Compassion-Focused Therapy for Prolonged Grief Symptoms

NCT03384615 | Completed DMC

• 1 other identifier: TABs
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Prolonged grief symptoms

  Prolonged grief (PG-13; Prigerson et al., 2009)

  From baseline (T1) to immediately after the intervention (8 weeks) (T2)

• Prolonged grief symptoms

  Prolonged grief (PG-13; Prigerson et al., 2009)

  From baseline (T1) to 6 months after the intervention (T4)

Secondary Outcomes (6)

• Prolonged Grief Disorder (PGD) (diagnostic criteria)

  From baseline (T1) to 6 months after the intervention (T4)

• Anxiety symptoms

  From baseline (T1) to 6 months after the intervention (T4)

• Depression symptoms

  From baseline (T1) to 6 months after the intervention (T4)

• Posttraumatic stress symptoms

  From baseline (T1) to 6 months after the intervention (T4)

• Utility measure

  From baseline (T1) to 6 months after the intervention (T4)

Other Outcomes (11)

• Mediator: Self-criticism

  Baseline (T1), session-by-session measures (SES1-8), to immediately after the intervention (8 weeks) (T2)

• Mediator: Fear of compassion

  Baseline (T1), session-by-session measures (SES1-8), to immediately after the intervention (8 weeks) (T2)

• Mediator: Experiential avoidance

  Baseline (T1), session-by-session measures (SES1-8), to immediately after the intervention (8 weeks) (T2)

Study Arms (2)

Compassion-focused therapy

EXPERIMENTAL

Behavioral: Compassion-Focused Therapy

Waitlist control group

NO INTERVENTION

Interventions

Compassion-Focused Therapy BEHAVIORAL

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.

Also known as: CFT for PGD symptoms

Compassion-focused therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Residence in the Central Region of Denmark
• Status of partner or child to the deceased
• A min. score of 25 on the PG-13 at 11 months after the loss

You may not qualify if:

• Insufficient ability to understand Danish
• Serious psychiatric disease, e.g., schizophrenia, bipolar disease
• Acute suicidal ideation
• Serious cognitive impairment, e.g., Alzheimer's disease
• Active treatment for serious disease, e.g., chemotherapy for cancer

Sponsors & Collaborators

• University of Aarhus: lead
• Utrecht University: collaborator
• Columbia University: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

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

Aarhus C, 8000, Denmark

Location

Related Links

• Link to the research unit's website

Study Officials

• Maja O'Connor, MSc., PhD

  University of Aarhus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Block randomization in REDcap (copyright by Vanderbuilt University, USA) conducted by external biostatistician

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 27, 2017
• Study Start: January 3, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: November 5, 2020

Record last verified: 2019-07

Locations

DK (1)