Compassion-Focused Therapy for Prolonged Grief Symptoms

NCT03384615 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2020-11-05

No results posted yet for this study

Summary

Prolonged grief disorder (PGD) is a novel diagnostic entity proposed to describe a psychiatric disorder that occurs after the loss of a loved one. The disorder is to be implemented in The International Classification of Diseases 11th Revision (ICD-11), scheduled for release in 2018. Failure to recognize and treat PGD may have negative effects on health, functional capacity and quality of life. However, very little is known about the characteristics and treatment of PGD in adult Danish populations although such knowledge is much needed before introducing the disorder in Danish health services.

The present study aims to develop, test and disseminate a group-based treatment manual for PGD in bereaved partners and their adult children. People with high levels of symptoms will be recruited from a large-scale survey study examining frequency, predictors and prognosis of PGD symptoms (NCT03049007). Participants will be randomized to group-based compassion-focused therapy (CFT) for grief or a waitlist control group. Treatment effects will be estimated with prolonged grief symptoms as the primary outcome. Secondary outcomes include depressive symptoms, posttraumatic stress symptoms, symptoms of anxiety, and quality-of-life. The investigators expect that CFT will yield statistically significant effects on prolonged grief symptom compared with the waitlist control group. If CFT is shown to be efficacious in reducing prolonged grief symptoms, the investigators will conduct moderation and mediation analyses with the aim of identifying what works, for whom. Finally, the investigators will perform cost-effectiveness analyses by linking the data with healthcare utilization data from the Danish National registries.

Conditions

  • Prolonged Grief Symptoms

Interventions

BEHAVIORAL

Compassion-Focused Therapy

CFT for PGD symptoms in the present project is inspired by two well-established CFT treatment manuals. The first is used for treatment of PTSD (Lee \& James, 2011) and the other for treatment of anger (Kolt, 2011). The manual for CFT for PGD adopts both structure and techniques from these into an 8-week, group-based program with weekly 2 1/4-hour sessions. Each session contains elements of psychoeducation on uncomplicated and prolonged grief reactions, identifying unhelpful strategies for self-protection and facilitating use of more helpful strategies, and training an open and compassionate management of grief-related distress through CFT exercises. Between the sessions the participant will train the exercises introduced at the previous session.

Sponsors & Collaborators

  • Utrecht University

    collaborator OTHER
  • Columbia University

    collaborator OTHER
  • University of Southern Denmark

    collaborator OTHER
  • University of Aarhus

    lead OTHER

Principal Investigators

  • Maja O'Connor, MSc., PhD · University of Aarhus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-03
Primary Completion
2020-01-01
Completion
2020-01-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03384615 on ClinicalTrials.gov