Viewing Study NCT03384615



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Last Modification Date: 2024-10-26 @ 12:37 PM
Study NCT ID: NCT03384615
Status: COMPLETED
Last Update Posted: 2020-11-05
First Post: 2017-12-14

Brief Title: Compassion-Focused Therapy for Prolonged Grief Symptoms
Sponsor: University of Aarhus
Organization: University of Aarhus

Study Overview

Official Title: The Aarhus Bereavement Study TABs A Randomized Controlled Trial of the Efficacy of Compassion-Focused Therapy for Prolonged Grief Symptoms in Bereaved Adults
Status: COMPLETED
Status Verified Date: 2019-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: Aims

Our primary hypotheses are

CFT will have a statistically significant and long-term effect on PGD symptoms compared with the waitlist control group

Secondary hypotheses are

Self-compassion self-criticism rumination and exposure to the loss will mediate the effects of CFT on PGD symptoms
Baseline PGD symptom level will moderate the intervention effects of CFT with higher symptom level predicting larger symptom improvement
Gender age type of loss attachment style neuroticism positive affect and social support will predict who will benefit most from treatment moderator analyses
CFT will reduce levels of depression anxiety and posttraumatic stress symptoms and increase quality-of-life QoL compared with the wait-list control group
Time spent on homework practice will moderate the intervention effects of CFT with more time spent on homework predicting larger symptom improvement
CFT is a cost-effective psychological treatment compared with the waitlist-control group

Design

The present project will be conducted as a randomized waitlist-controlled trial with a 11 allocation ratio and using block randomization conducted by an external biostatistician

Participants

The present randomized controlled trial RCT recruits patients from a large survey that invites all bereaved partners in the Central Denmark Region and their adult children age 18 years to participate in a survey regarding trajectories of grief This means that the present study recruits patients from an existing survey NCT03049007 All bereaved partners and their adult children from the existing survey study with clinically relevant levels of PGD 11 months after their loss minscore 25 on PG-13 will be invited to participate in the present RCT

Assessment points

Assessment of all three intervention groups will be provided at five points 1 before the intervention baseline 2 after each session the CFT group only 3 after the last intervention session post-intervention 4 3 months post-intervention and 5 6 months post-intervention In addition data on healthcare utilization will be retrieved from the Danish registries concerning health care services eg visit to the general practitioner use of medication number of hospitalizations

Sample size

Previous studies have generally found large effects of psychological interventions for PGD that included cognitive techniques with effect-sizes Cohens d ranging from 080-241 Although previous studies testing the efficacy of psychological treatments for prolonged grief have reported large effects we undertake a more conservative estimate as CFT so far has not been tested in a bereaved population

So far no values for minimal clinically important difference MCID have been established for the PG-13 When such indicators are missing the general literature on interpretation of clinical change suggests that a change corresponding to one half standard deviation could be a suitable substitute Copay et al 2007 Norman et al 2003 We therefore aim to be able to detect a clinically relevant effect of Cohens d 050 A final sample of 156 participants 2 x 78 11 allocation will enable us in a pre-post repeated-measures design to detect a difference between CFT and the control group with a two-sided alpha of 005 a pre-post correlation Rho of 05 a statistical power of 080 and an estimated dropout rate of 20

Statistical analyses

Analyses will be conducted using the statistical software IBM SPSS statistics v21 IMB Chicago IL and Stata v13 StataCorp College Stadium TX Baseline group differences will be explored with t tests and χ²-tests All main effects will be analyzed using Mixed Linear Models MLMs based on the intent-to-treat sample comparing groups over time on all outcome variables Each hypothesis will be tested in separate models

Intervention effects will be indicated by a statistically significant 2-way group x time interaction and results will be interpreted in terms of their effect sizes As we randomize the participants we do not expect that any differences in use of alternative treatments prior to or during the study period will exist between study groups However in case of an imbalance on this variable we will include it as a covariate in a second set of analyses

Possible mediating and moderating effects will be explored for statistically significant outcomes in the main analyses using MLMs Cost-effectiveness analyses will be investigated by aggregating healthcare utilization costs and by investigating the effect of CFT on Quality-Adjusted Life-Years QALYThe probability of CFT being cost-effective are investigated by calculating Cost-Effectiveness Acceptability Curves CEACs

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None