Treatment As Usual Research Articles

Efficacy of clozapine versus standard treatment in adult individuals with intellectual disability and treatment-resistant psychosis (CLOZAID): study protocol of a multicenter randomized clinical trial.

Intellectual disability (ID) affects approximately 1% of the worldwide population and individuals with ID have a higher comorbidity with mental illness, and specifically psychotic disorders. Unfortunately, among individuals with ID, limited research has been conducted since ID individuals are usually excluded from mental illness epidemiological studies and clinical trials. Here we perform a clinical trial to investigate the effectiveness of clozapine in the treatment of resistant psychosis in individuals with ID. The article highlights the complexity of diagnosing and treating psychopathological alterations associated with ID and advocates for more rigorous research in this field. A Phase IIB, open-label, randomized, multicenter clinical trial (NCT04529226) is currently ongoing to assess the efficacy of oral clozapine in individuals diagnosed with ID and suffering from treatment-resistant psychosis. We aim to recruit one-hundred and fourteen individuals (N=114) with ID and resistant psychosis, who will be randomized to TAU (treatment as usual) and treatment-with-clozapine conditions. As secondary outcomes, changes in other clinical scales (PANSS and SANS) and the improvement in functionality, assessed through changes in the Euro-QoL-5D-5L were assessed. The main outcome variables will be analyzed using generalized linear mixed models (GLMM), assessing the effects of status variable (TAU vs. Clozapine), time, and the interaction between them. The treatment of resistant psychosis among ID individuals must be directed by empirically supported research. CLOZAID clinical trial may provide relevant information about clinical guidelines to optimally treat adults with ID and treatment-resistant psychosis and the benefits and risks of an early use of clozapine in this underrepresented population in clinical trials. Clinicaltrials.gov: NCT04529226. EudraCT: 2020-000091-37.

Prevention of sickness absence through early identification and rehabilitation of at-risk patients with musculoskeletal disorders (PREVSAM): short term effects of a randomised controlled trial in primary care

Purpose To evaluate short-term effects of the PREVention of Sickness Absence for Musculoskeletal disorders (PREVSAM) model on sickness absence and patient-reported health outcomes. Methods Patients with musculoskeletal disorders were randomised to rehabilitation according to PREVSAM or treatment as usual (TAU) in primary care. Sickness absence and patient-reported health outcomes were evaluated after three months in 254 participants. Results The proportion of participants remaining in full- or part-time work were 86% in PREVSAM vs 78% in TAU (p = 0.097). The PREVSAM group had approximately four fewer sickness benefit days during three months from baseline (p range 0.078–0.126). No statistically significant difference was found in self-reported sickness absence days (PREVSAM 12.4 vs TAU 14.5; p = 0.634), nor were statistically significant differences between groups found in patient-reported health outcomes. Both groups showed significant improvements from baseline to three months, except for self-efficacy, and only the PREVSAM group showed significantly reduced depression symptoms. Conclusions The findings suggest that for sickness absence, the PREVSAM model may have an advantage over TAU, although the difference did not reach statistical significance at the p < 0.05 level, and similar positive effects on patient-reported health outcomes were found in both groups. Long-term effects must be evaluated before firm conclusions can be drawn.

Baseline trait mindfulness moderates the efficacy of mindfulness interventions and active controls: A meta-analysis of 177 randomised controlled trials.

Previous evidence suggests that benefits of mindfulness-based interventions (MBIs) may depend on individuals' baseline trait mindfulness (BTM) levels. This meta-analysis investigated moderating effects of BTM on changes in mental health outcomes and trait mindfulness in randomised controlled trials (RCTs) of MBIs. A total of 177 primary studies (total N = 13,486), comparing the treatment effects of MBIs against active, treatment-as-usual (TAU) and waitlist control groups, were synthesised via three-level meta-analysis. Lower BTM was associated with larger changes in mental health outcomes (B = -0.14, 95% CI [-0.21, -0.06], p < .001) and trait mindfulness (B = -0.09 [-0.16, -0.02], p = .009) in MBIs and active controls combined. These associations were significantly larger than from those in TAU and waitlist controls. Moderating effects were less tangible for changes in trait mindfulness in MBIs and active controls individually and less tangible in various sensitivity analyses which, however, were confounded by client type across the RCTs. Individuals low in BTM may, by a small effect size, benefit more from MBIs and active control interventions. BTM may thus affect the evaluation of treatment efficacy. MBIs and active interventions could be offered specifically to persons low in BTM.

Moderators and predictors of treatment outcome following adjunctive internet-delivered emotion regulation therapy relative to treatment as usual alone for adolescents with nonsuicidal self-injury disorder: Randomized controlled trial.

Despite the wide-ranging negative consequences of nonsuicidal self-injury (NSSI), there are few evidence-based treatments for NSSI among adolescents and little is known about what treatments that work best for whom. The objective of this study was to investigate moderators (i.e., for whom a specific treatment works) and predictors (i.e., factors associated with treatment outcome independent of treatment type) of treatment outcome in a randomized clinical trial comparing internet-delivered emotion regulation individual therapy for adolescents (IERITA) plus treatment as usual (TAU) to TAU alone. Adolescents (N=166; mean [SD] age=15.0 [1.2] years) with NSSI disorder were randomized to IERITA plus TAU (n=84) or TAU-only (n=82). Adolescent emotion regulation difficulties, suicidality, NSSI frequency, depressive symptoms, sleep difficulties, global functioning, and age, and parental invalidation, were measured pre-treatment and investigated as moderators and predictors of treatment outcome (i.e., NSSI frequency during treatment and for 4weeks post-treatment). A zero-inflated negative binomial generalized linear mixed effects regression model was used to estimate the rate of NSSI change as a function of both treatment condition and moderator/predictor. No significant moderators of treatment outcome were found. Parental invalidation was a significant predictor of treatment outcome regardless of treatment condition, such that high levels of parental invalidation pre-treatment were associated with a less favorable NSSI frequency. We did not find evidence of a differential treatment effect as a function of any of the examined client factors. Future research should investigate moderation in larger samples and with sufficient statistical power to detect moderation effects of smaller magnitude. Results suggest that parental invalidation may have a negative impact on treatment response and highlight the importance of further investigating parental invalidation in the context of NSSI treatments.

Advance Care Planning for Children With Rare Diseases: A Pilot RCT.

Pediatric rare diseases are often life-limiting conditions and/or require constant caregiving. Investigators assessed the initial efficacy of the FAmily CEntered (FACE) pediatric advance care planning (pACP), FACE-Rare, intervention on families' quality of life. A pilot-phase, single-blinded, intent-to-treat, randomized controlled clinical trial enrolled families from 1 pediatric quaternary hospital between 2021 and 2023. Intervention families received 3 weekly 60-minute (FACE-Rare pACP) sessions: (1) Carer Support Needs Assessment Tool or Action Plan, (2) Carer Support Needs Assessment Tol Action Plan Review, and (3) Pediatric Next Steps: Respecting Choices pACP. Controls received treatment as usual (TAU). Outcome measures were Beck Anxiety Inventory, Family Appraisal of Caregiving, Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality, and health care utilization. Generalized mixed effect models with γ response assessed the intervention effect at 3-month follow-up. Children (n = 21) were aged 1 to 10 years, 48% male, 24% Black; and 100% technology dependent. Primary family caregivers (n = 21) were aged 30 to 43 years, 19% male, 19% Black; and 27% household income below the Federal poverty level. Dyads underwent 1:1 randomization: 9 to FACE-Rare and 12 to TAU. TAU caregivers reported statistically lower meaning and peace than FACE-Rare caregivers (0.9, P = .03, confidence interval [CI]: 0.75-0.99). Black caregivers reported significantly less caregiver distress (0.7, P = .04, CI: 0.47-0.98) than non-Black caregivers. Poor families reported more anxiety (3.5, P = .002, CI: 1.62-7.94), more caregiver strain (1.2, P = .006, CI: 1.07-1.42); and less family well-being (0.8, P = .02, CI: 0.64-0.95). FACE®-Rare was feasible, acceptable, safe, and demonstrated initial efficacy, providing greater feelings of meaning and peace to caregivers. Poverty impacted well-being. A multisite trial is needed to determine generalizability.

Psychotherapies for the treatment of borderline personality disorder: A systematic review.

Borderline personality disorder (BPD) is the most common personality disorder, affecting 1.8% of the general population, 10% of psychiatric outpatients, and 15%-25% of psychiatric inpatients. Practice guidelines recommend psychotherapies as first-line treatments. However, psychotherapies commonly used for the treatment of BPD are numerous, and little is known about the comparative effectiveness of each individual psychotherapy versus treatment as usual (TAU) or other psychotherapies. To systematically assess the comparative effectiveness of commonly used psychotherapies versus TAU or versus other psychotherapies for BPD treatment. We conducted systematic literature searches in MEDLINE, EMBASE, the Cochrane Library, and APA PsycINFO up to July 14, 2022, and searched reference lists of pertinent articles and reviews. Inclusion criteria were (a) patients 13 years or older with a diagnosis of BPD, (b) treatment with commonly used psychotherapies, (c) comparison with TAU or another psychotherapy, (d) assessment of relevant BPD-related health outcomes, and (e) randomized or nonrandomized trials or controlled observational studies. Two investigators independently screened abstracts and full-text articles and graded the certainty of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach. We found 25 psychotherapy studies meeting inclusion criteria with data on 2,545 participants. Seventeen studies compared nine psychotherapies with TAU and nine studies compared eight psychotherapies with another psychotherapy for the treatment of BPD. Overall, both TAU and included psychotherapies were effective in treating the severity and symptoms of BPD. Moderate certainty of evidence suggests that systems training for emotional predictability and problem solving is more effective than TAU for the treatment of BPD; low certainty of evidence suggests that dialectical behavior therapy, schema therapy, transference-focused psychotherapy, acceptance and commitment therapy, manual-assisted cognitive therapy, and cognitive behavioral therapy are more effective than TAU for treating BPD. We were unable to draw conclusions from head-to-head comparisons of psychotherapies, which were limited to single studies with very low to low certainty of evidence. All commonly used psychotherapies improve BPD severity, symptoms, and functioning. Our assessment found no strong evidence suggesting that any one psychotherapy is more beneficial than another. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Effectiveness of early and intensive intervention on suicide prevention: CARS programme

The aim of this study was to evaluate the outcomes of the Programme for Management of Suicidal Behaviour and Suicide Prevention (CARS). Individuals treated in the emergency department of University Hospital Marqués de Valdecilla for suicidal thoughts or attempts (N = 401) between 1-March-2016 and 31-December-2018 were considered. No randomization by patients or groups was performed. Student's t-test, chi-square and repeated measure analysis of variance were used. Kaplan-Meier survival function and Cox proportional hazard regression models were employed to estimate the risks of relapse. Outcome of those who voluntary enrol CARS were compared with treatment as usual (TAU) at 6- and 12-months follow-up. The results indicate a significant reduction and delayed occurrence of suicidal behaviour over a 12-month follow-up period with the CARS programme compared to TAU, along with a decreased frequency of hospital admissions. CARS programme demonstrates a substantial impact, significantly reducing the risk of recurrent suicidal behaviour by 35.5 % and the risk of repeated suicidal attempts by 47.2 % at the 12-month follow-up. The programme exhibits a dual protective effect, diminishing suicidal behaviour and fostering improved long-term outcomes. In conclusion, CARS effectively reduced suicidal behaviour recurrence, achieving significant decreases in suicidal thoughts, plans and attempts.

Clinical effects of online cognitive behavioral group therapy for chronic pain patients and developing a therapeutic alliance: A pre-post pilot trial.

Research suggests that various psychosocial factors influence chronic pain, with psychotherapies like cognitive behavioral therapy proving effective. However, the limited availability and accessibility have prolonged suffering among patients with chronic pain. This challenge has led to a growing demand for accessible online interventions. We developed an online cognitive behavioral group therapy (CBGT) program, building upon our existing face-to-face CBGT program. We compared the scores obtained by patients during the treatment-as-usual (TAU)period with those collected at the beginning and at the end of the intervention. Patients with chronic pain (N = 22) agreed to participate in the online CBGT program, which was conducted once a week for 12 sessions. The sample size was decided based on the effect sizes of our past face-to-face CBGT. We assessed pain intensity [Visual Analogue Scale (VAS)], pain catastrophizing [pain catastrophizing scale (PCS)] and psychiatric assessment [Beck Depression Inventory-Second Edition (BDI)-II],State-Trait-Anxiety Inventory (STAI), and Short Form Health Survey(SF-36) at three points: entry, pretreatment, and posttreatment. We also evaluated the participants' therapeutic alliance with the treatment staff [short-form version of the Working Alliance Inventory (WAI-S)]. We utilized analyses of variance, Friedman test, paired t-tests, Wilcoxon signed-rank test, and Pearson correlation analysis for data evaluation. Results indicated a significant posttreatment improvement in VAS, PCS, and BDI-II scores compared to the TAU period. Furthermore, posttreatment WAI-S scores increased significantly compared to pretreatment scores. Also, positive correlations were observed among pre- and posttreatment changes in WAI-S, pain intensity, and pain catastrophizing scores. There is a possibility that a therapeutic alliance can be established, and therapeutic effects achieved through an online CBGT intervention; however, additional research is required to substantiate this potential.We have registered this clinical trial in UMIN-CTR on 04/21/2021 with the number UMIN000043982.

Effectiveness of an add-on brief group behavioral activation treatment for depression in psychiatric care: a randomized clinical trial.

Behavioral activation (BA) is an effective treatment for depression. We investigated the effectiveness of add-on group-format BA and peer support (PS) with treatment as usual (TAU) in a registered randomized clinical trial in psychiatric outpatient settings (ISRCTN10647845). Adult outpatients (N = 140) with major depressive disorder (MDD) and Patient Health Questionnaire (PHQ-9) score ≥10 were randomized into a) group BA, consisting of eight 90-minute weekly group sessions plus TAU; b) group PS, including eight 90-minute weekly group sessions plus TAU; or c) TAU alone. The primary outcome was a within-individual change in PHQ-9 score between baseline and 8 weeks. Secondary outcomes were 1) response, 2) remission, and 3) functional impairment at 8 weeks, plus 4) change in PHQ-9 at 6 months. Of the randomized patients, 100 (71.4%) completed treatments, including 29/45 (64.4%) patients in the BA group, 39/49 (79.6%) in the PS group, and 32/46 (69.6%) in the TAU group. By 8 weeks, PHQ-9 scores declined most in the TAU group [BA -0.28 (95% CI -2.48, 1.92), PS -0.58 (-2.09, 0.94) vs. TAU -3.32 (-5.21, -1.44); group-difference test, p = 0.034]. The secondary outcomes in the BA or PS arms did not significantly differ from those in TAU. Videotaped sessions revealed marked variation in briefly trained therapists' adherence to the treatment manual. In this randomized trial, the effectiveness of treatments with the added BA and PS groups did not exceed that of TAU alone. The preconditions in which brief BA or PS group interventions benefit outpatients with depression in psychiatric settings warrant critical investigation.

The effectiveness of a brief intervention for intensive care unit patients with hazardous alcohol use: a randomized controlled trial.

Screening for hazardous alcohol use and performing brief interventions (BIs) are recommended to reduce alcohol-related negative health consequences. We aimed to compare the effectiveness (defined as an at least 10% absolute difference) of BI with usual care in reducing alcohol intake in intensive care unit survivors with history of hazardous alcohol use. We used Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) score to assess history of alcohol use. Emergency admitted adult ICU patients in three Finnish university hospitals, with an AUDIT-C score > 5 (women), or > 6 (men). We randomized consenting eligible patients to receive a BI or treatment as usual (TAU). BI was delivered by the time of ICU discharge or shortly thereafter in the hospital ward. Control patients received TAU. The primary outcome was self-reported alcohol consumption during the preceding week 6 and 12months after randomization. Secondary outcomes were the change in AUDIT-C scores from baseline to 6 and 12months, health-related quality of life, and mortality. The trial was terminated early due to slow recruitment during the pandemic. We randomized 234 patients to receive BI (N = 117) or TAU (N = 117). At 6months, the median alcohol intake in the BI and TAU groups were 6.5g (interquartile range [IQR] 0-141) and 0g (0-72), respectively (p = 0.544). At 12months, it was 24g (0-146) and 0g (0-96) in the BI and TAU groups, respectively (p = 0.157). Median change in AUDIT-C from baseline to 6months was - 1 (- 4 to 0) and 2 (- 6 to 0), (p = 0.144) in the BI and TAU groups, and to 12months - 3 (- 5 to - 1) and - 4 (- 7 to - 1), respectively (p = 0.187). In total, 4% (n = 5) of patients in the BI group and 11% (n = 13) of patients in the TAU group were abstinent at 6months, and 10% (n = 12) and 15% (n = 17), respectively, at 12months. No between-groups difference in mortality emerged. As underpowered, our study cannot reject or confirm the hypothesis that a single BI early after critical illness is effective in reducing the amount of alcohol consumed compared to TAU. However, a considerable number in both groups reduced their alcohol consumption. ClinicalTrials.gov (NCT03047577).

Enhanced Skills Training in Affective and Interpersonal Regulation versus Treatment as Usual for ICD-11 Complex PTSD: A Pilot Randomised Controlled Trial (The RESTORE Trial)

Introduction: Complex PTSD (CPTSD) is a relatively new condition in ICD-11. This pilot randomised controlled trial aimed to compare a four-module intervention developed to target all symptoms of ICD-11 CPTSD, namely Enhanced Skills in Affective and Interpersonal Regulation (ESTAIR) with treatment as usual (TAU). The purpose of the study was to assess feasibility, safety, acceptability, and preliminary outcomes at the end of treatment and 3-month follow-up. Methods: A total of N = 56 eligible veterans with CPTSD were randomised to either ESTAIR (n = 28) or TAU (n = 28). Linear mixed models were conducted to assess CPTSD severity, the primary outcome, as measured by the International Trauma Questionnaire (ITQ). Results: Treatment dropout in ESTAIR and TAU was low and equivalent (18% vs. 11%; χ2 (1) = 1.19, p = 0.275), and study retention was high, supporting the feasibility of the study. No serious adverse effects and very few adverse effects occurred, none of which were deemed related to the study. ESTAIR provided significantly greater reduction in CPTSD severity across time for ITQ PTSD (p < 0.001) and DSO (p < 0.001) symptoms. CPTSD pre-to-post effect sizes for ESTAIR were large (PTSD d = 1.78; DSO d = 2.00). Remission of probable CPTSD diagnosis at post-treatment was substantially greater in ESTAIR compared to TAU with only 13.6% versus 84% (p < 0.001) retaining the diagnosis. Conclusion: A trial of ESTAIR versus TAU for the treatment of ICD-11 CPTSD indicates the potential efficacy of ESTAIR as well as its feasibility, safety, and acceptability.

Reducing time to differentiated service delivery for newly-diagnosed people living with HIV in Kigali, Rwanda: a pilot, unblinded, randomized controlled trial

BackgroundDifferentiated service delivery (DSD) programs for people living with HIV (PWH) limit eligibility to patients established on antiretroviral therapy (ART), yet uncertainty exists regarding the duration on ART necessary for newly-diagnosed PWH to be considered established. We aimed to determine the feasibility, acceptability, and preliminary impact of entry into DSD at six months after ART initiation for newly-diagnosed PWH.MethodsWe conducted a pilot randomized controlled trial in three health facilities in Rwanda. Participants were randomized to: (1) entry into DSD at six months after ART initiation after one suppressed viral load (DSD-1VL); (2) entry into DSD at six months after ART initiation after two consecutive suppressed viral loads (DSD-2VL); (3) treatment as usual (TAU). We examined feasibility by examining the proportion of participants assigned to intervention arms who entered DSD, assessed acceptability through patient surveys and by examining instances when clinical staff overrode the study assignment, and evaluated preliminary effectiveness by comparing study arms with respect to 12-month viral suppression.ResultsAmong 90 participants, 31 were randomized to DSD-1VL, 31 to DSD-2VL, and 28 to TAU. Among 62 participants randomized to DSD-1VL or DSD-2VL, 37 (60%) entered DSD at 6 months while 21 (34%) did not enter DSD because they were not virally suppressed. Patient-level acceptability was high for both clinical (mean score: 3.8 out of 5) and non-clinical (mean score: 4.1) elements of care and did not differ significantly across study arms. Viral suppression at 12 months was 81%, 81% and 68% in DSD-1VL, DSD-2VL, and TAU, respectively (p = 0.41).ConclusionsThe majority of participants randomized to intervention arms entered DSD and had similar rates of viral suppression compared to TAU. Results suggest that early DSD at six months after ART initiation is feasible for newly-diagnosed PWH, and support current WHO guidelines on DSD.Trial registrationClinicaltrials.gov NCT04567693; first registered on September 28, 2020.

Psychosocial and medication interventions to stop or reduce alcohol consumption during pregnancy.

Despite the known harms, alcohol consumption is common in pregnancy. Rates vary between countries, and are estimated to be 10% globally, with up to 25% in Europe. To assess the efficacy of psychosocial interventions and medications to reduce or stop alcohol consumption during pregnancy. We searched the Cochrane Drugs and Alcohol Group Specialised Register (via CRSLive), Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, Web of Science, and PsycINFO, from inception to 8 January 2024. We also searched for ongoing and unpublished studies via ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). All searches included non-English language literature. We handsearched references of topic-related systematic reviews and included studies. We included randomised controlled trials that compared medications or psychosocial interventions, or both, to placebo, no intervention, usual care, or other medications or psychosocial interventions used to reduce or stop alcohol use during pregnancy. Our primary outcomes of interest were abstinence from alcohol, reduction in alcohol consumption, retention in treatment, and women with any adverse event. We used standard Cochrane methodological procedures. We included eight studies (1369 participants) in which pregnant women received an intervention to stop or reduce alcohol use during pregnancy. In one study, almost half of participants had a current diagnosis of alcohol use disorder (AUD); in another study, 40% of participants had a lifetime diagnosis of AUD. Six studies took place in the USA, one in Spain, and one in the Netherlands. All included studies evaluated the efficacy of psychosocial interventions; we did not find any study that evaluated the efficacy of medications for the treatment of AUD during pregnancy. Psychosocial interventions were mainly brief interventions ranging from a single session of 10 to 60 minutes to five sessions of 10 minutes each. Pregnant women received the psychosocial intervention approximately at the end of the first trimester of pregnancy, and the outcome of alcohol use was reassessed 8 to 24 weeks after the psychosocial intervention. Women in the control group received treatment as usual (TAU) or similar treatments such as comprehensive assessment of alcohol use and advice to stop drinking during pregnancy. Globally, we found that, compared to TAU, psychosocial interventions may increase the rate of continuously abstinent participants (risk ratio (RR) 1.34, 95% confidence interval (CI) 1.14 to 1.57; I2 =0%; 3 studies; 378 women; low certainty evidence). Psychosocial interventions may have little to no effect on the number of drinks per day, but the evidence is very uncertain (mean difference -0.42, 95% CI -1.13 to 0.28; I2 = 86%; 2 studies; 157 women; very low certainty evidence). Psychosocial interventions probably have little to no effect on the number of women who completed treatment (RR 0.98, 95% CI 0.94 to 1.02; I2 = 0%; 7 studies; 1283 women; moderate certainty evidence). None of the included studies assessed adverse events of treatments. We downgraded the certainty of the evidence due to risk of bias and imprecision of the estimates. Brief psychosocial interventions may increase the rate of continuous abstinence among pregnant women who report alcohol use during pregnancy. Further studies should be conducted to investigate the efficacy and safety of psychosocial interventions and other treatments (e.g. medications) for women with AUD. These studies should provide detailed information on alcohol use before and during pregnancy using consistent measures such as the number of drinks per drinking day. When heterogeneous populations are recruited, more detailed information on alcohol use during pregnancy should be provided to allow future systematic reviews to be conducted. Other important information that would enhance the usefulness of these studies would be the presence of other comorbid conditions such as anxiety, mood disorders, and the use of other psychoactive substances.

Effects of repetitive transcranial magnetic stimulation on fear of cancer recurrence and its underlying neuromechanism

IntroductionMany breast cancer patients suffer from fear of cancer recurrence (FCR). However, effective physical intervention for FCR has been scarce. Previous studies have confirmed that repetitive transcranial magnetic stimulation (rTMS) can help improve patients' anxiety, depression, fear, and stress level. Therefore, this study aims to assess the efficacy of rTMS in the treatment of FCR in breast cancer patients and explore its underlying neural mechanism. Methods and analysisand analysis: Fifty breast cancer patients with high FCR (FCR total score >27), and fifty age- and gender-matched patients with low FCR (FCR total score <7) will be recruited to participate in this study. Patients in the high FCR group will be randomly assigned to receive 4-week low-frequency rTMS targeting the right dorsolateral prefrontal cortex (rDLPFC) + treatment as usual (TAU) (n = 25), or to receive sham stimulation + TAU (n = 25). Patients in the low FCR group will only receive TAU. All participants will take a baseline fMRI scan to examine the local activities and interactions of brain activity between the prefrontal cortex (DLPFC), amygdala and hippocampus. Fear of Cancer Recurrence Questionnaire (FCRQ7), Patient Health Questionnaire (PHQ9), Generalize Anxiety Disorder (GAD7), Numeric Rating Scale (NRS), and Insomnia Severity Index (ISI7) will be used to measure an individual's FCR, depression, anxiety, pain, and insomnia symptoms at week 0 (baseline), week 4 (the end of intervention), week 5 (1 week post-treatment), week 8 (1 month post-treatment), and week 16 (3 months post-treatment). Participants in the high FCR group will receive a post-treatment fMRI scan within 24 h after intervention to explore the neural mechanisms of rTMS treatment. The primary outcome of the study, whether the rTMS intervention is sufficient in relieving FCR in breast cancer patients, is measured by FCRQ7. Additionally, task activation, local activity and functional connectivity of the DLPFC, amygdala and hippocampus will be compared, between high and low FCR group, and before and after treatment. DiscussionStudies have shown that low-frequency rTMS can be used to treat patient's FCR. However, there is a lack of relevant evidence to support the efficacy of rTMS on FCR in cancer patients, and the neural mechanisms underlying the effects of rTMS on FCR need to be further investigated. Ethics and disseminationEthical approval for the study has been obtained from the Ethics Committee of Guangdong Provincial People's Hospital (reference number: KY-N-2022-136-01). The results of the investigation will be published in scientific papers. The data from the investigation will be made available online if necessary. Trial registrationNCT05881889 (ClinicalTrials.gov). Date of registration: May 31, 2023.

A pilot randomized controlled trial of medication adherence therapy: Psychosocial leverage using a significant other (MAT-PLUS) for individuals on extended-release naltrexone

BackgroundExtended-release naltrexone (XR-NTX) is an important treatment option for individuals with opioid use disorder (OUD) and/or alcohol use disorder (AUD). However, problems with retention are a major barrier to its overall effectiveness, and interventions to improve adherence are underdeveloped. The purpose of this study was to pilot test the MAT-PLUS intervention, which combines assertive outreach and involvement of a treatment significant other (TSO) to improve adherence to XR-NTX. MethodsAdults (N = 41) seeking treatment for OUD and/or AUD with XR-NTX were recruited from an inpatient addiction treatment center and randomized to the MAT-PLUS intervention or treatment as usual (TAU) for 16-weeks. TSOs (N = 19) of individuals in the MAT-PLUS condition were also enrolled. The primary outcome was the number of XR-NTX doses received and relapse to regular heavy use (opioid or alcohol) was a secondary outcome. ResultsParticipants in the MAT-PLUS group received 3.4 doses compared to 2.5 in TAU, which was significant after controlling for SUD diagnosis (p < 0.05). Rates of receipts of all prescribed doses were 61.1 % in MAT-PLUS compared to 30.4 % in TAU, giving an NNT of 3.3. Relapse rates and days of heavy use did not vary by treatment group. ConclusionsThis study demonstrates preliminary efficacy of the MAT-PLUS intervention for XR-NTX adherence. This study was limited by its small sample size and future research should broaden the intervention to apply across medications for SUD in larger samples. Family support with an emphasis on medication adherence has strong potential for improving addiction treatment outcomes.

Effects of a novel, brief psychological therapy (Managing Unusual Sensory Experiences) for hallucinations in first episode psychosis (MUSE FEP): Findings from an exploratory randomised controlled trial

Hallucinations are a common feature of psychosis, yet access to effective psychological treatment is limited. The Managing Unusual Sensory Experiences for First-Episode-Psychosis (MUSE-FEP) trial aimed to establish the feasibility and acceptability of a brief, hallucination-specific, digitally provided treatment, delivered by a non-specialist workforce for people with psychosis. MUSE uses psychoeducation about the causal mechanisms of hallucinations and tailored interventions to help a person understand and manage their experiences. We undertook a two-site, single-blind (rater) Randomised Controlled Trial and recruited 82 participants who were allocated 1:1 to MUSE and treatment as usual (TAU) (n = 40) or TAU alone (n = 42). Participants completed assessments before and after treatment (2 months), and at follow up (3–4 months). Information on recruitment rates, adherence, and completion of outcome assessments was collected. Analyses focussed on feasibility outcomes and initial estimates of intervention effects to inform a future trial. The trial is registered with the ISRCTN registry 16793301. Criteria for the feasibility of trial methodology and intervention delivery were met. The trial exceeded the recruitment target, had high retention rates (87.8%) at end of treatment, and at follow up (86.6%), with good acceptability of treatment. There were 3 serious adverse events in the therapy group, and 5 in the TAU group. Improvements were evident in both groups at the end of treatment and follow up, with a particular benefit in perceived recovery in the MUSE group. We showed it was feasible to increase access to psychological intervention but a definitive trial requires further changes to the trial design or treatment.

Bright light therapy versus physical exercise to prevent co-occurring depression in adolescents and young adults with attention-deficit/hyperactivity disorder: a multicentre, three-arm, randomised controlled, pilot phase-IIa trial

Abstract Depression is common in attention-deficit/hyperactivity disorder (ADHD), but preventive behavioural interventions are lacking. This randomised controlled, pilot phase-IIa trial aimed to study a physical exercise intervention (EI) and bright light therapy (BLT)—both implemented and monitored in an individual, naturalistic setting via a mobile health (m-health) system—for feasibility of trial design and interventions, and to estimate their effects on depressive symptoms in young people with ADHD. Two hundred seven participants aged 14–45 years were randomised to 10-week add-on intervention of either BLT (10,000 lx; daily 30-min sessions) (n = 70), EI (aerobic and muscle-strengthening activities 3 days/ week) (n = 69), or treatment-as-usual (TAU) (n = 68), of whom 165 (80%) were retained (BLT: n = 54; EI: n = 52; TAU: n = 59). Intervention adherence (i.e. ≥ 80% completed sessions) was very low for both BLT (n = 13, 22%) and EI (n = 4, 7%). Usability of the m-health system to conduct interventions was limited as indicated by objective and subjective data. Safety was high and comparable between groups. Changes in depressive symptoms (assessed via observer-blind ratings, Inventory of Depressive Symptomatology) between baseline and end of intervention were small (BLT: −0.124 [95% CI: −2.219, 1.971], EI: −2.646 [95% CI: −4.777, −0.515], TAU: −1.428 [95% CI: −3.381, 0.526]) with no group differences [F(2,153) = 1.45, p = 0.2384]. These findings suggest that the m-health approach did not achieve feasibility of EI and BLT in young people with ADHD. Prior to designing efficacy studies, strategies how to achieve high intervention adherence should be specifically investigated in this patient group. Trial registration ClinicalTrials.gov, NCT03371810, 13 December 2017.

Effects of mindfulness-based preoperative intervention for patients undergoing elective surgery: A meta-analysis

ObjectivePatients often experience pain and psychological distress when undergoing elective surgeries. Mindfulness-based interventions have been proposed as potential strategies to address these challenges. This meta-analysis aims to evaluate the efficacy of preoperative mindfulness-based interventions on several outcomes for patients undergoing elective surgery, including preoperative anxiety/depression, postoperative anxiety/depression, postoperative pain, and quality of life (QOL). MethodsThis meta-analysis encompassed randomized controlled trials published in the database PubMed, Cochrane, and Embase to August 2023. Mindfulness-based interventions were compared to control groups, who received treatment as usual (TAU). The RevMan software was employed to assess each outcome by using standardized mean difference based on patient-reported data. Subgroup analyses were further performed according to different categories of surgical types. ResultsEight RCTs with a total of 685 patients were identified. This meta-analysis demonstrated significant difference in preoperative anxiety (SMD:−0.36, 95% CI: −0.62 to −0.11, p = .006) and postoperative pain immediately (SMD:−0.65,95% CI: −1.09 to −0.20, p = .004), 2–3 days (SMD:-0.40, 95% CI:-0.78 to −0.02, p = .04),at 14 days (SMD:−0.48,95% CI: −0.85 to −0.12, p = .009) and 28 days (SMD:−0.89,95% CI: −1.55 to −0.23, p = .008) postoperatively. However, there were no differences between postoperative anxiety, preoperative/postoperative depression, and QOL. ConclusionOur findings suggest preoperative mindfulness-based interventions can effectively manage preoperative anxiety and postoperative pain in patients scheduled for elective surgery. Further research is warranted to explore the different timing and types of mindfulness-based intervention.

The effectiveness and safety of dialectical behavior therapy for suicidal ideation and behavior in autistic adults: a pragmatic randomized controlled trial.

Many autistic people in mental health are suicidal. This study evaluated the effectiveness of dialectical behavior therapy (DBT) v. treatment as usual (TAU) in reducing suicidal ideation and suicide attempts. At six Dutch mental health centers, 123 outpatients (18-65 years) with DSM-5 diagnosed autism spectrum disorder (ASD) and suicidal behavior were randomly assigned to the DBT intervention group (n = 63) or TAU control group (n = 60). Assessments were conducted at baseline, post-treatment at 6 months and 12-month follow-up. The primary outcomes were severity of suicidal ideation and frequency of suicide attempts. The severity of depression and social anxiety were secondary outcomes. At end-of-treatment, DBT significantly reduced both suicidal ideation (z = -2.24; p = 0.025; b = -4.41; s.e. = 197.0) and suicide attempts (z = -3.15; p = 0.002; IRR = 0.046; s.e. = 0.045) compared to TAU, but lost statistical significance at the 12-month follow-up. Depression severity significantly decreased with DBT (z = -1.99; p = 0.046: b = -2.74; s.e. = 1.37) remaining so at 12 months (z = -2.46; p = 0.014; b = -3.37; s.e. = 1.37). No effects were observed on social anxiety. Severe adverse events included two suicides in the TAU condition. DBT is an acceptable, safe, and short-term effective intervention to reduce suicidal ideation and suicide attempts in autistic adults with suicidal behavior.

Stepped Care for Patients to Optimize Whole Recovery (SC-POWR): An Effectiveness Trial Evaluating a Stepped Care Model for Individuals With Opioid Use Disorder and Chronic Pain.

Many patients who receive treatment for opioid use disorder (OUD) report experiencing chronic pain (CP), which is associated with high levels of ongoing nonmedical opioid use and low retention in OUD treatment. In pilot studies of patients with OUD receiving buprenorphine or methadone who had CP, cognitive behavioral therapy (CBT) attenuated nonmedical opioid use compared with treatment-as-usual (TAU), but patients in both treatment arms exhibited similar pain improvements. Adding exercise and stress reduction to this model may augment pain-related outcomes. With funding from National Institutes of Health, we plan to conduct a randomized clinical trial of 316 patients with OUD and CP to test the effectiveness of TAU compared with Stepped Care for Patients to Optimize Whole Recovery (SC-POWR) to reduce nonmedical opioid use and pain (primary outcomes) (Aim 1) and decrease pain intensity and interference, alcohol use, anxiety, depression and stress, and improve sleep (secondary outcomes) (Aim 2). Eligible participants will be randomized to receive TAU (buprenorphine or methadone and at least once a month individual or group counseling) or SC-POWR (ie, TAU and up to 12 CBT sessions) for 24 weeks. Based on prespecified nonresponse criteria, SC-POWR may be stepped up at week 6 to receive onsite weekly group sessions of exercise (Wii Fit, Tai Chi) and "stepped up" again at week 15 to receive weekly group sessions of stress reduction (relaxation training, auricular acupuncture). They will be followed for another 24 weeks to evaluate durability of treatment response for illicit opioid use, alcohol use, pain, anxiety, depression, stress, sleep, and retention in medications for OUD (Aim 3).