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.

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.

Study on the Acceptability of an ICT Platform for Older Adults with Mild Cognitive Impairment.

EhcoBUTLER is an Information and Communication Technology (ICT) solution funded by the European Union (H2020; ID: 643566) and intended especially for elderly people with mild cognitive impairment (MCI) to improve their health, independence and quality of life, particularly at the social level. The purpose of this study is to assess the acceptability of ehcoBUTLER based on a survey delivered to potential users and actors involved in their care, exploring their expectations and preferences, while anticipating the system's functional requirements. The survey was delivered online to 313 participants (11% end users, 25% informal caregivers, 48% formal caregivers and 16% administration/management staff) from eight countries. Participants rated the different functionalities of ehcoBUTLER positively, 86.1% perceiving it as an interesting and useful system. Likewise, they assessed it as a commercially attractive product (75.1%). End users expressed a stronger preference for the social module. Nevertheless, they would be ready to pay a low monthly price for ehcoBUTLER. Professionals would be willing to pay choosing its functionalities modularly, but they would also expect it to be funded by the National Health System, centres or businesses. The conclusion is that all participants found ehcoBUTLER interesting, useful and ergonomic. However, to effectively implement it, it is necessary to bridge the digital gap and address the issue of insufficient investment in products aimed at older adults with cognitive impairment. To supplement cognitive training systems with social, emotional or entertainment functionalities could improve adherence to their use.

Efficacy of an internet-based exposure treatment for flying phobia (NO-FEAR Airlines) with and without therapist guidance: a randomized controlled trial.

BACKGROUND: Internet-based treatments appear to be a promising way to enhance the in vivo exposure approach, specifically in terms of acceptability and access to treatment. However, the literature on specific phobias is scarce, and, as far as we know, there are no studies on Flying Phobia (FP). This study aims to investigate the effectiveness of an Internet-based exposure treatment for FP (NO-FEAR Airlines) that includes exposure scenarios composed of images and sounds, versus a waiting-list control group. A secondary aim is to explore two ways of delivering NO-FEAR Airlines, with and without therapist guidance. METHODS: A randomized controlled trial (RCT) was conducted in which 69 participants were allocated to: 1) NO-FEAR Airlines totally self-applied, 2) NO-FEAR Airlines with therapist guidance, 3) a waiting-list control group. Primary outcome measures were the Fear of Flying Questionnaire-II and the Fear of Flying Scale. Secondary outcomes included the Fear and Avoidance Scales, Clinician Severity Scale, and Patient's Improvement scale. Behavioral outcomes (post-treatment flights and safety behaviors) were also included. Mixed-model analyses with no ad hoc imputations were conducted for primary and secondary outcome measures. RESULTS: NO-FEAR Airlines (with and without therapist guidance) was significantly effective, compared to the waiting list control group, on all primary and secondary outcomes (all ps < .05), and no significant differences were found between the two ways of delivering the intervention. Significant improvements on diagnostic status and reliable change indexes were also found in both treatment groups at post-treatment. Regarding behavioral outcomes, significant differences in safety behaviors were found at post-treatment, compared to the waiting list. Treatment gains were maintained at 3- and 12-month follow-ups. CONCLUSION: FP can be treated effectively via the Internet. NO-FEAR Airlines helps to enhance the exposure technique and provide access to evidence-based psychological treatment to more people in need. These data are congruent with previous studies highlighting the usefulness of computer-assisted exposure programs for FP, and they contribute to the literature on Internet-based interventions. To the best of our knowledge, this is the first RCT to investigate the effectiveness of an Internet-based treatment for FP and explore two ways of delivering the intervention (with and without therapist guidance). TRIAL REGISTRATION: Clinicaltrials.gov: NCT02298478 ( https://clinicaltrials.gov/ct2/show/NCT02298478 ). Trial registration date 3 November 2014.

Protocol for a randomized controlled dismantling study of an internet-based intervention for depressive symptoms: exploring the contribution of behavioral activation and positive psychotherapy strategies.

BACKGROUND: There are evidence-based interventions for depression that include different components. However, the efficacy of their therapeutic components is unknown. Another important issue related to depression interventions is that, up to now, their therapeutic components have only focused on reducing negative symptoms rather than on improving positive affect and well-being. Because the low levels of positive affect are more strongly linked to depression than to other emotional disorders, it is important to include this variable as an important treatment target. Positive psychotherapeutic strategies (PPs) could help in this issue. The results obtained so far are consistent and promising, showing that Internet-based interventions are effective in treating depression. However, most of them are also multi-component, and it is important to make progress in investigating what each component contributes to the intervention. METHODS: The current study will be a three-armed, simple-blinded, randomized controlled clinical trial with a dismantling design. 192 participants will be randomly assigned to: a) an Internet-based Global Protocol condition, which includes traditional therapeutic components of evidence-based treatments for depression (Motivation for change, Psychoeducation, Cognitive Therapy, Behavioral Activation (BA), Relapse Prevention) and PPs component, offering strategies to enhance positive mood and promote psychological strengths; b) an Internet-based BA Protocol condition (without the PPs component), and c) an Internet-based PPs Protocol condition (without the BA component). Primary outcome measures will be the BDI-II and PANAS. Secondary outcomes will include other variables such as depression, anxiety and stress, quality of life, resilience, and wellbeing related measures. Treatment acceptance and usability will also be measured. Participants will be assessed at pre-, post-treatment, 3-, 6- and 12- month follow- ups. The data will be analyzed based on the Intention-to-treat principle. Per protocol analyses will also be performed. DISCUSSION: To the best of our knowledge, this is the first randomized dismantling intervention study for depression with the aim of exploring the contribution of a PPs component and the BA component in an Internet-based intervention. The three protocols are online interventions, helping to reach many people who need psychological treatments and otherwise would not have access to them. TRIAL REGISTRATION: Clinicalstrials.gov as NCT03159715 . Registered 19 May 2017.

An Internet-based treatment for flying phobia (NO-FEAR Airlines): study protocol for a randomized controlled trial.

BACKGROUND: Flying phobia (FP) is a common and disabling mental disorder. Although in vivo exposure is the treatment of choice, it is linked to a number of limitations in its implementation. Particularly important, is the limited access to the feared stimulus (i.e., plane). Moreover, the economic cost of in vivo exposure should be specially considered as well as the difficulty of applying the exposure technique in an appropriate way; controlling important variables such as the duration of the exposure or the number of sessions. ICTs could help to reduce these limitations. Computer-assisted treatments have remarkable advantages in treating FP. Furthermore, they can be delivered through the Internet, increasing their advantages and reaching more people in need. The Internet has been established as an effective way to treat a wide range of mental disorders. However, as far as we know, no controlled studies exist on FP treatment via the Internet. This study aims to evaluate the efficacy of an Internet-based treatment for FP (NO-FEAR Airlines) versus a waiting list control group. Secondary objectives will be to explore two ways of delivering NO-FEAR Airlines, with or without therapist guidance, and study the patients' acceptance of the program. This paper presents the study protocol. METHODS/DESIGN: The study is a randomized controlled trial. A minimum of 57 participants will be randomly assigned to three conditions: a) NO-FEAR Airlines totally self-applied, b) NO-FEAR Airlines with therapist guidance, or c) a waiting list control group (6 weeks). Primary outcomes measures will be the Fear of Flying Questionnaire-II and the Fear of Flying Scale. Secondary outcomes will be included to assess other relevant clinical measures, such as the Fear and Avoidance Scales, Clinician Severity Scale, and Patient's Improvement scale. Analyses of post-treatment flights will be conducted. Treatment acceptance and preference measures will also be included. Intention-to-treat and per protocol analyses will be conducted. DISCUSSION: An Internet-based treatment for FP could have considerable advantages in managing in vivo exposure limitations, specifically in terms of access to treatment, acceptance, adherence, and the cost-effectiveness of the intervention. This is the first randomized controlled trial to study this issue. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02298478 . Trial registration date 3 November 2014.

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.

Life-review therapy with computer supplements for depression in the elderly: a randomized controlled trial.

Life-review therapy has been recognized as an effective therapeutic approach for depression in older adults. Additionally, the use of new media is becoming increasingly common in psychological interventions. The aim of this study was to investigate a life-review therapy in a face-to-face setting with additional computer use. This study explored whether a six-week life-review therapy with computer supplements from the e-mental health Butler system constitutes an effective approach to treat depression in older adults aged 65 and over. A total of 36 participants with elevated levels of depressive symptoms were randomized to a treatment group or a waiting-list control group and completed the post-assessment. Fourteen individuals in the intervention group completed the follow-up assessment. Analyses revealed significant changes from pre- to post-treatment or follow-up for depression, well-being, self-esteem, and obsessive reminiscence, but not for integrative reminiscence and life satisfaction. Depressive symptoms decreased significantly over time until the three-month follow-up in the intervention group compared to the control group (pre to post: d = 1.13; pre to follow-up: d = 1.27; and group × time effect pre to post: d = 0.72). Furthermore, the therapy led to an increase in well-being and a decrease in obsessive reminiscence among the participants in the intervention group from pre-treatment to follow-up (well-being: d = 0.70; obsessive reminiscence: d = 0.93). Analyses further revealed a significant but small group × time effect regarding self-esteem (d = 0.19). By and large, the results indicate that the life-review therapy in this combined setting could be recommended for depressive older adults.

Smiling is fun: a Coping with Stress and Emotion Regulation Program.

Emotional disorders (Anxiety disorders and Mood disorders) are one of the most common health problems worldwide, and their economic costs are very high. People suffering from emotional disorders often use maladaptive emotion regulation strategies and have low coping behaviour that contributes to the presence of clinical symptoms. For this reason, it is important to develop strategies to monitor coping and promote emotion regulation in people exposed to high levels of stress. Information and Communication Technologies (ICT) can help us in this task. Recent systematic reviews of literature on evidence-based CBT treatments delivered via the Internet show that these approaches are effective. We have developed an intervention program ICT based: Coping with Stress and Emotion Regulation Program (Smiling is Fun), a self-applied program via the Internet. Smiling is Fun follows a transdiagnostic perspective, and it is based on CBT techniques. However, it also includes other psychological strategies to improve positive mood. The aim of the present work is to describe Smiling is Fun and the study designed to test its efficacy.

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).

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.

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.

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.

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.