Clinical trial NCT06932120: Technology-supported Interventions for Prolonged Grief Disorder (PGD)
Official title: Technology-supported Interventions for Prolonged Grief Disorder in Adults a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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)
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in the Inventory of Complicated Grief (ICG).
timeFrame: Immediately prior to treatment, Immediately after treatment, 3 months after treatment, 12 months after treatment
Secondary outcomes:
measure: Change in Beck Depression Inventory-II (BDI-II).
timeFrame: Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.
measure: Change in Typical Beliefs Questionnaire (TBQ).
timeFrame: Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.
measure: Change in Overall Anxiety Severity and Impairment Scale (OASIS).
timeFrame: Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.
measure: Change in Overall Depression Severity and Impairment Scale (ODSIS).
timeFrame: Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.
measure: Change in Short-Form of the International Positive and Negative Affect Schedule (iPANAS).
timeFrame: Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.
Other outcomes:
measure: Change in Structured Clinical Interview for Complicated Grief (SCI-CG).
timeFrame: Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.
measure: Change in Anxiety Disorders Interview Schedule (ADIS) Clinician Severity rating Scale .
timeFrame: Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.
measure: Change in Quality of Life Index (QLI).
timeFrame: Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.
measure: Change in The Work and Social Adjustment Scale (WSAS).
timeFrame: Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.
measure: Change in Posttraumatic Growth Inventory (PTGI).
timeFrame: Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment.
measure: Change in The Purpose-In-Life Test (PIL- 10).
timeFrame: Immediately prior to treatment, Immediately after treatment, 3 months after treatment, 12 months after treatment
measure: Change in The Five-Facet Mindfulness Questionnaire (FFMQ-15).
timeFrame: Immediately prior to treatment, Immediately after treatment, 3 months after treatment, 12 months after treatment
measure: Change in The Self-Compassion Scale-Short Form (SCS-SF).
timeFrame: Immediately prior to treatment, Immediately after treatment, 3 months after treatment, 12 months after treatment
measure: Scale of expectation and satisfaction with the treatment.
timeFrame: Scale of expectation: Immediately prior to treatment. Scale of satisfaction: Immediately after treatment.
measure: Opinion Questionnaire about the intervention.
timeFrame: Through intervention completion, an average of 12 weeks
measure: Usability System Scale (SUS).
timeFrame: Through intervention completion, an average of 12 weeks
measure: Participants' adherence to the intervention; Drop-outs rates.
timeFrame: Through intervention completion, an average of 12 weeks
measure: Participants' adherence to the intervention; number of sessions/modules completed.
timeFrame: Through intervention completion, an average of 12 weeks.
measure: Participants' adherence to the intervention; number of times participants enter the modules and review the contents.
timeFrame: Through intervention completion, an average of 12 weeks.
measure: Intensity of pain from the loss. Daily by the Mobile App.
timeFrame: Every day; From the first day of treatment to the end of treatment (an avergage of 12 weeks).
measure: Intensity of the sadness. Daily by the Mobile App.
timeFrame: Every day; From the first day of treatment to the end of treatment (an average of 12 weeks).
measure: Intensity of the anxiety. Daily by the Mobile App.
timeFrame: Every day; From the first day of treatment to the end of treatment (an average of 12 weeks).
measure: Motivation to continue treatment. Daily by the Mobile App.
timeFrame: Every day; From the first day of treatment to the end of treatment (an average of 12 weeks).
measure: Frequency of pleasant memories with the deceased loved one. Daily by the Mobile App.
timeFrame: Every day; From the first day of treatment to the end of treatment (an average of 12 weeks).
Locations:
city: Castellón de la Plana
country: Spain
facility: Universitat Jaume I
state: Castellón
city: Castellón de la Plana
country: Spain
facility: Universitat Jaume I
Study officials:
affiliation: Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón de la Plana, Spain.
name: Soledad Quero, Ph.D and psychology
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychology and Sociology, Universidad de Zaragoza, Zaragoza, Spain.
name: Daniel Campos, Ph.D and psychology
role: STUDY_DIRECTOR
References:
citation: 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#/
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.