piloted in a very rural region of the state. The program goal was to decrease youth involvement in the criminal justice system and create positive change within the communities and families involved in youth-initiated crimes. Interestingly, the rural location of the RJ program has run into unique challenges not experienced in the urban area. This paper examines preliminary outcomes data. Differences in juvenile justice and community involvement approaches that need to be addressed when establishing an RJ program in a geographically rural area are highlighted. Suggestions for how to incorporate RJ diversion programs into rural communities are provided.

Feasibility of a Career Development Intervention for Veterans in Vocational Rehabilitation: Protocol for a Pilot Randomized Controlled Trial

Background Veterans with psychiatric disorders want additional career development services to support their recovery and pursuit of meaningful employment. However, no career counseling programs have been designed for this specific population. We developed the Purposeful Pathways intervention to fill this need. Objective This study protocol aims to (1) evaluate the feasibility and acceptability of the Purposeful Pathways intervention for veterans living with psychiatric disorders and (2) explore preliminary clinical outcome data. Methods A total of 50 veterans who are participating in transitional work vocational rehabilitation services at a Veterans Affairs hospital will be randomized to either treatment as usual or the augmented treatment condition (treatment as usual plus Purposeful Pathways). Feasibility will be assessed via recruitment rates, clinician fidelity to treatment, retention rates, and acceptability of randomization procedures. Acceptability will be assessed via client satisfaction at treatment termination using quantitative and qualitative data collection. Preliminary clinical and vocational outcomes will be assessed at baseline, 6 weeks, 12 weeks (treatment termination), and a 3-month follow-up via quantitative measures assessing vocational functioning, vocational process, and mental and physical functioning. Results This pilot randomized controlled trial is beginning recruitment in June 2023 and is expected to continue through November 2025. Data collection is expected to be completed by February 2026, with full data analysis completed by March 2026. Conclusions Findings from this study will provide information on the feasibility and acceptability of the Purposeful Pathways intervention, as well as secondary outcomes related to vocational functioning, vocational process, and mental and physical functioning. Trial Registration ClinicalTrials.gov NCT04698967; https://clinicaltrials.gov/ct2/show/NCT04698967 International Registered Report Identifier (IRRID) PRR1-10.2196/47986

A-44 Piloting the Feasibility and Tolerability of a Post-Concussion Intervention

Abstract Purpose As yet, there is no gold standard treatment approach for persistent symptom experience following concussion, including sports-related concussion. As most methodologically sound studies indicate brain recovery following concussion is brief, it follows that other factors can maintain persistent symptom experience after the brain has healed. The literature indicates factors can include psychological status, avoidance of activity and emotion, poor sleep, and feeling isolated. As such, treatment should focus on these factors. Methods This pilot study examined the feasibility and tolerability of a virtual group intervention combining evidence-based concussion education with CBT- and ACT-based interventions to address the above factors. The goal of treatment was to redirect patients back to participation in values-based activities, with provision of coping strategies, thus decreasing focus on and experience of symptoms. Seventy-six patients who were at least three months post-injury and reporting continued post-concussion symptoms were clinically referred and sequentially enrolled in a virtual six-session concussion recovery group. The Concussion Symptom Checklist (CSC) was administered pre- and post-treatment to assess symptoms. Anonymous qualitative feedback about the group was also collected. Results Most patients remained enrolled in the group, missing no more than one session. Statistically significant decreases in both symptom severity and frequency were found from pre- to post-treatment. Qualitative patient feedback was predominantly positive. Conclusions The virtual concussion recovery group intervention was feasible, well-tolerated, and well-liked. Though no generalizations can be made from limited preliminary outcome data, there is indication that the severity and frequency of symptom experience, as measured by the CSC, decreased with this treatment.

Comparative humoral response of mRNA and inactivated vaccines against COVID-19 in healthy adults aged 60 years and older

A vaccine against coronavirus disease 2019 (COVID-19) is critically needed for older adults because of the increased morbidity and mortality rates. In this prospective study, we analysed the titre magnitude of the IgG antibodies directed against the SARS-CoV-2 Spike Protein S1 (S1-RBD) antigen in both CoronaVac and Pfizer-BioNTech groups. The samples were tested to detect antibodies that bind to the receptor-binding domain of the spike protein of SARS-CoV-2 using the Enzyme-Linked Immunosorbent Assay (ELISA) technique with SARS-CoV-2 IgG II Quant. The cut-off value was > 50 AU/mL. GraphPad Prism software was used. Statistical significance was defined at p < 0.05. The CoronaVac group (12 females, 13 males) had a mean age of 69.64 ± 1.38 years. The Pfizer-BioNTech group (13 males, 12 females) had a mean age of 72.36 ± 1.44 years. The anti- S1-RBD titre decrease rate from the 1st to the 3rd month for CoronaVac and Pfizer-BioNTech groups was 74.31% and 86.48%, respectively. There was no statistically significant difference in the antibody titre between the 1st month and 3rd month for the CoronaVac group. However, there was a significant difference between the 1st and 3rd month in the Pfizer-BioNTech group. In addition, there was no statistically significant difference in the genders between the 1st and 3rd month of the antibody titres for both the CoronaVac Pfizer-BioNTech group. The levels of anti-S1-RBD, the preliminary outcome data of our study, represents one piece of the puzzle of humoral response and duration of vaccination protection.

Piloting HealthScore: Feasibility and acceptability of a clinically integrated health coaching program for people living with cancer.

Cancer supportive care interventions often have limited generalizability, goal misalignment, and high costs. We developed and piloted a health coaching intervention, UNC HealthScore, in patients undergoing cancer treatment (ClinicalTrials.gov identifier NCT04923997). We present feasibility, acceptability, and preliminary outcome data. HealthScore is a six-month, theory-based, multicomponent intervention delivered through participant-driven coaching sessions. For the pilot study, participants were provided a Fitbit, responded to weekly symptom and physical function digital surveys, and met with a health coach weekly to develop and monitor goals. Coaching notes were discussed in weekly interdisciplinary team meetings and provided back to the treating oncology team. Symptom alerts were monitored and triaged through a study resource nurse to relevant supportive care services. Feasibility was determined based on intervention enrollment and completion. Acceptability was based on satisfaction with coaching and Fitbit-wearing and was informed by semistructured exit interviews. Outcomes evaluated for signs of improvement included several PROMIS (Patient-Reported Outcomes Measurement Information System) measures, including the primary intervention target, physical function. From May 2020 to March 2022, 50 participants completed the single-arm pilot. Feasibility was high: 66% enrolled and 71% completed the full intervention. Participants reported an average of 4.8 and 4.7 (out of 5) on the acceptability of coaching calls and using the Fitbit, respectively. Physical function scores rose 3.1 points (SE=1.1) from baseline to 3months, and 4.3 (SE=1.0) from baseline to 6 months, above established minimal clinically important difference (MCID). Improvements above MCID were also evident in anxiety and depression, and smaller improvements were demonstrated for emotional support, social isolation, cognitive function, symptom burden, and self-efficacy. HealthScore shows feasibility, acceptability, and promising preliminary outcomes. Randomized studies are underway to determine the efficacy of preserving physical function in patients with advanced cancer.

Canadian Spine Society

# Abstract 57. Radiographic reporting in adolescent idiopathic scoliosis: Is there a discrepancy comparing radiologists’ reports and surgeons’ assessments? {#article-title-2} Cobb angle measurement is the standard method for quantification of scoliosis in adolescent idiopathic scoliosis (AIS),

A Rehabilitation Program for Individuals With Chronic Low Back Pain: Protocol for a Randomized Clinical Trial.

Low back pain (LBP) is the leading cause of disability worldwide. Physical exercise, as a treatment, is beneficial for the improvement of quality of life in patients with LBP, and it is widely accepted. We aimed to develop a protocol for a feasibility study that is designed to compare the effectiveness of different interventions in reducing pain, functional, and psychosocial factors among patients with chronic LBP after 8 weeks of randomization. This is a study protocol for a randomized controlled trial that will consist of individuals with chronic LBP who are aged between 18 and 65 years. Participants will be allocated, through block randomization, to one of the following groups: the motor control exercises (MCEs), pain education, MCEs+pain education, and usual care groups. The primary outcome will be pain intensity, and the secondary outcomes will be the pressure pain threshold, which will be measured with a digital algometer; LBP-related disability; fears and beliefs; the fear of movement; quality of life; mood states; and levels of depression and anxiety. The trial was approved by the ethics committee for research involving human beings of the Federal University of Pelotas (reference number: 5.717.390) in September 2022, and it will be conducted until August 2023. The researchers are being trained to apply the questionnaires and carry out the interventions. Patient recruitment will begin at the end of 2022 and results are expected to be achieved by August 2023. Our trial will provide preliminary data regarding the feasibility and safety of MCEs and pain education for patients with LBP. It will also provide preliminary outcome data that can be used to identify the most efficient intervention and the level of health care that should be implemented in public health services. Brazilian Registry of Clinical Trials U1111-1221-4106; https://ensaiosclinicos.gov.br/rg/RBR-2xx2r2/. PRR1-10.2196/31345.

S751 The Vedolizumab Pregnancy Exposure Registry: An OTIS Pregnancy Study Update

Introduction: Vedolizumab is a gut-selective immunoglobulin (Ig) G1 monoclonal antibody that binds to α4β7 integrin; it is approved for the treatment of moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC) in the U.S. and elsewhere. Published studies on the effect of vedolizumab in human pregnancy are limited. Data from the ongoing Vedolizumab Pregnancy Exposure Registry (NCT02678052) in the U.S. and Canada have been collected by the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS). This prospective observational pregnancy cohort study planned to enroll and analyze the outcomes of 100 vedolizumab-exposed (Vedo) participants compared to 100 disease-matched (DM) and 100 healthy comparison (HC) participants. Methods: Pregnant women treated with vedolizumab for UC or CD with at least one dose in the first trimester were enrolled in the Vedo group. Pregnant women with UC or CD but no exposure to vedolizumab were enrolled in the DM group. Pregnant women with no exposure to any biologic during pregnancy and not diagnosed with an auto-inflammatory or other exclusionary disease were enrolled in the HC group. Data were collected from telephone interviews and maternal and pediatric medical records; live-born children were followed to one year of age with a dysmorphological examination and developmental screening. The Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) was administered to women with CD or UC. Results: Between December 2015 and March 2022, outcomes were collected for 301 women, 98 in the Vedo group, 104 in the DM group, and 99 in the HC group. SIBDQ mean scores were similar in the Vedo group, 5.8 (SD 1.0) and the DM group, 5.9 (SD 1.0). Preliminary descriptive outcome data are shown in Table. In the Vedo group 7.3% of pregnancies resulted in a fetus or infant with a major birth defect, compared to 7.8% in the DM group, and 4.7% in the HC group. No pattern of major birth defects was identified in the Vedo group. Conclusion: The proportion of pregnancies with vedolizumab exposure resulting in a major birth defect are similar to proportions in the disease comparison group, and did not represent a specific pattern. The Vedolizumab Pregnancy Exposure Registry is ongoing with formal statistical analysis planned once the study is completed in 2023. Table 1. - Pregnancy Outcomes in the Study Cohort Vedo-Total(N=98) DM-Total(N=104) HC-Total(N=99) Pregnancies ending with live born infant - n/N (%) 93/98 (94.9) 99/104 (95.2) 85/99 (85.9) Spontaneous abortion – N (Left Truncation Accounted Rate a ) 3 (8.7%) 3 (6.1%) 1 (6.4%) Termination - n/N (%) 0/98 (0.0) 0/104 (0.0) 0/99 (0.0) Stillbirth - n/N (%) 0/98 (0.0) 1/104 (1.0) 0/99 (0.0) Lost to follow-up (LTFU) - n/N (%) 2/98 (2.0) 1/104 (1.0) 13/99 (13.1) Preterm delivery – N (Rate b ) 13 (14.5%) 6 (6.1%) 6 (7.2%) Birth weight full term infants – mean g (SD) 3410.4 (436.7) 3428.8 (454.0) 3308.1 (432.3) Number of pregnancies with major birth defects among all pregnancies excluding LTFU – n/N’ (%) 7/96 (7.3) 8/103 (7.8) 4/86 (4.7) Serious infections in live born infants up to 1 year of age – n/N’(%) c 3/97 (3.1) 2/99 (2.0) 1/88 (1.1) Ages and Stages Screening at 1 year of age with concern – n/N’ (%) c 10/66 (15.2) 20/87 (23.0) 11/59 (18.6) aSpontaneous abortion rate computed using Fleming-Harrington estimate at 20 weeks' gestation, accounting for left truncation because women can enroll at various times in gestation;bComputed using Fleming-Harrington estimate at 37 weeks' gestation;cIncludes twins; % = (n/N') * 100. N' at each category: Number of pregnancies meeting the criteria specified in the row title.

1509P Efficacy and safety of vimseltinib in tenosynovial giant cell tumour (TGCT): Phase II expansion

TGCT is a rare, locally aggressive neoplasm caused by upregulation of the colony-stimulating factor 1 (CSF1) gene, resulting in aberrant CSF1 expression and recruitment of CSF1 receptor (CSF1R)-dependent inflammatory macrophages. Vimseltinib is an oral switch control tyrosine kinase inhibitor specifically designed to selectively and potently inhibit CSF1R. We report safety, efficacy, and preliminary patient-reported outcome data for patients (pts) with TGCT treated with the recommended phase 2 dose (RP2D; 30 mg twice weekly).

Feasibility of a Combined Neuromodulation and Yoga Intervention for Mild Traumatic Brain Injury and Chronic Pain: Protocol for an Open-label Pilot Trial.

BackgroundMild traumatic brain injury (mTBI) and chronic pain often co-occur and worsen rehabilitation outcomes. There is a need for improved multimodal nonpharmacologic treatments that could improve outcomes for both conditions. Yoga is a promising activity-based intervention for mTBI and chronic pain, and neuromodulation through transcranial magnetic stimulation is a promising noninvasive, nonpharmacological treatment for mTBI and chronic pain. Intermittent theta burst stimulation (iTBS) is a type of patterned, excitatory transcranial magnetic stimulation. iTBS can induce a window of neuroplasticity, making it ideally suited to boost the effects of treatments provided after it. Thus, iTBS may magnify the impacts of subsequently delivered interventions as compared to delivering those interventions alone and accordingly boost their impact on outcomes.ObjectiveThe aim of this study is to (1) develop a combined iTBS+yoga intervention for mTBI and chronic pain, (2) assess the intervention’s feasibility and acceptability, and (3) gather preliminary clinical outcome data on quality of life, function, and pain that will guide future studies.MethodsThis is a mixed methods, pilot, open-labeled, within-subject intervention study. We will enroll 20 US military veteran participants. The combined iTBS+yoga intervention will be provided in small group settings once a week for 6 weeks. The yoga intervention will follow the LoveYourBrain yoga protocol—specifically developed for individuals with TBI. iTBS will be administered immediately prior to the LoveYourBrain yoga session. We will collect preliminary quantitative outcome data before and after the intervention related to quality of life (TBI-quality of life), function (Mayo-Portland Adaptability Index), and pain (Brief Pain Inventory) to inform larger studies. We will collect qualitative data via semistructured interviews focused on intervention acceptability after completion of the intervention.ResultsThis study protocol was approved by Edward Hines Jr Veterans Administration Hospital Institutional Review Board (Hines IRB 1573116-4) and was prospectively registered on ClinicalTrials.gov (NCT04517604). This study includes a Food and Drug Administration Investigational Device Exemption (IDE: G200195). A 2-year research plan timeline was developed. As of March 2022, a total of 6 veterans have enrolled in the study. Data collection is ongoing and will be completed by November 2022. We expect the results of this study to be available by October 2024.ConclusionsWe will be able to provide preliminary evidence of safety, feasibility, and acceptability of a novel combined iTBS and yoga intervention for mTBI and chronic pain—conditions with unmet treatment needs.Trial RegistrationClinicalTrials.gov NCT04517604; https://www.clinicaltrials.gov/ct2/show/NCT04517604International Registered Report Identifier (IRRID)DERR1-10.2196/37836

Developing Implementation Capacity of a State Education Agency to Improve Outcomes for Students With Disabilities

The U.S. Department of Education’s Office of Special Education Programs has adopted a Results Driven Accountability (RDA) framework to support state education agencies (SEAs) in improving results for students with disabilities. RDA directed SEAs to focus on measurable outcomes. A leadership team in a large Midwestern state in the United States partnered with an institute of higher education implementation science purveyor team to systematically apply a particular approach, the Active Implementation Frameworks (AIFs), to build capacity, effectively implement, and scale an evidence-based program, Check &amp; Connect, to improve statewide graduation rates for Black and American Indian students with disabilities. The presented case example illustrates how the SEA partners with local education agencies’ district teams to continuously measure and manage changes in (a) system capacity and (b) practice fidelity to improve graduation rate outcomes. Application of the AIFs in education, measured implementation progress and preliminary outcome data, and implications for policy for individuals with disabilities are discussed.

A Group Counseling Model Based on Bowen Family Systems Theory for College Students with Codependency in Taiwan

ABSTRACT In this practice article we present a group counseling model based on Bowen theory for college students with codependency traits and related symptoms developed and piloted in Taiwan. Along with principles of Bowen theory applied to the group counseling model, we discuss group goals, leader roles, group process and development. We present preliminary outcome data on differentiation of self and on therapeutic factors of the group and offer suggestions for future group practice and research.

The Development of a Complex FEP Program at Semmelweis University

Introduction First episode psychosis (FEP) programs target the first 3-5 years after the first manifestation of a psychotic episode. Although follow-up results after 10-15 years are mixed, reported results of the first 5-10 years are promising in improving relapse prevention, functional outcomes and reducing mental health care costs, compared to treatment as usual. Objectives Our objective was to develop the first complex FEP program in Hungary. Methods Male and female inpatients, (age:17-40years), hospitalized due to a first psychotic episode and consenting to participate, were included, since 2019 October. Drug induced psychosis and organic background in the etiology of the psychotic episode were excluded. Duration of the program is 2-3 years, based on the individual needs of the patients. The program provides detailed clinical and neuropsychological examinations, MRI, pharmacotherapy, various psychosocial interventions, and support group for relatives. Results Twenty-eight patients [15 male,13 female, mean age=22,4 (18-40)years] were included. The program has been repeatedly limited by COVID-19 pandemic. Psychiatric control, pharmacotherapy, psychoeducation and supportive therapy, however could be continously provided via telepsychiatry, even during the lockdown. During the first 2 years, 90% of the patients remained in treatment, showed good compliance with pharmacotherapy; 10% of the patients were rehospitalized due to relapse. In the presentation, besides clinical experiences, preliminary clinical outcome data will also be presented. Conclusions The first complex FEP program in Hungary, although limited repeatedly by the pandemic, show promising clinical results with low relapse rates and high level of adherence to therapy in the first 2 years after a first psychotic episode.DisclosureNo significant relationships.