NCT06932120

Technology-supported Interventions for Prolonged Grief Disorder (PGD)

Technology-supported Interventions for Prolonged Grief Disorder in Adults a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 141 (estimated)
• Sponsor: Universitat Jaume I · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The main aim of this project is to test the efficacy of two formats of delivering an internet- based treatment(GROw) for Prolonged Grief Disorder (PGD) in order to enhance treatment adherence: in a blended format (that combines self-applied treatment online with face-to face sessions with a therapist by videoconference: BF-GROw) and self-applied online format supported by Ecological Momentary Assessment (EMAs) and Ecological Momentary Interventions (EMIs) (iGROw), compared with a waiting list (WL) control group in a community sample of patients with the diagnosis of PGD. The general initial hypothesis is that both treatment conditions (blended format and self-applied format supported by EMAs and EMIs) will significantly produce an improvement in grief symptoms, compared to the WL control group.

Detailed description

The grieving process is defined as a painful response, including cognitive, emotional and behavioural components, following the death of a loved one. This response of unique intensity and duration for each individual may involve symptoms such as intense emotions, worry, memories of the deceased and a decrease in activity, which will diminish over time. However, it is estimated that 10% of the population who experience the death of a loved one eventually develop prolonged grief disorder (PGD). There are now evidence-based psychological treatments that are effective in treating PGD. However, 70% of people who need them do not receive them. According to the scientific literature, self-administered technology-supported interventions have been developed to treat this problem and have demonstrated multiple benefits. This study aims to test the efficacy and efficiency of different treatment options that exist for this disorder through a randomized controlled trial. Participants will be adults with a diagnosis of PGD, according to ICD-11 criteria for PGD (WHO,2018) and will be randomly distributed into three groups: 1) blended intervention (BF-Grow group); 2) self-applied intervention supported by EMAs and EMIs (iGrow group); and 3) waiting-list group (WL control group). Both treatment groups will receive the same treatment (GROw) consisting of 8 modules: 1. Welcoming, 2. Understanding reactions to loss, 3. Coping with loss, 4. Loss integration and restoration (first steps), 5. Deepening integration and restoration of loss, 6. Consolidating loss integration and restoration, 7. Self-care, guilt and forgiveness in the grieving process and 8. Evaluating progress and looking to the future. On the one hand, group 1 (BF-Grow) will receive a treatment module every 10-12 days and in addition an individual session of approximately 30 minutes with a therapist. On the other hand, group 2 (iGrow) will carry out the entire intervention on a self-applied basis only and will be able to access the next module 7 days after the start of the previous one. In addition, this condition will be supported by an App which contains EMA and EMI tools. Participants will be evaluated at baseline, post-treatment, and 3- and 12-month follow-ups. This study will follow the Consolidated Standards for Reporting Trials (CONSORT)statement and the SPIRIT guidelines (Standard Protocol Items: Recommendations for Intervention Trials). Specific objectives of the study include: examine the efficacy of BF-Grow and iGROw intervention formats compared to a WL group in the post-treatment and In addition, post hoc comparisons will be conducted among the adjusted means of the three groups.

Conditions

• Prolonged Grief Disorder (PGD)

Interventions

Type	Name	Description
BEHAVIORAL	Internet-based treatment (GROw) combined with face-to-face videoconferencing sessions with a therapist in BF-GROw group	The treatment that will be applied is an internet-based treatment (GROw) (Tur et al., 2021, 2022)combined with face-to-face videoconferencing sessions with a therapist (blended) . This protocol has 8 weekly modules and lasts between 8 and 12 weeks. The modules included are: 1) Welcome (starting the program), 2) Understanding reactions to loss, 3) Coping with loss, 4) Loss integration and restoration (first steps), 5) Deeping integration and restoration of loss, 6) Consolidating loss integration and restoration, 7) Self-care, guilt, and forgiveness in the grieving process, and 8) Evaluating progress and looking to the future. BF-GROw group will receive a treatment module every 10-12 days. This protocol is available online: (https://psicologiaytecnologia.labpsitec.es).
BEHAVIORAL	Internet-based treatment (GROw) supported by the App developed which contains the EMA and EMI tools in iGROw group.	The treatment that will be applied is an internet-based treatment (GROw) (Tur et al., 2021, 2022) supported by the App developed which contains the Ecological Momentary Assessment (EMA) and Ecological Momentary Intervention (EMI) tools . This protocol has 8 weekly modules and lasts between 8 and 12 weeks. The modules included are: 1) Welcome (starting the program), 2) Understanding reactions to loss, 3) Coping with loss, 4) Loss integration and restoration (first steps), 5) Deeping integration and restoration of loss, 6) Consolidating loss integration and restoration, 7) Self-care, guilt, and forgiveness in the grieving process, and 8) Evaluating progress and looking to the future. This protocol is available online: (https://psicologiaytecnologia.labpsitec.es).

Timeline

• Start date: 2025-11-10
• Primary completion: 2026-11-10
• Completion: 2027-09-30
• First posted: 2025-04-17
• Last updated: 2026-01-21

Locations

2 sites across 1 country: Spain