An Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD): A Multiple-baseline Case Series Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Grief
- Sponsor
- Universitat Jaume I
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Change in Emotional Pain: intensity of sadness, anger, anxiety, guilt and grief
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in Emotional Pain: intensity of sadness, anger, anxiety, guilt and grief
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)