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

Universitat Jaume I

Status: Completed

Conditions: Grief

Treatments: Behavioral: GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)

Study type: Interventional

Funder types: Other

Identifiers

NCT04376385

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Details and patient eligibility

About

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

Full 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).

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 5 patient groups

Treatment condition - 9 days wait

Experimental group

Description:

Internet-based Self Applied Treatment Program. Main components: Motivation for change, Psychoeducation, Behavioral activation, Exposure, Mindfulness and compassion strategies, integration of loss, restoration and reconstruction of meaning, Cognitive reappraisal and Relapse prevention

Treatment:

Behavioral: GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)

Treatment condition - 12 days wait

Experimental group

Description:

Internet-based Self Applied Treatment Program. Main components: Motivation for change, Psychoeducation, Behavioral activation, Exposure, Mindfulness and compassion strategies, integration of loss, restoration and reconstruction of meaning, Cognitive reappraisal and Relapse prevention

Treatment:

Behavioral: GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)

Treatment condition - 17 days wait

Experimental group

Description:

Internet-based Self Applied Treatment Program. Main components: Motivation for change, Psychoeducation, Behavioral activation, Exposure, Mindfulness and compassion strategies, integration of loss, restoration and reconstruction of meaning, Cognitive reappraisal and Relapse prevention

Treatment:

Behavioral: GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)

Treatment condition - 19 days wait

Experimental group

Description:

Internet-based Self Applied Treatment Program. Main components: Motivation for change, Psychoeducation, Behavioral activation, Exposure, Mindfulness and compassion strategies, integration of loss, restoration and reconstruction of meaning, Cognitive reappraisal and Relapse prevention

Treatment:

Behavioral: GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)

Treatment condition - 33 days wait

Experimental group

Description:

Internet-based Self Applied Treatment Program. Main components: Motivation for change, Psychoeducation, Behavioral activation, Exposure, Mindfulness and compassion strategies, integration of loss, restoration and reconstruction of meaning, Cognitive reappraisal and Relapse prevention

Treatment:

Behavioral: GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)