To Treatment As Usual Research Articles

Culturally adapted cognitive behavioural group therapy for mental disorders in refugees plus problem solving training (ReTreat): study protocol for a multicentre randomised controlled trial

IntroductionSince a high proportion of refugees in Germany suffer from mental disorders, culturally adapted treatments are needed that target a broad range of symptoms. There is much evidence for the...

Smartphone-assisted guided self-help cognitive behavioral therapy for young people with distressing voices (SmartVoices): study protocol for a randomized controlled trial

BackgroundThe long-standing view that auditory verbal hallucinations (AVH) or hearing voices is a sign of schizophrenia has been challenged by research demonstrating that they lie on a continuum ranging from normal to pathological experience related to distress and need for care. Hearing voices is more prevalent in adolescence than in later life, and hearing voices during adolescence indicates a risk for severe psychopathology, functional impairments, and suicide later in life. While there is increasing evidence for the efficacy of cognitive behavioral therapy for voices (CBTv) in adults with schizophrenia, research on psychological treatments for youth with distressing voices has been scarce. The aim of the current study is to examine the efficacy of CBTv, delivered using smartphone-based Ecological Momentary Assessment Intervention (EMI) in a transdiagnostic sample of youth.MethodsThis is a superiority randomized controlled trial comparing 8 weeks of CBTv-based EMI in addition to treatment as usual (TAU) versus TAU only. TAU covers both no treatment and any form of psychiatric/psychological treatment. In the EMI condition, participants will be prompted twice a day to complete an EMA survey, and receive one intervention proposal per assessment. One-hundred fifty-four youth aged 14–25 years with distressing voices will be recruited from psychiatric clinics, local private practices, internet forums, and advertisements in print and social media. Before and after the intervention phase, participants will undergo a 9-day EMA. Single-blinded assessments will be conducted at baseline (T0) and at 3-month (T1) and 6-month (T2) follow-up. The primary outcome is the distress dimension of the Auditory Hallucinations subscale of the Psychotic Symptom Rating Scales at T1. Secondary outcomes include perceived hostile intention, power, and dominance of voices, passive, aggressive, and assertive relating to voices, and negative core beliefs about the self.DiscussionAdolescence provides a crucial window of opportunity for early intervention for hearing voices. However, youth are notoriously reluctant help-seekers. This study offers a low-intensity psychological intervention for youth with distressing voices beyond diagnostic boundaries that, using a mobile technology approach, may match the treatment preferences of the generation of “digital natives.”Trial registrationGerman Clinical Trials Register DRKS00026243. Registered on 2 September 2021

Effectiveness of Group CBT on Internalizing and Externalizing Symptoms in Children with Mixed Psychiatric Disorders.

Our study addressed the gap in research on the effectiveness of cognitive behavioral therapy (CBT) in treating children with mixed psychiatric disorders. We examined the immediate and long-term effects of group CBT (GCBT), delivered in naturalistic clinical settings, on reducing internalizing and externalizing symptoms in children with mixed psychiatric disorders. Further, we compared the effectiveness of cost-effective, manualized GCBT to treatment as usual (TAU) consisting of individually tailored psychiatric outpatient services delivered by mental health care specialists. Children aged 6-12 years (n = 103) diagnosed with psychiatric disorders, more than 70% with psychiatric comorbidity, were assigned either directly to GCBT (GCBT group; n = 52) or TAU for approximately 3 months, after which they received GCBT (TAU + GCBT group; n = 51). Internalizing and externalizing symptoms were assessed using parent- and teacher-report questionnaires (Child Behavior Checklist and Teacher Report Form) at referral to treatment, pre-treatment, post-treatment, and six-month follow-up. Parent- and teacher-rated internalizing symptoms and parent-rated externalizing symptoms were reduced immediately after GCBT. Long-term GCBT gains were prominent for parent-rated externalizing symptoms. No differences were observed between the effectiveness of GCBT and TAU. Our results suggest that GCBT and TAU services are equally effective in treating internalizing and externalizing symptoms in children with mixed psychiatric disorders, providing support for the broader use of cost-effective manualized GCBT. Manualized GCBT, which requires relatively short training, can also be delivered at primary healthcare levels. Our results are of relevance to cost-effectiveness and global mental health staff shortages.

Effectiveness of Acceptance and Commitment Therapy on the Positive and Negative Symptoms and Emotion Regulation of Patients with Schizophrenia Spectrum Disorders: A Single-case Clinical Trial Study

Background: The literature suggests the increasing application of acceptance and commitment therapy (ACT) for people with schizophrenia spectrum disorders (SSD). Objectives: This study aimed to determine the effectiveness of ACT on the positive and negative symptoms and emotion regulation of patients with SSD. Methods: The experimental design of the current study was an AB (baseline and intervention phases) along with the follow-up phase, in addition to Treatment-As-Usual (TAU), ACT sessions were held for the participants. Among the 20 participants who had inclusion criteria to the study, five participant (three men and two women in the age range of 32 - 43 years) were randomly allocated to participate in the intervention through drawing and evaluated using the Positive and Negative Syndrome Scale (PANSS) and Difficulties in Emotion Regulation Scale (DERS) in three phases of baseline, intervention, and follow-up. For data analysis, non-overlapping indices and Cohen's d effect size were measured, and visual diagrams were plotted for interpretation. Results: The present results showed that the effect sizes of psychotic symptoms in the first to fifth participants were 1.7, 1.9, 0.6, 4, and 1.4, respectively in the intervention phase relative to the baseline; the effect size was only large for the fourth participant. Also, the effect sizes of emotion regulation in the first to fifth participants were 0.8, 1.6, 1.5, 1.2, and 2.7, respectively; the effect size was only large for the fifth participant. Conclusions: The results of data analysis showed that ACT is effective in reducing psychotic symptoms and improving emotion regulation. The effect size of ACT was the largest for the fourth participant; medium for the first, second, and fifth participants; and small for the third participant.

Design of an RCT on cost-effectiveness of group schema therapy versus individual schema therapy for patients with Cluster-C personality disorder: the QUEST-CLC study protocol

BackgroundGiven the high prevalence of Cluster-C Personality Disorders (PDs) in clinical populations, disease burden, high societal costs and poor prognosis of comorbid disorders, a major gain in health care can be achieved if Cluster-C PDs are adequately treated. The only controlled cost-effectiveness study published so far found Individual Schema Therapy (IST) to be superior to Treatment as Usual (TAU). Group ST (GST) might improve cost-effectiveness as larger numbers can be treated in (>50%) less time compared to IST. However, to date there is no RCT supporting its (cost-) effectiveness. The overall aim of this study is to assess the evidence for GST for Cluster-C PDs and to improve treatment allocation for individual patients. Three main questions are addressed: 1) Is GST for Cluster-C PDs (cost-)effective compared to TAU? 2) Is GST for Cluster-C PDs (cost-) effective compared to IST? 3) Which patient-characteristics predict better response to GST, IST, or TAU?MethodsIn a multicenter RCT, the treatment conditions GST, IST, and TAU are compared in 378 Cluster-C PD patients within 10 sites. GST and IST follow treatment protocols and are completed within 1 year. TAU is the optimal alternative treatment available at the site according to regular procedures. Severity of the Cluster-C PD is the primary outcome, assessed with clinical interviews by independent raters blind for treatment. Functioning and wellbeing are important secondary outcomes. Assessments take place at week 0 (baseline), 17 (mid-GST), 34 (post-GST), 51 (post-booster sessions of GST), and 2 years (FU). Patient characteristics predicting better response to a specific treatment are studied, e.g., childhood trauma, autistic features, and introversion. A tool supporting patients and clinicians in matching treatment to patient will be developed. An economic evaluation investigates the cost-effectiveness and cost-utility from a societal perspective. A process evaluation by qualitative methods explores experiences of participants, loved ones and therapists regarding recovery, quality of life, and improving treatment.DiscussionThis study will determine the (cost-)effectiveness of treatments for Cluster-C PDs regarding treatment type as well as optimal matching of patient to treatment and deliver insight into which aspects help Cluster-C-PD patients recover and create a fulfilling life.Trial registrationDutch Trial Register: NL9209. Registered on 28-01-2021,

Randomized Controlled Trial of a Brief Mindfulness-Based Intervention for Suicidal Ideation Among Veterans.

This study was a preliminary evaluation of a manualized, brief mindfulness-based intervention (MB-SI) for veterans with suicidal ideation (SI), admitted into an inpatient psychiatric unit (IPU). A randomized, controlled pilot study of 20 veterans aged 18-70 years with SI, admitted into a psychiatric unit, assigned to treatment as usual (TAU) or MB-SI groups. Outcome data were collected at three time points: preintervention (beginning of first session), postintervention (end of last session), and 1-month postintervention. Primary outcomes were safety and feasibility. Secondary outcome measures were SI and behavior, mindfulness state and trait, cognitive reappraisal, and emotion regulation. Additionally, psychiatric and emergency department admissions were examined. Data analysis included Generalized Linear Models, Wilcoxon Signed-Rank, Mann-Whitney U, and Fisher's exact tests for secondary outcomes. Mindfulness-based intervention for suicidal ideation was feasible to implement on an IPU, and there were no associated adverse effects. Mindfulness-based intervention for suicidal ideation participants experienced statistically significant increase in Toronto Mindfulness Scale curiosity scores 1-month postintervention compared to preintervention and greater Toronto Mindfulness Scale decentering scores 1-month postintervention compared to TAU. Emotion Regulation Questionnaire Reappraisal scores significantly increased for the MB-SI group and significantly decreased for TAU over time. IPU and emergency department admissions were not statistically different between groups or over time. Both TAU and MB-SI participants experienced a significant reduction in Columbia-Suicide Severity Rating Scale-SI scores after the intervention. MB-SI participants experienced a higher increase in Five-Facet Mindfulness Questionnaire scores postintervention compared to TAU. Mindfulness-based intervention for suicidal ideation is feasible and safe to implement among veterans during an inpatient psychiatric admission with SI, as it is not associated with increased SI or adverse effects. Preliminary evidence suggests that MB-SI increases veterans' propensity to view experiences with curiosity while disengaging from experience without emotional overreaction. Further, more rigorous research is warranted to determine efficacy of MB-SI. The clinicaltrials.gov registration number is NCT04099173 and dates are July 16, 2019 (initial release) and February 24, 2022 (most recent update).

The effect of an integrated care intervention of multidisciplinary mental health treatment and employment services for trauma-affected refugees: study protocol for a randomised controlled trial

BackgroundThe complexity of past trauma and ongoing post-migration stressors challenges the existing mental health treatment for trauma-affected refugees. Therefore, interventions are needed to accommodate these complex challenges in mental health treatment. This study examines the effect of an add-on integrated care intervention compared to treatment as usual (TAU) for trauma-affected refugees in a randomised controlled trial (RCT).MethodsThe study is carried out at a Danish outpatient clinic and will include 197 treatment-seeking refugees with post-traumatic stress disorder (PTSD) who are unemployed and affiliated with municipal employment services. Mental health TAU comprises 10 sessions with a medical doctor (pharmacological treatment and psychoeducation) and 16–20 sessions with a psychologist (manual-based cognitive behavioural therapy) for a period of 8 to 12 months. The add-on intervention strengthens coordination between mental health treatment and employment interventions with three cross-sectoral collaborative meetings during the mental health treatment. The integrated care intervention draws attention to the bidirectional impact of mental health problems and post-migration stressors and focuses on cross-sectoral shared plans. The primary outcome is functioning, measured by WHODAS 2.0, the interviewer-administered 12-item version, with secondary outcomes measuring quality of life, mental health symptoms, and post-migration stressors.DiscussionThe RCT is novel in intervention design for trauma-affected refugees and will bring forward new perspectives and knowledge of integrated care interventions for trauma-affected refugees. The integrated care intervention is expected to reduce post-migration stressors that negatively affect the treatment of trauma-related mental health problems, thereby improving preconditions for enhanced treatment outcomes. The intervention builds on existing practices in the Danish healthcare and employment sectors, which ensures high scalability and sustainability for future practices.Trial registrationClinicalTrials.gov Identifier: NCT04244864, registered 28 January 2020. Protocol version: 17 September 2022, version 2.

Technology assisted language intervention (TALI) for children who are deaf/hard of hearing: promising impact on pragmatic skills

ABSTRACT Children who are deaf and hard of hearing (DHH) often demonstrate pragmatic language difficulties which can impact academic and social outcomes. This randomized control trial for DHH children, ages 3–12 years, explored the Technology-Assisted Language Intervention (TALI), incorporating augmentative and alternative communication technology (AAC) into traditional speech/language therapy, compared to treatment-as-usual (TAU) to determine impact on pragmatics. Pragmatic outcome measures included parent reported Pragmatics Profile of the CELF-5 (for children age ≥5 years) and CELF-P Descriptive Pragmatics Profile (for children <5 years) in addition to parent reported Social and Communication domains of the Vineland Adaptive Behavior Scales,Third Edition (VABS). Over 24 weeks, children ≥5 years in the TALI made significantly more progress (increase in raw scores) on the Pragmatics Profile compared to children in TAU (12.7 points vs. −6.0 points; p = 0.04) and also showed significant gains on two of the three subscales. For children ≥5 years, no significant VABS changes were seen in either intervention group. For children <5 years, there were no statistically significant differences in growth on the CELF-P total pragmatics raw score or on any subdomain. However, children in TALI had significant increases in the mean VABS Communication (86.7–99.1) and Social domain standard scores (91.8–97.4;p = 0.01), while gains for children in TAU on the Communication and Social domain standard scores were not statistically significant. These promising results support the need for additional research exploring the effectiveness of AAC supported speech/language therapy to enhance DHH children’s pragmatic language skills. Trial registration: ClinicalTrials.gov identifier: NCT02998164.

Socio-Cognitive Behavioral Therapy for Latinx Adolescent with Suicidal Behaviors: A Pilot Randomized Trial.

Evidence-based treatment for Latinx/Hispanic (L/H) with suicidal behaviors (SB) is scarce. This study evaluated the acceptability and preliminary efficacy of a socio-cognitive-behavioral therapy protocol for SB (SCBT-SB) with L/H adolescents and the feasibility of conducting a randomized controlled trial (RCT) of SCBT-SB compared to treatment-as-usual (TAU). A pilot RCT was conducted with 46 L/H teens. The target outcomes included suicidal ideation (SI), suicide attempts (SAs), and depressive/internalizing symptoms. Results indicated that the SCBT-SB was acceptable and an RCT with diverse L/H families is feasible to implement. Within group analyses showed reductions over time for each group in SI and depressive/internalizing symptoms. Intent-to-treat between-group analyses showed a medium effect for the SCBT-SB at the twelve-month follow-up for depressive/internalizing symptoms and a large effect for SA. Although results must be interpreted cautiously given the small sample size, outcomes suggest that SCBT-SB may be a promising psychosocial treatment for depressive/internalizing symptoms, and SAs in L/H youth.

Reducing short term suicide risk after hospitalization: A randomized controlled trial of the Collaborative Assessment and Management of Suicidality

BackgroundThis study compared the “next day appointment” (NDA) use of the Collaborative Assessment and Management of Suicidality (CAMS) to treatment as usual (TAU) for individuals discharged from the hospital following a suicide-related crisis. We hypothesized that CAMS would significantly reduce suicidal thoughts and behaviors as well as improve psychological distress, quality of life/overall functioning, treatment retention and patient satisfaction. MethodsParticipants were 150 individuals who had at least one lifetime actual, aborted, or interrupted attempt and were admitted following a suicide-related crisis. There were 75 participants in the experimental condition who received adherent CAMS and 75 participants who received TAU. Suicidal thoughts and behaviors, psychological distress, and quality of life/overall functioning were assessed at baseline and at 1, 3, 6, and 12 months post-baseline. Treatment retention and patient satisfaction were assessed at post-treatment. ResultsParticipants in both conditions improved from baseline to 12 months but CAMS was not superior to TAU for the primary outcomes. A small but significant improvement was found in probability of suicidal ideation at 3 months favoring TAU and amount of suicidal ideation at 12 months favoring CAMS. CAMS participants experienced less psychological distress at 12 months compared to baseline. LimitationsThe study was limited by only one research clinic, lower than expected recruitment, and imbalance of suicidal ideation at baseline. Conclusions: All participants improved but CAMS was not more effective than TAU. The NDA clinic was feasible and acceptable to clients and staff in both conditions and future research should investigate its potential benefit.

A feasibility randomised controlled trial with an embedded qualitative evaluation of perinatal emotional skills groups for women with borderline personality disorder: protocol for the EASE study

BackgroundBorderline personality disorder (BPD) is a severe mental disorder characterised by emotional instability, impaired interpersonal functioning and an increased risk of suicide. There is no clear evidence about how best to help women with BPD during the perinatal period. Perinatal Emotional Skills Groups (ESGs) consist of 12 group sessions, focussing on core skills in emotion regulation, interpersonal effectiveness, distress tolerance and mindfulness and how these skills can best be utilised during the perinatal period. Prior observational research has shown that perinatal ESGs may help women with BPD. We set out to test the feasibility of conducting a randomised controlled trial to investigate the clinical effectiveness of perinatal ESGs.MethodsA two-arm, parallel-group, feasibility randomised controlled trial of Perinatal ESGs in addition to Treatment as Usual (TAU) versus TAU for women aged over 18 years, who are likely to have a diagnosis of BPD and are either pregnant or are within 12 months of having a live birth. We will exclude women who have a co-existing organic, psychotic mental disorder or substance use dependence syndrome; those with cognitive or language difficulties that would preclude them from consenting or participating in study procedures; those judged to pose an acute risk to their baby and those requiring admission to a mother and baby unit. After consenting to participation and completing screening assessments, eligible individuals will be randomly allocated, on a 1:1 ratio, to either ESGs + TAU or to TAU. Randomisation will be stratified according to recruitment centre.Feasibility outcomes will be the proportion of participants: (1) consenting; (2) completing baseline measures and randomised; (3) completing the intervention and (4) completing follow-up assessments. All study participants will complete a battery of self-report measures at 2 and 4 months post-randomisation. A nested qualitative study will examine participants’ and therapists’ experiences of the trial and the intervention.DiscussionEvidence is lacking about how to help women with BPD during the perinatal period. Perinatal ESGs are a promising intervention and if they prove to be an effective adjunct to usual care, a large population of vulnerable women and their children could experience substantial health gains.Trial registrationISRCTN80470632.

Examining the Effectiveness of the FaCES Adolescent SBIRT Intervention

PurposeThe Facilitating Change for Excellence in SBIRT (FaCES) is a service package for adolescent primary care that was developed based on best practices and evidence, but was empirically untested. The aim of this study is to compare the FaCES intervention to treatment as usual (TAU) for rural adolescent primary care patients. MethodsIn this modified cluster-randomized stepped wedge design, providers who completed at least 20 adolescent TAU visits received training in the FaCES package in random order. Adolescent patients (N = 1,226) waiting for appointments were continuously recruited into the study and completed a baseline assessment before their scheduled appointment and an on-line 3-month follow-up. Participants received either FaCES or TAU, depending on whether their provider had been trained in FaCES. Due to COVID-19 disruptions, only 14 of the 29 providers were trained before study recruitment activities ceased. ResultsMore than 80% of the sample indicated no prior use of tobacco, alcohol, or marijuana at study entry. The Arm × Time interaction failed to reach significance for the substance use outcomes considered. In the FaCES condition, the group with no prior use had an increased probability of substance use at 3-month follow-up, while the group reporting prior use had a decreased probability of use at follow-up. Participants who reported no use at baseline had an increased probability of use at follow-up, whether they received the FaCES intervention or TAU. DiscussionThis study was unable to demonstrate the effectiveness of FaCES. Findings suggest some natural movement in substance use risk over time.

Effectiveness of two video-based multicomponent treatments for fibromyalgia: The added value of cognitive restructuring and mindfulness in a three-arm randomised controlled trial

Background/objectivesThe aim of this study was to examine the effectiveness of two video-based multicomponent programs (FIBROWALK) and the Multicomponent Physiotherapy Program (MPP) for patients with fibromyalgia (FM) compared to treatment-as-usual (TAU) only. We posit that FIBROWALK, due to inclusion of specific psychological ingredients (cognitive restructuring and mindfulness), can produce additional clinical benefits when compared to TAU or MPP alone. MethodsA total of 330 patients with FM were recruited and randomly allocated (1:1:1) to TAU only, TAU + FIBROWALK, or TAU + MPP. FIBROWALK and MPP consisted of weekly videos on pain neuroscience education, therapeutic exercise and self-management patient education, but only the FIBROWALK intervention provided cognitive restructuring and mindfulness. Both programs were structurally equivalent. Between-group differences in functional impairment, pain, kinesiophobia, anxious-depressive symptoms and physical functioning were evaluated at post-treatment following Intention-To-Treat and complete-case approaches. ResultsCompared to TAU only, individuals in the FIBROWALK arm showed larger improvements in all clinical outcomes; similarly, participants in the MPP program also showed greater improvements in functional impairment, perceived pain, kinesiophobia, depressive symptoms compared to TAU only. The FIBROWALK intervention showed superior effects in improving pain, anxiety and depressive symptoms and physical functioning compared to MPP. ConclusionsThis RCT supports the short-term effectiveness of the video-based multicomponent programs FIBROWALK and MPP for FM and provides evidence that cognitive-behavioural and mindfulness-based techniques can be clinically useful in the context of physiotherapeutic multicomponent treatment programs. Trial registration numberNCT04571528.

Transdiagnostic Internet-Delivered Cognitive Behavioral Therapy for Symptoms of Postpartum Anxiety and Depression: Feasibility Randomized Controlled Trial.

BackgroundPostpartum depression (PPD) and postpartum anxiety (PPA) are often comorbid and are associated with significant personal and economic costs. Fewer than half of the mothers experiencing PPD or PPA symptoms receive face-to-face treatment, suggesting a need for alternative delivery formats such as internet-delivered cognitive behavioral therapy (ICBT).ObjectiveThis pilot study aimed to examine the impact of a therapist-assisted, transdiagnostic ICBT program on symptoms of PPD and PPA, as there is only one previous study on transdiagnostic ICBT with this population, which did not include therapist assistance.MethodsClients endorsing the symptoms of PPD or PPA (N=63) were randomized to an 8-week transdiagnostic ICBT course (Wellbeing Course for New Moms) or to treatment as usual (TAU). Clients completed measures of depression, anxiety, stress, postnatal bonding, and relationship satisfaction, as well as measures of treatment satisfaction and therapeutic alliance, before treatment, after treatment, and at the 1-month follow-up. Outcome measures were also completed at the 6-month follow-up for clients who completed the ICBT course.ResultsBoth the ICBT and TAU groups experienced statistically significant improvements over time. The ICBT group experienced larger improvements after treatment and at the 1-month follow-up on more measures than the TAU group, with medium between-group Cohen d effects on primary outcome measures for anxiety (Cohen d=0.65, 95% CI 0.13-1.17), PPD (Cohen d=0.52, 95% CI 0.01-1.04), and depression (Cohen d=0.56, 95% CI 0.05-1.08), and on secondary outcome measures of overall distress (Cohen d=0.69, 95% CI 0.17-1.21), anxiety (Cohen d=0.59, 95% CI 0.07-1.11), and stress (Cohen d=0.76, 95% CI 0.23-1.28). Time-by-group interactions for proportional reductions between groups over time were only significant after treatment and at the 1-month follow-up for the primary anxiety measure (P=.006). This study was underpowered for detecting small or medium effects. Overall, clients perceived the treatment as credible, and 95% (21/22) of the clients were satisfied with the treatment content and therapist support.ConclusionsFindings from this pilot study provide preliminary support for transdiagnostic ICBT in treating PPD and PPA symptoms to improve access to psychological treatments.Trial RegistrationClinicalTrials.gov NCT04012580; https://clinicaltrials.gov/ct2/show/NCT04012580

Guided imagery for treatment (GIFT): protocol of a pilot trial of guided imagery versus treatment as usual to address radiotherapy-related distress in head and neck cancer

BackgroundCancers of the head and neck region are associated with high symptom burden and elevated levels of psychological distress. Radiotherapy (RT) is a common treatment for patients with head and neck cancer (HNC) that is associated with psychological distress related to the immobilizing nature of the treatment, frequency of treatment delivery, and side effects. Guided imagery is a relaxation technique that is beneficial in reducing psychological distress in patients with other cancer diagnoses but has not been studied in this patient population. The purpose of this study is to evaluate the feasibility and acceptability of a brief guided imagery intervention (guided imagery for treatment, GIFT) to reduce RT-related anxiety and depression in patients with HNC relative to treatment as usual (TAU).MethodsPatients with HNC planning to receive RT will be recruited to participate in a randomized controlled trial evaluating a brief, two-session guided imagery intervention (GIFT) relative to TAU alone. Primary aims include acceptability and feasibility evaluated through quantitative and qualitative methods. Measures of anxiety and depression, symptom burden, health-related quality of life, and anxiolytic medication use will be collected at baseline, during treatment, and at 1-month follow-up.DiscussionThere are no published interventions of guided imagery for anxiety and depression in patients with HNC despite its efficacy in other populations of patients with cancer. This proposed project evaluates the feasibility and acceptability of an intervention that has the potential to reduce psychological distress in a vulnerable population. Additionally, we will preliminarily examine the impact of behavioral intervention on psychological distress and the use of anxiolytic medication, a novel area of study.Trial registrationClinicaltrials.gov NCT03662698; registered on 9/6/2018.

Building Emotional Awareness and Mental Health (BEAM): study protocol for a phase III randomized controlled trial of the BEAM app-based program for mothers of children 18–36 months

BackgroundThe prevalence of maternal depression and anxiety has increased during the COVID-19 pandemic, and pregnant individuals are experiencing concerningly elevated levels of mental health symptoms worldwide. Many individuals may now be at heightened risk of postpartum mental health disorders. There are significant concerns that a cohort of children may be at-risk for impaired self-regulation and mental illness due to elevated exposure to perinatal mental illness. With both an increased prevalence of depression and limited availability of services due to the pandemic, there is an urgent need for accessible eHealth interventions for mothers of young children. The aims of this trial are to evaluate the efficacy of the Building Emotion Awareness and Mental Health (BEAM) app-based program for reducing maternal depression symptoms (primary outcome) and improve anxiety symptoms, parenting stress, family relationships, and mother and child functioning (secondary outcomes) compared to treatment as usual (TAU).MethodsA two-arm randomized controlled trial (RCT) with repeated measures will be used to evaluate the efficacy of the BEAM intervention compared to TAU among a sample of 140 mothers with children aged 18 to 36 months, who self-report moderate-to-severe symptoms of depression and/or anxiety. Individuals will be recruited online, and those randomized to the treatment group will participate in 10 weeks of psychoeducation modules, an online social support forum, and weekly group teletherapy sessions. Assessments will occur at 18–36 months postpartum (pre-test, T1), immediately after the last week of the BEAM intervention (post-test, T2), and at 3 months after the intervention (follow-up, T3).DiscussioneHealth interventions have the potential to address elevated maternal mental health symptoms, parenting stress, and child functioning concerns during and after the COVID-19 pandemic and to provide accessible programming to mothers who are in need of support. This RCT will build on an open pilot trial of the BEAM program and provide further evaluation of this evidence-based intervention. Findings will increase our understanding of depression in mothers with young children and reveal the potential for long-term improvements in maternal and child health and family well-being.Trial registrationClinicalTrials.govNCT05306626. Registered on April 1, 2022

Proactive Electronic Visits for Smoking Cessation and Chronic Obstructive Pulmonary Disease Screening in Primary Care: Randomized Controlled Trial of Feasibility, Acceptability, and Efficacy.

BackgroundMost smokers with chronic obstructive pulmonary disease (COPD) have not yet been diagnosed, a statistic that has remained unchanged for over two decades. A dual-focused telehealth intervention that promotes smoking cessation, while also facilitating COPD screening, could help address national priorities to improve the diagnosis, prevention, treatment, and management of COPD. The purpose of this study was to preliminarily evaluate an integrated asynchronous smoking cessation and COPD screening e-visit (electronic visit) that could be delivered proactively to adult smokers at risk for COPD, who are treated within primary care.ObjectiveThe aims of this study were (1) to examine e-visit feasibility and acceptability, particularly as compared to in-lab diagnostic pulmonary function testing (PFT), and (2) to examine the efficacy of smoking cessation e-visits relative to treatment as usual (TAU), all within primary care.MethodsIn a randomized clinical trial, 125 primary care patients who smoke were randomized 2:1 to receive either proactive e-visits or TAU. Participants randomized to the e-visit condition were screened for COPD symptoms via the COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE). Those with scores ≥2 were invited to complete both home spirometry and in-lab PFTs, in addition to two smoking cessation e-visits. Smoking cessation e-visits assessed smoking history and motivation to quit and included completion of an algorithm to determine the best Food and Drug Administration–approved cessation medication to prescribe. Primary outcomes included measures related to (1) e-visit acceptability, feasibility, and treatment metrics; (2) smoking cessation outcomes (cessation medication use, 24-hour quit attempts, smoking reduction ≥50%, self-reported abstinence, and biochemically confirmed abstinence); and (3) COPD screening outcomes.ResultsOf 85 participants assigned to the e-visits, 64 (75.3%) were invited to complete home spirometry and in-lab PFTs based on CAPTURE. Among those eligible for spirometry, 76.6% (49/64) completed home spirometry, and 35.9% (23/64) completed in-lab PFTs. At 1 month, all cessation outcomes favored the e-visit, with a significant effect for cessation medication use (odds ratio [OR]=3.22). At 3 months, all cessation outcomes except for 24-hour quit attempts favored the e-visit, with significant effects for cessation medication use (OR=3.96) and smoking reduction (OR=3.09).ConclusionsA proactive, asynchronous e-visit for smoking cessation and COPD screening may offer a feasible, efficacious approach for broad interventions within primary care.Trial RegistrationClinicalTrials.gov NCT04155073; https://clinicaltrials.gov/ct2/show/NCT04155073

The Efficacy of Early Interventions for Children with Autism Spectrum Disorders: A Systematic Review and Meta-Analysis.

The superiority of early interventions for children with autism spectrum disorders (ASDs) compared to treatment as usual (TAU) has recently been questioned. This study was aimed to investigate the efficacy of early interventions in improving the cognitive ability, language, and adaptive behavior of pre-school children with ASDs through a systematic review of randomized controlled trials (RCTs). In total, 33 RCTs were included in the meta-analysis using the random effects model. The total sample consisted of 2581 children (age range: 12–132 months). Early interventions led to positive outcomes for cognitive ability (g = 0.32; 95% CI: 0.05, 0.58; p = 0.02), daily living skills (g = 0.35; 95% CI: 0.08, 0.63; p = 0.01), and motor skills (g = 0.39; 95% CI: 0.16, 0.62; p = 0.001), while no positive outcomes were found for the remaining variables. However, when studies without the blinding of outcome assessment were excluded, positive outcomes of early interventions only remained for daily living skills (g = 0.28; 95% CI: 0.04, 0.52; p = 0.02) and motor skills (g = 0.40; 95% CI: 0.11, 0.69; p = 0.007). Although early intervention might not have positive impacts on children with ASDs for several outcomes compared to controls, these results should be interpreted with caution considering the great variability in participant and intervention characteristics.

Psychological interventions to prevent relapse in anxiety and depression: A systematic review and meta-analysis.

ObjectivesThe aim of this review is to establish the effectiveness of psychological relapse prevention interventions, as stand-alone interventions and in combination with maintenance antidepressant treatment (M-ADM) or antidepressant medication (ADM) discontinuation for patients with remitted anxiety disorders or major depressive disorders (MDD).MethodsA systematic review and a meta-analysis were conducted. A literature search was conducted in PubMed, PsycINFO and Embase for randomised controlled trials (RCTs) comparing psychological relapse prevention interventions to treatment as usual (TAU), with the proportion of relapse/recurrence and/or time to relapse/recurrence as outcome measure.ResultsThirty-six RCTs were included. During a 24-month period, psychological interventions significantly reduced risk of relapse/recurrence for patients with remitted MDD (RR 0.76, 95% CI: 0.68–0.86, p<0.001). This effect persisted with longer follow-up periods, although these results were less robust. Also, psychological interventions combined with M-ADM significantly reduced relapse during a 24-month period (RR 0.76, 95% CI: 0.62–0.94, p = 0.010), but this effect was not significant for longer follow-up periods. No meta-analysis could be performed on relapse prevention in anxiety disorders, as only two studies focused on relapse prevention in anxiety disorders.ConclusionsIn patients with remitted MDD, psychological relapse prevention interventions substantially reduce risk of relapse/recurrence. It is recommended to offer these interventions to remitted MDD patients. Studies on anxiety disorders are needed.Systematic review registration numberPROSPERO 2018: CRD42018103142.

Mindfulness-Based Interdisciplinary Pain Management Program for Complex Polymorbid Pain in Veterans: A Randomized Controlled Trial

ObjectiveTo evaluate the effects of interdisciplinary pain management on pain-related disability and opioid reduction in polymorbid pain patients with 2 or more comorbid psychiatric conditions. DesignTwo-arm randomized controlled trial testing a 3-week intervention with assessments at pre-treatment, post-treatment, 6-month, and 12-month follow-up. SettingDepartment of Veterans Affairs medical facility. Participants103 military veterans (N=103) with moderate (or worse) levels of pain-related disability, depression, anxiety, and/or posttraumatic stress disorder randomly assigned to usual care (n=53) and interdisciplinary pain management (n=50). All participants reported recent persistent opioid use. Trial participants had high levels of comorbid medical and mental health conditions. InterventionsExperimental arm—a 3-week, interdisciplinary pain management program guided by a structured manual; comparison arm—usual care in a large Department of Veterans Affairs medical facility. Main Outcome MeasuresOswestry Disability Index (pain disability); Timeline Followback Interview and Medication Event Monitoring System (opioid use). Analysis used generalized linear mixed model with all posttreatment observations (posttreatment, 6-month follow-up, 12-month follow-up) entered simultaneously to create a single posttreatment effect. ResultsVeterans with polymorbid pain randomized to the interdisciplinary pain program reported significantly greater decreases in pain-related disability compared to veterans randomized to treatment as usual (TAU) at posttreatment, 6-month, and 12-month follow-up. Aggregated mean pain disability scores (ie, a summary effect of all posttreatment observations) for the interdisciplinary pain program were -9.1 (95% CI: -14.4, -3.7, P=.001) points lower than TAU. There was no difference between groups in the proportion of participants who resumed opioid use during trial participation (32% in both arms). ConclusionThese findings offer the first evidence of short- and long-term interdisciplinary pain management efficacy in polymorbid pain patients, but more work is needed to examine how to effectively decrease opioid use in this population.