Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Adults with Prolonged Grief Disorder (PGD): A Study Protocol for a Randomized Feasibility Trial

Introduction Grief is an emotional reaction to the loss of a loved one with a natural recovery. Approximately 10% of people who lose a loved one develop prolonged grief disorder (PGD). Internet-based and computer-based interventions (ie, internet-delivered cognitive–behavioural therapy, iCBT) are a...

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Main Authors: Alba Lopez-Montoyo, Diana Castilla, Cintia Tur, Daniel Campos, Rocio Herrero, Sonia Mor, Soledad Quero
Format: Article
Language:English
Published: BMJ Publishing Group 2021-07-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/11/7/e046477.full
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spelling doaj-5d7181ff75db4ec39722568b622db80c2021-10-09T00:00:05ZengBMJ Publishing GroupBMJ Open2044-60552021-07-0111710.1136/bmjopen-2020-046477Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Adults with Prolonged Grief Disorder (PGD): A Study Protocol for a Randomized Feasibility TrialAlba Lopez-Montoyo0Diana Castilla1Cintia Tur2Daniel Campos3Rocio Herrero4Sonia Mor5Soledad Quero6Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain2 Psychology and Sociology, Universidad de Zaragoza, Zaragoza, SpainDepartment of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón de la Plana, SpainDepartment of Psychology and Sociology, University of Zaragoza, Huesca, SpainDepartment of Personality, Evaluation and Psychological Treatments, Universidad de Valencia, Valencia, SpainDepartment of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón de la Plana, SpainDepartment of Basic, Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón de la Plana, SpainIntroduction Grief is an emotional reaction to the loss of a loved one with a natural recovery. Approximately 10% of people who lose a loved one develop prolonged grief disorder (PGD). Internet-based and computer-based interventions (ie, internet-delivered cognitive–behavioural therapy, iCBT) are a cost-effective alternative that makes it possible to reach more people with PGD. The main aim of this study is to assess the feasibility of a new iCBT—called GROw—for PGD. As a secondary objective, the potential effectiveness of GROw will be explored.Methods and analysis This study is a two-arm feasibility randomised trial. A total of 48 adults with PGD who meet the eligibility criteria will be randomised to the experimental group (iCBT: GROw) or the active control group (face-to-face CBT treatment). The treatment is organised sequentially in eight modules in the iCBT format and 8–10 sessions in the face-to-face format, and both formats have the same therapeutic components. There will be five assessment points with qualitative and quantitative evaluations: screening, baseline, after the intervention, 3-month follow-up and 12-month follow-up. Consistent with the objectives, the measures are related to the feasibility outcomes for the main aim of the study (participant adherence, expectations and satisfaction with the treatment, preferences, alliance and utility) and psychological and mental health outcomes for secondary analyses (symptoms of grief, symptoms of depression, symptoms of anxiety, affectivity, quality of life, work and social adaptation, post-traumatic growth, purpose in life, mindfulness and compassion).Ethics and dissemination The Ethics Committee of the Universitat Jaume I (Castellón, Spain) granted approval for the study (CD/002/2019). Dissemination will include publications and presentations at national and international conferences.Trial registration number NCT04462146.https://bmjopen.bmj.com/content/11/7/e046477.full
collection DOAJ
language English
format Article
sources DOAJ
author Alba Lopez-Montoyo
Diana Castilla
Cintia Tur
Daniel Campos
Rocio Herrero
Sonia Mor
Soledad Quero
spellingShingle Alba Lopez-Montoyo
Diana Castilla
Cintia Tur
Daniel Campos
Rocio Herrero
Sonia Mor
Soledad Quero
Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Adults with Prolonged Grief Disorder (PGD): A Study Protocol for a Randomized Feasibility Trial
BMJ Open
author_facet Alba Lopez-Montoyo
Diana Castilla
Cintia Tur
Daniel Campos
Rocio Herrero
Sonia Mor
Soledad Quero
author_sort Alba Lopez-Montoyo
title Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Adults with Prolonged Grief Disorder (PGD): A Study Protocol for a Randomized Feasibility Trial
title_short Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Adults with Prolonged Grief Disorder (PGD): A Study Protocol for a Randomized Feasibility Trial
title_full Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Adults with Prolonged Grief Disorder (PGD): A Study Protocol for a Randomized Feasibility Trial
title_fullStr Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Adults with Prolonged Grief Disorder (PGD): A Study Protocol for a Randomized Feasibility Trial
title_full_unstemmed Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Adults with Prolonged Grief Disorder (PGD): A Study Protocol for a Randomized Feasibility Trial
title_sort internet-delivered cognitive-behavioral therapy (icbt) for adults with prolonged grief disorder (pgd): a study protocol for a randomized feasibility trial
publisher BMJ Publishing Group
series BMJ Open
issn 2044-6055
publishDate 2021-07-01
description Introduction Grief is an emotional reaction to the loss of a loved one with a natural recovery. Approximately 10% of people who lose a loved one develop prolonged grief disorder (PGD). Internet-based and computer-based interventions (ie, internet-delivered cognitive–behavioural therapy, iCBT) are a cost-effective alternative that makes it possible to reach more people with PGD. The main aim of this study is to assess the feasibility of a new iCBT—called GROw—for PGD. As a secondary objective, the potential effectiveness of GROw will be explored.Methods and analysis This study is a two-arm feasibility randomised trial. A total of 48 adults with PGD who meet the eligibility criteria will be randomised to the experimental group (iCBT: GROw) or the active control group (face-to-face CBT treatment). The treatment is organised sequentially in eight modules in the iCBT format and 8–10 sessions in the face-to-face format, and both formats have the same therapeutic components. There will be five assessment points with qualitative and quantitative evaluations: screening, baseline, after the intervention, 3-month follow-up and 12-month follow-up. Consistent with the objectives, the measures are related to the feasibility outcomes for the main aim of the study (participant adherence, expectations and satisfaction with the treatment, preferences, alliance and utility) and psychological and mental health outcomes for secondary analyses (symptoms of grief, symptoms of depression, symptoms of anxiety, affectivity, quality of life, work and social adaptation, post-traumatic growth, purpose in life, mindfulness and compassion).Ethics and dissemination The Ethics Committee of the Universitat Jaume I (Castellón, Spain) granted approval for the study (CD/002/2019). Dissemination will include publications and presentations at national and international conferences.Trial registration number NCT04462146.
url https://bmjopen.bmj.com/content/11/7/e046477.full
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