ABSTRACT
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.
ABSTRACT
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.
Subject(s)
COVID-19 , Emotional Regulation , Health Personnel , Humans , Randomized Controlled Trials as Topic , SARS-CoV-2 , Smartphone , Treatment OutcomeABSTRACT
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.
Subject(s)
Cognitive Behavioral Therapy , Quality of Life , Adult , Feasibility Studies , Grief , Humans , Internet , Randomized Controlled Trials as Topic , Spain , Treatment OutcomeABSTRACT
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.