Complicated Grief DisorderNCT06093113
Alba - a Mobile App to Provide Bereavement Support for Adolescents in Grief
A study testing Alba - Youth in grief in people with Complicated Grief Disorder, run by Uppsala University at 1 site in Sweden.
Trial summary
The goal of this two-armed randomised controlled trial is to evaluate a psychosocial self-management mobile app providing bereavement support to adolescents in grief. The main questions it aims to answer are: 1. How do adolescents in grief interact with and use the app? 2. Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Complicated Grief Disorder
- What is being tested?
- Alba - Youth in grief
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSweden
- Study dates
- 10 Dec 2023to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12-19 years old
- Lost a parent or sibling to any cause of death at least one months ago
- Comprehend the Swedish language
- Have access to a mobile/smartphone
Who cannot join
- Loss occurred less than one month ago
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of a Mobile App to Provide Bereavement Support for Adolescents in Grief
The goal of this two-armed randomised controlled trial is to evaluate a psychosocial self-management mobile app providing bereavement support to adolescents in grief. The main questions it aims to answer are:
- How do adolescents in grief interact with and use the app?
- How do bereaved adolescents perceive the usability of the app?
- Is the intervention feasible?
- How is the meaningfulness of using the app perceived among adolescents in grief and what effect do the adolescents perceive it to have on their grieving process and everyday life?
- Does access to the app affect symptoms of grief, complicated grief, post-traumatic stress and depression among bereaved adolescents?
Read more
Participants will:
- Test the app (intervention group) or a website containing (control group) psychoeducation for 2 months
- Fill out online questionnaires regarding their mental health (baseline, post, 6 months, 12 months).
- Fill out an online questionnaire regarding the acceptability and usability of the app (intervention group)
- Be asked to participate in narrative interviews (intervention group)
Researchers will compare the intervention group with the control group to see if the app has an effect on bereaved adolescents mental health.
Read the detailed description
The need for professional support is evident in teenagers' grief and approximately half of the bereaved teenagers in Sweden report feeling in need of some type of help or support. Some teenagers in bereavement find it hard to seek help or that seeking help is embarrassing. It could also be hard to recognise if and when they need help, as they might have a low level of knowledge regarding symptoms of grief. Children and teenagers in need of preventive interventions often do not receive the care they need, but effective preventive interventions can support bereaved teenagers to work through their grief adaptively and thus decrease the risk of the negative consequences and complications of loss, such as experiencing complicated grief, depression or post-traumatic stress. This may in turn reduce the need for clinical interventions for psychopathology.
A mobile app could be used as a platform for bereavement support and be a comforting aid available to bereaved teenagers without drawing the attention or knowledge of their peers. Web-based support can lead to younger people seek help at an earlier stage, due to lower stigmatisation. Mobile apps offer additional advantage over face-to-face and web-based interventions because of their availability, accessibility, the immediate support they can provide, and their anonymity (e.g., reducing barriers to seeking help for grief), low costs, and possible tailoring to the user (e.g., the user is in control over when and how to use the app). Therefore, mobile health (mHealth) offers a particularly great and ubiquitous platform for delivering mental health and supportive interventions to teenagers. However, there are few apps for children and teenagers and the benefit of mHealth for children is largely not evaluated. With this background, the research group has using Patient- and Public Involvement worked with 6 bereaved teenagers to develop a psychosocial self-management mobil app for adolescents in grief.
The overall purpose of this project is to evaluate a psychosocial self-management mobile app to provide bereavement support and self-help strategies to adolescents who have lost a parent or a sibling in fatal causes, in a randomised controlled trial. In order to evaluate the acceptability and feasibility of the intervention in bereaved teenagers, the trial will include a pilot phase during which results for recruitment, drop-out randomisation, retention rates and data collection will be used to identify and analyse potential issues with the trial before progression. Data related to the feasibility of the intervention and the accessibility of the app will in addition be collected during the post-assessment and be used to identify needed modifications for the app and the intervention. This data will, along with user-data, be used for evaluation of how bereaved adolescents use and engage with the app. To evaluate the effects of the app on bereaved adolescents mental health symptoms of grief, complicated grief, depression and post-traumatic stress will be measure at baseline, post 2 months of app/website usage, and at 6- and 12 months post randomisation, and compared between the intervention- and control group. Finally, to evaluate the meaningfulness of using the app and the self-perceived effect of the app intervention on bereaved adolescents' grieving process and everyday life, 10-15 participants of the intervention group will be asked to participate in narrative interviews. participants will be recruited using advertisement and in cooperation with non-profit organisations.
- Conditions
- Complicated Grief Disorder
- Being tested
- Alba - Youth in grief, Control website
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alba - Youth in griefBehavioural
The app will build on principles of cognitive behavioural theory and therapy (CBT) and contains five main sections: Learning, Self-assessment, Manage symptoms, Find support and a Personal space.
Control websiteBehavioural
The website will contain information about grief and grief reactions similar to some of the information given in the app.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will complete a web based pre-assessment and then be given access to the app "Alba" for two months followed by a web based post-assessment including questions regarding their experiences of using the app, and follow-up questionnaires. Receives: Behavioral: Alba - Youth in grief |
| Control group | Active comparator | Participants will get access to a website containing information about grief and grief reactions. Receives: Behavioral: Control website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (from baseline) in Traumatic Grief Inventory-Kids-Self report
16-item, self-rated measure of complicated grief, total score ranges from 16 to 80, where higher score indicates more symptoms
Measured: 2, 6 and 12 months
Secondary outcomes (3)
Change (from baseline) in Hogan Inventory for Bereavement- Short Form for Children and Adolescents
21-item, self-rated measure of grief and personal growth, total score ranges from 10 to 50 for the subscale grief with a higher score indicating more symptoms, and a total score of 11 to 55 for the subscale personal growth.
Measured: 2, 6 and 12 months
Change (from baseline) in Child PTSD Symptom Scale
27 item, self-rated measure of post-traumatic stress, total score ranges from 0 to 80 for the 20 symptom items, where a higher score indicating more symptoms
Measured: 2, 6 and 12 months
Change (from baseline) in Patient Health Questionnaire-9
9 item, self-rated measure of depression, total score ranges from 0 to 27, and a higher score indicates more symptoms
Measured: 2, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start10 Dec 2023
- Primary completion1 May 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complicated Grief DisorderStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Intervention group and active control group.
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josefin Sveen, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093113
- Sponsor's protocol ID
- 2023-04309-01
- Other IDs
- 2023
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2023
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Publications
Rhodin R, Eklund R, Silven Hagstrom A, Gjestad R, Dyregrov A, Sveen J. Effects and User-Reported Experiences of a Self-Management Mobile Health App for Grieving Adolescents: Randomized Controlled Trial. J Med Internet Res. 2026 Jul 15;28:e94777. doi: 10.2196/94777.
PubMed 42459115
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Mobile App to Provide Bereavement Support for Adolescents in Grief
- ClinicalTrials.gov ID
- NCT06093113
- Acronym / sponsor ID
- 2023-04309-01
- Conditions
- Complicated Grief Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 23 Oct 2023 (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.
The goal of this two-armed randomised controlled trial is to evaluate a psychosocial self-management mobile app providing bereavement support to adolescents in grief. The main questions it aims to answer are:
- How do adolescents in grief interact with and use the app?
- How do bereaved adolescents perceive the usability of the app?
- Is the intervention feasible?
- How is the meaningfulness of using the app perceived among adolescents in grief and what effect do the adolescents perceive it to have on their grieving process and everyday life?
- Does access to the app affect symptoms of grief, complicated grief, post-traumatic stress and depression among bereaved adolescents?
Participants will:
- Test the app (intervention group) or a website containing (control group) psychoeducation for 2 months
- Fill out online questionnaires regarding their mental health (baseline, post, 6 months, 12 months).
- Fill out an online questionnaire regarding the acceptability and usability of the app (intervention group)
- Be asked to participate in narrative interviews (intervention group)
Researchers will compare the intervention group with the control group to see if the app has an effect on bereaved adolescents mental health.
Detailed description
The need for professional support is evident in teenagers' grief and approximately half of the bereaved teenagers in Sweden report feeling in need of some type of help or support. Some teenagers in bereavement find it hard to seek help or that seeking help is embarrassing. It could also be hard to recognise if and when they need help, as they might have a low level of knowledge regarding symptoms of grief. Children and teenagers in need of preventive interventions often do not receive the care they need, but effective preventive interventions can support bereaved teenagers to work through their grief adaptively and thus decrease the risk of the negative consequences and complications of loss, such as experiencing complicated grief, depression or post-traumatic stress. This may in turn reduce the need for clinical interventions for psychopathology.
A mobile app could be used as a platform for bereavement support and be a comforting aid available to bereaved teenagers without drawing the attention or knowledge of their peers. Web-based support can lead to younger people seek help at an earlier stage, due to lower stigmatisation. Mobile apps offer additional advantage over face-to-face and web-based interventions because of their availability, accessibility, the immediate support they can provide, and their anonymity (e.g., reducing barriers to seeking help for grief), low costs, and possible tailoring to the user (e.g., the user is in control over when and how to use the app). Therefore, mobile health (mHealth) offers a particularly great and ubiquitous platform for delivering mental health and supportive interventions to teenagers. However, there are few apps for children and teenagers and the benefit of mHealth for children is largely not evaluated. With this background, the research group has using Patient- and Public Involvement worked with 6 bereaved teenagers to develop a psychosocial self-management mobil app for adolescents in grief.
The overall purpose of this project is to evaluate a psychosocial self-management mobile app to provide bereavement support and self-help strategies to adolescents who have lost a parent or a sibling in fatal causes, in a randomised controlled trial. In order to evaluate the acceptability and feasibility of the intervention in bereaved teenagers, the trial will include a pilot phase during which results for recruitment, drop-out randomisation, retention rates and data collection will be used to identify and analyse potential issues with the trial before progression. Data related to the feasibility of the intervention and the accessibility of the app will in addition be collected during the post-assessment and be used to identify needed modifications for the app and the intervention. This data will, along with user-data, be used for evaluation of how bereaved adolescents use and engage with the app. To evaluate the effects of the app on bereaved adolescents mental health symptoms of grief, complicated grief, depression and post-traumatic stress will be measure at baseline, post 2 months of app/website usage, and at 6- and 12 months post randomisation, and compared between the intervention- and control group. Finally, to evaluate the meaningfulness of using the app and the self-perceived effect of the app intervention on bereaved adolescents' grieving process and everyday life, 10-15 participants of the intervention group will be asked to participate in narrative interviews. participants will be recruited using advertisement and in cooperation with non-profit organisations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group and active control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Alba - Youth in griefParticipants will complete a web based pre-assessment and then be given access to the app "Alba" for two months followed by a web based post-assessment including questions regarding their experiences of using the app, and follow-up questionnaires. |
| Control group | Active comparator | Behavioral: Control websiteParticipants will get access to a website containing information about grief and grief reactions. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 12-19 years old
- Lost a parent or sibling to any cause of death at least one months ago
- Comprehend the Swedish language
- Have access to a mobile/smartphone
Key exclusion criteria (1 listed)
- Loss occurred less than one month ago
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 |
|---|---|---|
| Alba - Youth in griefThe app will build on principles of cognitive behavioural theory and therapy (CBT) and contains five main sections: Learning, Self-assessment, Manage symptoms, Find support and a Personal space. | Behavioural | Intervention group |
| Control websiteThe website will contain information about grief and grief reactions similar to some of the information given in the app. | Behavioural | Control group |
Primary outcome
Change (from baseline) in Traumatic Grief Inventory-Kids-Self report
Time frame: 2, 6 and 12 months
16-item, self-rated measure of complicated grief, total score ranges from 16 to 80, where higher score indicates more symptoms
3 secondary outcomes
Change (from baseline) in Hogan Inventory for Bereavement- Short Form for Children and Adolescents
Time frame: 2, 6 and 12 months
Change (from baseline) in Child PTSD Symptom Scale
Time frame: 2, 6 and 12 months
Change (from baseline) in Patient Health Questionnaire-9
Time frame: 2, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Derived from this study: PubMed 42459115Rhodin R, Eklund R, Silven Hagstrom A, Gjestad R, Dyregrov A, Sveen J. Effects and User-Reported Experiences of a Self-Management Mobile Health App for Grieving Adolescents: Randomized Controlled Trial. J Med Internet Res. 2026 Jul 15;28:e94777. doi: 10.2196/94777.
- Individual participant dataSharing planned: Yes. All collected IPD
Related trials for Complicated Grief Disorder
Recruiting
Transcranial Magnetic Stimulation to Treat Prolonged Grief Disorder
Prolonged Grief Disorder, Complicated Grief
Not yet recruiting
Sleep Difficulties After Loss: Exploring the Beneficial Effect of Brief Behavioral Therapy for Insomnia in a Sample of Bereaved Individuals
Insomnia, Insomnia Chronic
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. This study is not recruiting at the moment.
Josefin Sveen, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alba - Youth in grief in people with Complicated Grief Disorder, run by Uppsala University at 1 site in Sweden.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Nov 2024. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change (from baseline) in Traumatic Grief Inventory-Kids-Self report (time frame: 2, 6 and 12 months). 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 NCT06093113, which also lists 1 linked publication.
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 1 Nov 2024.