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

Universitat Jaume I

Status: Unknown

Conditions: Prolonged Grief Disorder

Treatments: Behavioral: Videoconference treatment with a therapist; Behavioral: Internet-based Self Applied Treatment Program

Study type: Interventional

Funder types: Other

Identifiers

NCT04462146

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Details and patient eligibility

About

The purpose of this study is to investigate the feasibility, acceptability and preliminary efficacy of an internet delivered cognitive behavior treatment (ICBT) for people with prolonged grief disorder (PGD) compared to a face-to-face intervention for PGD.

Full description

Grief is an intense emotional reaction to the loss of a loved one. It produces feelings of regret and longing that usually decrease over time. However, some people have difficulty adapting to the loss and develop Prolonged Grief Disorder (PGD). An open clinical trial will be conducted to investigate the feasibility [initial efficacy and acceptability] of an Internet delivered cognitive behavior treatment (ICBT) for adult people diagnosed with prolonged grief disorder (PGD). There will be at least 24 participants that will be randomly assigned to experimental group (internet-based treatment for PGD) or active control group (traditional face- to-face intervention for PGD). Four assessment moments will be included (pre-treatment, post-treatment, 3 months follow-up and 12 months follow-up). The present study aims to improve knowledge about the feasibility, acceptability and preliminary efficacy of an ICBT for PGD and conduct a preliminary comparison between two intervention conditions (internet-based intervention vs. traditional face-to-face intervention). Also, the investigators aim to collect information that can help to improve the efficacy and acceptability of Internet-based interventions in general.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Meeting diagnostic criteria for PGD
• Sign an informed consent
• Ability to understand and read Spanish
• Ability 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, psychotic 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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24 participants in 2 patient groups

Internet-based intervention

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: Internet-based Self Applied Treatment Program

Face-to-face treatment by videoconference

Active Comparator group

Description:

Face-to-face Intervention by videoconference applied by a therapist: 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: Videoconference treatment with a therapist