Prolonged Grief SymptomsNCT03384615
Compassion-Focused Therapy for Prolonged Grief Symptoms
A study testing Compassion-Focused Therapy in people with Prolonged Grief Symptoms, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Prolonged Grief Symptoms
- What is being tested?
- Compassion-Focused Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Jan 2018to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residence in the Central Region of Denmark
- Status of partner or child to the deceased
- A min. score of 25 on the PG-13 at 11 months after the loss
Who cannot join
- Insufficient ability to understand Danish
- Serious psychiatric disease, e.g., schizophrenia, bipolar disease
- Acute suicidal ideation
- Serious cognitive impairment, e.g., Alzheimer's disease
- Active treatment for serious disease, e.g., chemotherapy for cancer
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Unit for Bereavement Research, Dept. of Psychology, Aarhus University
Aarhus C, 8000
About this study
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
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.
Read the 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 1:1 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 (min.score >= 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 (e.g., 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 0.80-2.41. 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 Cohen's d 0.50. A final sample of 156 participants (2 x 78, 1:1 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 0.05, a pre-post correlation (Rho) of 0.5, a statistical power of 0.80, and an estimated dropout rate of 20%.
Statistical analyses
Analyses will be conducted using the statistical software IBM SPSS statistics, v.21 (IMB, Chicago, IL) and Stata v.13 (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 (QALY).The probability of CFT being cost-effective are investigated by calculating Cost-Effectiveness Acceptability Curves (CEACs).
- Conditions
- Prolonged Grief Symptoms
- Being tested
- Compassion-Focused Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion-Focused TherapyBehavioural
Also called CFT for PGD symptoms
CFT for PGD symptoms in the present project is inspired by two well-established CFT treatment manuals. The first is used for treatment of PTSD (Lee \& James, 2011) and the other for treatment of anger (Kolt, 2011). The manual for CFT for PGD adopts both structure and techniques from these into an 8-week, group-based program with weekly 2 1/4-hour sessions. Each session contains elements of psychoeducation on uncomplicated and prolonged grief reactions, identifying unhelpful strategies for self-protection and facilitating use of more helpful strategies, and training an open and compassionate management of grief-related distress through CFT exercises. Between the sessions the participant will train the exercises introduced at the previous session.
| Study group | Role | What they receive |
|---|---|---|
| Compassion-focused therapy | Experimental | Not described Receives: Behavioral: Compassion-Focused Therapy |
| Waitlist control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged grief symptoms
Prolonged grief (PG-13; Prigerson et al., 2009)
Measured: From baseline (T1) to immediately after the intervention (8 weeks) (T2)
Prolonged grief symptoms
Prolonged grief (PG-13; Prigerson et al., 2009)
Measured: From baseline (T1) to 6 months after the intervention (T4)
Secondary outcomes (6)
Prolonged Grief Disorder (PGD) (diagnostic criteria)
Prolonged Grief Disorder (PG-13; Prigerson et al., 2009)
Measured: From baseline (T1) to 6 months after the intervention (T4)
Anxiety symptoms
Generalized Anxiety Disorder 7 (GAD-7; Spitzer et al., 2006)
Measured: From baseline (T1) to 6 months after the intervention (T4)
Depression symptoms
Center for Epidemiologic Studies Short Depression Scale (CES-D 10; Radloff, 1977)
Measured: From baseline (T1) to 6 months after the intervention (T4)
Posttraumatic stress symptoms
PTSD checklist - Civilian Version (PCL-C; Ruggiero et al., 1999)
Measured: From baseline (T1) to 6 months after the intervention (T4)
Utility measure
The 12-Item Short Form Health Survey (SF-12; Ware et al., 1996)
Measured: From baseline (T1) to 6 months after the intervention (T4)
Well-being
The WHO-5 (Heun et al., 2001)
Measured: From baseline (T1) to 6 months after the intervention (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start3 Jan 2018
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged Grief SymptomsStudies 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
- Block randomization in REDcap (copyright by Vanderbuilt University, USA) conducted by external biostatistician
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Utrecht University, Columbia University, University of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Maja O'Connor, MSc., PhD, Study director, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384615
- Sponsor's protocol ID
- TABs
- Status last verified
- Jul 2019
- First submitted
- 14 Dec 2017
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03384615
- Acronym / sponsor ID
- TABs
- Conditions
- Prolonged Grief Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Utrecht University, Columbia University, University of Southern Denmark
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 27 Dec 2017 (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.
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 1:1 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 (min.score >= 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 (e.g., 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 0.80-2.41. 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 Cohen's d 0.50. A final sample of 156 participants (2 x 78, 1:1 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 0.05, a pre-post correlation (Rho) of 0.5, a statistical power of 0.80, and an estimated dropout rate of 20%.
Statistical analyses
Analyses will be conducted using the statistical software IBM SPSS statistics, v.21 (IMB, Chicago, IL) and Stata v.13 (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 (QALY).The probability of CFT being cost-effective are investigated by calculating Cost-Effectiveness Acceptability Curves (CEACs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Block randomization in REDcap (copyright by Vanderbuilt University, USA) conducted by external biostatistician
| Arm | Type | Receives |
|---|---|---|
| Compassion-focused therapy | Experimental | Behavioral: Compassion-Focused Therapy |
| Waitlist control group | No intervention | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Residence in the Central Region of Denmark
- Status of partner or child to the deceased
- A min. score of 25 on the PG-13 at 11 months after the loss
Key exclusion criteria (5 listed)
- Insufficient ability to understand Danish
- Serious psychiatric disease, e.g., schizophrenia, bipolar disease
- Acute suicidal ideation
- Serious cognitive impairment, e.g., Alzheimer's disease
- Active treatment for serious disease, e.g., chemotherapy for cancer
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 |
|---|---|---|
| Compassion-Focused TherapyAlso: CFT for PGD symptomsCFT for PGD symptoms in the present project is inspired by two well-established CFT treatment manuals. The first is used for treatment of PTSD (Lee \& James, 2011) and the other for treatment of anger (Kolt, 2011). The manual for CFT for PGD adopts both structure and techniques from these into an 8-week, group-based program with weekly 2 1/4-hour sessions. Each session contains elements of psychoeducation on uncomplicated and prolonged grief reactions, identifying unhelpful strategies for self-protection and facilitating use of more helpful strategies, and training an open and compassionate management of grief-related distress through CFT exercises. Between the sessions the participant will train the exercises introduced at the previous session. | Behavioural | Compassion-focused therapy |
Primary outcome
Prolonged grief symptoms
Time frame: From baseline (T1) to immediately after the intervention (8 weeks) (T2)
Prolonged grief (PG-13; Prigerson et al., 2009)
Prolonged grief symptoms
Time frame: From baseline (T1) to 6 months after the intervention (T4)
Prolonged grief (PG-13; Prigerson et al., 2009)
6 secondary outcomes
Prolonged Grief Disorder (PGD) (diagnostic criteria)
Time frame: From baseline (T1) to 6 months after the intervention (T4)
Anxiety symptoms
Time frame: From baseline (T1) to 6 months after the intervention (T4)
Depression symptoms
Time frame: From baseline (T1) to 6 months after the intervention (T4)
Posttraumatic stress symptoms
Time frame: From baseline (T1) to 6 months after the intervention (T4)
Utility measure
Time frame: From baseline (T1) to 6 months after the intervention (T4)
Well-being
Time frame: From baseline (T1) to 6 months after the intervention (T4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Link to the research unit's websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Maja O'Connor, MSc., PhD study director
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion-Focused Therapy in people with Prolonged Grief Symptoms, run by University of Aarhus at 1 site in Denmark.
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 5 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: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolonged grief symptoms (time frame: From baseline (T1) to immediately after the intervention (8 weeks) (T2)). The study lists 2 primary outcomes in all. 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 5 Nov 2020.