Enhancing Internet-based psychotherapy for adults with emotional disorders using ecological momentary assessments and interventions: Study protocol of a feasibility trial with "My EMI, Emotional Well-being" app.

Introduction: Emotional disorders are the most frequent mental health problems globally. To ensure the dissemination of psychological treatments for these conditions, novel forms of delivery (e.g., Internet or mobile apps) and more scalable forms of psychotherapy (e.g., transdiagnostic interventions) have become increasingly popular. Research, however, shows that a significant number of patients, around 40 % according to some studies, do not respond to the interventions as expected (i.e., not-on-track patients). Ecological momentary assessments (EMAs) and ecological momentary interventions (EMIs) could simplify tailoring treatments to the patients' progress and rapidly respond to undesired outcomes during psychotherapy. Therefore, these would facilitate measurement-based care with little therapist involvement. This study aims to explore the feasibility of an app-based system called My EMI, Emotional Well-being for people with emotional disorders. According to daily EMAs, the app will provide personalized EMIs while participants receive a self-applied online transdiagnostic treatment. The app will be used as an add-tool to the online intervention to address emotion dysregulation, foster adherence, and reinforce contents. The current study describes the study protocol for this trial. Method and analysis: A single-group, open trial design will be used. Participants will be 30 adults suffering from emotional disorders. Primary outcomes will be app usability, acceptability, and response rates. Secondary outcomes will be either evaluated in Qualtrics at pre-treatment, post-treatment, and 3-month follow-up (depression and anxiety severity, and transdiagnostic dimensions of emotional disorders) or daily throughout the study with the app (EMAs of mood and five transdiagnostic mechanisms of therapeutic change). EMIs will consist of brief, evidence-based transdiagnostic CBT digital content (images, infographics, or videos) delivered just-in-time. Only if problems persist, short phone calls or episodic videocalls will be conducted. The Ethics Committee of the Jaume I University approved the study and all its procedures (CD/111/2021) in December 2021. Discussion: Identifying personalized and scalable interventions is paramount to improve mental health care, especially its accessibility, and to reduce the psychological distress of people with mental health problems. Feasibility data of the app (EMA and EMI system) supported by a self-applied online transdiagnostic intervention will be important to explore whether this modern approach is a real option to move forward personalized psychological interventions for persons with emotional disorders. Trial registration: ClinicalTrials.gov Identifier: NCT05109780. Registered 05 November 2021, https://clinicaltrials.gov/ct2/show/NCT05109780.

Languages and Psychotherapy: The Effect of Foreign Language on Fear Extinction.

BACKGROUND: Using a foreign language can influence emotion modulation, but whether different psychotherapy processes would be affected by a foreign language is still unclear. The current study explored the foreign language effect on the extinction of fear. METHOD: During the conditioning phase, part of the neutral stimuli presented to the participants were associated with a threat, while they performed a countdown task in their native language. In the extinction phase, participants performed the same task either in their native/foreign language and were informed that the threat would no longer appear. We collected self-reports of fear, and pupil dilation and electrodermal activity as physiological measures of arousal. RESULTS: Extinction was successful, indicated by greater self-reported fear and pupil dilation during the threat condition compared to neutral in the conditioning phase, but no significant differences during extinction. Although the foreign language group presented higher arousal, fear extinction occurred regardless of the linguistic context. CONCLUSIONS: Fear extinction via verbal instructions is equally effective in a foreign and a native language context. These results indicate that evidence should be continue to be gathered on the role of foreign languages using basic paradigms with clinical applications.

Languages and Psychotherapy: The Effect of Foreign Language on Fear Extinction / Lenguas y Psicoterapia: El Efecto de la Lengua Extranjera en la Extinción del Miedo

Background: Using a foreign language can influence emotion modulation, but whether different psychotherapy processes would be affected by a foreign language is still unclear. The current study explored the foreign language effect on the extinction of fear. Method: During the conditioning phase, part of the neutral stimuli presented to the participants were associated with a threat, while they performed a countdown task in their native language. In the extinction phase, participants performed the same task either in their native/foreign language and were informed that the threat would no longer appear. We collected self-reports of fear, and pupil dilation and electrodermal activity as physiological measures of arousal. Results: Extinction was successful, indicated by greater self-reported fear and pupil dilation during the threat condition compared to neutral in the conditioning phase, but no significant differences during extinction. Although the foreign language group presented higher arousal, fear extinction occurred regardless of the linguistic context. Conclusions: Fear extinction via verbal instructions is equally effective in a foreign and a native language context. These results indicate that evidence should be continue to be gathered on the role of foreign languages using basic paradigms with clinical applications.(AU)

Antecedentes: Usar un idioma extranjero puede influir la modulación de las emociones, pero no está claro si su uso podría influir diferentes procesos psicoterapéuticos. Este estudio explora el efecto de la lengua extranjera en la extinción del miedo. Método: Durante el condicionamiento, parte de los estímulos presentados se asociaron a amenaza, mientras los participantes realizaban una tarea de cuenta regresiva en un contexto de lengua nativa. En la fase de extinción, se realizó la misma tarea en su lengua nativa/extranjera, y se informó de que ya no habría amenaza. Se recogieron autoinformes de miedo, así como dilatación de pupila y actividad electrodérmica como medidas fisiológicas de excitación. Resultados: La extinción fue satisfactoria, como muestran una mayor dilatación pupilar y los autoinformes de miedo al comparar las condiciones de amenaza y neutral en la fase de condicionamiento, y no encontrar diferencias significativas durante la extinción. Aunque el grupo de lengua extranjera presentó una mayor excitación, la extinción del miedo ocurre independientemente del contexto lingüístico. Conclusiones: La extinción del miedo mediante instrucciones verbales es igualmente eficaz en contexto de lengua extranjera y nativa. Estos resultados invitan a seguir reuniendo pruebas sobre el papel de las lenguas extranjeras mediante paradigmas con aplicaciones clínicas.(AU)

Enhancing mental health literacy in obsessive-compulsive disorder and reducing stigma via smartphone: A randomized controlled trial protocol.

Background: Obsessive-compulsive disorder (OCD) is a disabling disorder that can be successfully treated. However, individuals with OCD do not seek or delay seeking treatment. This delay may be explained by poor mental health literacy and stigmatizing attitudes toward OCD in community. In order to work on these variables, a gamified mental health mobile application (app) called esTOCma has been developed. The purpose of this study is to describe the protocol for a study to test the efficacy of esTOCma, increasing mental health literacy and help-seeking intention, reducing the stigmatizing attitudes and social distance suffered by people with OCD, as well as the distress associated with obsessive-compulsive symptoms. Methods: A randomized controlled trial with a crossover design with two conditions (immediate-use App group versus delayed-use App group) will be conducted on a non-clinical adult sample of the community of a minimum size of 200 participants. Participants in the immediate-use App group will start using the app at baseline until completion (10 days); whereas participants in the delayed-use App group will wait 10 days, and then start using the app until completion (10 days). The outcomes will be measured at four assessment points (baseline; 10 days from baseline; and 20 days from baseline; and after 3 months). The following instruments will be administered: Attribution Questionnaire, General Help-Seeking Questionnaire, Social Distance Scale, Mental Health Literacy, Psychoeducation Questionnaire, Social Desirability Scale, Single-Item Self-esteem Scale, and Obsessive-Compulsive Inventory-Revised. Discussion: This protocol presents the first study to describe a randomized control trial of a mental health app focused on changing mental health literacy, stigmatizing attitudes, social distance and help-seeking intention associated with OCD. An app intervention of these characteristics is especially relevant nowadays as the COVID-19 pandemic has increased obsessive-compulsive symptoms and severity. An improvement in general knowledge about OCD and a reduction in stigma could be associated with earlier OCD detection and an increase in help-seeking intention, which could result in greater wellbeing. Moreover, normalizing intrusions and knowledge about the cognitive OCD model could serve as a protective variable in vulnerable individuals. Trial registration: ClinicalTrials.gov identifier: NCT04777292. Registered February 23, 2021, https://clinicaltrials.gov/ct2/show/NCT04777292.

Using Artificial Intelligence to Enhance Ongoing Psychological Interventions for Emotional Problems in Real- or Close to Real-Time: A Systematic Review.

Emotional disorders are the most common mental disorders globally. Psychological treatments have been found to be useful for a significant number of cases, but up to 40% of patients do not respond to psychotherapy as expected. Artificial intelligence (AI) methods might enhance psychotherapy by providing therapists and patients with real- or close to real-time recommendations according to the patient's response to treatment. The goal of this investigation is to systematically review the evidence on the use of AI-based methods to enhance outcomes in psychological interventions in real-time or close to real-time. The search included studies indexed in the electronic databases Scopus, Pubmed, Web of Science, and Cochrane Library. The terms used for the electronic search included variations of the words "psychotherapy", "artificial intelligence", and "emotional disorders". From the 85 full texts assessed, only 10 studies met our eligibility criteria. In these, the most frequently used AI technique was conversational AI agents, which are chatbots based on software that can be accessed online with a computer or a smartphone. Overall, the reviewed investigations indicated significant positive consequences of using AI to enhance psychotherapy and reduce clinical symptomatology. Additionally, most studies reported high satisfaction, engagement, and retention rates when implementing AI to enhance psychotherapy in real- or close to real-time. Despite the potential of AI to make interventions more flexible and tailored to patients' needs, more methodologically robust studies are needed.

An Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Prolonged Grief Disorder (PGD) in adults: A multiple-baseline single-case experimental design study.

The death of a loved one has physical, psychological, and social consequences. Between 9.8 and 21.5 % of people who lose a loved one develop Prolonged Grief Disorder (PGD). Internet- and computer-based interventions (i.e., Internet-delivered Cognitive-Behavioral Therapy, iCBT) are cost-effective and scalable alternatives that make it possible to reach more people with PGD. The main goal of the present investigation was to examine the effect and feasibility (usability and satisfaction) of an iCBT (GROw program) for adults with PGD. A secondary objective was to detect adherence to the app (Emotional Monitor) used to measure daily grief symptoms. The study had a single-case multiple-baseline AB design with six participants. The GROw program is organized sequentially in eight modules, and it is based on the dual-process model of coping with bereavement. Evaluations included a pre-to-post treatment assessment of depression, grief symptoms, and typical grief beliefs, along with daily measures of symptom frequency and intensity on the Emotional Monitor App. Treatment opinions and adherence to the App were also collected. Efficacy data were calculated using a Nonoverlap of All Pairs (NAP) analysis and Reliable Change Index (RCI). The mean age of the sample was 29.5 years (SD = 8.19). Two participants dropped out of the study. Adherence to the App varied across patients (4.8 % -77.8 %). Most participants (75 %) showed a clinically significant change (recovered) in depression, and 50 % obtained a clinically significant improvement (recovered) in symptoms of loss and typical beliefs in complicated grief. The participants reported high usability and satisfaction with the treatment content and format. In sum, the GROw program was very well accepted and generally feasible, and it has strong potential for treating PGD. The results support scaling up the treatment by using more complex designs with larger samples (i.e., randomized controlled trials comparing GROw with active conditions).

Ecological momentary intervention to enhance emotion regulation in healthcare workers via smartphone: a randomized controlled trial protocol.

BACKGROUND: CUIDA-TE is an APP that offers transdiagnostic cognitive behavioral therapy focused on enhancing emotion regulation. As a novelty, it incorporates ecological momentary interventions (EMI), which can provide psychological support in real time, when suffering arises. The main goal of the study is to evaluate the efficacy of CUIDA-TE to improve emotion regulation in healthcare workers, a population that has been particularly emotionally impacted by the COVID-19 pandemic. METHODS: In this three-arm, randomized controlled trial (RCT) the study sample will be composed of a minimum of 174 healthcare workers. They will be randomly assigned to a 2-month EMI group (CUIDA-TE APP, n ≥ 58), a 2-month ecological momentary assessment (EMA) only group (MONITOR EMOCIONAL APP, n ≥ 58), or a wait-list control group (no daily monitoring nor intervention, n ≥ 58). CUIDA-TE will provide EMI if EMA reveals emotional problems, poor sleep quality/quantity, burnout, stress, or low perceived self-efficacy when regulating emotions. Depression will be the primary outcome. Secondary outcomes will include emotion regulation, quality of life, and resilience. Treatment acceptance and usability will also be measured. Primary and secondary outcomes will be obtained at pre- and post-intervention measurements, and at the 3-month follow-up for all groups. DISCUSSION: To our knowledge, this is the first RCT that evaluates the efficacy of an APP-based EMI to improve emotion regulation skills in healthcare workers. This type of intervention might ultimately help disseminate treatments and reach a larger number of individuals than traditional face-to-face individual therapies. TRIAL REGISTRATION: ClinicalTrial.gov : NCT04958941 Registered 7 Jun 2021. STUDY STATUS: Participant recruitment has not started.

Efficacy of an internet-based psychological intervention for problem gambling and gambling disorder: Study protocol for a randomized controlled trial.

Gambling Disorder is a prevalent non-substance use disorder, which contrasts with the low number of people requesting treatment. Information and Communication Technologies (ICT) could help to enhance the dissemination of evidence-based treatments and considerably reduce the costs. The current study seeks to assess the efficacy of an online psychological intervention for people suffering from gambling problems in Spain. The proposed study will be a two-arm, parallel-group, randomized controlled trial. A total of 134 participants (problem and pathological gamblers) will be randomly allocated to a waiting list control group (N = 67) or an intervention group (N = 67). The intervention program includes 8 modules, and it is based on motivational interviewing, cognitive-behavioral therapy (CBT), and extensions and innovations of CBT. It includes several complementary tools that are present throughout the entire intervention. Therapeutic support will be provided once a week through a phone call with a maximum length of 10 min. The primary outcome measure will be gambling severity and gambling-related cognitions, and secondary outcome measures will be readiness to change, and gambling self-efficacy. Other variables that will be considered are depression and anxiety symptoms, positive and negative affect, difficulties in emotion regulation strategies, impulsivity, and quality of life. Individuals will be assessed at baseline, post-treatment, and 3-, 6-, and 12-month follow-ups. During the treatment, participants will also respond to a daily Ecological Momentary Intervention (EMI) in order to evaluate urges to gamble, self-efficacy to cope with gambling urges, gambling urge frequency, and whether gambling behaviour occurs. The EMI includes immediate automatic feedback depending on the participant's responses. Treatment acceptance and satisfaction will also be assessed. The data will be analysed both per protocol and by Intention-to-treat. As far as we know, this is the first randomized controlled trial of an online psychological intervention for gambling disorder in Spain. It will expand our knowledge about treatments delivered via the Internet and contribute to improving treatment dissemination, reaching people suffering from this problem who otherwise would not receive help. TRIAL REGISTRATION: Clinicaltrials.gov as NCT04074681. Registered 22 July 2019.

mHealth for the Monitoring of Brace Compliance and Wellbeing in Adolescents with Idiopathic Scoliosis: Study Protocol for a Feasibility Study.

Attempts to optimize monitoring of brace adherence prescribed to adolescents with idiopathic scoliosis (IS) have generally relied on sensors. Sensors, however, are intrusive and do not allow the assessment of psychological and physical consequences of brace use that might underlie poor adherence. Mobile applications have emerged as alternatives to monitor brace compliance. However, the feasibility and utility of these app-based systems to assess key psychological and physical domains associated with non-adherence remain unexplored. This feasibility study aims to test the usability, acceptability, and clinical utility of an app-based system that monitors brace use and related psychological and physical factors. Forty adolescents with IS daily respond to the app for 90 days. The patient responses may generate clinical alarms (e.g., brace non-adherence, discomfort, or distress) that will be sent daily to the medical team. Primary outcomes will be app usability, acceptability, and response rates. Secondary outcomes will include brace adherence, the number of side effects reported, number and type of clinical alarms, stress, quality of life, perceived health status, and mood. If accepted by patients and clinicians, apps may allow rapid detection and response to undesired events in adolescents undergoing brace treatment.

Predicting response to transdiagnostic iCBT for emotional disorders from patient and therapist involvement.

BACKGROUND: Transdiagnostic iCBT has been shown to be effective for the treatment of emotional disorders. Less is known about the optimal level of therapist and patient involvement in these interventions. Specific characteristics of Internet-delivered interventions include treatment adherence (e.g., amount of review of the materials) and guidance (e.g., amount of therapist support). Exploring the importance of these elements in treatment outcome may help to maximize the efficiency of Internet-delivered psychological interventions. AIM: In this study, we aimed to analyze the relationship between patient and therapist involvement (i.e., platform usage and amount of therapist guidance) in a sample of patients with emotional disorders who received transdiagnostic iCBT in Spanish public specialized mental healthcare services. METHOD: This is a secondary analysis of a randomized controlled trial. The sample included 63 patients who completed transdiagnostic iCBT for emotional disorders. Platform usage metrics included number of logins into the platform and number of times the participants reviewed the modules. Therapist guidance was measured as the number of support phone calls with a therapist and their total duration (minutes). Logistic regressions and ROC analyses were performed to explore the predictive value of platform usage and therapist guidance in symptom reduction. Clinical outcomes included depressive and anxiety symptoms assessed at baseline and post-intervention. The bivariate relationship between the platform usage and therapist guidance variables was also explored. RESULTS: Overall, platform usage and therapist guidance were not associated with symptom improvement. However, the patient and therapist involvement parameters were intercorrelated. Specifically, the number of calls and their duration were associated with a greater number of logins (r = 0.61; p < .001) and more frequent reviews of the modules (0.46 ≤ r ≤ 0.60; p < .001). Higher baseline depression and anxiety were, respectively, associated with greater improvements in depression (r = -0.37, p = .003) and anxiety after treatment completion (r = -0.48, p < .001). DISCUSSION: The results suggest that there is no reliable cut-off point for platform usage and therapist guidance in predicting optimal symptom reduction. However, significant associations were found between platform usage and guidance variables that warrant additional research. More research on this topic is necessary to further clarify the role of these and other platform usage and guidance variables in Internet-delivered iCBT outcomes.

Characterizing Breakthrough Cancer Pain Using Ecological Momentary Assessment with a Smartphone App: Feasibility and Clinical Findings.

BACKGROUND: mobile applications (apps) facilitate cancer pain ecological momentary assessment (EMA) and provide more reliable data than retrospective monitoring. The aims of this study are (a) to describe the status of persons with cancer pain when assessed ecologically, (b) to analyze the utility of clinical alarms integrated into the app, and (c) to test the feasibility of implementing an app for daily oncological pain monitoring. METHODS: in this feasibility study, 21 patients (mean age = 56.95 years, SD = 10.53, 81.0% men) responded to an app-based evaluation of physical status (baseline and breakthrough cancer pain (BTcP)) and mental health variables (fatigue, mood, and coping) daily during 30 days. RESULTS: cancer pain characterization with the app was similar to data from the literature using retrospective assessments in terms of BTcP duration and perceived medication effectiveness. However, BTcP was less frequent when evaluated ecologically. Pain, fatigue, and mood were comparable in the morning and evening. Passive coping strategies were the most employed daily. Clinical alarms appear to be useful to detect and address adverse events. App implementation was feasible and acceptable. CONCLUSION: apps reduce recall bias and facilitate a rapid response to adverse events in oncological care. Future efforts should be addressed to integrate EMA and ecological momentary interventions to facilitate pain self-management via apps.

Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Adults with Prolonged Grief Disorder (PGD): A Study Protocol for a Randomized Feasibility Trial.

INTRODUCTION: Grief is an emotional reaction to the loss of a loved one with a natural recovery. Approximately 10% of people who lose a loved one develop prolonged grief disorder (PGD). Internet-based and computer-based interventions (ie, internet-delivered cognitive-behavioural therapy, iCBT) are a cost-effective alternative that makes it possible to reach more people with PGD. The main aim of this study is to assess the feasibility of a new iCBT-called GROw-for PGD. As a secondary objective, the potential effectiveness of GROw will be explored. METHODS AND ANALYSIS: This study is a two-arm feasibility randomised trial. A total of 48 adults with PGD who meet the eligibility criteria will be randomised to the experimental group (iCBT: GROw) or the active control group (face-to-face CBT treatment). The treatment is organised sequentially in eight modules in the iCBT format and 8-10 sessions in the face-to-face format, and both formats have the same therapeutic components. There will be five assessment points with qualitative and quantitative evaluations: screening, baseline, after the intervention, 3-month follow-up and 12-month follow-up. Consistent with the objectives, the measures are related to the feasibility outcomes for the main aim of the study (participant adherence, expectations and satisfaction with the treatment, preferences, alliance and utility) and psychological and mental health outcomes for secondary analyses (symptoms of grief, symptoms of depression, symptoms of anxiety, affectivity, quality of life, work and social adaptation, post-traumatic growth, purpose in life, mindfulness and compassion). ETHICS AND DISSEMINATION: The Ethics Committee of the Universitat Jaume I (Castellón, Spain) granted approval for the study (CD/002/2019). Dissemination will include publications and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: NCT04462146.

An Internet-based treatment for Flying Phobia using 360° images: Study protocol for a feasibility pilot study.

BACKGROUND: Flying Phobia (FP) is a prevalent disorder that can cause serious interference in a person's life. ICBT interventions have already shown their efficacy in several studies, but studies in the field of specific phobias are still scarce. Moreover, few studies have investigated the feasibility of using different types of images in exposure scenarios in ICBTs and no studies have been carried out on the role of sense of presence and reality judgement. The aim of the present study is to explore the feasibility of an ICBT for FP (NO-FEAR Airlines) using two types of images with different levels of immersion (still and navigable images). A secondary aim is to explore the potential effectiveness of the two experimental conditions using two types of images compared to a waiting list control group. Finally, the role of navigable images compared to the still images in the level of anxiety, sense of presence, and reality judgement will also be explored. This paper presents the study protocol. METHODS: This study is a three-armed feasibility pilot study with the following conditions: NO-FEAR Airlines with navigable images, NO-FEAR Airlines with still images, and a waiting list group. A minimum of 60 participants will be recruited. The intervention will have a maximum duration of 6 weeks. Measurements will be taken at four different moments: baseline, post-intervention, and two follow-ups (3- and 12-month). Participants' opinions, preference, satisfaction and acceptance regarding the images used in the exposure scenarios will be assessed. FP symptomatology outcomes will also be considered for secondary analyses. The anxiety, sense of presence, and reality judgement in the exposure scenarios will also be analysed. DISCUSSION: This study will conduct a pilot study on the feasibility of an ICBT for FP and it is the first one to explore the evaluation of patients of the two type of images (still and navigable) and the role of presence and reality judgement in exposure scenarios delivered through the Internet. Research in this field can have an impact on the way these scenarios are designed and developed, as well as helping to explore whether they have any effect on adherence. TRIAL REGISTRATION: NCT03900559. Trial Registration date 3 April 2019, retrospectively registered.

Blended transdiagnostic group CBT for emotional disorders: A feasibility trial protocol.

INTRODUCTION: Emotional disorders (anxiety and depressive disorders) are a relevant public health concern associated with high prevalence, high costs, and important disability. Therefore, research priorities include designing and testing cost-effective interventions to reach everyone in need. Internet-delivered interventions for emotional disorders are effective and can help to disseminate and implement evidence-based treatments. However, although these treatments are generally effective, not all patients benefit from this treatment format equally. Blended treatments are a new form of intervention that combines the strengths of face-to-face and Internet approaches. Nevertheless, research on blended interventions has focused primarily on individual therapy, and less attention has been paid to the potential of using this format in group psychotherapy. This study aims to analyze the feasibility of blended transdiagnostic group CBT for emotional disorders. The current article describes the study protocol for this trial. METHOD AND ANALYSIS: A one-armed pilot trial will be conducted. Participants will be 30 adults suffering from DSM-5 anxiety and/or depressive disorders. The treatment consists of a blended transdiagnostic group intervention delivered during a period of 24 weeks. Groups of 6 to 10 patients will attend a total of eight 2-hour, face-to-face sessions, alternated with the use of an online platform where they will find the contents of the treatment protocol. The intervention has four core components: present-focused awareness, cognitive flexibility, identification and modification of behavioral and cognitive patterns of emotional avoidance, and interoceptive and situational exposure. These components are delivered in 16 modules. Assessments will be performed at baseline, during the treatment, at post-treatment, and at 3-month follow-up. Clinical and treatment acceptability outcomes will be included. Quantitative and qualitative data (participants' views about blended group psychotherapy) will be analyzed. ETHICS AND DISSEMINATION: The trial has received ethical approval from the Ethics Committee of Universitat Jaume I (September 2019) and will be conducted in accordance with the study protocol, the Declaration of Helsinki, and good clinical practice. The results of this study will be disseminated by presentation at conferences and will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04008576. Registered 05 July 2019, https://clinicaltrials.gov/ct2/show/NCT04008576.

Negative and Positive Affect Regulation in a Transdiagnostic Internet-Based Protocol for Emotional Disorders: Randomized Controlled Trial.

BACKGROUND: Emotional disorders (EDs) are among the most prevalent mental disorders. Existing evidence-based psychological treatments are not sufficient to reduce the disease burden of mental disorders. It is therefore essential to implement innovative solutions to achieve a successful dissemination of psychological treatment protocols, and in this regard, the use of information and communication technologies such as the internet can be very useful. Furthermore, the literature suggests that not everyone with an ED receives the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which attempts to address the underlying processes common to EDs. Most of these transdiagnostic interventions focus primarily on downregulating negative affectivity (NA), and less attention has been paid to strengths and the upregulation of positive affectivity, despite its importance for well-being and mental health. OBJECTIVE: This study aims to evaluate the efficacy of a transdiagnostic internet-based treatment for EDs in a community sample. METHODS: A 3-armed randomized controlled trial was conducted. A total of 216 participants were randomly assigned to a transdiagnostic internet-based protocol (TIBP), a TIBP+ positive affect (PA) component, or a waiting list (WL) control group. The treatment protocol contained core components mainly addressed to downregulate NA (ie, present-focused emotional awareness and acceptance, cognitive flexibility, behavioral and emotional avoidance patterns, and interoceptive and situational exposure) as well as a PA regulation component to promote psychological strengths and enhance well-being. Data on depression, anxiety, quality of life, neuroticism and extraversion, and PA/NA before and after treatment were analyzed. Expectations and opinions of treatment were also analyzed. RESULTS: Within-group comparisons indicated significant pre-post reductions in the two experimental conditions. In the TIBP+PA condition, the effect sizes were large for all primary outcomes (d=1.42, Beck Depression Inventory [BDI-II]; d=0.91, Beck Anxiety Inventory [BAI]; d=1.27, Positive and Negative Affect Schedule-Positive [PANAS-P]; d=1.26, Positive and Negative Affect Schedule-Negative [PANAS-N]), whereas the TIBP condition yielded large effect sizes for BDI-II (d=1.19) and PANAS-N (d=1.28) and medium effect sizes for BAI (d=0.63) and PANAS-P (d=0.69). Between-group comparisons revealed that participants who received one of the two active treatments scored better at posttreatment than WL participants. Although there were no statistically significant differences between the two intervention groups on the PA measure, effect sizes were consistently larger in the TIBP+PA condition than in the standard transdiagnostic protocol. CONCLUSIONS: Overall, the findings indicate that EDs can be effectively treated with a transdiagnostic intervention via the internet, as significant improvements in depression, anxiety, and quality of life measures were observed. Regarding PA measures, promising effects were found, but more research is needed to study the role of PA as a therapeutic component. TRIAL REGISTRATION: ClinicalTrials.gov NCT02578758; https://clinicaltrials.gov/ct2/show/NCT02578758. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-017-1297-z.

A guided Internet-delivered intervention for adjustment disorders: A randomized controlled trial.

Evidence of self-help interventions for adjustment disorder (AjD) is limited. This study aims at testing in a randomized controlled trial (RCT) the effectiveness of a disorder-specific, Internet-delivered cognitive-behavioural therapy (ICBT) intervention for AjD. Participants were randomly allocated to either an ICBT with brief weekly telephone support (n = 34) or a waiting list group (n = 34). Beck's inventories for depression and anxiety were used as primary outcomes. The secondary outcomes were AjD symptoms, post-traumatic growth, positive and negative affect, and quality of life. In all, 76.5% of the participants completed the intervention. Compared with the control group, participants in the intervention condition showed significantly greater improvement in all outcomes (Cohen's d ranged from 0.54 to 1.21) except in anxiety symptoms measured by Beck Anxiety Inventory (d = 0.27). Only ICBT group showed a significant improvement in post-traumatic growth, positive and negative affect, and quality of life. The number of cases that achieved clinically meaningful change in all outcome measures was also higher in the ICBT group. All therapeutic gains were maintained at 3-, 6- and 12-month follow-ups. The current study provides evidence on the effectiveness of ICBT interventions to reduce the impact of AjD. Results suggest that brief self-help intervention with minimal therapist support is more effective than the mere passage of time in reducing the distress symptoms associated to the disorder and also can confer additional benefits.

Brief Acceptance and Commitment Therapy for Fibromyalgia: Feasibility and Effectiveness of a Replicated Single-Case Design.

Objective: Overall, the literature on the effectiveness of psychological treatments in general and those for fibromyalgia in particular has been dominated by research designs that focus on large groups and explore changes on average, so the treatment impact at the individual level remains unclear. In this quasi-experimental, replicated single-case design, we will test the feasibility and effectiveness of a brief acceptance and committed therapy intervention using ecological momentary assessment supported by technology. Methods: The sample comprised 7 patients (3 in the individual condition and 4 in the group condition) who received a brief, 5-week psychological treatment. Patient evolution was assessed one week prior to treatment onset and during the whole study with a smartphone app. Because ecological momentary assessment and the use of an app are not frequent practices in routine care, we also evaluated the feasibility of this assessment methodology (i.e., compliance with the app). Change was investigated with a nonoverlap of all pairs index. Outcomes were pain interference with sleep and social activities, fatigue, sadness, and pain intensity. Results: Patient change was not uniform across outcomes. Four patients (two in each condition) showed relatively moderate levels of change (approximately 60% nonoverlap in several outcomes). The remaining patients showed more modest improvements which affected a reduced number of outcomes. Based on nonoverlapping indices, there was no clear evidence in favor of any treatment format. Conclusions: An alternative design to large-scale trials, one that focuses on the individual change, exists and it can be implemented in pain research. The use of technology (e.g., smartphones) simplifies such designs by facilitating ecological momentary assessment. Based on our findings showing that changes were not homogeneous across patients or outcomes, more single-case designs and patient-centered analyses (e.g., responder and moderation analyses) are required.

Telemonitoring in Chronic Pain Management Using Smartphone Apps: A Randomized Controlled Trial Comparing Usual Assessment against App-Based Monitoring with and without Clinical Alarms.

BACKGROUND: The usefulness of mHealth in helping to target face-to-face interventions for chronic pain more effectively remains unclear. In the present study, we aim to test whether the Pain Monitor mobile phone application (app) is well accepted by clinicians, and can help improve existent medical treatments for patients with chronic musculoskeletal pain. Regarding this last goal, we compared three treatment conditions, namely usual treatment, usual treatment with an app without alarms and usual treatment with an app with alarms. All treatments lasted one month. The three treatments were compared for all outcomes, i.e., pain severity and interference, fatigue, depressed mood, anxiety and anger. METHODS: In this randomized controlled trial, the usual monitoring method (i.e., onsite; n = 44) was compared with daily ecological momentary assessment using the Pain Monitor app-both with (n = 43) and without alarms (n = 45). Alarms were sent to the clinicians in the presence of pre-established undesired clinical events and could be used to make treatment adjustments throughout the one-month study. RESULTS: With the exception of anger, clinically significant changes (CSC; 30% improvement) were greater in the app + alarm condition across outcomes (e.g., 43.6% of patients experienced a CSC in depressed mood in the app + alarm condition, which occurred in less than 29% of patients in the other groups). The clinicians were willing to use the app, especially the version with alarms. CONCLUSIONS: The use of apps may have some benefits in individual health care, especially when using alarms to tailor treatments.

Designing ICTs for Users with Mild Cognitive Impairment: A Usability Study.

BACKGROUND: Research has supported the cost-effectiveness of cognitive training tools enhanced by information and communication technologies (ICT) in several populations, including individuals with mild cognitive impairment (MCI) and age-related cognitive decline. The implementation of ICTs in this population, however, is sometimes challenging to their cognitive and age characteristics. Ultimately, this might compromise the effectiveness of ICT-enhanced therapies in this population. The aim of this study is to test the usability and acceptability of a European project prototype for elderly care, in an attempt to explore the ICT design needs of users with MCI. METHODS: Participants were 28 individuals aged 58-95 years and with a diagnosis of MCI. RESULTS: The results showed a low perception of peripheral elements and the need to place main interaction elements in the centre of the screen. The correlation between the general level of autonomy (daily life activities) and the ICT autonomy level was significant and positive. The speed of audio help had a significant impact on performance. CONCLUSION: The present work contributes to the literature on ICT usability needs of users with MCI. Some usability recommendations for designing interfaces for this type of user are provided in the text.