To Treatment As Usual Research Articles

Parent stress and social support in a randomized controlled trial of individual versus group parent training for children with HKD/ADHD

AbstractObjectivesAssess (a) the relative benefit of individual versus group parent training compared to treatment as usual (TAU) with an emphasis on parent outcomes. Investigate (b) if group parent training increases social support more than other modes of treatment and explore (c) how social support interacts with different modes of treatment.MethodCompared individual with group parent training and treatment as usual (TAU) in a randomized controlled trial for N = 237 children with Hyperkinetic Disorder/Attention Deficit Hyperactivity Disorder (HKD/ADHD). Employed two formats of the same cognitive‐behavioural parent training in the same settings to maximize comparability. Controlled for medication status and assessed changes from pre‐ to post‐treatment and 6‐month follow‐up.ResultsParents reported more positive changes in the parent training groups than in TAU in relation to child behaviour problems and moodiness as well as more positive changes in parent stress and sense of competence. However, gains on parent stress were limited after group training as were gains on satisfaction. Social support improved similarly in all treatment groups. While results indicated clear main effects of social support on all child and parent measures, interactions of social support and treatment outcomes were found for child moodiness and parent stress.ConclusionsCognitive‐behavioural parent training is beneficial beyond TAU, especially when it can be provided individually. Surprisingly, group training did not reduce parent stress more than TAU or individual training. Social support related to all measures and interacted with treatment on some outcomes. The findings have numerous implications for research and practice.

Music therapy group for women outpatients with major depressive disorder under treatment as usual in a psychiatric institution: non-randomized pilot trial

Major Depressive Disorder (MDD) is a prevalent mental illness in the world. Pharmacological treatment is typically the first choice, but Humanistic Music Therapy (HMT) may offer additional benefits when added to Treatment As Usual (TAU). This single-arm pilot study aimed to assess the effectiveness of Group HMT as an intervention for adult women diagnosed with MDD, in a psychiatric institution. The study comprised 12 outpatient women with MDD who received more than one year of pharmacological treatment. A pre-test/post-test design using the Hamilton Depression (HAM-D-21), Personal and Social Performance (PSP), and Global Assessment of Functioning (GAF) scales were employed to evaluate symptom severity and patient changes. Results indicated a significant decrease in HAM-D scores from 15.7 to 6.6 (p ≤ .005), a notable improvement in personal and social functioning (PSP scale) (p ≤ .05), and an increase in global activity level (GAF scale) (p ≤ .05). In conclusion, adult women with MDD receiving TAU in a psychiatric institution experienced a significant reduction in depressive symptoms and enhancement in global activity, personal, and social functioning when HMT was added to their treatment regimen. This study is limited by being non-randomized, unblinded, and, with a small population. A randomized controlled trials are required to confirm the benefits of HMT.

The Effectiveness of Modular Transdiagnostic Cognitive Behavioral Therapy Versus Treatment as Usual for Youths Displaying School Attendance Problems: A Randomized Controlled Trial

School attendance problems (SAPs) are associated with negative short- and long-term outcomes. Despite high prevalence of SAPs, there is a shortage of evidence-based interventions. Existing approaches often target either school refusal or truancy, leaving a gap in effective interventions addressing both types of SAPs. This randomized controlled trial (RCT) assessed the effectiveness of Back2School (B2S), a modular transdiagnostic cognitive behavioral therapy (CBT) for SAPs, compared to treatment as usual (TAU). Outcomes included youths’ school attendance and mental health. A group (B2S, TAU) × time (Pre, Post, 3-Month Follow-Up) design involving 152 youths (B2S; n = 74, TAU; n = 78) with SAPs (i.e., ≥ 10% absence in the past three months), aged 6–16 years (M = 12.2, SD = 2.2, males = 60%) were used. B2S comprised three months of CBT with youths, parents, and school involvement, while TAU comprised public and/or private intervention services. On average, youths in B2S received 15.0, (SD = 3.9) hours of intervention, while those in TAU received 13.4, (SD = 21.6). Intervention effects were investigated using mixed linear models. Both B2S and TAU exhibited significant within-group improvements in school attendance, with no significant differences between them. However, the B2S group significantly outperformed TAU in reducing youths’ emotional problems, conduct problems, problems with peers, the overall impact of problems, and increasing youths self-efficacy for attending school and parent self-efficacy for dealing with a SAP. This RCT represents the first evaluation of a modular transdiagnostic CBT for youths displaying SAPs, showing significant mental health and self-efficacy benefits. (Clinical trial registration: ClinicalTrials.gov: NCT03459677).

Patterns of cognitive-emotional change after cognitive-behavioural treatment in emotional disorders: A 12-month longitudinal cluster analysis.

The aim of this study was to use cluster analysis based on the trajectory of five cognitive-emotional processes (worry, rumination, metacognition, cognitive reappraisal and expressive suppression) over time to explore differences in clinical and performance variables in primary care patients with emotional symptoms. We compared the effect of adding transdiagnostic cognitive-behavioural therapy (TD-CBT) to treatment as usual (TAU) according to cluster membership and sought to determine the variables that predicted cluster membership. 732 participants completed scales about cognitive-emotional processes, anxiety and depressive symptoms, functioning, and quality of life (QoL) at baseline, posttreatment, and at 12 months. Longitudinal cluster analysis and logistic regression analyses were carried out. A two-cluster solution was chosen as the best fit, named as "less" or "more" improvement in cognitive-emotional processes. Individuals who achieved more improvement in cognitive-emotional processes showed lower emotional symptoms and better QoL and functioning at all three time points. TAU+TD-CBT, income level, QoL and anxiety symptoms were significant predictors of cluster membership. These results underscore the value of adding TD-CBT to reduce maladaptive cognitive-emotional regulation strategies. These findings highlight the importance of the processes of change in therapy and demonstrate the relevance of the patient's cognitive-emotional profile in improving treatment outcomes.

Hospital admissions among patients with Comorbid Substance Use disorders: a secondary analysis of predictors from the NavSTAR Trial

BackgroundIndividuals with substance use disorders (SUDs) frequently use acute hospital services. The Navigation Services to Avoid Rehospitalization (NavSTAR) trial found that a patient navigation intervention for hospitalized patients with comorbid SUDs reduced subsequent inpatient admissions compared to treatment-as-usual (TAU).MethodsThis secondary analysis extends previous findings from the NavSTAR trial by examining whether selected patient characteristics independently predicted hospital service utilization and moderated the effect of the NavSTAR intervention. Participants were 400 medical/surgical hospital patients with comorbid SUDs. We analyzed 30- and 90-day inpatient readmissions (one or more readmissions) and cumulative incidence of inpatient admissions through 12 months using multivariable logistic and negative binomial regression, respectively.ResultsConsistent with primary findings and controlling for patient factors, NavSTAR participants were less likely than TAU participants to be readmitted within 30 (P = 0.001) and 90 (P = 0.03) days and had fewer total readmissions over 12 months (P = 0.008). Hospitalization in the previous year (P < 0.001) was associated with cumulative readmissions over 12 months, whereas Medicaid insurance (P = 0.03) and index diagnoses of infection (P = 0.001) and injuries, poisonings, or procedural complications (P = 0.004) were associated with fewer readmissions. None of the selected covariates moderated the effect of the NavSTAR intervention.ConclusionsPrevious findings showed that patient navigation could reduce repeat hospital admissions among patients with comorbid SUDs. Several patient factors were independently associated with readmission. Future research should investigate risk factors for hospital readmission among patients with comorbid SUDs to optimize interventions.Trial RegistrationNIH ClinicalTrials.gov NCT02599818, Registered November 9, 2015 https://classic.clinicaltrials.gov/ct2/show/NCT02599818.

The effectiveness of abstinence-based and harm reduction-based interventions in reducing problematic substance use in adults who are experiencing homelessness in high income countries: A systematic review and meta-analysis: A systematic review.

The effectiveness of abstinence-based and harm reduction-based interventions in reducing problematic substance use in adults who are experiencing homelessness in high income countries: A systematic review and meta-analysis: A systematic review.

Quasi-randomized trial of solution-focused brief therapy intervention for readiness to change and alcohol and other drug use in a Brazilian community-based treatment center

Objective Strategies to increase readiness to change may enhance community-based substance use treatment outcomes. This study evaluated the effect of solution-focused brief therapy (SFBT) on readiness to change and substance use compared to treatment as usual (TAU) in a Brazilian community-based substance use treatment center. Methods One hundred two adults (M = 36.79, SD = 10.29) were quasi-randomized into SFBT or TAU groups. Assessments were completed at baseline, post-test, and 1-month follow-up. The primary outcome was the changes in readiness to change at post-test and 1-month follow-up. The secondary outcome was the change in substance use at 1-month follow-up. Results Through Quade non-parametric analysis of covariance (ANCOVA), both groups decreased tobacco, alcohol, and cocaine/crack use at 1-month follow-up, but SFBT had greater reductions in alcohol use (p = .05). ANCOVA analysis demonstrated no differences between groups on readiness to change at any time point. However, among participants who used multiple substances (n = 59), SFBT showed higher readiness to change at post-test (p = .05). Conclusions These findings strengthen the evidence that SFBT holds promise for positive community-based substance use treatment outcomes.

Comparative analysis of treatment options for chronic heart failure and depression: a systematic review and Bayesian network meta-analysis.

Different interventions have been evaluated for the treatment of depression in heart failure (HF) patients. However, clear and established recommendations are lacking. PubMed, Scopus, and Web of Science databases were systematically searched for randomized controlled trials (RCT) evaluating the effect of various treatment options on depression scores in heart failure patients. The primary outcome was a change in depression scores presented as standardized mean difference (SMD). A Bayesian network for meta-analysis was constructed. Twenty-five RCTs were included, randomizing 6014 patients with confirmed heart failure and depression between 2003 and 2022. Compared to treatment as usual (TAU), only cognitive behavioral therapy (CBT) (SMD - 0.60, CI95% [- 1.0, - 0.17]) leads to a significant reduction in depression scores. Other interventions did not improve depression scores significantly. Our results show that for patients with HF and depression, CBT can significantly improve measures of depression, being the most efficacious treatment.

Validation of the predictive value of BDNF -87 methylation for antidepressant treatment success in severely depressed patients—a randomized rater-blinded trial

BackgroundBrain-derived neurotrophic factor (BDNF) is essential for antidepressant treatment of major depressive disorder (MDD). Our repeated studies suggest that DNA methylation of a specific CpG site in the promoter region of exon IV of the BDNF gene (CpG -87) might be predictive of the efficacy of monoaminergic antidepressants such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and others. This trial aims to evaluate whether knowing the biomarker is non-inferior to treatment-as-usual (TAU) regarding remission rates while exhibiting significantly fewer adverse events (AE).MethodsThe BDNF trial is a prospective, randomized, rater-blinded diagnostic study conducted at five university hospitals in Germany. The study’s main hypothesis is that {1} knowing the methylation status of CpG -87 is non-inferior to not knowing it with respect to the remission rate while it significantly reduces the AE rate in patients experiencing at least one AE. The baseline assessment will occur upon hospitalization and a follow-up assessment on day 49 (± 3). A telephone follow-up will be conducted on day 70 (± 3). A total of 256 patients will be recruited, and methylation will be evaluated in all participants. They will be randomly assigned to either the marker or the TAU group. In the marker group, the methylation results will be shared with both the patient and their treating physician. In the TAU group, neither the patients nor their treating physicians will receive the marker status. The primary endpoints include the rate of patients achieving remission on day 49 (± 3), defined as a score of ≤ 10 on the Hamilton Depression Rating Scale (HDRS-24), and the occurrence of AE.Ethics and disseminationThe trial protocol has received approval from the Institutional Review Boards at the five participating universities. This trial holds significance in generating valuable data on a predictive biomarker for antidepressant treatment in patients with MDD. The findings will be shared with study participants, disseminated through professional society meetings, and published in peer-reviewed journals.Trial registrationGerman Clinical Trial Register DRKS00032503. Registered on 17 August 2023.

Cognitive–behavioral therapy for patients with somatoform disorders: A pilot preliminary randomized controlled trial

Background and objective: Cognitive–behavioral therapy (CBT) for somatoform disorders (SFDs) is understudied in China. Western findings may not be applicable to Chinese culture. This preliminary study evaluated the efficacy of CBT for patients in China, relative to treatment-as-usual (TAU). Methods: Seventy patients with SFDs randomly received either combined CBT and TAU (CBT + TAU), or TAU alone between January 2018 to May 2019. The CBT + TAU group received 12 weekly individual 50-minute CBT sessions. Participants were blindly assessed at 4 timepoints (baseline, week 6, end of treatment: week 12; 12 weeks post-treatment: week 24) using the following outcome measures: SQSS (Self-screening Questionnaire for Somatic Symptoms); PHQ-15 (Patient-Health-Questionnaire-15) and the WI (Whiteley Index); GAD-7 (General Anxiety Disorder-7); HAMD-17 (Hamilton Depression Rating Scale-17); Family Burden Interview Schedule (FBIS); Sheehan Disability Scale (SDS); and the Short Form of Quality-of-Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF). The primary endpoint was the difference between the SQSS total score at week 24 and the baseline. A mixed model for repeated measures was used to analyze inter- and intra-group changes from the baseline. Results: At week 24, The least-squares mean (LSM) change of the total score on the SQSS was −18.87 points and −9.69 points, respectively in the CBT + TAU group and in the TAU group (LSM difference, −9.18 points; 95% confidence interval, −15.72 to −2.64; P = 0.0068). At week 24, the LSM changes from baseline in the WI, HAMD, PHQ15, FBIS and SDS total scores were significantly different between the two groups, however, there was no significant difference in the Q-LES-Q-SF. The SQSS of group effect sizes were 0.63 at 24 weeks. The dropout rates of the CBT + TAU and TAU groups were comparable (22.9% and 19.3%). Conclusions: These preliminary findings suggest that CBT may be helpful for improving the symptoms of patients with SFDs in China.

Experience real-time, health and biological outcoMes of personal recovery in PeOple With mEntal disorders in Residential facilities (EMPOWER): a cohort study

Introduction Deinstitutionalization has resulted in diverse mental health care models, influenced by local resources, funding, and cultural factors. In Italy, 127 Department of Mental Health (DMHs) provide care for individuals with mental disorders. People with severe mental disorders (SMD) live independently or in residential facilities (RFs). Approximately half of the Italian DMH budget is allocated to RFs, serving around 3.6% of people with SMD. Italian RFs prioritize personal recovery, empowering individuals with SMD to live fulfilling lives despite symptoms and psychosocial challenges. While personal recovery is known to improve well-being and cost-effectiveness, its implementation in Italian RFs remains incomplete. There is insufficient evidence regarding its impact on various outcomes for residents, including health, psychosocial, and biological factors.Objectives The EMPOWER Study aims to assess whether adding personal recovery to Treatment As Usual (TAU) in Italian RFs could improve functioning (primary outcome), health, biological status, productivity and interpersonal relationships (secondary outcomes) among patients receiving the personal recovery-oriented treatment, compared with TAU. Additionally, data will be collected from informal caregivers, mental health professionals, and concerning the recovery orientation of RFs.MethodsThis study employs a longitudinal cohort design, gathering data at baseline and six-month follow-up in Italian RFs. A cohort of residents over 18 y.o. who receive a personal recovery-oriented treatment, the Mental Health Recovery Star (N=20), is compared to a matched group of residents receiving the TAU (N=20). International standardized assessments collect patients’ data on functioning, psychopathology, need for care, quality of life (QoL), positivity, social network, service satisfaction, and patient stigma. Informal caregivers’ data includes burden, QoL, positivity, and service satisfaction. Mental health professionals’ data encompasses burnout, stress, stigma, positivity, and work satisfaction. The working alliance between professionals and patients is assessed. Clinical and biological exams (blood and saliva samples) are collected, along with actigraphy data on patients’ circadian rhythm and physical activities. Digital data through a mobile app captures psychopathology, productive activities, social network, using the Experience Sampling Method with questions defined with patients. Focus groups with patients, professionals, and informal caregivers are facilitated by an expert by experience. Recovery orientation of RFs is assessed.ResultsNot yet available.ConclusionsThis study aims to generate novel insight that could improve our treatment approaches for patients in residential facilities.Disclosure of InterestNone Declared

Vagus nerve stimulation (VNS) as a long-term adjunctive treatment option in patients with difficult-to-treat depression (DTD)

IntroductionVNS is a long-term adjunctive treatment option in patients with DTD. It has been shown that patients with VNS as add-on to treatment-as-usual (TAU) have higher response and remission rates than TAU alone. Data on the impact of VNS on the other complex concomitant treatments are limited.ObjectivesIn this study we evaluated changes in drug load from baseline to 12 months as well as the impact of previous ECT response status at baseline on changes in mean depression severity after 12 months of VNS.MethodsWe included n=20 DTD patients (mean age 52.6 years) in the prospective, observational, naturalistic Restore-Life study, who have been treated with adjunctive VNS as add-on to treatment as usual. The RESTORE-Life study is a multi-center study. In this analysis, we report on exploratory results from a single tertiary center. An index has been calculated for each drug by comparing the actual dose with the standard dose of the drug. The drug load for each patient has been constructed by summing up the indices of all agents prescribed for the patient.Results We observed a slight decrease in mean drug load from 4.5 at baseline to 4.4 at 12 months (p=0.594). The drug load was lower in previous ECT-responders than in ECT-non-responders at both timepoints. There was a significant decrease in mean MADRS score from 27.3 at baseline to 15.3 at 12 months (p=0.001). Patients with a history of ECT response at baseline have experienced significantly greater improvement in mean MADRS score at 12 months (p=0.013). Number of maintenance electroconvulsive therapy (ECT) and esketamine sessions decreased from 37 ECT and 58 esketamine sessions in the first six months to 17 ECT (-54%) and 29 esketamine (-50%) sessions between months 6 and 12. VNS-related adverse events were present in 50 % of patients at 12 months (voice alteration/hoarseness 45%, dyspnea and pain during stimulation each 5%). There was no discontinuation of VNS due to adverse events.Conclusions Overall, VNS was associated with significant decrease in mean MADRS score at 12 months, whereas we did not detect any significant change in medication load. A more extended observation period might be necessary to observe changes in medication load. There was a reduction in the need of maintenance treatment sessions of ECT and esketamine. History of ECT response may be predictive for greater improvement of depression severity in VNS patients.Disclosure of InterestE. Kavakbasi Grant / Research support from: The Sponsor of the Restore-Life study is LivaNova. Our institution received fees from LivaNova for study visits of the Restore-Life study. LivaNova had no influence on the content of this work., H. Bauermeister: None Declared, L. Lemcke: None Declared, B. Baune: None Declared

Efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) in Individuals With Chronic Pain and Opioid Use Disorder: Protocol for a Randomized Clinical Trial of a Digital Cognitive Behavioral Treatment.

Chronic pain is common among individuals with opioid use disorder (OUD) who are maintained on medications for OUD (MOUD; eg, buprenorphine or methadone). Chronic pain is associated with worse retention and higher levels of substance use. Treatment of individuals with chronic pain receiving MOUD can be challenging due to their increased clinical complexity. Given the acute and growing nature of the opioid crisis, MOUD is increasingly offered in a wide range of settings, where high-quality, clinician-delivered, empirically validated behavioral treatment for chronic pain may not be available. Therefore, digital treatments that support patient self-management of chronic pain and OUD have the potential for wider implementation to fill this gap. This study aims to evaluate the efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT), an interactive digital treatment program with asynchronous coach feedback, compared to treatment as usual (TAU) in individuals with chronic pain and OUD receiving MOUD. Adult participants (n=160) receiving MOUD and reporting bothersome or high-impact chronic pain will be recruited from outpatient opioid treatment programs in Connecticut (United States) and randomized 1:1 to either IMPACT+TAU or TAU only. Participants randomized to IMPACT+TAU will complete an interactive digital treatment that includes 9 modules promoting training in pain and addiction coping skills and a progressive walking program. The program is augmented with a weekly personalized voice message from a trained coach based on daily participant-reported pain intensity and interference, craving to use opioids, sleep quality, daily steps, pain self-efficacy, MOUD adherence, and engagement with IMPACT collected through digital surveys. Outcomes will be assessed at 3, 6, and 9 months post randomization. The primary outcome is MOUD retention at 3 months post randomization (ie, post treatment). Secondary outcomes include pain interference, physical functioning, MOUD adherence, substance use, craving, pain intensity, sleep disturbance, pain catastrophizing, and pain self-efficacy. Semistructured qualitative interviews with study participants (n=34) randomized to IMPACT (completers and noncompleters) will be conducted to evaluate the usability and quality of the program and its outcomes. The study has received institutional review board approval and began recruitment at 1 site in July 2022. Recruitment at a second site started in January 2023, with a third and final site anticipated to begin recruitment in January 2024. Data collection is expected to continue through June 2025. Establishing efficacy for a digital treatment for addiction and chronic pain that can be integrated into MOUD clinics will provide options for individuals with OUD, which reduce barriers to behavioral treatment. Participant feedback on the intervention will inform updates or modifications to improve engagement and efficacy. ClinicalTrials.gov NCT05204576; https://clinicaltrials.gov/ct2/show/NCT05204576. DERR1-10.2196/54342.

Design of the STRIVE-IPF trial- study of therapeutic plasma exchange, rituximab, and intravenous immunoglobulin for acute exacerbations of idiopathic pulmonary fibrosis

BackgroundAcute exacerbations of idiopathic pulmonary fibrosis (AE-IPF) affect a significant proportion of patients with IPF. There are limited data to inform therapeutic strategies for AE-IPF, despite its high mortality. We discuss the rationale and design of STRIVE-IPF, a randomized, multi-center, open-label Phase IIb clinical trial to determine the efficacy of combined therapeutic plasma exchange (TPE), rituximab, and intravenous immunoglobulin (IVIG), in comparison to treatment as usual (TAU), among patients with acute IPF exacerbations.MethodsThe STRIVE-IPF trial will randomize 51 patients among five sites in the United States. The inclusion criteria have been designed to select a study population with AE-IPF, as defined by American Thoracic Society criteria, while excluding patients with an alternative cause for a respiratory decompensation. The primary endpoint of this trial is six-month survival. Secondary endpoints include supplement oxygen requirement and six-minute walk distance which will be assessed immediately prior to treatment and after completion of therapy on day 19, as well as at periodic subsequent visits.DiscussionThe experimental AE-IPF therapy proposed in this clinical trial was adapted from treatment regimens used in other antibody-mediated diseases. The regimen is initiated with TPE, which is expected to rapidly reduce circulating autoantibodies, followed by rituximab to reduce B-cells and finally IVIG, which likely has multiple effects, including affecting feedback inhibition of residual B-cells by Fc receptor occupancy. We have reported potential benefits of this experimental therapy for AE-IPF in previous anecdotal reports. This clinical trial has the potential to profoundly affect current paradigms and treatment approaches to patients with AE-IPF.Trial registrationClinicalTrials.gov identifier: NCT03286556.

Measuring the Effect of the Early assessment Team (MEET) for patients referred to outpatient mental health care: a study protocol for a randomised controlled trial

BackgroundReferrals to specialised mental health care (such as community mental health centres; CMHC) have increased over the last two decades. Patients often have multifaceted problems, which cannot only be solved by such care. Resources are limited, and triaging is challenging. A novel method which approaches patients early and individually upon referral to a CMHC—possibly with a brief intervention—is an Early assessment Team (EaT). In an EaT, two therapists meet the patient early in the process and seek to solve the present problem, often involving community services, primary health care, etc.; attention is paid to symptoms and functional strife, rather than diagnoses. This is in contrast to treatment as usual (TAU), where the patient (after being on a waiting list) meets one therapist, who focuses on history and situation to assign a diagnosis and eventually start a longitudinal treatment. The aim of this study is to describe and compare EaT and TAU regarding such outcomes as work and social adjustment, mental health, quality of life, use of health services, and patient satisfaction. The primary outcome is a change in perceived function from baseline to 12-month follow-up, measured by the Work and Social Adjustment Scale.MethodPatients (18 years and above; n = 588) referred to outpatient health care at a CMHC are randomised to EaT or TAU. Measures (patient self-reports and clinician reports, patients’ records, and register data) are collected at baseline, after the first and last meeting, and at 2, 4, 8, 12, and 24 months after inclusion. Some participants will be invited to participate in qualitative interviews.Trial designThe study is a single-centre, non-blinded, RCT with two conditions involving a longitudinal and mixed design (quantitative and qualitative data).DiscussionThis study will examine an intervention designed to determine early on which patients will benefit from parallel or other measures than assessment and treatment in CMHC and whether these will facilitate their recovery. Findings may potentially contribute to the development of the organisation of mental health services.Trial registrationClinicalTrials.gov NCT05087446. Registered on 21 October 2021.

An Integrated Care Pathway for depression in adolescents: protocol for a Type 1 Hybrid Effectiveness-implementation, Non-randomized, Cluster Controlled Trial

IntroductionOur group developed an Integrated Care Pathway to facilitate the delivery of evidence-based care for adolescents experiencing depression called CARIBOU-2 (Care for Adolescents who Receive Information ‘Bout OUtcomes, 2nd iteration). The core pathway components are assessment, psychoeducation, psychotherapy options, medication options, caregiver support, measurement-based care team reviews and graduation. We aim to test the clinical and implementation effectiveness of the CARIBOU-2 pathway relative to treatment-as-usual (TAU) in community mental health settings.Methods and analysisWe will use a Type 1 Hybrid Effectiveness-Implementation, Non-randomized Cluster Controlled Trial Design. Primary participants will be adolescents (planned n = 300, aged 13–18 years) with depressive symptoms, presenting to one of six community mental health agencies. All sites will begin in the TAU condition and transition to the CARIBOU-2 intervention after enrolling 25 adolescents. The primary clinical outcome is the rate of change of depressive symptoms from baseline to the 24-week endpoint using the Childhood Depression Rating Scale—Revised (CDRS-R). Generalized mixed effects modelling will be conducted to compare this outcome between intervention types. Our primary hypothesis is that there will be a greater rate of reduction in depressive symptoms in the group receiving the CARIBOU-2 intervention relative to TAU over 24 weeks as per the CDRS-R. Implementation outcomes will also be examined, including clinician fidelity to the pathway and its components, and cost-effectiveness.Ethics and disseminationResearch ethics board approvals have been obtained. Should our results support our hypotheses, systematic implementation of the CARIBOU-2 intervention in other community mental health agencies would be indicated.

“Maze Out”: a study protocol for a randomised controlled trial using a mix methods approach exploring the potential and examining the effectiveness of a serious game in the treatment of eating disorders

BackgroundEating Disorders (ED) are severe and costly mental health disorders. The effects of existing treatment approaches are limited and there is a need to develop novel interventions, including digital strategies that can increase engagement and effectiveness. Maze Out is a new serious game coproduced by patients and ED therapists, which allows patients to “play” with the reality of an ED and reflect on associated challenges.ObjectivesThe present study has two main objectives: (1) to evaluate the effectiveness of adding Maze Out to treatment as usual (TAU) in a randomised controlled trial (RCT); and (2) to examine in depth the potential of Maze Out by examining how it is perceived and used in the context of an RCT.MethodsParticipants will be recruited from mental health care services, endocrinology departments or Community Centres offering treatment for ED. Patients suffering from ED (N = 94) will be randomised to either TAU or TAU plus Maze Out. Primary outcome will be measured in terms of changes in self-efficacy, measured by a 5-item self-efficacy questionnaire (5-item SE_ED). Secondary outcome measures will include feelings of ineffectiveness and self-image, as measured by Eating Disorder Inventory, version 3 (EDI-3), Brief INSPIRE-O and Structural Analysis of Social Behaviour Intrex Questionnaire (SAS-B). Data will be collected at baseline (enrolment in the study), and subsequently 8 and 15 weeks after inclusion. Experiences of playing Maze Out will be examined in a sub-sample of participants, utilising both quantitative user analytics and qualitative interview data of patients, interview data of significant others, and healthcare professionals to explore the possible impact of Maze Out on disorder insight, communication patterns between patients and therapists and understanding of their disorder.DiscussionTo our knowledge Maze Out is the first serious game coproduced by patients and therapists. It is a novel and theoretically grounded intervention that may significantly contribute to the healing process of ED. If found effective, the potential for wide-spread impact and scalability is considerable.Trial registration ClinicalTrials.gov NCT05621018.

A Hybrid Type 1 trial of a multi-component mHealth intervention to improve post-hospital transitions of care for patients with serious mental illness: Study protocol

BackgroundThe transition from acute (e.g., psychiatric hospitalization) to outpatient care is associated with increased risk for rehospitalization, treatment disengagement, and suicide among people with serious mental illness (SMI). Mobile interventions (i.e., mHealth) have the potential to increase monitoring and improve coping post-acute care for this population. This protocol paper describes a Hybrid Type 1 effectiveness-implementation study, in which a randomized controlled trial will be conducted to determine the effectiveness of a multi-component mHealth intervention (tFOCUS) for improving outcomes for adults with SMI transitioning from acute to outpatient care. MethodsAdults meeting criteria for schizophrenia-spectrum or major mood disorders (n = 180) will be recruited from a psychiatric hospital and randomized to treatment-as-usual (TAU) plus standard discharge planning and aftercare (CHECK-IN) or TAU plus tFOCUS. tFOCUS is a 12-week intervention, consisting of: (a) a patient-facing mHealth smartphone app with daily self-assessment prompts and targeted coping strategies; (b) a clinician-facing web dashboard; and, (c) mHealth aftercare advisors, who will conduct brief post-hospital clinical calls with patients (e.g., safety concerns, treatment engagement) and encourage app use. Follow-ups will be conducted at 6-, 12-, and 24-weeks post-discharge to assess primary and secondary outcomes, as well as target mechanisms. We also will assess barriers and facilitators to future implementation of tFOCUS via qualitative interviews of stakeholders and input from a Community Advisory Board throughout the project. ConclusionsInformation gathered during this project, in combination with successful study outcomes, will inform a potential tFOCUS intervention scale-up across a range of psychiatric hospitals and healthcare systems.Clinicaltrials.govregistration: NCT05703412

Short- and Long-Term Outcomes of an Adventure Therapy Programme on Borderline Personality Disorder: A Pragmatic Controlled Clinical Trial.

Adventure Therapy (AT) is a therapeutic intervention utilizing the natural environment and adventure activities as tools for psychotherapeutic interventions. It has been demonstrated to be appropriate for the intervention of patients with borderline personality disorder (BPD). This study aims to evaluate the response to AT treatment compared with the response to treatment as usual (TAU), based on cognitive behavioural therapy, in the short and long term, assessing clinical, psychosocial, and functional outcomes; quality of life; and physical health levels. This study extends the sample of and is a follow-up to a pilot study published in 2021, with a sample of 30 patients in the AT group and 10 in the control group. It does not allow us to affirm that AT provides better outcomes than TAU, as the positive effects observed immediately after therapy seem to be attenuated in the long term. Therefore, the effectiveness of long-term psychotherapy did not show differences between AT and TAU therapies in the treatment of BPD patients. However, the effects of intangibles observed during therapy by professionals and patients were not reflected in the measurements collected. Therefore, we believe it is necessary to increase the programme duration, complement treatment with a specific physical health programme, assess results with more specific instruments, and/or move towards a qualitative methodology to measure perceived changes in clinical improvement. New studies are needed to evaluate the results of the proposed changes.

An e-mental health intervention to reduce depression symptoms in individuals with obesity: study protocol for the randomized, controlled, two-armed, confirmatory LightMood trial

BackgroundPatients with obesity often experience psychological distress, specifically depression symptoms. Due to various barriers, such as limitations of healthcare offers, digital interventions, for example medical apps, can provide a suitable approach to support affected people. In the envisaged prospective randomized controlled trial, we aim to examine the efficacy of the LightMood intervention. The LightMood intervention is a manualized and user-centered, digital intervention for patients with obesity, with a duration of 4 months, which contains elements of cognitive behavioral therapy and mindfulness-based and skills-based exercises. We expect the LightMood intervention to be superior to treatment as usual (TAU) in terms of reducing depression symptoms.MethodsThe trial incorporates four distinct measurement time points: the baseline assessment, the post-treatment assessment, and 1- and 3-month follow-up assessments. Furthermore, we implemented in-treatment assessments for both groups. Participants will be randomized into two groups (LightMood intervention vs TAU). The aim is to include 128 participants (64 per group) in the study. Inclusion criteria are patients who are obese, at least 18 years old, with a private Internet access, and with adequate digital literacy and show depression symptoms (PHQ ≥ 10). Exclusion criteria are weekly outpatient individual psychotherapy, obesity surgery within the last year or planned within the next 7 months, no private Internet access, and the prescription of a new psychotropic drug within the last 2 weeks. The primary outcome is the post-assessment reduction in depression symptoms. Secondary outcomes will include the improvement in self-efficacy, quality of life, mindfulness, reduction in eating disorder symptoms, and body mass index (BMI). Furthermore, we expect a positive development of depression symptoms throughout the different time points (T1, T2, and T3) in patients with obesity.DiscussionLightMood is an evidence-based, efficient, low-threshold online intervention that aims to reduce depression symptoms in people with obesity. Online interventions could offer a promising alternative to conventional face-to-face therapy. The primary objective of the current study is to add essential insight into the feasibility, efficacy, effectiveness, and acceptance of e-mental health interventions for people with obesity and depression symptoms.Trial registrationGerman Clinical Trial Register (DRKS), DRKS00029219. Registered on May 19, 2023