Prolonged Grief Disorder (PGD)
Conditions
Keywords
Prolonged grief disorder, Efficacy, Randomized controlled trial, Internet-based treatment, blended intervention, Ecological Momentary Assessment (EMA), Ecological Momentary Intervention (EMI)
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.
Interventions
BEHAVIORALInternet-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).
BEHAVIORALInternet-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).
Sponsors
Universitat Jaume I
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Inventory of Complicated Grief (ICG). | Immediately prior to treatment, Immediately after treatment, 3 months after treatment, 12 months after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Beck Depression Inventory-II (BDI-II). | Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment. | 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. |
| Change in Typical Beliefs Questionnaire (TBQ). | Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment. | 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. |
| Change in Overall Anxiety Severity and Impairment Scale (OASIS). | Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment. | 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. |
| Change in Overall Depression Severity and Impairment Scale (ODSIS). | Immediately prior to treatment, immediately after treatment, 3 months after treatment, 12 months after treatment. | 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. |
| 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. | The International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) is a shortened version of the original 20-item PANAS to measure two dimensions of affect, positive and negative affect. The scale is composed of 10 items using a Likert-type scale with assigned scores of: Not at all (0); A little (1); Quite a lot (2); A lot (3); Very much (4). 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. |
Countries
Spain
Contacts
CONTACTSoledad Quero, Ph.D and psychology
CONTACTLaura De la Coba Cañizares, Psychology
PRINCIPAL_INVESTIGATORSoledad Quero, Ph.D and psychology
Department of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón de la Plana, Spain.
STUDY_DIRECTORDaniel Campos, Ph.D and psychology
Department of Psychology and Sociology, Universidad de Zaragoza, Zaragoza, Spain.
Outcome results
None listed