[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659421":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":59,"studyPopulation":55,"armGroups":60,"interventions":72,"overallOfficials":83,"centralContacts":94,"locations":104,"responsibleParty":128,"collaborators":131,"id":133,"slug":134,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":55,"eligibilityCriteria":139,"healthyVolunteers":135,"sex":140,"minAge":141,"maxAge":55,"enrollmentInfo":142,"targetDuration":55,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":156,"whyStopped":55,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Medical Research Council Cognition and Brain Sciences Unit","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":33},[9,13],{"measure":10,"description":11,"timeFrame":12},"User Version of the Mobile Application Rating Scale (uMARS)","The User Version of the Mobile Application Rating Scale (uMARS) (Stoyanov et al., 2016) consists of 20 items divided into 5 subscales: engagement, functionality, aesthetics, information and subjective quality. Participants can also leave a comment about the app (free text). High scores indicate better rating of a mobile application.","After App use (at either 4 or 8 weeks, depending on arm)",{"measure":14,"description":15,"timeFrame":16},"International Prolonged Grief Disorder Scale (IPGDS)","The IPGDS (Killikelly et al., 2020; Killikelly \\& Maercker, 2023) is a self-report measure and contains 14 items, which are scored on a five-point likert scale from 1 (not at all) to 5 (always) higher scores indicate greater severity.","At Baseline, 4 weeks and 8 weeks.",[18,21,24,27,30],{"measure":19,"description":20,"timeFrame":16},"Generalized Anxiety Disorder-7 (GAD-7)","The GAD-7 (Spitzer et al., 2006) is a 7-item self-report measure of generalised anxiety symptom severity. Scores range from 0 to 21; higher scores indicate greater severity.",{"measure":22,"description":23,"timeFrame":16},"Patient Health Questionnaire (PHQ-9)","The PHQ-9 (Kroenke et al., 2001) is a 9-item self-report measure of depressive symptom severity. Scores range from 0 to 27; higher scores indicate greater severity.",{"measure":25,"description":26,"timeFrame":16},"Work and Social Adjustment Scale (WSAS)","The WSAS (Mundt et al., 2002) is a 5-item self-report measure of functional impairment attributed to mental health problems across work, home management, social leisure, private leisure, and close relationships. Items are rated from 0 to 8. Higher scores indicate greater impairment.",{"measure":28,"description":29,"timeFrame":16},"International Trauma Questionnaire (ITQ)","The ITQ (Cloitre et al., 2018) is an 18-item self-report measure assessing symptoms of posttraumatic stress disorder (6 items) and disturbances in self-organization (6 items). It additionally includes 6 items measuring functional impairment (3 for each category). The scale is scored on a 5 point likert scale ranging from 0 (not at all) to 4 (extremely), with higher scores indicating higher severity.",{"measure":31,"description":32,"timeFrame":16},"Oxford Grief - Social Disconnection Scale (OG-SD)","The OG-SD (Smith, Wild \\& Ehlers, 2020) is a 15-item scale, measure social (dis)connection in grief. Items are rated on a likert scale ranging from 1 (I fully disagree) to 7 (I fully agree). Higher scores indicate higher levels of perceived disconnection.",[34,38,42,46],{"measure":35,"description":36,"timeFrame":37},"Grief and Response to Altered Core Experience of the Self Questionnaire (GRACES-Q)","The GRACES-Q (Shalev et al., unpublished) is a 25-item self-report measure of reaction and grief-like responses to changes to the self following the onset of a mental health condition. Respondents rate statements from 0 to 5 across five subscales covering identity discontinuity and self-alienation, longing and grieving the past self, grieving the future self, acceptance and moving forward, and dual-process oscillation. In this trial, the GRACES-Q is administered only to participants who disclose a mental health condition (formally diagnosed or suspected).","At Baseline and post-treatment",{"measure":39,"description":40,"timeFrame":41},"EmBody task","The EmBody tool based on Nummenmaa et al., (2014) is a tool, which lets participants rate where in their bodies they feel different grief-related emotions. 13 emotions from the IPGDS have been chosen. Participants are presented with an outline of a person and can click on the relevant body part. Participants are asked for each emotion about where they can feel activation and where they can feel deactivation. The task is administered only to participants who complete the GRACES-Q and rate at least 'somewhat agree' on item 13 (\"I feel grief over who I was before my \\[mental health condition\\]\", or item 19 (\"I feel like I am grieving the person I could have been if I had not had my \\[mental health condition\\]\").","Baseline",{"measure":43,"description":44,"timeFrame":45},"Prolonged Grief Disorder-13-Revised (PG-13-R)","The PG13-R (Prigerson et al., 2021) is a grief measure containing 13 items, 10 of which are scored on a 5-point Likert scale from \"not at all\" to \"overwhelmingly\". The remaining three questions are either yes or no questions or ask about the duration since loss. We use the PG-13-R at screening to assess prolonged grief disorder symptoms between 3 and 6 months post-loss. A score of 30 or more serves as a clinical cut-off. However, prolonged grief disorder can only be diagnosed after 6 months.","Screening (if less than 6 months since loss)",{"measure":47,"description":48,"timeFrame":49},"Prolonged Grief Symptoms - short ecological assessment (PGS-SEA)","The PGS-SEA (Ergun et al., 2025) is a two-item questionnaire intended for short ecological momentary assessment of grief symptoms. The two items are rated on a 5 point Likert scale from 1 (not at all) to 5 (extremely), with higher scores indicating higher severity.","Twice daily for four weeks during intervention period.",{"allocation":51,"interventionModel":52,"interventionModelDescription":53,"primaryPurpose":54,"observationalModel":55,"timePerspective":55,"maskingInfo":56},"RANDOMIZED","CROSSOVER","Two crossover arms undergo four weeks of app intervention and four weeks of waiting in opposite order. Participants are randomised 1:1 using stratified minimisation on baseline IPGDS severity. Outcome assessments occur at baseline, after four weeks and after eight weeks.","SUPPORTIVE_CARE",null,{"masking":57,"maskingDescription":58,"whoMasked":55},"NONE","Participants cannot be masked to condition during the study periods, as they know whether they have app access. All assessments are online and completed independently by the participants. Researchers do not provide any input into assessments (beyond technical support). Randomisation is done by a researcher not involved in the running of the trial. Participants are not informed of their allocated sequence until the start of the first study period, so baseline assessments are completed without knowledge of allocation.","Rationale:\n\nGrief after the loss of a loved one is an inevitable part of life. However, even adaptive non-clinical grief trajectories are difficult and may be disruptive for individuals. Typical grief reactions include sadness, longing for the deceased person, feelings of emptiness and nostalgia.\n\nFollowing bereavement, grief has been shown to fluctuate strongly throughout people's everyday lives and is described as arriving in 'waves' or 'pangs'. This is also highlighted by the dual-processing model of coping with bereavement, which suggests that coping with bereavement is characterized by oscillation between loss-oriented and restoration-oriented coping, meaning that people have to focus on processing their loss as well as on rebuilding their everyday life.\n\nWhilst specialist support for grief is available and effective, it is often reserved for those with clinical levels of grief and is subject to long waiting lists and strict eligibility criteria. This leaves the much larger group of bereaved people who are going through a non-clinical grief reaction with relatively little structured support, even though their grief can still be painful and disruptive. Mental health online applications (apps) can promote convenience, accessibility, anonymity, reduced stigma and improved flexibility. Online bereavement support has therefore been suggested to close the gap.\n\nA new class of interventions called ecological momentary interventions (EMIs) could be particularly well suited for individuals who have lost a loved one and may struggle with subclinical levels of grief-related distress. EMIs function like any self-supporting app, just that instead of people using them when they choose to, they get prompted multiple times a day to engage with the app or practice a specific skill. This should guarantee that participants practice these skills in their everyday lives, increasing the likelihood that they will successfully integrate them in their daily routines.\n\nIn previous work, the investigators developed a self-supporting app for grief support. The development process was a collaborative, iterative process which involved researchers, grief experts (therapists, chaplains, grief support workers, etc.) and bereaved adults. The investigators now wish to evaluate the benefits of the EMI grief app with bereaved adults experiencing grief. Specifically, they aim to assess the feasibility and acceptability of the app, including adherence to the prompted exercises and obtain preliminary estimates of its effect on grief related symptoms.\n\nDesign:\n\nThis is a single-blind, crossover randomised controlled trial conducted at the MRC Cognition and Brain Sciences Unit (MRC-CBU), University of Cambridge, UK. The trial uses a crossover design to test the app against an initial waiting list group, which later receives access to the interventions. Adults who have experienced a loss at least three months ago will be randomized into one of the two arms (intervention first vs. waiting first). Every group receives access to the app for four weeks total. The app is intended for subclinical use and thus participants with diagnoses of prolonged grief disorder or posttraumatic stress disorder will be excluded from the study.\n\nParticipants in the study will fill out an assessment of grief related difficulties and mental health symptoms at three timepoints: baseline, after four weeks, and after eight weeks. During the active intervention window, participants will gain access to the app for four weeks. Participants will also be prompted twice daily to fill out prolonged grief symptoms - short ecological assessment and complete a short exercise. The app content is based on Cognitive Behavioural Therapy (CBT) principles, the dual processing model of coping with bereavement and Worden's four tasks of mourning.\n\nA Monte Carlo simulation was conducted for the between-subjects comparison of IPGDS scores at four weeks (app versus wait-list), which is the most power-restrictive analysis in the trial, namely the between-subjects wait-list intervention effect. Assuming a true intervention effect size of at least d = 0.45, a total sample of 80 participants provides 80% power to detect this effect, accounting for an anticipated 20% attrition rate and resulting in 64 completers (32 per condition).\n\nOutcomes:\n\nThe primary outcomes of the study are the feasibility and acceptability of the app as well as the reduction of grief symptoms. This is measured using adherence to app prompts (in percentage), the User Version of the Mobile Application Rating Scale and the International Prolonged Grief Disorder Scale (IPGDS). Reduction in IPGDS scores is the sole inferential outcome. Feasibility and acceptability will be judged against pre-specified benchmarks (mean completion of at least 50% of prompts and mean uMARS score of at least 3.0) and reported descriptively with 95% confidence intervals.\n\nSecondary outcomes include the Patient Health Questionnaire -9, Generalized Anxiety Disorder -7, work and social adjustment Scale, Oxford Grief - Social Disconnection Scale, and the International Trauma Questionnaire.\n\nExploratory measures include the Grief and Response to Altered Core Experience of the Self Questionnaire (GRACES-Q). Participants who report a sense of identity loss will also map this experience with a brief body-mapping task that will include grief and a range of other emotions (the emBODY tool).\n\nRandomisation and blinding:\n\nStratified minimisation based on initial IPGDS scores, executed by an independent researcher. Outcome assessors at baseline, post-treatment, and follow-up are blind to treatment allocation.",[61,68],{"label":62,"type":63,"description":64,"interventionNames":65},"Daybreak first (Daybreak then waiting list)","EXPERIMENTAL","Four weeks of app use, followed by four weeks of 'waiting' for follow up assessment.\n\nParticipants are prompted twice daily to fill out a two-item grief questionnaire (Ergun et al., 2025) and complete a short exercise (of approximately 5 minutes). Participants also have access to the grief support app, which they can use in a self-guided way. The app includes a Psychoeducation module, longer writing exercises, a library of all prompted short exercises a signposting registry and a memory wall, where participants can keep memories of the deceased person (such as pictures, links to music, written text, etc.). The app is based on CBT Principles, the dual processing model of coping with bereavement (Stroebe \\& Schut, 1999) and Worden's four tasks of mourning (Worden, 2018).",[66,67],"Behavioral: Self-guided grief app (Daybreak)","Other: Waiting list",{"label":69,"type":63,"description":70,"interventionNames":71},"Waiting list first (waiting list then Daybreak)","Four weeks of waiting list, followed by four weeks of app use.\n\nParticipants are prompted twice daily to fill out a two-item grief questionnaire (Ergun et al., 2025) and complete a short exercise (of approximately 5 minutes). Participants also have access to the grief support app, which they can use in a self-guided way. The app includes a Psychoeducation module, longer writing exercises, a library of all prompted short exercises a signposting registry and a memory wall, where participants can keep memories of the deceased person (such as pictures, links to music, written text, etc.). The app is based on CBT principles, the dual processing model of coping with bereavement (Stroebe \\& Schut, 1999) and Worden's four tasks of mourning (Worden, 2018).",[66,67],[73,78],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":55},"BEHAVIORAL","Self-guided grief app (Daybreak)","Self-guided app use with twice daily prompts to complete short questionnaires (2 questions) and a short exercise (approximately 5-minute duration. Exercises are based CBT principles as well as the dual processing model of coping with bereavement (Stroebe \\& Schut, 1999) and Worden's four tasks of mourning (Worden, 2018). The short exercises are divided into multiple categories: activation, social activation, relaxation and remembrance. Participants receive a reminder after 30 minutes. Each prompt can be responded to until the next prompt to allow for flexibility in people's lifestyles.\n\nTreatment adherence is measured by engagement with app content and percentage of prompts filled out.\n\nEach arm experiences this treatment condition at a different timepoint",[62,69],{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":55},"OTHER","Waiting list","Waitlist - Participants are instructed to wait for four weeks until the next assessment.",[62,69],[84,88,92],{"name":85,"affiliation":86,"role":87},"Clare Killikelly, PhD","University of Zurich","PRINCIPAL_INVESTIGATOR",{"name":89,"affiliation":90,"role":91},"Tim Dalgleish, PhD","MRC Cognition and Brain Sciences Unit, University of Cambridge, UK","STUDY_DIRECTOR",{"name":93,"affiliation":90,"role":91},"Anna Bevan, PhD",[95,100],{"name":96,"role":97,"phone":98,"phoneExt":55,"email":99},"Ido Shalev, PhD","CONTACT","+447541030621","is622@cam.ac.uk",{"name":101,"role":97,"phone":102,"phoneExt":55,"email":103},"Ayala Licht-Handler, MSc","+447723334249","Ayalasara.licht-handler@uzh.ch",[105],{"facility":106,"status":55,"city":107,"state":108,"zip":109,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":117,"contacts":118},"MRC Cognition and Brain Sciences Unit (MRC-CBU), University of Cambridge","Cambridge","Cambridgeshire","CB2 7EF","United Kingdom","UK",{"type":113,"coordinates":114},"Point",[115,116],0.11667,52.2,{"lat":116,"lon":115},[119,120,121,122,124,125,126],{"name":96,"role":97,"phone":98,"phoneExt":55,"email":99},{"name":101,"role":97,"phone":102,"phoneExt":55,"email":103},{"name":89,"role":87,"phone":55,"phoneExt":55,"email":55},{"name":93,"role":123,"phone":55,"phoneExt":55,"email":55},"SUB_INVESTIGATOR",{"name":96,"role":123,"phone":55,"phoneExt":55,"email":55},{"name":101,"role":123,"phone":55,"phoneExt":55,"email":55},{"name":127,"role":123,"phone":55,"phoneExt":55,"email":55},"Annika Pfiffner",{"type":87,"investigatorFullName":129,"investigatorTitle":130,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"Ido Shalev","Assistant Research Professor",[132],{"name":86,"class":79},"100659421","a-grief-support-app-for-adults-experiencing-bereavement-100659421",false,"NCT07862244","A Grief Support App for Adults Experiencing Bereavement","DayBreak: A Pilot Randomised Trial of a Grief Support App for Adults Experiencing Bereavement","Inclusion Criteria:\n\n* Aged 18+\n* Fluent in English (reading and writing)\n* GP in the UK\n* Capable of giving informed consent\n* Loss of a loved one at least three months ago\n* Smartphone with access to apple store or google play store\n\nExclusion Criteria:\n\n* High risk of suicidal intent or self-harm\n* Current psychiatric inpatient stay\n* Current psychological treatment for grief\n* Diagnosis of PGD or PTSD - If loss less than 6 months ago needs to score below clinical cut-off on PG-13-R\n* Severe cognitive impairment or learning difficulties","ALL","18 Years",{"count":143,"type":144},80,"ESTIMATED","INTERVENTIONAL",[147],"NA","Losing a loved one is a difficult experience. Some people may require psychological support, but even for those who do not, grief can often feel overwhelming. Many bereaved adults report there not being enough support that is easily available for them. Some researchers have suggested that online interventions, such as phone applications (apps) could be a good way to make support easier to access. Apps can also allow people to access support anonymously. Apps can also help by prompting people to practice different skills. This means that they can test them out in their real life and learn how to best integrate them. This type of app might be particularly helpful for grief as grief does not always stay consistent but rather changes in intensity throughout the day and year.\n\nThe investigators have developed a grief app called Daybreak. The app was developed together with grief experts and bereaved adults. The app includes information about grief, writing exercises, short exercises, a registry of resources for grief support and a place to store memories of the deceased person. In addition, the app prompts twice daily to answer two questions about the grief and do a small exercise.\n\nThe investigators now wish to see how well the app works. To achieve this, each participant will be randomly sorted into two groups. Both groups will have access to the app for four weeks. One group will immediately access the app for four weeks and then have a four-week waiting period (eight weeks in total), while the other group start with the waiting period and then gets access to the app for four weeks (also eight weeks). Different grief-related symptoms will be measured at the beginning, middle and end of the experiment, as well as asking all participants to rate the feasibility and acceptability of the app itself. The researchers can also see how often the app was used and if people responded to the questions in the app. In the end, researchers would inspect if participants liked the app, if they used the app regularly and if the app changed any of the grief-related difficulties.",[150],"Grief",[150,152,153,154,155],"Loss","Ecological Momentary Intervention","App","Grief Support","NOT_YET_RECRUITING","2026-10-06",{"date":159,"type":160},"2026-10-09","ACTUAL",{"date":162,"type":144},"2026-10-05",{"date":164,"type":144},"2027-03-30",{"name":5,"class":6},1]