About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Parallel
Treatments tested in this trial
Internet-based treatment (GROw) combined with face-to-face videoconferencing sessions with a therapist in BF-GROw group
BehavioralThe 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.
BehavioralThe 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).
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
Change in Structured Clinical Interview for Complicated Grief (SCI-CG).
The SCI-CG is a 31-item clinician-administered instrument to assess the presence of complicated grief symptoms. Each item is answered on a 3-point Likert-type scale (Not present, Unsure or misleading, and Present). The maximum score is 93 and is calculated by adding the scores for each item.
Change in Anxiety Disorders Interview Schedule (ADIS) Clinician Severity rating Scale .
This instrument assesses the severity of symptoms evaluated by the clinician and the scale ranged from 0-8.Clinicians assign ratings from 0 (absent) to 8 (very severely disabling) reflecting the intensity of symptoms, associated avoidance, and interference with functioning. Higher scores indicating greater severity.
Change in Quality of Life Index (QLI).
It is a self-administered instrument that includes 10 items that evaluate the patients' quality of life in different areas and in a global manner. It uses a 10-point Likert-type scale: 1 (poor) to 10 (excellent).Higher scores indicate improvement.
Change in The Work and Social Adjustment Scale (WSAS).
It is a self-administered instrument that assesses psychosocial functional impairment. It consists of 5 items that are scored on a scale from 0 (not at all) to 8 (very severe). The maximum score is 40 and is calculated by adding the score of all items, the higher the score, the greater the interference in different areas.
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