CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 113 enrolled
Drug / intervention
Group-based Cognitive Behavioural Therapy for Complicated Grief Reactions +1 morebehavioral
Likely dose
Not stated in record
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Search/NCT04694807
NCT04694807N/ACompleted

The Efficacy of Group Versus Individual Cognitive Behavioural Therapy for Complicated Grief Reactions in Old Age: A Randomized Non-inferiority Trial

University of Aarhus·interventional·Posted Jan 5, 2021·Updated Aug 22, 2025

In Brief

A clinical study evaluating Group-based Cognitive Behavioural Therapy for Complicated Grief Reactions and Individually delivered Cognitive Behavioural Therapy for Complicated Grief Reactions for Bereavement and 4 related conditions. Completed, enrolled 113 participants across 1 site.

Detailed Summary

While most bereaved individuals cope adaptively with the loss of a loved one, a significant minority experiences more severe and complicated grief reactions. Complicated grief reactions is an umbrella term for different types of post-loss complications, including symptoms of Prolonged Grief Disorder (PGD), depression, anxiety, and posttraumatic stress. These post-loss complications may all cause persistent suffering and functional impairment, thus pointing to a need for efficacious treatment. While Cognitive Behavioural Therapy (CBT) is a relatively well-documented efficacious treatment for symptoms of PGD, depression, anxiety, and posttraumatic stress in the period after a loss, the relative efficacy of a transdiagnostic individually delivered versus group-based CBT for these types of complicated grief reactions (CBTgrief) remain unknown. Furthermore, little evidence exists about the relative cost-effectiveness of individually delivered versus group-based CBTgrief and why and how it works. The theory of CBTgrief proposes that it works by targeting three maintaining mechanisms in PGD: 1) Insufficient integration of the loss, 2) negative loss-related cognitions, and 3) depressive and anxious avoidance. These maintaining mechanisms have also shown to be statistically associated with depression, anxiety, and posttraumatic stress in the period after a loss, suggesting that different types of complicated grief reactions might share some of the same maintaining mechanisms. However, this proposed theory of change has yet to be empirically tested as a whole. These knowledge gaps are crucial for the understanding of efficacious and cost-effective treatment formats as well as central treatment mechanisms in the psychological treatment of complicated grief reactions. The present study thus aims to examine the relative efficacy of an individually delivered versus group-based CBTgrief by means of a randomized non-inferiority trial. Secondary aims include an investigation of the relative cost-effectiveness of individually delivered versus group-based CBTgrief as well as treatment mediators. Finally, explorative analyses of potential moderators of intervention effects of CBTgrief will be conducted.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJan 5, 2021
Enrollment StartApr 23, 2021
Primary CompletionMay 31, 2025
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 5.5 years ago

Interventions

Group-based Cognitive Behavioural Therapy for Complicated Grief Reactionsbehavioral

CBTgrief is a transdiagnostic psychotherapeutic treatment for complicated grief reactions, i.e., symptoms of prolonged grief disorder as well as post-loss depression, anxiety, and posttraumatic stress. The treatment manual is developed by Professor Paul A. Boelen. CBTgrief includes methods such as psycho-education, homework, exposure, alteration of grief-related negative automatic thoughts, behavioural activation, and goal-oriented work. CBTgrief consists of 12 sessions with a session duration of 2.25 hours for the group format. Group-based CBTgrief will follow the same content and exercises for each session as individually delivered CBTgrief.

Individually delivered Cognitive Behavioural Therapy for Complicated Grief Reactionsbehavioral

CBTgrief is a transdiagnostic psychotherapeutic treatment for complicated grief reactions, i.e., symptoms of prolonged grief disorder as well as post-loss depression, anxiety, and posttraumatic stress. The treatment manual is developed by Professor Paul A. Boelen. CBTgrief includes methods such as psycho-education, homework, exposure, alteration of grief-related negative automatic thoughts, behavioural activation, and goal-oriented work. CBTgrief consists of 12 sessions with a session duration of 1 hour for the individually delivered format. Individually delivered CBTgrief will follow the same content and exercises for each session as group-based CBTgrief.