NCT04694807

Cognitive Behavioural Therapy for Complicated Grief Reactions in Old Age

Completed NA Last updated 22 August 2025

What this trial tests

NA trial testing Group-based Cognitive Behavioural Therapy for Complicated Grief Reactions in Bereavement in 113 participants. Completed in 31 May 2025.

Timeline

23 April 2021

Primary endpoint
31 May 2025

31 May 2025

Quick facts

Lead sponsor	University of Aarhus
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	113
Start date	23 April 2021
Primary completion	31 May 2025
Estimated completion	31 May 2025
Sites	1 location across Denmark

Drugs / interventions tested

• Group-based Cognitive Behavioural Therapy for Complicated Grief Reactions
• Individually delivered Cognitive Behavioural Therapy for Complicated Grief Reactions

Conditions studied

• Bereavement — all drugs for Bereavement →
• Prolonged Grief Disorder — all drugs for Prolonged Grief Disorder →
• Depression — all drugs for Depression →
• Anxiety — all drugs for Anxiety →

Sponsor

University of Aarhus

Who can join

65 and older, any sex, with Bereavement or Prolonged Grief Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Group Vs Individual Grief-Focused Cognitive Behavioral Therapy for Older Adults: A Randomized Clinical Trial.
   Komischke K, Boelen PA, Maccallum F, O'Connor M. · · 2026 · PMID 41533372 · DOI 10.1001/jamapsychiatry.2025.4106