A Swedish Internet CBT for Prolonged Grief Disorder: a Three-armed RCT
ConditionProlonged Grief Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUppsala University
About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
iCBT for prolonged grief
BehavioralParticipants 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 control
BehavioralParticipants will undergo a 10-week internet-delivered, therapist-led treatment, which includes psychoeducation about grief and common grief reactions.
Treatment groups
270 Participants
are divided into 3 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Active controlActive comparator 1 intervention
Group C: Waitlist controlNo intervention 0 interventions
Trial outcomes
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.
Time frame
0, 5 and 10 weeks. Follow-up at 6 and 12 months post-treatment.Secondary outcomes
1
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
Time frame
0, 5 and 10 weeks. Follow-up at 6 and 12 months post-treatment.2
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
Time frame
0, 5 and 10 weeks. Follow-up at 6 and 12 months post-treatment.3
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
Time frame
0, 5 and 10 weeks. Follow-up at 6 and 12 months post-treatment.4
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
Time frame
0, 5 and 10 weeks. Follow-up at 6 and 12 months post-treatment.Other outcomes
1
Demographics
Age, gender, time since loss, marital status, employment status, loss-related variables
Time frame
0 months2
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.
Time frame
Week 23
Negative effects questionnaire
Negative effects questionnaire (NEQ; Rozental et al., 2019)
Time frame
Week 104
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.
Time frame
Week 10Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov