Cognitive Behavioural Therapy for Complicated Grief Reactions in Old Age

NCT04694807 | Completed

• 1 other identifier: 35880
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bereavement; Prolonged Grief Disorder; Depression; Anxiety; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Symptoms of prolonged grief disorder

  Changes in symptoms of prolonged grief disorder will be measured with Prolonged Grief Disorder-13 (PG-13; Prigerson et al., 2009). Higher total scores indicate higher symptom level (minimum value: 11; maximum value: 57).

  From baseline (T1) to post-intervention (T3; up to one week after the 12th session) and to six months follow-up (T5).

Secondary Outcomes (11)

• Depressive symptoms

  From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).

• Anxiety symptoms

  From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).

• Posttraumatic stress symptoms

  From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).

• Quality adjusted life years

  From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).

• Functional impairment

  From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).

Other Outcomes (12)

• Mediator: Insufficient integration of the loss

  Baseline (T1), mid-intervention (T2; immediately after the 6th session), post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), six months follow-up (T5).

• Mediator: Negative loss-related cognitions

  Baseline (T1), mid-intervention (T2; immediately after the 6th session), post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), six months follow-up (T5).

• Mediator: Avoidance behaviors

  Baseline (T1), mid-intervention (T2; immediately after the 6th session), post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), six months follow-up (T5).

Study Arms (2)

Group-based Cognitive Behavioural Therapy

EXPERIMENTAL

A group delivered treatment format of CBTgrief (12 sessions).

Behavioral: Group-based Cognitive Behavioural Therapy for Complicated Grief Reactions

Individually delivered Cognitive Behavioural Therapy

ACTIVE COMPARATOR

An individual delivered treatment format of CBTgrief (12 sessions).

Behavioral: Individually delivered Cognitive Behavioural Therapy for Complicated Grief Reactions

Interventions

Group-based Cognitive Behavioural Therapy for Complicated Grief Reactions BEHAVIORAL

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.

Also known as: Group CBTgrief

Group-based Cognitive Behavioural Therapy

Individually delivered Cognitive Behavioural Therapy for Complicated Grief Reactions BEHAVIORAL

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.

Also known as: Individual CBTgrief

Individually delivered Cognitive Behavioural Therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years (older adult).
• Lost a loved one (e.g., spouse, partner) ≥ 6 months ago.
• Clinically relevant symptoms of one or more types of complicated grief reactions (i.e. symptoms of prolonged grief (PG-13 ≥ 29), depression (CESD-10 ≥ 10), anxiety (GAD-7 ≥ 10), and/or posttraumatic stress (PCL ≥ 31)).

You may not qualify if:

• No clinically relevant symptoms of one or more types of complicated grief reactions (i.e. symptoms of prolonged grief, depression, anxiety and/or posttraumatic stress).
• No informed consent given.
• Insufficient Danish proficiency.
• Inability to transport oneself to the clinic.
• Severe psychopathology (e.g., schizophrenia).
• Severe cognitive impairment (e.g., Alzheimer's disease).
• Substance abuse.
• Acute suicidal ideation.

Sponsors & Collaborators

• University of Aarhus: lead
• Utrecht University: collaborator
• The Danish National Center for Grief: collaborator

Study Sites (1)

Unit for Bereavement Research, Dept. of Psychology, Aarhus University

Aarhus C, 8000, Denmark

Location

Related Publications (1)

• Komischke K, Boelen PA, Maccallum F, O'Connor M. Group Vs Individual Grief-Focused Cognitive Behavioral Therapy for Older Adults: A Randomized Clinical Trial. JAMA Psychiatry. 2026 Jan 14. doi: 10.1001/jamapsychiatry.2025.4106. Online ahead of print.

  PMID: 41533372 DERIVED

Related Links

• Link to the research unit's website

MeSH Terms

Conditions

Prolonged Grief Disorder; Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic

Study Officials

• Maja O'Connor, PhD

  University of Aarhus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: However, the investigator, therapists, and participants are masked in terms of not knowing which treatment the participants will be randomized to until after the completion of baseline assessment (T1).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Block randomization with a 1:1 allocation ratio to individually delivered versus group-based CBTgrief at the clinic in Copenhagen, and with a 1:2 allocation ratio to individually delivered versus group-based CBTgrief at the clinic in Odense. Randomization is conducted by an independent employee at the Danish National Center for Grief (DNCG). The allocation will take place after completion of baseline questionnaire (T1).

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: January 5, 2021
• Study Start: April 23, 2021
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)