GriefNCT07862244
A Grief Support App for Adults Experiencing Bereavement
A study testing Self-guided grief app (Daybreak) and Waiting list in people with Grief, run by Medical Research Council Cognition and Brain Sciences Unit at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grief
- What is being tested?
- Self-guided grief app (Daybreak) and Waiting list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Oct 2026to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18+
- Fluent in English (reading and writing)
- GP in the UK
- Capable of giving informed consent
- Loss of a loved one at least three months ago
- Smartphone with access to apple store or google play store
Who cannot join
- High risk of suicidal intent or self-harm
- Current psychiatric inpatient stay
- Current psychological treatment for grief
- Diagnosis of PGD or PTSD - If loss less than 6 months ago needs to score below clinical cut-off on PG-13-R
- Severe cognitive impairment or learning difficulties
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
MRC Cognition and Brain Sciences Unit (MRC-CBU), University of Cambridge
Cambridge, Cambridgeshire, CB2 7EF
Ido Shalev, PhD, +447541030621, is622@cam.ac.uk
Ayala Licht-Handler, MSc, +447723334249, Ayalasara.licht-handler@uzh.ch
About this study
Official title: DayBreak: A Pilot Randomised Trial of a Grief Support App for Adults Experiencing Bereavement
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.
The 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.
The 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.
Read the detailed description
Rationale:
Grief 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.
Following 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.
Whilst 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.
A 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.
In 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.
Design:
This 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.
Participants 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.
A 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).
Outcomes:
The 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.
Secondary 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.
Exploratory 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).
Randomisation and blinding:
Stratified 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.
- Conditions
- Grief
- Being tested
- Self-guided grief app (Daybreak), Waiting list
- Keywords
- Grief, Loss, Ecological Momentary Intervention, App, Grief Support
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-guided grief app (Daybreak)Behavioural
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.
Treatment adherence is measured by engagement with app content and percentage of prompts filled out.
Each arm experiences this treatment condition at a different timepoint
Waiting listOther
Waitlist - Participants are instructed to wait for four weeks until the next assessment.
| Study group | Role | What they receive |
|---|---|---|
| Daybreak first (Daybreak then waiting list) | Experimental | Four weeks of app use, followed by four weeks of 'waiting' for follow up assessment.
Participants 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). Receives: Behavioral: Self-guided grief app (Daybreak); Other: Waiting list |
| Waiting list first (waiting list then Daybreak) | Experimental | Four weeks of waiting list, followed by four weeks of app use.
Participants 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). Receives: Behavioral: Self-guided grief app (Daybreak); Other: Waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After App use (at either 4 or 8 weeks, depending on arm)
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.
Measured: At Baseline, 4 weeks and 8 weeks.
Secondary outcomes (5)
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.
Measured: At Baseline, 4 weeks and 8 weeks.
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.
Measured: At Baseline, 4 weeks and 8 weeks.
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.
Measured: At Baseline, 4 weeks and 8 weeks.
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.
Measured: At Baseline, 4 weeks and 8 weeks.
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.
Measured: At Baseline, 4 weeks and 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start5 Oct 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for GriefStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Council Cognition and Brain Sciences Unit
- Sponsor type
- Other government
- Collaborators
- University of Zurich
- Responsible party
- Principal investigator, Ido Shalev, Medical Research Council Cognition and Brain Sciences Unit
- Investigators
- Clare Killikelly, PhD, Principal investigator, University of ZurichTim Dalgleish, PhD, Study director, MRC Cognition and Brain Sciences Unit, University of Cambridge, UKAnna Bevan, PhD, Study director, MRC Cognition and Brain Sciences Unit, University of Cambridge, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862244
- Sponsor's protocol ID
- PRE.2026.067
- Other IDs
- TMSGI1_218018
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised individual-level data from the trial will be made publicly available via an open-access data repository at the conclusion of the study. Shared data will include de-identified participant-level outcome measures, demographic and loss related variables, all parameters consistent with informed consent and institutional data-sharing policies.
Publications
Arizmendi BJ, O'Connor MF. What is "normal" in grief? Aust Crit Care. 2015 May;28(2):58-62; quiz 63. doi: 10.1016/j.aucc.2015.01.005. Epub 2015 Feb 21.
PubMed 25716103Bernstein EE, Bentley KH, Nock MK, Stein MB, Beck S, Kleiman EM. An Ecological Momentary Intervention Study of Emotional Responses to Smartphone-Prompted CBT Skills Practice and the Relationship to Clinical Outcomes. Behav Ther. 2022 Mar;53(2):267-280. doi: 10.1016/j.beth.2021.09.001. Epub 2021 Sep 24.
PubMed 35227403Cloitre M, Shevlin M, Brewin CR, Bisson JI, Roberts NP, Maercker A, Karatzias T, Hyland P. The International Trauma Questionnaire: development of a self-report measure of ICD-11 PTSD and complex PTSD. Acta Psychiatr Scand. 2018 Dec;138(6):536-546. doi: 10.1111/acps.12956. Epub 2018 Sep 3.
PubMed 30178492Eklund R, Eisma MC, Boelen PA, Arnberg FK, Sveen J. Mobile app for prolonged grief among bereaved parents: study protocol for a randomised controlled trial. BMJ Open. 2021 Dec 7;11(12):e052763. doi: 10.1136/bmjopen-2021-052763.
PubMed 34876429Ergun TD, Ten Klooster PM, Bohlmeijer ET, Westerhof GJ, Franzen M, Lenferink LIM. Assessing prolonged grief symptoms using experience sampling methodology: The development of the prolonged grief symptoms - short ecological assessment (PGS-SEA) scale. Compr Psychiatry. 2025 Jul;140:152597. doi: 10.1016/j.comppsych.2025.152597. Epub 2025 Apr 16.
PubMed 40262368Killikelly C, Maercker A. The Cultural Supplement: A New Method for Assessing Culturally Relevant Prolonged Grief Disorder Symptoms. Clin Psychol Eur. 2023 Mar 31;5(1):e7655. doi: 10.32872/cpe.7655. eCollection 2023 Mar.
PubMed 37065001Killikelly C, Zhou N, Merzhvynska M, Stelzer EM, Dotschung T, Rohner S, Sun LH, Maercker A. Development of the international prolonged grief disorder scale for the ICD-11: Measurement of core symptoms and culture items adapted for chinese and german-speaking samples. J Affect Disord. 2020 Dec 1;277:568-576. doi: 10.1016/j.jad.2020.08.057. Epub 2020 Aug 27.
PubMed 32896722Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Lenferink, L. I. M., Terbrack, E., van Eersel, J. H. W., Zuidersma, M., Franzen, M., & Riese, H.; Fluctuations of prolonged grief disorder reactions in the daily life of bereaved people: An experience sampling study; Current Psychology; 2024; 43(47); 35821-35832.
Li J, Li Y, Wang Y, Jishi W, Fang J. What we know about grief intervention: a bibliometric analysis. Front Psychiatry. 2023 Aug 4;14:1152660. doi: 10.3389/fpsyt.2023.1152660. eCollection 2023.
PubMed 37608997Lowe B, Kroenke K, Herzog W, Grafe K. Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9). J Affect Disord. 2004 Jul;81(1):61-6. doi: 10.1016/S0165-0327(03)00198-8.
PubMed 15183601Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
PubMed 11983645Nummenmaa L, Glerean E, Hari R, Hietanen JK. Bodily maps of emotions. Proc Natl Acad Sci U S A. 2014 Jan 14;111(2):646-51. doi: 10.1073/pnas.1321664111. Epub 2013 Dec 30.
PubMed 24379370Pop-Jordanova N. Grief: Aetiology, Symptoms and Management. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2021 Oct 26;42(2):9-18. doi: 10.2478/prilozi-2021-0014.
PubMed 34699700Prigerson HG, Boelen PA, Xu J, Smith KV, Maciejewski PK. Validation of the new DSM-5-TR criteria for prolonged grief disorder and the PG-13-Revised (PG-13-R) scale. World Psychiatry. 2021 Feb;20(1):96-106. doi: 10.1002/wps.20823.
PubMed 33432758
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DayBreak: A Pilot Randomised Trial of a Grief Support App for Adults Experiencing Bereavement
- ClinicalTrials.gov ID
- NCT07862244
- Acronym / sponsor ID
- PRE.2026.067
- Conditions
- Grief
- Keywords
- Grief, Loss, Ecological Momentary Intervention, App, Grief Support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical Research Council Cognition and Brain Sciences UnitOther government
- Collaborators
- University of Zurich
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The 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.
The 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.
Detailed description
Rationale:
Grief 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.
Following 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.
Whilst 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.
A 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.
In 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.
Design:
This 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.
Participants 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.
A 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).
Outcomes:
The 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.
Secondary 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.
Exploratory 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).
Randomisation and blinding:
Stratified 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Daybreak first (Daybreak then waiting list) | Experimental | Behavioral: Self-guided grief app (Daybreak), Other: Waiting listFour weeks of app use, followed by four weeks of 'waiting' for follow up assessment. Participants 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). |
| Waiting list first (waiting list then Daybreak) | Experimental | Behavioral: Self-guided grief app (Daybreak), Other: Waiting listFour weeks of waiting list, followed by four weeks of app use. Participants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18+
- Fluent in English (reading and writing)
- GP in the UK
- Capable of giving informed consent
- Loss of a loved one at least three months ago
Key exclusion criteria (5 listed)
- High risk of suicidal intent or self-harm
- Current psychiatric inpatient stay
- Current psychological treatment for grief
- Diagnosis of PGD or PTSD - If loss less than 6 months ago needs to score below clinical cut-off on PG-13-R
- Severe cognitive impairment or learning difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. Treatment adherence is measured by engagement with app content and percentage of prompts filled out. Each arm experiences this treatment condition at a different timepoint | Behavioural | Daybreak first (Daybreak then waiting list), Waiting list first (waiting list then Daybreak) |
| Waiting listWaitlist - Participants are instructed to wait for four weeks until the next assessment. | Other | Daybreak first (Daybreak then waiting list), Waiting list first (waiting list then Daybreak) |
Primary outcome
User Version of the Mobile Application Rating Scale (uMARS)
Time frame: After App use (at either 4 or 8 weeks, depending on arm)
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.
International Prolonged Grief Disorder Scale (IPGDS)
Time frame: At Baseline, 4 weeks and 8 weeks.
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.
5 secondary outcomes
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: At Baseline, 4 weeks and 8 weeks.
Patient Health Questionnaire (PHQ-9)
Time frame: At Baseline, 4 weeks and 8 weeks.
Work and Social Adjustment Scale (WSAS)
Time frame: At Baseline, 4 weeks and 8 weeks.
International Trauma Questionnaire (ITQ)
Time frame: At Baseline, 4 weeks and 8 weeks.
Oxford Grief - Social Disconnection Scale (OG-SD)
Time frame: At Baseline, 4 weeks and 8 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 25716103Arizmendi BJ, O'Connor MF. What is "normal" in grief? Aust Crit Care. 2015 May;28(2):58-62; quiz 63. doi: 10.1016/j.aucc.2015.01.005. Epub 2015 Feb 21.
- Background: PubMed 35227403Bernstein EE, Bentley KH, Nock MK, Stein MB, Beck S, Kleiman EM. An Ecological Momentary Intervention Study of Emotional Responses to Smartphone-Prompted CBT Skills Practice and the Relationship to Clinical Outcomes. Behav Ther. 2022 Mar;53(2):267-280. doi: 10.1016/j.beth.2021.09.001. Epub 2021 Sep 24.
- Background: PubMed 30178492Cloitre M, Shevlin M, Brewin CR, Bisson JI, Roberts NP, Maercker A, Karatzias T, Hyland P. The International Trauma Questionnaire: development of a self-report measure of ICD-11 PTSD and complex PTSD. Acta Psychiatr Scand. 2018 Dec;138(6):536-546. doi: 10.1111/acps.12956. Epub 2018 Sep 3.
- Background: PubMed 34876429Eklund R, Eisma MC, Boelen PA, Arnberg FK, Sveen J. Mobile app for prolonged grief among bereaved parents: study protocol for a randomised controlled trial. BMJ Open. 2021 Dec 7;11(12):e052763. doi: 10.1136/bmjopen-2021-052763.
- Background: PubMed 40262368Ergun TD, Ten Klooster PM, Bohlmeijer ET, Westerhof GJ, Franzen M, Lenferink LIM. Assessing prolonged grief symptoms using experience sampling methodology: The development of the prolonged grief symptoms - short ecological assessment (PGS-SEA) scale. Compr Psychiatry. 2025 Jul;140:152597. doi: 10.1016/j.comppsych.2025.152597. Epub 2025 Apr 16.
- Background: PubMed 37065001Killikelly C, Maercker A. The Cultural Supplement: A New Method for Assessing Culturally Relevant Prolonged Grief Disorder Symptoms. Clin Psychol Eur. 2023 Mar 31;5(1):e7655. doi: 10.32872/cpe.7655. eCollection 2023 Mar.
- Background: PubMed 32896722Killikelly C, Zhou N, Merzhvynska M, Stelzer EM, Dotschung T, Rohner S, Sun LH, Maercker A. Development of the international prolonged grief disorder scale for the ICD-11: Measurement of core symptoms and culture items adapted for chinese and german-speaking samples. J Affect Disord. 2020 Dec 1;277:568-576. doi: 10.1016/j.jad.2020.08.057. Epub 2020 Aug 27.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- BackgroundLenferink, L. I. M., Terbrack, E., van Eersel, J. H. W., Zuidersma, M., Franzen, M., & Riese, H.; Fluctuations of prolonged grief disorder reactions in the daily life of bereaved people: An experience sampling study; Current Psychology; 2024; 43(47); 35821-35832.
- Background: PubMed 37608997Li J, Li Y, Wang Y, Jishi W, Fang J. What we know about grief intervention: a bibliometric analysis. Front Psychiatry. 2023 Aug 4;14:1152660. doi: 10.3389/fpsyt.2023.1152660. eCollection 2023.
- Background: PubMed 15183601Lowe B, Kroenke K, Herzog W, Grafe K. Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9). J Affect Disord. 2004 Jul;81(1):61-6. doi: 10.1016/S0165-0327(03)00198-8.
- Background: PubMed 11983645Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
- Individual participant dataSharing planned: Yes. Anonymised individual-level data from the trial will be made publicly available via an open-access data repository at the conclusion of the study. Shared data will include de-identified participant-level outcome measures, demographic and loss related variables, all parameters consistent with informed consent and institutional data-sharing policies.
Related trials for Grief
Recruiting
Technology-supported Interventions for Prolonged Grief Disorder (PGD)
Prolonged Grief Disorder (PGD)
Recruiting
Accelerated Resolution Therapy for Early Maladaptive Grief
Grief
Not yet recruiting
Mechanisms Underlying Late-Life Prolonged Grief Disorder
Prolonged Grief Disorder
Active, not recruiting
Iyengar Yoga for Prolonged Grief Disorder
Prolonged Grief Disorder
Active, not recruiting
Musical Playlist of the Grief Journey
Music Therapy, Bereavement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clare Killikelly, PhD principal investigator
University of Zurich
Tim Dalgleish, PhD study director
MRC Cognition and Brain Sciences Unit, University of Cambridge, UK
Anna Bevan, PhD study director
MRC Cognition and Brain Sciences Unit, University of Cambridge, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-guided grief app (Daybreak) and Waiting list in people with Grief, run by Medical Research Council Cognition and Brain Sciences Unit at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ido Shalev, PhD (+447541030621, is622@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User Version of the Mobile Application Rating Scale (uMARS) (time frame: After App use (at either 4 or 8 weeks, depending on arm)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07862244, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.