Dataset Information

Effects of a Novel, Transdiagnostic Ecological Momentary Intervention for Prevention, and Early Intervention of Severe Mental Disorder in Youth (EMIcompass): Findings From an Exploratory Randomized Controlled Trial.

ABSTRACT:

Background/hypothesis

Digital interventions targeting transdiagnostic mechanisms in daily life may be a promising translational strategy for prevention and early intervention of psychotic and other severe mental disorders. We aimed to investigate the feasibility and initial signals of efficacy of a transdiagnostic, compassion-focused, hybrid ecological momentary intervention for improving resilience (ie, EMIcompass) in youth with early mental health problems.

Study design

In an exploratory, assessor-blind randomized controlled trial, youth aged 14-25 with current distress, broad at-risk mental state, or first episode of severe mental disorder were randomly allocated to experimental (EMIcompass+treatment as usual [TAU]) or control condition (TAU). Data on primary (stress reactivity) and secondary candidate mechanisms as well as candidate primary (psychological distress) and secondary outcomes were collected.

Study results

Criteria for the feasibility of trial methodology and intervention delivery were met (n = 92 randomized participants). No serious adverse events were observed. Initial outcome signals were evident for reduced momentary stress reactivity (stress×time×condition, B = -0.10 95%CI -0.16--0.03, d = -0.10), aberrant salience (condition, B = -0.38, 95%CI -0.57--0.18, d = -0.56) as well as enhanced momentary resilience (condition, B = 0.55, 95%CI 0.18-0.92, d = 0.33) and quality of life (condition, B = 0.82, 95%CI 0.10-1.55, d = 0.60) across post-intervention and 4-week follow-up. No outcome signals were observed for self-reported psychological distress (condition, B = 0.57, 95%CI -1.59-2.72, d = 0.09), but there was suggestive evidence of reduced observer-rated symptoms at the 4-week follow-up (B = -1.41, 95%CI -2.85-0.02, d = -0.41).

Conclusions

Our findings provide evidence of feasibility and initial signals that EMIcompass may reduce stress reactivity and improve quality of life. A definitive trial is now warranted.

SUBMITTER: Reininghaus U

PROVIDER: S-EPMC10154707 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effects of a Novel, Transdiagnostic Ecological Momentary Intervention for Prevention, and Early Intervention of Severe Mental Disorder in Youth (EMIcompass): Findings From an Exploratory Randomized Controlled Trial.

Reininghaus Ulrich U Paetzold Isabell I Rauschenberg Christian C Hirjak Dusan D Banaschewski Tobias T Meyer-Lindenberg Andreas A Boehnke Jan R JR Boecking Benjamin B Schick Anita A

Schizophrenia bulletin 20230501 3

<h4>Background/hypothesis</h4>Digital interventions targeting transdiagnostic mechanisms in daily life may be a promising translational strategy for prevention and early intervention of psychotic and other severe mental disorders. We aimed to investigate the feasibility and initial signals of efficacy of a transdiagnostic, compassion-focused, hybrid ecological momentary intervention for improving resilience (ie, EMIcompass) in youth with early mental health problems.<h4>Study design</h4>In an ex ...[more]

PMID: 36738168

Similar Datasets

Project description:BackgroundMost mental disorders first emerge in youth and, in their early stages, surface as subthreshold expressions of symptoms comprising a transdiagnostic phenotype of psychosis, mania, depression, and anxiety. Elevated stress reactivity is one of the most widely studied mechanisms underlying psychotic and affective mental health problems. Thus, targeting stress reactivity in youth is a promising indicated and translational preventive strategy for adverse mental health outcomes that could develop later in life and for improving resilience. Compassion-focused interventions offer a wide range of innovative therapeutic techniques that are particularly amenable to being implemented as ecological momentary interventions (EMIs), a specific type of mobile health intervention, to enable youth to access interventions in a given moment and context in daily life. This approach may bridge the current gap in youth mental health care.ObjectiveThis study aims to investigate the clinical feasibility, candidate underlying mechanisms, and initial signals of the efficacy of a novel, transdiagnostic, hybrid EMI for improving resilience to stress in youth-EMIcompass.MethodsIn an exploratory randomized controlled trial, youth aged between 14 and 25 years with current distress, a broad Clinical High At-Risk Mental State, or the first episode of a severe mental disorder will be randomly allocated to the EMIcompass intervention (ie, EMI plus face-to-face training sessions) in addition to treatment as usual or a control condition of treatment as usual only. Primary (stress reactivity) and secondary candidate mechanisms (resilience, interpersonal sensitivity, threat anticipation, negative affective appraisals, and momentary physiological markers of stress reactivity), as well as primary (psychological distress) and secondary outcomes (primary psychiatric symptoms and general psychopathology), will be assessed at baseline, postintervention, and at the 4-week follow-up.ResultsThe first enrollment was in August 2019, and as of May 2021, enrollment and randomization was completed (N=92). We expect data collection to be completed by August 2021.ConclusionsThis study is the first to establish feasibility, evidence on underlying mechanisms, and preliminary signals of the efficacy of a compassion-focused EMI in youth. If successful, a confirmatory randomized controlled trial will be warranted. Overall, our approach has the potential to significantly advance preventive interventions in youth mental health provision.Trial registrationGerman Clinical Trials Register DRKS00017265; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017265.International registered report identifier (irrid)DERR1-10.2196/27462.

Project description:ImportanceTargeting low self-esteem in youth exposed to childhood adversity is a promising strategy for preventing adult mental disorders. Ecological momentary interventions (EMIs) allow for the delivery of youth-friendly, adaptive interventions for improving self-esteem, but robust trial-based evidence is pending.ObjectiveTo examine the efficacy of SELFIE, a novel transdiagnostic, blended EMI for improving self-esteem plus care as usual (CAU) compared with CAU only.Design, setting, and participantsThis was a 2-arm, parallel-group, assessor-blinded, randomized clinical trial conducted from December 2018 to December 2022. The study took place at Dutch secondary mental health services and within the general population and included youth (aged 12-26 years) with low self-esteem (Rosenberg Self-Esteem Scale [RSES] <26) exposed to childhood adversity.InterventionsA novel blended EMI (3 face-to-face sessions, email contacts, app-based, adaptive EMI) plus CAU or CAU only.Main outcomes and measuresThe primary outcome was RSES self-esteem at postintervention and 6-month follow-up. Secondary outcomes included positive and negative self-esteem, schematic self-beliefs, momentary self-esteem and affect, general psychopathology, quality of life, observer-rated symptoms, and functioning.ResultsA total of 174 participants (mean [SD] age, 20.7 [3.1] years; 154 female [89%]) were included in the intention-to-treat sample, who were primarily exposed to childhood emotional abuse or neglect, verbal or indirect bullying, and/or parental conflict. At postintervention, 153 participants (87.9%) and, at follow-up, 140 participants (80.5%), provided primary outcome data. RSES self-esteem was, on average, higher in the experimental condition (blended EMI + CAU) than in the control condition (CAU) across both postintervention and follow-up as a primary outcome (B = 2.32; 95% CI, 1.14-3.50; P < .001; Cohen d-type effect size [hereafter, Cohen d] = 0.54). Small to moderate effect sizes were observed suggestive of beneficial effects on positive (B = 3.85; 95% CI, 1.83-5.88; P < .001; Cohen d = 0.53) and negative (B = -3.78; 95% CI, -6.59 to -0.98; P = .008; Cohen d = -0.38) self-esteem, positive (B = 1.58; 95% CI, 0.41-2.75; P = .008; Cohen d = 0.38) and negative (B = -1.71; 95% CI, -2.93 to -0.48; P = .006; Cohen d = -0.39) schematic self-beliefs, momentary self-esteem (B = 0.29; 95% CI, 0.01-0.57; P = .04; Cohen d = 0.24), momentary positive affect (B = 0.23; 95% CI, 0.01-0.45; P = .04; Cohen d = 0.20), momentary negative affect (B = -0.33; 95% CI, -0.59 to -0.03, P = .01, Cohen d = -0.27), general psychopathology (B = -17.62; 95% CI, -33.03 to -2.21; P = .03; Cohen d = -0.34), and quality of life (B = 1.16; 95% CI, 0.18-2.13; P = .02; Cohen d = 0.33) across postintervention and follow-up. No beneficial effects on symptoms and functioning were observed.Conclusions and relevanceA transdiagnostic, blended EMI demonstrated efficacy on the primary outcome of self-esteem and signaled beneficial effects on several secondary outcomes. Further work should focus on implementing this novel EMI in routine public mental health provision.Trial registrationDutch Trial Register Identifier:NL7129(NTR7475).

Project description:BackgroundMemory and learning deficits are among the most impactful and longest-lasting symptoms experienced by people with chronic traumatic brain injury (TBI). Despite the persistence of post-TBI memory deficits and their implications for community reintegration, memory rehabilitation is restricted to short-term care within structured therapy sessions. Technology shows promise to extend memory rehabilitation into daily life and to increase the number and contextual diversity of learning opportunities. Ecological momentary assessment and intervention frameworks leverage mobile phone technology to assess and support individuals' behaviors across contexts and have shown benefits in other chronic conditions. However, few studies have used regular outreach via text messaging for adults with chronic TBI, and none have done so to assess and support memory.ObjectiveThis study aimed to develop and test the usability of memory ecological momentary intervention (MEMI), a text message-based assessment and intervention tool for memory in daily life. MEMI is designed to introduce new information, cue retrieval of the information, and assess learning across time and contexts. We tested MEMI via an iterative, user-centered design process to ready it for a future trial.MethodsWe developed MEMI by leveraging automated text messages for prompts using a REDCap (Research Electronic Data Capture)/Twilio interface linking to the Gorilla web-based behavioral experimental platform. We recruited 14 adults with chronic, moderate-severe TBI from the Vanderbilt Brain Injury Patient Registry to participate in 3 rounds of usability testing: one round of ThinkAloud sessions using the platform and providing real-time feedback to an experimenter (n=4) and 2 rounds of real-world usability testing in which participants used MEMI in their daily lives for a week and provided feedback (n=5/round). We analyzed engagement and quantitative and qualitative user feedback to assess MEMI's usability and acceptability.ResultsParticipants were highly engaged with MEMI, completing an average of 11.8 out of 12 (98%) possible sessions. They rated MEMI as highly usable, with scores on the System Usability Scale across all rounds equivalent to an A+ on a standardized scale. In semistructured interviews, they stated that MEMI was simple and easy to use, that daily retrieval sessions were not burdensome, and that they perceived MEMI as helpful for memory. We identified a few small issues (eg, instruction wording) and made improvements between usability testing rounds.ConclusionsTesting MEMI with adults with chronic TBI revealed that this technology is highly usable and favorably rated for this population. We incorporated feedback regarding users' preferences and plan to test the efficacy of this tool in a future clinical trial.

Project description:BackgroundThe development of mobile computing technology has enabled the delivery of psychological interventions while people go about their everyday lives. The original visions of the potential of these "ecological momentary interventions" were presented over a decade ago, and the widespread adoption of smartphones in the intervening years has led to a variety of research studies exploring the feasibility of these aspirations. However, there is a dearth of research describing the different dimensions, characteristics, and features of these interventions, as constructed.ObjectiveTo provide an overview of the definitions given for "ecological momentary interventions" in the treatment of common mental health disorders, and describe the set of technological and interaction possibilities which have been used in the design of these interventions.MethodsA systematic search identified relevant literature published between 2009 and 2020 in the PubMed, PsycInfo, and ACM Guide to the Computing Literature databases. Following screening, data were extracted from eligible articles using a standardized extraction worksheet. Selected articles were then thematically categorized.ResultsThe search identified 583 articles of which 64 met the inclusion criteria. The interventions target a range of mental health problems, with diverse aims, intervention designs and evaluation approaches. The studies employed a variety of features for intervention delivery, but recent research is overwhelmingly comprised of studies based on smartphone apps (30 of 42 papers that described an intervention). Twenty two studies employed sensors for the collection of data in order to provide just-in-time support or predict psychological states.ConclusionsWith the shift towards smartphone apps, the vision for EMIs has begun to be realised. Recent years have seen increased exploration of the use of sensors and machine learning, but the role of humans in the delivery of EMI is also varied. The variety of capabilities exhibited by EMIs motivates development of a more precise vocabulary for capturing both automatic and human tailoring of these interventions.

Project description:BackgroundHealthy behaviors are crucial for maintaining a person's health and well-being. The effects of health behavior interventions are mediated by individual and contextual factors that vary over time. Recently emerging smartphone-based ecological momentary interventions (EMIs) can use real-time user reports (ecological momentary assessments [EMAs]) to trigger appropriate support when needed in daily life.ObjectiveThis systematic review aims to assess the characteristics of smartphone-delivered EMIs using self-reported EMAs in relation to their effects on health behaviors, user engagement, and user perspectives.MethodsWe searched MEDLINE, Embase, PsycINFO, and CINAHL in June 2019 and updated the search in March 2020. We included experimental studies that incorporated EMIs based on EMAs delivered through smartphone apps to promote health behaviors in any health domain. Studies were independently screened. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed. We performed a narrative synthesis of intervention effects, user perspectives and engagement, and intervention design and characteristics. Quality appraisal was conducted for all included studies.ResultsWe included 19 papers describing 17 unique studies and comprising 652 participants. Most studies were quasi-experimental (13/17, 76%), had small sample sizes, and great heterogeneity in intervention designs and measurements. EMIs were most popular in the mental health domain (8/17, 47%), followed by substance abuse (3/17, 18%), diet, weight loss, physical activity (4/17, 24%), and smoking (2/17, 12%). Of the 17 studies, the 4 (24%) included randomized controlled trials reported nonstatistically significant effects on health behaviors, and 4 (24%) quasi-experimental studies reported statistically significant pre-post improvements in self-reported primary outcomes, namely depressive (P<.001) and psychotic symptoms (P=.03), drinking frequency (P<.001), and eating patterns (P=.01). EMA was commonly used to capture subjective experiences as well as behaviors, whereas sensors were rarely used. Generally, users perceived EMIs to be helpful. Common suggestions for improvement included enhancing personalization, multimedia and interactive capabilities (eg, voice recording), and lowering the EMA reporting burden. EMI and EMA components were rarely reported and were not described in a standardized manner across studies, hampering progress in this field. A reporting checklist was developed to facilitate the interpretation and comparison of findings and enhance the transparency and replicability of future studies using EMAs and EMIs.ConclusionsThe use of smartphone-delivered EMIs using self-reported EMAs to promote behavior change is an emerging area of research, with few studies evaluating efficacy. Such interventions could present an opportunity to enhance health but need further assessment in larger participant cohorts and well-designed evaluations following reporting checklists. Future research should explore combining self-reported EMAs of subjective experiences with objective data passively collected via sensors to promote personalization while minimizing user burden, as well as explore different EMA data collection methods (eg, chatbots).Trial registrationPROSPERO CRD42019138739; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=138739.

Dataset Information

Effects of a Novel, Transdiagnostic Ecological Momentary Intervention for Prevention, and Early Intervention of Severe Mental Disorder in Youth (EMIcompass): Findings From an Exploratory Randomized Controlled Trial.

Background/hypothesis

Study design

Study results

Conclusions

Publications

Effects of a Novel, Transdiagnostic Ecological Momentary Intervention for Prevention, and Early Intervention of Severe Mental Disorder in Youth (EMIcompass): Findings From an Exploratory Randomized Controlled Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets