Technology-supported Interventions for Prolonged Grief Disorder (PGD)

Universitat Jaume I

Status: Enrolling

Conditions: Prolonged Grief Disorder (PGD)

Treatments: Behavioral: Internet-based treatment (GROw) combined with face-to-face videoconferencing sessions with a therapist in BF-GROw group; Behavioral: Internet-based treatment (GROw) supported by the App developed which contains the EMA and EMI tools in iGROw group.

Study type: Interventional

Funder types: Other

Identifiers

NCT06932120

UJaumeI_iGROw_1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 141 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 3 patient groups

BF-Grow group: Blended Format group

Experimental group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

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 group

Description:

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.