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

Abstract

IntroductionGrief 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 analysisThis 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 disseminationThe 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 numberNCT04462146.

An Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Prolonged Grief Disorder (PGD) in adults: A multiple-baseline single-case experimental design study

“…In addition, we included elements (i.e., cognitive reappraisal) of other computerized psychological treatments for grief ( Hoffmann et al, 2018 ; Shear, 2015b ; Wagner et al, 2006 ) and new mindfulness activities and compassion and self-compassion strategies ( Campos et al, 2019 ; García-Campayo et al, 2016 ; García-Campayo et al, 2016 ; García-Campayo, 2018 ; Lopez-Montoyo et al, 2019 ; Navarro-Gil et al, 2020 ). More information about this treatment can be found in Tur et al (2021) .…”

Internet-based self-administered intervention to reduce anxiety and depression symptomatology and improve well-being in 7 countries: protocol of a randomized control trial

“…Additionally, although technology is successfully used in psychology research (Mancone et al, 2023), few studies evaluate the acceptability and feasibility of the online treatment (Tur et al, 2021(Tur et al, ), 10.3389/fpsyg.2024 Frontiers in Psychology 12 frontiersin.org which would allow making the necessary adjustments to ensure the intervention's effectiveness. These two elements represent strengths in the design of Well-being Online.…”

GROw, an Internet-delivered Cognitive-Behavioral Therapy (iCBT) for Adults with Prolonged Grief Disorder (PGD)

“…The assessment points were: baseline (t1), immediately after the intervention (t2), 3-month follow-up (t3), 12-month follow-up (t4), and evaluation of participants who dropped out of the treatment (t5). Modifying the published protocol for this study (Tur et al, 2021), the evaluation of reasons for dropping out was included to collect additional information, and potential effectiveness was explored using a mixed-model analysis approach. Furthermore, follow-up measures are not presented in this manuscript because this evaluation is currently in progress.…”

“…According to the CONSORT statement for feasibility studies , a formal sample size calculation is not required. For the secondary objective of this study (explore the potential effectiveness of GROw), a sample of 48 people (24 per group) was proposed in the protocol for this study (Tur et al, 2021), based on an estimated 30% dropout rate .…”

“…In addition, we included elements (i.e., cognitive reappraisal) of other computerized psychological treatments for grief and new mindfulness activities and compassion and self-compassion strategies . More information about this treatment can be found in Tur et al (2021).…”