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Prolonged Grief Disorder (PGD)NCT06932120

Technology-supported Interventions for Prolonged Grief Disorder (PGD)

A study testing Internet-based treatment (GROw) combined with face-to-face videoconferencing sessions with a therapist in BF-GROw group and Internet-based treatment (GROw) supported by the App developed which contains the EMA and EMI tools in iGROw group. in people with Prolonged Grief Disorder (PGD), run by Universitat Jaume I at 2 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Prolonged Grief Disorder (PGD)
What is being tested?
Internet-based treatment (GROw) combined with face-to-face videoconferencing sessions with a therapist in BF-GROw group and Internet-based treatment (GROw) supported by the App developed which contains the EMA and EMI tools in iGROw group.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
141 participants
Where
2 sitesSpain
Study dates
10 Nov 2025to 30 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Soledad Quero, Ph.D and psychology contact

964 38 76 41 ext. +34

squero@uji.es

Laura De la Coba Cañizares, Psychology contact

964387651 ext. +34

lde@uji.es

Spain2 sites, 2 recruiting
  • Universitat Jaume I

    Castellon, Castellón de La Plana, 12071

    Soledad Quero, Ph.D and Psychology, 964 38 76 41 ext. +34, squero@uji.es

    Laura De La Coba Cañizares, Ph.D student and psychology

    Recruiting
  • Universitat Jaume I

    Castellon, Castellón, 12071

    Soledad Quero, Ph.D and Psychology, 964 38 76 41, squero@uji.es

    Not yet recruiting

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Internet-based treatment (GROw) combined with face-to-face videoconferencing sessions with a therapist in BF-GROw group, Internet-based treatment (GROw) supported by the App developed which contains the EMA and EMI tools in iGROw group.
Keywords
Prolonged grief disorder, Efficacy, Randomized controlled trial, Internet-based treatment, blended intervention, Ecological Momentary Assessment (EMA), Ecological Momentary Intervention (EMI)
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.

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

    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).

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

    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).

Study groups in NCT06932120
Study groupRoleWhat they receive
BF-Grow group: Blended Format groupExperimentalArm 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.
Receives: 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 groupExperimentalArm 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 intervention is expected to last 8 to 14 weeks, though duration may be adjusted based on each participant's individual therapeutic needs. This condition will be supported by the App developed which contains the EMA and EMI tools.
Receives: Behavioral: Internet-based treatment (GROw) supported by the App developed which contains the EMA and EMI tools in iGROw group.
Waiting List (WL) control groupNo interventionArm 3: Waiting List control group. Participants in the WL group will answer the pre- and post-evaluation and they will assigned to the iGROW treatment condition after completing the waiting-list period (10-12 weeks) for ethical reasons.

What is being measured

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

  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.

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

Secondary outcomes (5)
  1. Change in Beck Depression Inventory-II (BDI-II).

    It is a self-report measure composed of 21 items that assess the severity of depressive symptomatology in the last two weeks. It uses a response scale from 0 to 3, with higher scores indicating greater severity. It is calculated by adding the score of the 21 items and the maximum total score is 63.

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

  2. Change in Typical Beliefs Questionnaire (TBQ).

    A 25-item self-report instrument that assesses cognitions that hinder adjustment to loss. Structured in five factors: "Protesting the death", "Negative thoughts about the world", "Needing the person", "Less grief is a mistake" and "Suffering too much". It measures the degree of agreement regarding different affirmations using a Likert-type response system ranging from 0 (not at all) to 4 (strongly agree). A total score from 0 to 100 is calculated by adding up all the items.

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

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

    It is a self-applied instrument that assesses the frequency and severity of anxiety symptoms. It also measures the degree of avoidance and interference in all areas of the patient's life. It consists of 5 items with a response scale from 0 to 4. Higher scores indicate greater severity or frequency of symptomatology. The maximum score is 20 and is calculated by adding the score obtained for each of the 5 items.

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

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

    It is a self-applied instrument that assesses the frequency and severity of depression symptoms. It also measures the degree of avoidance and interference in all areas of the patient's life. It consists of 5 items with a response scale from 0 to 4. One additional item has been included to assess suicide ideation. The maximum score is 20 and is calculated by adding the score obtained for each of the 5 items.

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

  5. Change in the International Positive and Negative Affect Schedule (PANAS).

    The International Positive and Negative Affect Schedule (PANAS) is a 20-item self-report questionnaire that assesses two independent dimensions of affect: Positive Affect (PA) and Negative Affect (NA). Each subscale comprises 10 items rated on a 5-point Likert scale, with higher scores indicating greater levels of positive or negative affect, respectively. Subscale scores are calculated by summing the corresponding items, yielding scores ranging from 10 to 50 for each dimension. The person rates a list of words describing feelings and emotions that people have, indicating to what extent they describe how he/she has been feeling lately.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2025
  2. Study start10 Nov 2025
  3. Primary completion10 Nov 2026 (estimated)
  4. Study completion30 Sep 2027 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
141 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06932120
Sponsor's protocol ID
UJaumeI_iGROw_1
Status last verified
Oct 2026
First submitted
17 Mar 2025
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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#/

  • 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.

    PubMed 32670101
  • 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.

    PubMed 35865996
  • 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.

    PubMed 34230018
  • 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.

    PubMed 15958807
  • 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.

    PubMed 28110678
  • 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.

    PubMed 33913789

Questions about this trial

What is this clinical trial studying?

A study testing Internet-based treatment (GROw) combined with face-to-face videoconferencing sessions with a therapist in BF-GROw group and Internet-based treatment (GROw) supported by the App developed which contains the EMA and EMI tools in iGROw group. in people with Prolonged Grief Disorder (PGD), run by Universitat Jaume I at 2 sites in Spain.

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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Soledad Quero, Ph.D and psychology (964 38 76 41 ext. +34, squero@uji.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Inventory of Complicated Grief (ICG). (time frame: Immediately prior to treatment, Immediately after treatment, 3 months after treatment, 12 months after treatment). 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 NCT06932120, which also lists 7 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 20 Oct 2026.

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