Cost-effectiveness of telephone cognitive behavioral therapy for osteoarthritis-related insomnia.

BACKGROUND: Osteoarthritis-related insomnia is the most common form of comorbid insomnia among older Americans. A randomized clinical trial found that six sessions of telephone-delivered cognitive behavioral therapy for insomnia (CBT-I) improved sleep outcomes in this population. Using these data, we evaluated the incremental cost-effectiveness of CBT-I from a healthcare sector perspective. METHODS: The study was based on 325 community-dwelling older adults with insomnia and osteoarthritis pain enrolled with Kaiser Permanente of Washington State. We measured quality-adjusted life years (QALYs) using the EuroQol 5-dimension scale. Arthritis-specific quality of life was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Insomnia-specific quality of life was measured using the Insomnia Severity Index (ISI) and nights without clinical insomnia (i.e., "insomnia-free nights"). Total healthcare costs included intervention and healthcare utilization costs. RESULTS: Over the 12 months after randomization, CBT-I improved ISI and WOMAC by -2.6 points (95% CI: -2.9 to -2.4) and -2.6 points (95% CI: -3.4 to -1.8), respectively. The ISI improvement translated into 89 additional insomnia-free nights (95% CI: 79 to 98) over the 12 months. CBT-I did not significantly reduce total healthcare costs (-$1072 [95% CI: -$1968 to $92]). Improvements in condition-specific measures were not reflected in QALYs gained (-0.01 [95% CI: -0.01 to 0.01]); at a willingness-to-pay of $150,000 per QALY, CBT-I resulted in a positive net monetary benefit of $369 with substantial uncertainty (95% CI: -$1737 to $2270). CONCLUSION: CBT-I improved sleep and arthritis function without increasing costs. These findings support the consideration of telephone CBT-I for treating insomnia among older adults with comorbid OA. Our findings also suggest potential limitations of the general quality of life measures in assessing interventions designed to improve sleep and arthritis outcomes.

Ateneo General de la Residencia de Psicopedagogía: Abordaje psicopedagógico en pacientes con perfil externalizante / General Athenaeum of the Psychopedagogical Residence: Psychopedagogical approach in patients with externalizing profile

Ateneo centrado en la intervención psicopedagógica en niños y niñas con conductas externalizantes, En una pirmera parte, se desarrollan algunos conceptos que forman parte del marco teórico del equipo, y más adelante, los referidos a la Terapia Cognitivo Conductual. Se define la conducta y sus funciones, diferenciando conductas internalizantes y externalizantes. Luego se ejemplifican las estrategias de la Terapia Cognitivo Conductual utilizadas en cada uno de los tres subsistemas (familia, escuela y niño/a) a partir de diferentes casos clínicos. Por último, se reflexiona invitando a seguir repensando las intervenciones y prácticas clínicas con pacientes con estas características.

PTSD Coach Online-Arabic: A Randomized Controlled Pilot Trial to Examine Feasibility, Acceptability, and Preliminary Effectiveness.

The Egyptian Revolution of 2011 resulted in high-level exposure to sociopolitical violence, placing a large burden on the mental health care system that cannot be effectively met given the small number of available providers in Egypt. We conducted a nonblinded, randomized controlled pilot trial of an online, self-directed tool for managing posttraumatic stress symptoms (PTSS). The study aimed to evaluate the feasibility, acceptability, and preliminary effectiveness of the PTSD Coach Online-Arabic. Trauma-exposed Egyptian adults with clinically significant PTSS (N = 87; intervention group: n = 41) completed assessments at baseline, weekly over the treatment period, posttest, and 3-month follow-up. Of participants who completed weekly surveys, 88.9% used the program; 22.0% of participants reported regular, weekly use. Most tools received good likeability and perceived benefit scores, but lower perceived benefit scores on three tools suggest that some content may require additional adaptation. Intent-to-treat analyses using multilevel modeling with multiple imputation to account for missing data were conducted. Effect sizes for PTSS were below the cutoff for small effects at posttest, d = -0.14, but demonstrated a small positive effect at 3-months, d = -0.25. There was a small positive effect of treatment on anxiety at posttest, d = -0.37, and a medium effect at 3-month follow-up, d = -0.49. Treatment effects for depressed mood were below the cutoff for small effects at posttest and 3-months, ds = -0.14 and -0.18. These findings suggest that the PTSD Coach Online-Arabic may be a promising supplemental resource for support in this setting.

Profile of Somryst Prescription Digital Therapeutic for Chronic Insomnia: Overview of Safety and Efficacy.

Introduction: Prescription digital therapeutics (PDTs) represent a new class of software-based medical devices authorized by the Food and Drug Administration (FDA) to treat disease. Somryst™, the first PDT for treating chronic insomnia, delivers cognitive behavioral therapy for insomnia (CBT-I) via a mobile application. CBT-I is the guideline-recommended, first-line treatment for chronic insomnia, but availability of CBT-I therapists is limited. Somryst addresses this need by providing asynchronous access to CBT-I treatment. As a contactless therapeutic medium, Somryst is also an ideal option when face-to-face therapy is not available or recommended for safety reasons (e.g. because of possible exposure to the SARS-CoV-2 virus). Areas covered: This review summarizes the mechanisms of action and technical features of Somryst, and describes safety and effectiveness data from the randomized trials on which FDA clearance was based. Expert opinion: Somryst demonstrates robust clinical efficacy with a favorable benefit-to-risk profile for treating adults with chronic insomnia. FDA clearance was based on data from 2 clinical trials of the first-generation web-based CBT-I platform Sleep Healthy Using the Internet (SHUTi). Somryst, and PDTs in general, are promising devices to address the need for greater accessibility to effective therapies.

Effectiveness of the “Trisquel” board game intervention program for patients with schizophrenia spectrum disorders.

Schizophrenia spectrum disorders present emotional, cognitive and/or behavioural alterations relat- ed to daily functioning. Therefore, it is necessary to develop intervention programs focused on the improvement of these constructs. The aim of this work is to analyse the effect of the intervention program “Trisquel” on cognitive functioning, symptomatologic perception and psychosocial functioning.

Updates in technology-based interventions for attention deficit hyperactivity disorder.

PURPOSE OF REVIEW: Technological advancement has led to the development of novel treatment approaches for attention deficit hyperactivity disorder (ADHD). This review aims to review recent studies which employ the use of technology to treat ADHD, with particular focus on studies published during a 1-year period from February 2019 to February 2020. RECENT FINDINGS: Most recent studies involved children aged 12 years and below. Interventions included cognitive training through games, neurofeedback and a combination of several approaches. More novel approaches included trigeminal nerve stimulation and brain-computer interface, and studies had utilized technology such as X-box Kinect and eye tracker. There was a shift towards delivering intervention at home and in school, enabled by technology. The study outcomes were variable and mainly included executive functioning measures and clinical ratings. These interventions were generally safe with few reported adverse events. SUMMARY: Technology has enabled interventions to be delivered outside of the clinic setting and presented an opportunity for increased access to care and early intervention. Better quality studies are needed to inform on the efficacy of these interventions.

Using Interpretation Bias Modification to Reduce Anger in Veterans with Posttraumatic Stress Disorder: A Pilot Study.

Difficulty controlling anger is the most commonly reported reintegration concern among veterans with posttraumatic stress disorder (PTSD). One of the mechanisms associated with problematic anger is a tendency to interpret ambiguous interpersonal situations as hostile, known as the hostile interpretation bias (HIB). A computer-based interpretation bias modification (IBM) intervention has been shown to successfully reduce HIB and anger but has not been tested in veterans with PTSD. The current study was a pilot trial of this IBM intervention modified to address problematic anger among veterans with PTSD. Veterans with PTSD and a high level of anger (N = 7) completed eight sessions of IBM treatment over the course of 4 weeks. Participants completed self-report questionnaires at pre- and posttreatment assessment visits, as well as a treatment acceptability interview at posttreatment. Veterans experienced large reductions in hostile interpretation bias and anger from pre- to posttreatment, ds = 1.03-1.96, although these estimates may be unstable due to the small sample size. The feasibility for recruitment, retention, and treatment completion were high. Questionnaire and interview data demonstrated that most participants were satisfied with the treatment and found it helpful and easy to use. Overall, IBM for anger was feasible and acceptable to veterans with PTSD and was associated with reductions in hostile interpretations and self-reported anger outcomes. Further research examining this approach is warranted.

Efficacy of mobile app-based interactive cognitive behavioral therapy using a chatbot for panic disorder.

BACKGROUND: Cognitive behavioral therapy (CBT) is a well-established treatment for panic disorder, but many fewer patients receive this treatment compared to medication-based therapy. Mobile app-based interactive CBT using a chatbot can increase patient access to CBT. We performed a preliminary study to determine whether short-term use of a newly developed chatbot is feasible and effective for relieving panic symptoms. METHOD: Forty-one patients were randomly assigned to either a chatbot group (n = 21) or control group (n = 20) for a period of 4 weeks. The chatbot group was guided in the use of the chatbot application, while the control group was provided with a book on panic disorder. MAIN RESULTS: The severity of panic disorder was significantly decreased in the chatbot group, but not in the control group. The social phobia score was significantly decreased and the control helplessness score was significantly increased in the chatbot group compared to the control group. DISCUSSION AND CONCLUSION: We found that mobile app-based interactive CBT using the chatbot was feasible and effective for reducing the severity of panic symptoms. Using this novel approach to provide CBT would allow clinicians to effect positive therapeutic outcomes with easy accessibility, interactivity, and self-management for patients with panic symptoms.

A tablet computer-based cognitive training program for young children with cognitive impairment: A randomized controlled trial.

BACKGROUND: Evidences suggest that cognitive training facilitates cognitive function, and most studies have targeted adults and children older than 4 years of age. This study investigated the applicability and efficacy of a tablet computer-based cognitive training program for young children with cognitive impairment of cognitive age between 18 and 36 months. METHODS: Thirty-eight children were randomly assigned to the intervention (n = 20, administered a tablet computer-based cognitive training program, for 30 minutes per session and twice a week over a period of 12 weeks) and control (n = 18, received the traditional rehabilitation program) groups. Mental scale of Bayley Scales of Infant Development II (BSID II), Pediatric Evaluation of Disability Inventory (PEDI), interest/persistence domain of the Laboratory Temperament Assessment Battery (LAP-TAB), Early Childhood Behavior Questionnaire (ECBQ), and Goal Attainment Scale (GAS) were evaluated before and after 12 weeks of therapeutic intervention. RESULTS: The tablet computer-based cognitive training program was applicable to all children in the intervention group without any problems including irritable behavior or obsession about a tablet computer. After 12 weeks, Mental scale of BSID II, PEDI (social function), LAB-TAB (observation), LAB-TAB (manipulation), and GAS showed statistically significant improvements in the intervention group, compared with the values in the control group (P < .05). After adjusting for the pre-treatment measurements and cognitive age, the tablet computer-based cognitive training program had significant effect on the post-treatment measurements of Mental scale of BSID II, PEDI (social function), LAB-TAB (observation), LAB-TAB (manipulation), and GAS (P < .05). There was no association between the change in the scores and the severity of cognitive delay in the most of the measurements, however, the self-care domain of PEDI showed a negative association with the severity of the cognitive delay (r = -0.462, P = .04). CONCLUSIONS: Application of a tablet computer-based cognitive training program was feasible and showed improvements in cognitive function in young children with cognitive impairment of cognitive age between 18 and 36 months, regardless of the severity of the cognitive delay. But severe cognitive delay can be related with less improvement in the self-care domain of PEDI. TRIAL REGISTRATION NUMBER: https://cris.nih.go.kr (KCT0002889).

Results of the Nursing Outcomes Classification/NOC for patients with obsessive-compulsive disorder.

OBJECTIVE: To analyze the application of nursing outcomes and indicators selected from the Nursing Outcomes Classification (NOC) to evaluate patients with obsessive-compulsive disorder (OCD) in outpatient follow-up. METHOD: Outcome-based research. First, a consensus was achieved between nurses specialized in mental health (MH) and in the nursing process to select NOC-related outcomes and indicators, followed by the elaboration of their conceptual and operational definitions. Then, an instrument was created with these, which was tested in a pilot group of six patients treated at a MH outpatient clinic. The instrument was applied to patients with OCD undergoing Group Cognitive Behavioral Therapy (GCBT). The study was approved by the Research Ethics Committee of the institution. RESULTS: Four NOC outcomes and 17 indicators were selected. There was a significant change in the scores of nine indicators after CBGT. CONCLUSION: The study showed feasibility for evaluating symptoms of patients with OCD through NOC outcomes and indicators in an outpatient situation.

Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT) for paediatric patients with congenital cerebellar diseases: study protocol of a randomised controlled trial.

BACKGROUND: Patients with cerebellar malformations exhibit not only movement problems, but also important deficits in social cognition. Thus, rehabilitation approaches should not only involve the recovery of motor function but also of higher-order abilities such as processing of social stimuli. In keeping with the general role of the cerebellum in anticipating and predicting events, we used a VR-based rehabilitation system to implement a social cognition intensive training specifically tailored to improve predictive abilities in social scenarios (VR-Spirit). METHODS/DESIGN: The study is an interventional randomised controlled trial that aims to recruit 42 children, adolescents and young adults with congenital cerebellar malformations, randomly allocated to the experimental group or the active control group. The experimental group is administered the VR-Spirit, requiring the participants to compete with different avatars in the reaching of recreational equipment and implicitly prompting them to form expectations about their playing preference. The active control group participates in a VR-training with standard games currently adopted for motor rehabilitation. Both trainings are composed by eight 45-min sessions and are administered in the GRAIL VR laboratory (Motekforce Link, Netherlands), an integrated platform that allows patients to move in natural and attractive VR environments. An evaluation session in VR with the same paradigm used in the VR-Spirit but implemented in a different scenario is administered at the beginning (T0) of the two trainings (T1) and at the end (T2). Moreover, a battery of neurocognitive tests spanning different domains is administered to all participants at T0, T2 and in a follow-up session after 2 months from the end of the two trainings (T3). DISCUSSION: This study offers a novel approach for rehabilitation based on specific neural mechanisms of the cerebellum. We aim to investigate the feasibility and efficacy of a new, intensive, social cognition training in a sample of Italian patients aged 7-25 years with congenital cerebellar malformations. We expect that VR-Spirit could enhance social prediction ability and indirectly improve cognitive performance in diverse domains. Moreover, through the comparison with a VR-active control training we aim to verify the specificity of VR-Spirit in improving social perception skills. TRIAL REGISTRATION: ISRCTN, ID: ISRCTN 22332873. Retrospectively registered on 12 March 2018.

Outcomes of a Robot-Assisted Social-Emotional Understanding Intervention for Young Children with Autism Spectrum Disorders.

This study is a randomized control trial aimed at testing the role of a human-assisted social robot as an intervention mediator in a socio-emotional understanding protocol for children with autism spectrum disorders (ASD). Fourteen children (4-8 years old) were randomly assigned to 10 sessions of a cognitive behavioural therapy (CBT) intervention implemented in a group setting either with or without the assistance of a social robot. The CBT protocol was based on Rational Emotive Behaviour Therapy (REBT) principles. Pre- and post-intervention assessments were conducted using the Test of Emotional Comprehension (TEC) and the Emotional Lexicon Test (ELT). Substantial improvements in contextualized emotion recognition, comprehension and emotional perspective-taking through the use of human-assisted social robots were attained.

Kids and Teens in Court (KTIC): A Model for Preparing Child Witnesses for Court.

Each year, numerous children testify in the United States in either criminal, civil, or juvenile court cases. Typically, children who testify are alleged victims of sexual or physical abuse or neglect, witnesses to violent crime, or subjects in custodial hearings in civil court. As more maltreatment cases are prosecuted and child custody is contested, an increasing number of children are being called as witnesses in court. Many of these children have already been traumatized by the experiences that led to their need to testify, and participation in the court process can have additional negative effects. This article describes the development and recent formative evaluation of a court preparation program that provides psychoeducation and utilizes components of evidence-based trauma treatment approaches, such as relaxation and in vivo exposure, to support child witnesses and reduce the risk of retraumatization. Children and adolescents participating in the program attend group sessions conducted by mental health clinicians and complete a court-related anxiety measure before and after each session. Results from 175 participants are reported. Findings indicated significant decreases in court-related anxiety with large program effects. Challenges encountered by the program and future directions are discussed.

Results of the Nursing Outcomes Classification/NOC for patients with obsessive-compulsive disorder / Resultados de la Nursing Outcomes Classification/NOC para pacientes con trastorno obsesivo-compulsivo / Resultados da Nursing Outcomes Classification/NOC para pacientes com transtorno obsessivo-compulsivo

ABSTRACT Objective: To analyze the application of nursing outcomes and indicators selected from the Nursing Outcomes Classification (NOC) to evaluate patients with obsessive-compulsive disorder (OCD) in outpatient follow-up. Method: Outcome-based research. First, a consensus was achieved between nurses specialized in mental health (MH) and in the nursing process to select NOC-related outcomes and indicators, followed by the elaboration of their conceptual and operational definitions. Then, an instrument was created with these, which was tested in a pilot group of six patients treated at a MH outpatient clinic. The instrument was applied to patients with OCD undergoing Group Cognitive Behavioral Therapy (GCBT). The study was approved by the Research Ethics Committee of the institution. Results: Four NOC outcomes and 17 indicators were selected. There was a significant change in the scores of nine indicators after CBGT. Conclusion: The study showed feasibility for evaluating symptoms of patients with OCD through NOC outcomes and indicators in an outpatient situation.

RESUMEN Objetivo: Evaluar la aplicación de resultados e indicadores de enfermería seleccionados en la Nursing Outcomes Classification (NOC) para examinar a los pacientes con Trastorno Obsesivo-Compulsivo (TOC) en seguimiento ambulatorio. Método: Investigación de resultados. Primeramente, se realizó un acuerdo entre enfermeros expertos en salud mental (SM) y en proceso de enfermería para seleccionar los resultados e indicadores de la NOC, seguido de la elaboración de sus definiciones conceptuales y operativas. Después, se construyó un instrumento con las informaciones recolectadas, y lo aplicaron a un grupo piloto con seis pacientes, que recibían atención en el ambulatorio de SM. Se aplicó el instrumento a los pacientes con TOC, sometidos a Terapia Cognitivo-Conductual en Grupo (TCCG). Estudio aprobado por el Comité de Ética en Investigación de la institución. Resultados: Se seleccionaron cuatro resultados y 17 indicadores NOC. Se observó una modificación significativa de los puntajes de nueve indicadores después de la TCCG. Conclusión: El estudio apuntó la viabilidad de evaluación de los síntomas de pacientes con TOC por medio de los resultados e indicadores de la NOC en el ámbito ambulatorio.

RESUMO Objetivo: Analisar a aplicação de resultados e indicadores de enfermagem selecionados na Nursing Outcomes Classification (NOC) para avaliar pacientes com Transtorno Obsessivo-Compulsivo (TOC) em acompanhamento ambulatorial. Método: Pesquisa de resultados. Primeiro, realizou-se consenso entre enfermeiros especialistas em saúde mental (SM) e em processo de enfermagem para seleção de resultados e indicadores da NOC, seguido da elaboração das suas definições conceituais e operacionais. Depois, construiu-se um instrumento com estes, que foi testado em grupo piloto de seis pacientes atendidos em ambulatório de SM. O instrumento foi aplicado aos pacientes com TOC submetidos a Terapia Cognitivo-Comportamental em Grupo (TCCG). Estudo aprovado pelo Comitê de Ética em Pesquisa da instituição. Resultados: Foram selecionados quatro resultados e 17 indicadores NOC. Observou-se modificação significativa dos escores de nove indicadores após a TCCG. Conclusão: O estudo apontou viabilidade de avaliação dos sintomas de pacientes com TOC através dos resultados e indicadores da NOC em cenário ambulatorial.

Randomised controlled clinical trial of a structured cognitive rehabilitation in patients with attention deficit following mild traumatic brain injury: study protocol.

OBJECTIVES: To measure the clinical, structural and functional changes of an individualised structured cognitive rehabilitation in mild traumatic brain injury (mTBI) population. SETTING: A single centre study, Malaysia. PARTICIPANTS: Adults aged between 18 and 60 years with mTBI as a result of road traffic accident, with no previous history of head trauma, minimum of 9 years education and abnormal cognition at 3 months will be included. The exclusion criteria include pre-existing chronic illness or neurological/psychiatric condition, long-term medication that affects cognitive/psychological status, clinical evidence of substance intoxication at the time of injury and major polytrauma. Based on multiple estimated calculations, the minimum intended sample size is 50 participants (Cohen's d effect size=0.35; alpha level of 0.05; 85% power to detect statistical significance; 40% attrition rate). INTERVENTIONS: Intervention group will receive individualised structured cognitive rehabilitation. Control group will receive the best patient-centred care for attention disorders. Therapy frequency for both groups will be 1 hour per week for 12 weeks. OUTCOME MEASURES: Primary: Neuropsychological Assessment Battery-Screening Module (S-NAB) scores. Secondary: Diffusion Tensor Imaging (DTI) parameters and Goal Attainment Scaling score (GAS). RESULTS: Results will include descriptive statistics of population demographics, CogniPlus cognitive program and metacognitive strategies. The effect of intervention will be the effect size of S-NAB scores and mean GAS T scores. DTI parameters will be compared between groups via repeated measure analysis. Correlation analysis of outcome measures will be calculated using Pearson's correlation coefficient. CONCLUSION: This is a complex clinical intervention with multiple outcome measures to provide a comprehensive evidence-based treatment model. ETHICS AND DISSEMINATION: The study protocol was approved by the Medical Research Ethics Committee UMMC (MREC ID NO: 2016928-4293). The findings of the trial will be disseminated through peer-reviewed journals and scientific conferences. TRIAL REGISTRATION NUMBER: NCT03237676.

A randomized controlled trial comparing guided internet-based multi-component treatment and internet-based guided sleep restriction treatment to care as usual in insomnia.

BACKGROUND: Internet-based cognitive behavioral treatment (iCBT-I) for insomnia comprising different sleep-related cognitive and behavioral interventional components has shown some promise. However, it is not known which components are necessary for a good treatment outcome. METHOD: People suffering from insomnia (N = 104) without any other comorbid psychiatric disorders were randomized (2:2:1) to two guided internet-based self-help interventions for insomnia [multi-component cognitive behavioral self-help intervention (MCT); sleep restriction intervention for insomnia (SRT)], and care as usual [CAU]. In all three conditions, additional care or treatment was allowed. The primary outcome was insomnia severity measured with the insomnia severity index (ISI) at eight weeks. Furthermore, the two active conditions were compared regarding sleep efficacy from daily diary data over the eight weeks, and other measures from the daily protocols. Secondary outcomes included sleep quality, depressive symptoms, dysfunctional beliefs, and quality of life at post-treatment (eight weeks) and follow-up (six months after randomization). RESULTS: Both conditions were more effective than CAU at post-treatment, with medium to large between-group effect sizes on the primary outcome (ISI; MCT: Cohen's d = -1.15; SRT: d = -0.68) and small to medium between-group effect sizes for secondary outcomes. Treatment gains were maintained at six-month follow-up. Active conditions did not differ from each other on all measures from pre to post, except for dysfunctional beliefs about sleep, and sleep protocol data throughout the intervention. Participants in MCT were significantly more satisfied with the intervention than participants in SRT. CONCLUSIONS: Results of the present study indicate that CAU + MCT and CAU + SRT are both effective compared to CAU. There were no statistical differences regarding efficacy between the two active conditions, but participants in MCT reported to be more satisfied with the intervention.

Digital Delivery of Cognitive Behavioral Therapy for Insomnia.

PURPOSE OF REVIEW: Digital cognitive behavioral therapy (dCBT) has been available for over a decade. We reviewed the evidence that accumulated over the past 5 years and discuss the implications for introducing dCBT into standard healthcare. RECENT FINDINGS: Studies have consistently supported the use of dCBT to treat insomnia. Evidence is now demonstrating large short-term effects and smaller long-term effects up to 1.5 years after treatment across populations with various co-occurring health problems. The effects also extend into a range of psychological well-being factors. Mediators and moderators have been studied to understand mechanisms and create new opportunities to enhance effectiveness and reduce dropout. Incorporating personalized guidance in dCBT may further enhance effectiveness. The evidence for dCBT for insomnia is strong and suggests that dCBT is ready for application in standard healthcare. Further research, digital innovation, and development of effective implementation methods are required to ensure dCBT fulfills its potential.

Effects of two types of smartphone-based stress management programmes on depressive and anxiety symptoms among hospital nurses in Vietnam: a protocol for three-arm randomised controlled trial.

INTRODUCTION: Due to an increasing demand for healthcare in low-income and middle-income countries in Asia, it is important to develop a strategy to manage work-related stress in healthcare settings, particularly among nurses in these countries. The purpose of this three-arm randomised controlled trial (RCT) is to examine the effects of a newly developed smartphone-based multimodule stress management programme on reducing severity of depressive and anxiety symptoms as primary outcomes at 3-month and 7-month follow-ups among hospital nurses in Vietnam. METHODS AND ANALYSIS: The target study population will be registered nurses working in a large general hospital (which employs approximately about 2000 nurses) in Vietnam. They will be invited to participate in this study. Participants who fulfil the eligibility criteria will be randomly allocated to the free-choice, multimodule stress management (intervention group A, n=360), the internet cognitive behavioural therapy (iCBT), that is, fixed-order stress management (intervention group B, n=360), or a treatment as usual control group (n=360). Two types (free-choice and fixed sequential order) of smartphone-based six-module stress management programmes will be developed. Participants in the intervention groups will be required to complete one of the programmes within 10 weeks after the baseline survey. The primary outcomes are depressive and anxiety symptoms, measured by using the Depression Anxiety and Stress Scales (DASS) at 3-month and 7 month follow-ups. ETHICS AND DISSEMINATION: The study procedures have been approved by the Research Ethics Review Board of Graduate School of Medicine/Faculty of Medicine, the University of Tokyo (no 11991) and the Ethical Review Board for Biomedical Research of Hanoi University of Public Health (no 346/2018/YTCC-HD3). If a significant effect of the intervention programmes will be found in the RCT, the programmes will be made available to all nurses in the hospital including the control group. If the positive effects are found in this RCT, the e-stress management programmes will be disseminated to all nurses in Vietnam. TRIAL REGISTRATION NUMBER: UMIN000033139; Pre-results.

Telephone-Delivered Cognitive Behavioural Therapy for Treating Symptoms of Anxiety and Depression in Parkinson's Disease: A Pilot Trial.

Objectives: To determine the feasibility, acceptability and initial efficacy of telephone-delivered cognitive behavioral therapy (CBT) for the treatment of anxiety and depressive symptoms in people with Parkinson's disease. Methods: A small randomized controlled trial compared telephone-based CBT to waitlist control. Eleven participants aged >50 years with Parkinson's disease and anxiety and/or depressive symptoms above recommended clinical cut-offs, were randomized to one of two conditions. Participants completed self-report measures of symptom severity and quality of life. Their carers were invited to participate and completed self-reported measures of symptoms and carer burden. At the end of the 10-week intervention period, participants and carers were reassessed on baseline measures, and again one month later. Results: The CBT program was associated with significantly reduced depressive symptoms (Cohen's d = .90) at post-treatment with gains maintained at one-month follow-up. Anxiety symptom decreases (Cohen's d = 0.36) were not statistically different. Waitlist was associated with significantly worsened anxiety. Carer symptoms also reduced with CBT. No changes on quality of life were found. Good acceptability and feedback was received. Conclusions: Telephone-based CBT reduced symptoms of depression in participants with Parkinson's disease but not anxiety. Clinical Implications: Telephone-based CBT is a promising treatment option.