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Prolonged Grief DisorderNCT04552717

My Grief - an App for Parents With Prolonged Grief After Losing a Child to Cancer

A study testing My Grief in people with Prolonged Grief Disorder, run by Uppsala University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Bereaved parents are at increased risk of developing mental and physical health problems and bereavement is even associated with an increased risk of mortality, especially in mothers. Prolonged grief disorder (PGD) are persistent and intensive grief reactions which can persist for years. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prolonged Grief Disorder
What is being tested?
My Grief
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
1 siteSweden
Study dates
15 Sep 2021to 8 May 2023
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Parents/caregivers of children who have died of cancer, at the earliest 12 month ago
  • Have symptoms of prolonged grief (PGD)
  • Understand Swedish language
  • Have access to a smartphone

Who cannot join

  • Ongoing severe psychiatric problems (e.g. suicidal thoughts, psychosis)

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • National Centre for Disaster Psychiatry, Department of Neuroscience, Uppsala university

    Uppsala, 75185

Other trials in Sweden

About this study

Official title: My Grief - Development and Evaluation of an App for Parents With Prolonged Grief Disorder After Losing a Child to Cancer: a Randomized Controlled Trial

Bereaved parents are at increased risk of developing mental and physical health problems and bereavement is even associated with an increased risk of mortality, especially in mothers. Prolonged grief disorder (PGD) are persistent and intensive grief reactions which can persist for years. It is characterized by an intense and lasting yearning for the deceased, intense emotional pain, such as difficulty accepting the loss and an inability to experience positive mood. Parents are among the most vulnerable to develop PGD.

The goal is to increase the accessibility to evidence-based and cost-effective interventions for parents of children who have died of cancer, and thus facilitate the grieving process and decrease the risk for parents to develop long-term distress.

Read more

Specific aims are:

  • To evaluate the acceptability and feasibility of a mobile app, "My Grief ", a self-help app for prolonged grief, in parents who lost a child to cancer.
  • To evaluate possible beneficial effects of the mobile app on parents' mental health.
Read the detailed description

There is a lack of studies evaluating the effect of interventions for bereaved parents. Thus, there is a need for accessible interventions with documented efficacy for preventing or reducing negative mental health consequences after the loss of a child. Today, many individuals carry smartphones and these devices can be used to access self-help interventions aiming to improve both physical and mental health. Currently, there are an excess of apps available for smartphone users that assert that they help people with their physical or mental health. However, for most of these apps, there is a lack of empirical support, i.e., their efficacy is unknown. It is therefore important to evaluate mobile apps in scientific studies with rigorous designs. In addition, before conducting rigorous studies of novel psychosocial interventions, such as a mobile app, it is important to conduct more basic work evaluating development and feasibility of the intervention. One such self-help app, the PTSD Coach, has been evaluated in a randomized controlled trial conducted with traumatized participants recruited from the community, which found that access to the PTSD Coach app was associated with improvements in posttraumatic stress (PTS) symptoms, depression, and psychosocial functioning. The PTSD Coach app is based on cognitive behavioural therapy (CBT) principles and there is a growing body of evidence that elements of CBT are effective interventions for prolonged grief. Thus, an app targeting prolonged grief using elements of CBT could potentially be effective in improving the mental health in bereaved parents. To our knowledge no such app has been developed and evaluated. The Grief Coach app will be based on the smartphone app PTSD Coach. A Swedish version of the PTSD Coach has been developed and a pilot study has been conducted as well as an ongoing RCT. Consultant programmers at Uppsala University will develop the mobile app. The content of the app will be developed together with experts in the field of grief, inspired by other grief apps and CBT therapy manuals, to modify parts of the PTSD Coach app to grief.

The main aim of this study is to examine the effectiveness of the app My Grief as compared to a waiting list comparison in reducing symptoms of prolonged grief in bereaved parents. The primary hypothesis is that the parents in the intervention group will report decreased levels of prolonged grief symptoms after having used the app. A second aim is to examine the effect of the app on related mental health problems (posttraumatic stress symptoms, depression symptoms, quality of life) and cognitive behavioral variables putatively explaining the effect of CBT techniques (i.e., grief avoidance, grief rumination and negative grief cognitions). The secondary hypotheses are that the parents in the intervention group will report improved mental health (i.e., lower symptom levels of depression and posttraumatic stress, higher quality of life), and lower grief avoidance, grief rumination, negative grief-related cognitions. A third aim is to evaluate the feasibility of the app, including participant satisfaction, evaluation of the app's strengths and weaknesses, and adverse events.

Potential participants are identified using the Swedish Childhood Cancer Registry, the Cause of Death Registry, and the Swedish Population Register at the Swedish Tax Agency. By linking the Cause of Death Registry with the Swedish Childhood Cancer Registry, children diagnosed with a malignancy and who died due to the malignancy 1 to 10 years previously will be identified. Next, the children's parents/caregivers are identified through the Swedish Population Register and will be sent a letter with an invitation to participate in the study. Participants will complete a web based pre-assessment and then given access to the app for three months followed by a web based post-assessment and an interview via telephone regarding their experiences of using the app, with follow-ups att 6 and 12 months.

Being tested
My Grief
Medical subject headings
Prolonged Grief Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • My GriefOther

    The app will build on principles of cognitive behavioural theory and therapy (CBT) and contains four main sections: Learning, Self-assessment, Manage symptoms and Find support.

Study groups in NCT04552717
Study groupRoleWhat they receive
InterventionExperimentalParticipants will complete a web based pre-assessment and then given access to the app "My Grief" for three months followed by a web based post-assessment and an interview via telephone regarding their experiences of using the app, and follow-up questionnaires.
Receives: Other: My Grief
Waitlist controllNo interventionParticipants will get access to the app after three months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change (from baseline) in Prolonged Grief Disorder-13 instrument, PG-13

    13-item, self-rated measure of prolonged grief, total score ranges from 11 to 55, where a higher score indicates more symptoms

    Measured: 3, 6 and 12 months

Secondary outcomes (6)
  1. Change (from baseline) in Posttraumatic stress disorder checklist for DSM-5, PCL-5

    20-item, self-rated measure of posttraumatic stress disorder, total score range from 0-80, and a higher score indicates more symptoms

    Measured: 3, 6 and 12 months

  2. Change (from baseline) in Patient Health Questionnaire, PHQ-9

    9-item, self-rated measure of depression, total score ranges from 0-27, and a higher score indicates more symptoms

    Measured: 3, 6 and 12 months

  3. Change (from baseline) in Utrecht Grief Rumination Scale, UGRS

    15-item, self-rated measure of grief rumination, total scores range from 15 to 75, and a higher score indicates more grief rumination

    Measured: 3, 6 and 12 months

  4. Change (from baseline) in Depressive and Anxious Avoidance in Prolonged Grief questionnaire

    9-item, self-rated measure of avoidance, total score ranges from 9-72, and a higher score indicates more avoidance

    Measured: 3, 6 and 12 months

  5. Change (from baseline) in 18 items from the Grief Cognitions Questionniare, GCQ

    18-items, self-rated measure of grief cognitions, total score ranges from 0-90, and a higher score indicates more grief cognitions

    Measured: 3, 6 and 12 months

  6. Change (from baseline) in Brunnsviken Brief Quality of Life Inventory, BBQ

    12 items, self-rated measure of quality of life, covering six different life domains, Total score ranges from 0-96, higher scores indicates higher quality of life.

    Measured: 3, 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.

  1. First posted17 Sep 2020
  2. Study start15 Sep 2021
  3. Primary completion31 Dec 2022
  4. Study completion8 May 2023

Resources

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
wait-list controll and intervention group
Masking
None (open label)
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04552717
Sponsor's protocol ID
2020-01704
Status last verified
May 2023
First submitted
10 Sep 2020
Last updated
11 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD

Publications

  • Sveen J, Eisma MC, Boelen PA, Arnberg FK, Eklund R. My grief app for prolonged grief in bereaved parents: a randomised waitlist-controlled trial. Cogn Behav Ther. 2025 Jul;54(4):514-530. doi: 10.1080/16506073.2024.2429068. Epub 2024 Nov 14.

    PubMed 39540459
  • Eklund R, Eisma MC, Boelen PA, Arnberg FK, Sveen J. My Grief App for Prolonged Grief in Bereaved Parents: A Pilot Study. Front Psychiatry. 2022 Apr 25;13:872314. doi: 10.3389/fpsyt.2022.872314. eCollection 2022.

    PubMed 35546953
  • Eklund 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 34876429

Questions about this trial

What is this clinical trial studying?

A study testing My Grief in people with Prolonged 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: finished, as of the sponsor's last update on 11 May 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Prolonged Grief Disorder-13 instrument, PG-13 (time frame: 3, 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 NCT04552717, which also lists 3 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 11 May 2023.

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