Technology-supported Interventions for Prolonged Grief Disorder (PGD)

NCT06932120 | Recruiting

• 1 other identifier: UJaumeI_iGROw_1
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prolonged Grief Disorder (PGD)

Keywords

Prolonged grief disorder; Efficacy; Randomized controlled trial; Internet-based treatment; blended intervention; Ecological Momentary Assessment (EMA); Ecological Momentary Intervention (EMI)

Outcome Measures

Primary Outcomes (1)

• Change in the Inventory of Complicated Grief (ICG).

  The Inventory of Complicated Grief (ICG) is a self-administered instrument that assesses grief symptoms in adults. It is a simple instrument that allows distinguishing normal grief reactions from complicated ones.The instrument consists of 19 items written in the first person with five response options (Likert): 0; never 1; rarely 2; sometimes 3; often and 4; always. about the client's thoughts and behaviors related to immediate grief. The items assess the frequency of emotional, cognitive and behavioral symptoms characteristic of the grieving process.

  Immediately prior to treatment, Immediately after treatment, 3 months after treatment, 12 months after treatment

Secondary Outcomes (5)

• Change in Beck Depression Inventory-II (BDI-II).

  Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.

• Change in Typical Beliefs Questionnaire (TBQ).

  Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.

• Change in Overall Anxiety Severity and Impairment Scale (OASIS).

  Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.

• Change in Overall Depression Severity and Impairment Scale (ODSIS).

  Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.

• Change in Short-Form of the International Positive and Negative Affect Schedule (iPANAS).

  Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.

Other Outcomes (19)

• Change in Structured Clinical Interview for Complicated Grief (SCI-CG).

  Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.

• Change in Anxiety Disorders Interview Schedule (ADIS) Clinician Severity rating Scale .

  Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.

• Change in Quality of Life Index (QLI).

  Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.

Study Arms (3)

BF-Grow group: Blended Format group

EXPERIMENTAL

Arm 1: Experimental. BF-Grow group. Patients of the BF-GROw group will receive a treatment module every 10-12 days, in addition to an individual session by videoconference (approximately 30 minutes). In total they will receive between 8-10 sessions with the therapist. During these sessions, the therapist will be resolved.

Behavioral: Internet-based treatment (GROw) combined with face-to-face videoconferencing sessions with a therapist in BF-GROw group

iGROw group: Self-applied online format group

EXPERIMENTAL

Arm 2: Experimental. iGrow group. Patients of the iGrow group will carry out the treatment in a totally self-applied way. They will be able to access the next module once 7 days have elapsed since the start of the previous one. The total time of access to treatment will be about 12-14 weeks. This condition will be supported by the App developed which contains the EMA and EMI tools.

Behavioral: Internet-based treatment (GROw) supported by the App developed which contains the EMA and EMI tools in iGROw group.

Waiting List (WL) control group

NO INTERVENTION

Arm 3: Waiting List control group. Participants in the WL will answer the pre- and post-evaluation and they will be randomly assigned to one of the two treatment conditions after spending time on the waiting list (10-12 weeks) for ethical reasons.

Interventions

Internet-based treatment (GROw) supported by the App developed which contains the EMA and EMI tools in iGROw group. BEHAVIORAL

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).

iGROw group: Self-applied online format group

Internet-based treatment (GROw) combined with face-to-face videoconferencing sessions with a therapist in BF-GROw group BEHAVIORAL

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).

BF-Grow group: Blended Format group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being at least 18 years old.
• Meeting diagnostic criteria for Prolonged Grieft Disorder based on the International Classification of Diseases 11 edition (ICD-11).
• Sign an informed consent.
• Ability to understand and read Spanish.
• Ability to use a computer.
• Having an e-mail address.
• Having an internet connection and Access to a Smartphone.

You may not qualify if:

• Presence of high risk of suicide.
• Presence of axis I severe mental disorder: substance abuse or dependence, psychotic disorder, dementia, bipolar disorder; severe personality disorder or medical illness whose severity or characteristics prevent treatment.
• Receiving other psychological treatment during the study.
• An increase and/or change in the medication during the study period, in the case of receiving pharmacological treatment.

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (2)

Universitat Jaume I

Castellon, Castellón de La Plana, 12071, Spain

RECRUITING

Universitat Jaume I

Castellon, Castellón, 12071, Spain

NOT YET RECRUITING

Related Publications (7)

• WHO. (2018). ICD-11 international classification of diseases for mortality and morbidity statistics (11th revision). Retrieved from https://icd.who.int/ct11_2018/ icd11_mms/en/release#/

  BACKGROUND

• Wagner B, Rosenberg N, Hofmann L, Maass U. Web-Based Bereavement Care: A Systematic Review and Meta-Analysis. Front Psychiatry. 2020 Jun 24;11:525. doi: 10.3389/fpsyt.2020.00525. eCollection 2020.

  PMID: 32670101 BACKGROUND

• Tur C, Campos D, Suso-Ribera C, Kazlauskas E, Castilla D, Zaragoza I, Garcia-Palacios A, Quero S. An Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Prolonged Grief Disorder (PGD) in adults: A multiple-baseline single-case experimental design study. Internet Interv. 2022 Jul 7;29:100558. doi: 10.1016/j.invent.2022.100558. eCollection 2022 Sep.

  PMID: 35865996 BACKGROUND

• Tur C, Campos D, Herrero R, Mor S, Lopez-Montoyo A, Castilla D, Quero S. Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Adults with Prolonged Grief Disorder (PGD): A Study Protocol for a Randomized Feasibility Trial. BMJ Open. 2021 Jul 6;11(7):e046477. doi: 10.1136/bmjopen-2020-046477.

  PMID: 34230018 BACKGROUND

• Kessler RC, Demler O, Frank RG, Olfson M, Pincus HA, Walters EE, Wang P, Wells KB, Zaslavsky AM. Prevalence and treatment of mental disorders, 1990 to 2003. N Engl J Med. 2005 Jun 16;352(24):2515-23. doi: 10.1056/NEJMsa043266.

  PMID: 15958807 BACKGROUND

• Kazdin AE. Addressing the treatment gap: A key challenge for extending evidence-based psychosocial interventions. Behav Res Ther. 2017 Jan;88:7-18. doi: 10.1016/j.brat.2016.06.004.

  PMID: 28110678 BACKGROUND

• Dias N, Boring E, Johnson LA, Grossoehme DH, Murphy S, Friebert S. Developing a theoretically grounded, digital, ecological momentary intervention for parental bereavement care using the ORBIT model-Phase 1. Death Stud. 2024;48(10):1015-1024. doi: 10.1080/07481187.2021.1914239. Epub 2021 Apr 29.

  PMID: 33913789 BACKGROUND

MeSH Terms

Conditions

Prolonged Grief Disorder

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Soledad Quero, Ph.D and psychology

  Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón de la Plana, Spain.

  PRINCIPAL INVESTIGATOR

• Daniel Campos, Ph.D and psychology

  Department of Psychology and Sociology, Universidad de Zaragoza, Zaragoza, Spain.

  STUDY DIRECTOR

Central Study Contacts

Soledad Quero, Ph.D and psychology

CONTACT

964 38 76 41; squero@uji.es

Laura De la Coba Cañizares, Psychology

CONTACT

964387651; lde@uji.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial with two treatment conditions and one WL control condition: a three-armed simple-blind RCT. Patients will be assessed for eligibility and if they meet the inclusion criteria, they will be randomly allocated to one of the three experimental conditions (BF-Grow, iGROw and WL group). The allocation schedule will be generated through an independent researcher who will be unaware of the characteristics of the study. Patients will agree to participate before the random allocation and without knowing to which treatment they will be assigned.

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 17, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

ES (2)