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

NCT04552717 | Completed

• 1 other identifier: 2020-01704
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Prolonged Grief Disorder

Outcome Measures

Primary Outcomes (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

  3, 6 and 12 months

Secondary Outcomes (6)

• Change (from baseline) in Posttraumatic stress disorder checklist for DSM-5, PCL-5

  3, 6 and 12 months

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

  3, 6 and 12 months

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

  3, 6 and 12 months

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

  3, 6 and 12 months

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

  3, 6 and 12 months

Other Outcomes (3)

• Feasibility of the intervention and the application

  3 months

• Acceptability of the intervention and the application

  3 months

• Participants demographics

  0 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants 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.

Other: My Grief

Waitlist controll

NO INTERVENTION

Participants will get access to the app after three months.

Interventions

My Grief OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

National Centre for Disaster Psychiatry, Department of Neuroscience, Uppsala university

Uppsala, 75185, Sweden

Location

Related Publications (3)

• 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.

  PMID: 39540459 DERIVED

• 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.

  PMID: 35546953 DERIVED

• 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.

  PMID: 34876429 DERIVED

MeSH Terms

Conditions

Prolonged Grief Disorder

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Josefin Sveen, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: wait-list controll and intervention group

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 17, 2020
• Study Start: September 15, 2021
• Primary Completion: December 31, 2022
• Study Completion: May 8, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

SE (1)