Clinical trial NCT04376385: An Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)
Official title: An Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD): A Multiple-baseline Case Series Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Grief
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in Emotional Pain: intensity of sadness, anger, anxiety, guilt and grief
timeFrame: 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
Secondary outcomes:
measure: Change in frequency of sad memories
timeFrame: 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
measure: Change in frequency of memories that produce anger
timeFrame: 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
measure: Change in frequency of memories that produce anxiety
timeFrame: 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
measure: Change in frequency of memories that produce guilt
timeFrame: 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
measure: Change in frequency of pleasant memories
timeFrame: 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
measure: Change in emotion avoidance frequency
timeFrame: 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
measure: Change in thoughts avoidance frequency
timeFrame: 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
measure: Change in difficulty accepting the death
timeFrame: 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
measure: Change in difficulty accepting the death
timeFrame: 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
Other outcomes:
measure: Satisfaction with the treatment
timeFrame: At the end of the treatment
measure: Change in Prolonged Grief Disorder-13 (PG-13)
timeFrame: Before and after treatment, at 3 and 12 months
measure: Change in ADIS Clinician's severity rating scale
timeFrame: Before and after treatment, at 3 and 12 months
Locations:
city: Castellón de la Plana
country: Spain
facility: Universitat Jaume I
state: Castellón
Study officials:
References: