A Swedish Internet CBT for Prolonged Grief Disorder: a Three-armed RCT

NCT06667674 | Recruiting

• 1 other identifier: 2024-02632-01
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of internet-delivered Cognitive Behavioral Therapy (iCBT) in reducing symptoms of prolonged grief in adults diagnosed with prolonged grief disorder. The main questions the study aims to answer are:

• Does iCBT reduce symptoms of prolonged grief disorder, posttraumatic stress, and depression following the death of a loved one in the short and long term?
• What mechanisms contribute to the effectiveness of iCBT in treating prolonged grief disorder? The iCBT intervention will be compared to a waitlist control group and an active control group to see if iCBT reduces symptoms of prolonged grief disorder more effectively than no treatment or a placebo treatment. Participants will:
• Be randomly assigned to either the iCBT group, an active control group or a waitlist control group
• Complete online assessments of symptom severity, grief cognitions, and level of avoidance before, during and after intervention
• Engage in 10 weeks of a therapist-guided online treatment

Conditions

Prolonged Grief Disorder

Outcome Measures

Primary Outcomes (1)

• Change (from baseline) in Traumatic Grief Inventory Self Report Plus, TGI-SR+

  A 22-item, self-rated measure of prolonged grief symptoms. Total score ranges from 22 to 110, where a higher score indicates more symptoms.

  0, 5 and 10 weeks. Follow-up at 6 and 12 months post-treatment.

Secondary Outcomes (7)

• Change (from baseline) in Posttraumatic stress disorder checklist for DSM-5, PCL-5

  0, 5 and 10 weeks. Follow-up at 6 and 12 months post-treatment.

• Change (from baseline) in Patient Health Questionnaire, PHQ-9

  0, 5 and 10 weeks. Follow-up at 6 and 12 months post-treatment.

• Change (from baseline) in Depressive and Anxious Avoidance in Prolonged Grief questionnaire, DAAPGQ

  0, 5 and 10 weeks. Follow-up at 6 and 12 months post-treatment.

• Change (from baseline) in Grief Cognitions Questionniare, GCQ

  0, 5 and 10 weeks. Follow-up at 6 and 12 months post-treatment.

• Change (from baseline) in the short version of Traumatic Grief Inventory Self Report Plus, Short version TGI-SR+

  Weekly assessments between week 0 and week 10, excluding week 5.

Other Outcomes (4)

• Demographics

  0 months

• Treatment Credibility Scale, TCS

  Week 2

• Negative effects questionnaire

  Week 10

Study Arms (3)

Intervention group

EXPERIMENTAL

Participants will receive cognitive behavioral therapy treatment (iCBT) for prolonged grief.

Behavioral: iCBT for prolonged grief

Active control

ACTIVE COMPARATOR

Participants will receive psychoeducation about grief and common grief reactions.

Behavioral: Active control

Waitlist control

NO INTERVENTION

Participants will be offered the iCBT treatment for prolonged grief after 10 weeks.

Interventions

iCBT for prolonged grief BEHAVIORAL

Participants will undergo a 10-week internet-delivered, therapist-led cognitive behavioral therapy treatment (iCBT) for prolonged grief, which includes psychoeducation about grief and common grief reactions, exposure, cognitive restructuring and behavioral activation.

Intervention group

Active control BEHAVIORAL

Participants will undergo a 10-week internet-delivered, therapist-led treatment, which includes psychoeducation about grief and common grief reactions.

Active control

Eligibility Criteria

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

You may qualify if:

• Currently residing in Sweden
• Lost a relative or close friend to any cause of death at least six months ago
• Suffers from prolonged grief disorder

You may not qualify if:

• Ongoing severe psychiatric problems that may prevent treatment implementation or require more urgent care (e.g., participants with untreated psychotic disorder, untreated bipolar disorder, ongoing substance abuse, elevated suicide risk)
• Change in dosage of any medication for mental health issues (e.g., antidepressant medication) in the past four weeks or in the next two months

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (2)

Region Uppsala, KBT via nätet, Nära vård digitalt

Uppsala, 751 85, Sweden

RECRUITING

Uppsala university, Dep of Womens and Childrens Health

Uppsala, 75185, Sweden

RECRUITING

MeSH Terms

Conditions

Prolonged Grief Disorder

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Josefin Sveen, Professor

CONTACT

+46 738 66 70 87; josefin.sveen@uu.se

Study Design

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

Model Details: Active control group, waitlist control group and intervention group.

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: April 23, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

SE (2)