Prolonged Grief DisorderNCT06667674
A Swedish Internet CBT for Prolonged Grief Disorder: a Three-armed RCT
A study testing iCBT for prolonged grief in people with Prolonged Grief Disorder, run by Uppsala University at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolonged Grief Disorder
- What is being tested?
- iCBT for prolonged grief
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 2 sitesSweden
- Study dates
- 23 Apr 2025to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Region Uppsala, KBT via nätet, Nära vård digitalt
Uppsala, 751 85
Lina Ciardella, Lic. psychologist, +46186172167, lina.ciardella@regionuppsala.se
- Recruiting
Uppsala university, Dep of Womens and Childrens Health
Uppsala, 75185
Josefin Sveen, Phd, +46184715478, josefin.sveen@uu.se
About this study
Official title: 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:
Read more
- 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
Read the 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.
- Conditions
- Prolonged Grief Disorder
- Being tested
- iCBT for prolonged grief, Active control
- Medical subject headings
- Prolonged Grief Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCBT for prolonged griefBehavioural
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 controlBehavioural
Participants will undergo a 10-week internet-delivered, therapist-led treatment, which includes psychoeducation about grief and common grief reactions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will receive cognitive behavioral therapy treatment (iCBT) for prolonged grief. Receives: Behavioral: iCBT for prolonged grief |
| Active control | Active comparator | Participants will receive psychoeducation about grief and common grief reactions. Receives: Behavioral: Active control |
| Waitlist control | No intervention | Participants will be offered the iCBT treatment for prolonged grief after 10 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
A 20-item, self-rated measure of posttraumatic stress disorder. Total score ranges from 0-80, and a higher score indicates more symptoms
Measured: 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
Measured: 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
Measured: 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
Measured: 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+
Five items from TGI-SR+, measuring PGD symptoms. Total score ranges from 5-25, and a higher score indicates more symptoms.
Measured: Weekly assessments between week 0 and week 10, excluding week 5.
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.
Measured: 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.
Measured: Weekly assessments between week 0 and week 10, excluding week 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start23 Apr 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged Grief DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active control group, waitlist control group and intervention group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667674
- Sponsor's protocol ID
- 2024-02632-01
- Status last verified
- Apr 2025
- First submitted
- 30 Oct 2024
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanisms of Change of Online Cognitive Behavioural Therapy for Prolonged Grief Disorder After Loss: a Three-armed Randomised Control Trial
- ClinicalTrials.gov ID
- NCT06667674
- Acronym / sponsor ID
- 2024-02632-01
- Conditions
- Prolonged Grief Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Active control group, waitlist control group and intervention group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: iCBT for prolonged griefParticipants will receive cognitive behavioral therapy treatment (iCBT) for prolonged grief. |
| Active control | Active comparator | Behavioral: Active controlParticipants will receive psychoeducation about grief and common grief reactions. |
| Waitlist control | No intervention | –Participants will be offered the iCBT treatment for prolonged grief after 10 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCBT for prolonged griefParticipants 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. | Behavioural | Intervention group |
| Active controlParticipants will undergo a 10-week internet-delivered, therapist-led treatment, which includes psychoeducation about grief and common grief reactions. | Behavioural | Active control |
Primary outcome
Change (from baseline) in Traumatic Grief Inventory Self Report Plus, TGI-SR+
Time frame: 0, 5 and 10 weeks. Follow-up at 6 and 12 months post-treatment.
A 22-item, self-rated measure of prolonged grief symptoms. Total score ranges from 22 to 110, where a higher score indicates more symptoms.
7 secondary outcomes
Change (from baseline) in Posttraumatic stress disorder checklist for DSM-5, PCL-5
Time frame: 0, 5 and 10 weeks. Follow-up at 6 and 12 months post-treatment.
Change (from baseline) in Patient Health Questionnaire, PHQ-9
Time frame: 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
Time frame: 0, 5 and 10 weeks. Follow-up at 6 and 12 months post-treatment.
Change (from baseline) in Grief Cognitions Questionniare, GCQ
Time frame: 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+
Time frame: Weekly assessments between week 0 and week 10, excluding week 5.
Change (from baseline) in Short Form Posttraumatic stress disorder checklist for DSM-5, Short form PCL-5
Time frame: Weekly assessments between week 0 and week 10, excluding week 5.
Change (from baseline) in Patient Health Questionnaire, PHQ-2
Time frame: Weekly assessments between week 0 and week 10, excluding week 5.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCBT for prolonged grief in people with Prolonged Grief Disorder, run by Uppsala University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josefin Sveen, Professor (+46 738 66 70 87, josefin.sveen@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change (from baseline) in Traumatic Grief Inventory Self Report Plus, TGI-SR+ (time frame: 0, 5 and 10 weeks. Follow-up at 6 and 12 months post-treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.