A Grief Support App for Adults Experiencing Bereavement
ConditionGrief
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical Research Council Cognition and Brain Sciences Unit
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18+
Fluent in English (reading and writing)
GP in the UK
Capable of giving informed consent
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Self-guided grief app (Daybreak)
BehavioralSelf-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 list
Other interventionWaitlist - Participants are instructed to wait for four weeks until the next assessment.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Daybreak first (Daybreak then waiting list)Experimental treatment 2 interventions
Group B: Waiting list first (waiting list then Daybreak)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
After App use (at either 4 or 8 weeks, depending on arm)2
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.
Time frame
At Baseline, 4 weeks and 8 weeks.Secondary outcomes
1
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.
Time frame
At Baseline, 4 weeks and 8 weeks.2
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.
Time frame
At Baseline, 4 weeks and 8 weeks.3
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.
Time frame
At Baseline, 4 weeks and 8 weeks.4
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.
Time frame
At Baseline, 4 weeks and 8 weeks.Other outcomes
1
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).
Time frame
At Baseline and post-treatment2
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 \[mental health condition\]").
Time frame
Baseline3
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.
Time frame
Screening (if less than 6 months since loss)4
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.
Time frame
Twice daily for four weeks during intervention period.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical Research Council Cognition and Brain Sciences Unit
Lead sponsor
University of Zurich
Collaborator
Source ClinicalTrials.gov
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