An Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)

Not Applicable

Completed

• Conditions: Grief

• Registration Number: NCT04376385
• Lead Sponsor: Universitat Jaume I

Brief Summary

The purpose os this study is examine the effect and feasibility (usability and satisfaction) of an iCBT (GROw program) for adults with PGD

Detailed Description

The death of a loved one has physical, psychological, and social consequences. Between 9.8 and 21.5% of people who lose a loved one develop Prolonged Grief Disorder (PGD). Internet- and computer-based interventions (i.e., Internet-delivered Cognitive-Behavioral Therapy, iCBT) are cost-effective and scalable alternatives that make it possible to reach more people with PGD. The main goal of the present investigation was to examine the effect and feasibility (usability and satisfaction) of an iCBT (GROw program) for adults with PGD. A secondary objective was to detect adherence to the app (Emotional Monitor) used to measure daily grief symptoms. The study had a single-case multiple-baseline AB design with six participants. The GROw program is organized sequentially in eight modules, and it is based on the dual-process model of coping with bereavement. Evaluations included a pre-to-post treatment assessment of depression, grief symptoms, and typical grief beliefs, along with daily measures of symptom frequency and intensity on the Emotional Monitor App. Treatment opinions and adherence to the App were also collected. Efficacy data were calculated using a Nonoverlap of All Pairs (NAP) analysis and Reliable Change Index (RCI).

Study Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-06
• Study Start: 2020-11-01
• Primary Completion: 2021-05-01
• Study Completion: 2021-10-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-09
• Last Update Posted: 2022-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Age ≥ 18 years
• Meeting diagnostic criterio for PGD
• Sign an informed consent
• Ability to understand and read Spanish
• Abilitiy to use a computer and having access to the Internet
• Having an e-mail address

Exclusion Criteria

• Presence of risk of suicide or self-destructive behaviors
• Presence of another severe mental disorder (substance abuse or dependence, pshychotic disorder, dementia o bipolar disorder)
• Presence of severe personality disorder
• Presence of a medical condition whose severity or characteristics prevent the performance of treatment
• Receiving other psychological treatment during the study for PGD
• An increase and/or change in the medication during the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Emotional Pain: intensity of sadness, anger, anxiety, guilt and grief	Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment	\* Evaluation from mobile app; Item 1: In relation to the death of your loved one; What intensity of sadness have you felt TODAY? Item2: In relation to the death of your loved one; What intensity of anger have you felt TODAY? Item 3: In relation to the death of your loved one; What intensity of anxiety have you felt TODAY? Item 4: In relation to the death of your loved one; What intensity of guilt have you felt TODAY? Item 5: In relation to the death of your loved one; What intensity of pain from loss have you felt TODAY?; \* Evaluation from mobile app

Secondary Outcome Measures

Name	Time	Method
Change in emotion avoidance frequency	Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment	Item: How often have you wished TODAY to get rid of your unpleasant emotions related to your loved one?; \* Evaluation from mobile app
Change in thoughts avoidance frequency	Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment	Item: How often have you tried TODAY to get rid of unpleasant thoughts related to your loved one?; \* Evaluation from mobile app
Change in frequency of memories that produce guilt	Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment	Item: How often have you remembered TODAY the absence of your loved one with a huge and deep guilt?; \* Evaluation from mobile app
Change in frequency of memories that produce anger	Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment	Item: How often have you remembered TODAY the absence of your loved one with a huge and deep anger?; \* Evaluation from mobile app
Change in frequency of memories that produce anxiety	Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment	Item: How often have you remembered TODAY the absence of your loved one with enormous and deep anxiety?; \* Evaluation from mobile app
Change in frequency of pleasant memories	Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment	Item: How often have you had pleasant memories with your loved one TODAY?; \* Evaluation from mobile app
Change in difficulty accepting the death	Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment	Item: How often have you wished TODAY intensely that your loved one was with you?
Change in frequency of sad memories	Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment	Item: How often have you remembered TODAY the absence of your loved one with enormous and deep sadness?; \* Evaluation from mobile app

Trial Locations

Locations (1)

Universitat Jaume I; 🇪🇸 Castellón de la Plana, Castellón, Spain