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

Efficacy and Mechanisms of Change of Online Cognitive Behavioural Therapy for Prolonged Grief Disorder After Loss: a Three-armed Randomised Control Trial

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

Study Overview

• Status: Recruiting
• Conditions: Prolonged Grief Disorder
• Intervention / Treatment: Behavioral: iCBT for prolonged grief; Behavioral: Active control

Detailed Description

The death of a loved one can lead to various mental and physical health problems. Previous research has shown that Cognitive Behavioral Therapy (CBT) can be effective in recuding symptoms of prolonged grief. However, most previous studies have had small sample sizes and lacked follow-up assessments over time.

The purpose of this project is to conduct a large randomized controlled trial (RCT) to evaluate the effectiveness of internet-delivered cognitive-behavioral therapy (iCBT) in reducing symptoms of prolonged grief, depression, and posttraumatic stress in adults who have lost a loved one. The iCBT treatment will be compared against both an active control condition and a waitlist condition. Participants in the active control condition will receive a simplified version of the iCBT treatment, which is also therapist-led but lacks active CBT components. The waitlist control group will receive the iCBT treatment after 10 weeks. Follow-up assessments will be conducted at 6 and 12 months after treatment completion.

The study will also examine potential moderators (such as baseline symptom levels and loss characteristics) and mediators (such as belief in treatment efficacy, changes in negative cognitions and level of avoidance) on treatment effects. This may provide insights into the effectiveness of prolonged grief treatment and factors that influence treatment outcomes.

Participants will be recruited through advertisements on social media platforms, and organisations and clinical contacts. Individuals interested in participating in the study register their interest on a website linked to the research project, and complete an initial screening form. Potential participants are contacted by phone to schedule an assessment interview over video, which includes the structured diagnostic interview Mini International Neuropsychiatric Interview (M.I.N.I.). Subsequently, eligible participants are randomized to iCBT, active control, or waitlist control. The participants will be informed that they have been randomly assigned to either a waitlist or one of two grief treatment programs but will not know which of the treatments they are in, and are thus blind at the beginning of the study. The treatment is accessed on a digital platfom.

This study is the first of its kind in Sweden to examine the effectiveness of internet-delivered treatment for prolonged grief. Additionally, it is the first trial to assess both short- and long-term effects of iCBT for prolonged grief compared to an active control group.

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Josefin Sveen, Professor; Phone Number: +46 738 66 70 87; Email: josefin.sveen@uu.se

Study Locations

• Sweden
  • Uppsala, Sweden, 751 85
    • Recruiting
    • Region Uppsala, KBT via nätet, Nära vård digitalt
    • Contact: Lina Ciardella, Lic. psychologist; Phone Number: +46186172167; Email: lina.ciardella@regionuppsala.se
  • Uppsala, Sweden, 75185
    • Recruiting
    • Uppsala university, Dep of Womens and Childrens Health
    • Contact: Josefin Sveen, Phd; Phone Number: +46184715478; Email: josefin.sveen@uu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Participants will receive cognitive behavioral therapy treatment (iCBT) for prolonged grief.	Behavioral: iCBT for prolonged grief; 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.
Active Comparator: Active control; Participants will receive psychoeducation about grief and common grief reactions.	Behavioral: Active control; Participants will undergo a 10-week internet-delivered, therapist-led treatment, which includes psychoeducation about grief and common grief reactions.
No Intervention: Waitlist control; Participants will be offered the iCBT treatment for prolonged grief after 10 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change (from baseline) in Posttraumatic stress disorder checklist for DSM-5, PCL-5	A 20-item, self-rated measure of posttraumatic stress disorder. Total score ranges from 0-80, and a higher score indicates more symptoms	0, 5 and 10 weeks. Follow-up at 6 and 12 months post-treatment.
Change (from baseline) in Patient Health Questionnaire, PHQ-9	A 9-item, self-rated measure of depression. Total score ranges from 0-27, and a higher score indicates more symptoms	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	A 9-item, self-rated measure of avoidance. Total score ranges from 9-72, and a higher score indicates more avoidance	0, 5 and 10 weeks. Follow-up at 6 and 12 months post-treatment.
Change (from baseline) in Grief Cognitions Questionniare, GCQ	An 18-item, self-rated measure of grief cognitions. Total score ranges from 0-90, and a higher score indicates more grief cognitions	0, 5 and 10 weeks. Follow-up at 6 and 12 months post-treatment.
Change (from baseline) in Short Form Posttraumatic stress disorder checklist for DSM-5, Short form PCL-5	Four items from PCL-5, measuring PTSD symptoms. Total score ranges from 0-16, and a higher score indicates more symptoms.	Weekly assessments between week 0 and week 10, excluding week 5.
Change (from baseline) in Patient Health Questionnaire, PHQ-2	Two items from PHQ-9, measuring depression. Total score ranges from 0-6, and a higher score indicates more symptoms.	Weekly assessments between week 0 and week 10, excluding week 5.
Change (from baseline) in the short version of Traumatic Grief Inventory Self Report Plus, Short version TGI-SR+	Five items from TGI-SR+, measuring PGD symptoms. Total score ranges from 5-25, and a higher score indicates more symptoms.	Weekly assessments between week 0 and week 10, excluding week 5.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	Age, gender, time since loss, marital status, employment status, loss-related variables	0 months
Treatment Credibility Scale, TCS	A 5-item, self-rated measure of participants' view of treatment credibility. Total score ranges from 5-50, and higher scores indicate stronger beliefs in treatment efficacy and credibility.	Week 2
Client Satisfaction Questionnaire Eight, CSQ-8	An 8-item, self-rated measure of participants' treatment experience. Total score ranges from 8-32, where a higher score indicates greater satisfaction with the treatment.	Week 10
Negative effects questionnaire	Negative effects questionnaire (NEQ; Rozental et al., 2019)	Week 10

Collaborators and Investigators

• Sponsor: Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Prolonged Grief Disorder
• Other Study ID Numbers: 2024-02632-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No