Treating prolonged grief disorder with prolonged grief-specific cognitive behavioral therapy: study protocol for a randomized controlled trial

Abstract

BackgroundProlonged grief disorder (PGD) has emerged as a well-defined and relatively common mental disorder that will be included in the upcoming revision of the International Classification of Diseases. Recent trials with grief-specific, mostly cognitive behavioral interventions for patients with a clinically relevant diagnosis of PGD showed large effect sizes. However, a small trial suggested that non-specific behavioral activation might suffice to improve PGD. So, more evidence for the relative efficacy of grief-specific treatments is needed, as is more research on the predictors of treatment success. The purpose of the proposed trial is to evaluate a newly developed and successfully pilot-tested, prolonged grief-specific, integrative cognitive behavioral therapy (PG-CBT) compared to an active yet unspecific treatment, present-centered therapy (PCT).MethodsIn a multicenter, randomized controlled trial with 204 adults with a primary diagnosis of PGD, PG-CBT is compared to PCT, assuming the superiority of PG-CBT. Both treatments consist of 20 to 24 individual sessions, with an overall treatment length of about 6 months. The primary outcome, grief symptom severity, is assessed by blinded interviewers 12 months after randomization. Secondary outcomes are grief symptom severity at post treatment, in addition to self-reported overall mental health symptoms, depressive and somatoform symptoms at post treatment and 12 months post randomization. Possible moderators and mediators of treatment success are also explored.DiscussionThe trial is designed to avoid bias as much as possible (stratified randomization performed independently, blinded outcome assessment, intention-to-treat-analysis, balanced treatment dose, continuous supervision, control for allegiance effects) thereby enhancing internal validity. At the same time, some aspects of the trial will ensure clinical relevance (recruiting at outpatient clinics that are part of routine health care and keeping exclusion criteria to a minimum). Since the trial is powered adequately for the primary outcome, all secondary analyses including moderator analyses are exploratory by nature. The results will extend the knowledge on efficacious treatment of PGD and its predictors.Trial registrationGerman Clinical Trials Register, ID: DRKS00012317. Registered on 6 September 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2618-3) contains supplementary material, which is available to authorized users.

Feasibility of Present-Centered Therapy for Prolonged Grief Disorder: Results of a Pilot Study

“…Future studies are needed to address the question of the efficacy of PCT adapted to PGD compared to adequate control conditions. Based on our results, it seems reasonable to choose and evaluate PCT as an active control condition compared to a grief-focused CBT, including exposure and cognitive structuring, in a current RCT (35). Furthermore, the need for specific treatment components, such as exposure, cognitive restructuring techniques, or behavioral activation, should be addressed in dismantling studies targeting patients suffering from PGD.…”

When does grief become pathological? Evaluation of the ICD-11 diagnostic proposal for prolonged grief in a treatment-seeking sample

“…Nine new items were included in the PG13 + 9 in order to cover most of the features in the ICD-11 proposal (Killikelly & Maercker, 2017;Maercker et al, 2013). The full PG13 + 9 has been published elsewhere (Rosner et al, 2018).…”

“…Participants were recruited for a multicentre RCT to evaluate grief-specific integrative cognitive behavioural therapy in comparison to an active but nonspecific control condition, present-centred therapy, at four university outpatient mental health clinics in Germany from May 2017 to December 2018 (Rosner, Rimane, Vogel, Rau, & Hagl, 2018; trial registration: DRKS00012317). The study protocol has been approved by the Institutional Review Board of the Catholic University Eichstaett-Ingolstadt (2016/21).…”

Narrative reconstruction therapy for prolonged grief disorder – a pilot study

“…This disorder is characterized by a persistent and pervasive longing or a persistent preoccupation with the deceased, accompanied by intense emotional pain following the death of a significant other. In recent decades, several therapies have been evaluated for the treatment of PGD 1 (Boelen, de Keijser, van den Hout, & van den Bout, 2007 ; Rosner, Rimane, Vogel, Rau, & Hagl, 2018 ; Shear et al, 2016 ). Most of these interventions drew on cognitive behavioural therapy (CBT) approaches and included psychoeducation about normal and prolonged grief processes, exposure to internal and external stimuli connected with the most painful aspects of the loss, and cognitive restructuring.…”