Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04694807
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2020-12-16
Brief Title:
Cognitive Behavioural Therapy for Complicated Grief Reactions in Old Age
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
The Efficacy of Group Versus Individual Cognitive Behavioural Therapy for Complicated Grief Reactions in Old Age A Randomized Non-inferiority Trial
Status:
RECRUITING
Status Verified Date:
2023-11
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:
While most bereaved individuals cope adaptively with the loss of a loved one a significant minority experiences more severe and complicated grief reactions Complicated grief reactions is an umbrella term for different types of post-loss complications including symptoms of Prolonged Grief Disorder PGD depression anxiety and posttraumatic stress These post-loss complications may all cause persistent suffering and functional impairment thus pointing to a need for efficacious treatment
While Cognitive Behavioural Therapy CBT is a relatively well-documented efficacious treatment for symptoms of PGD depression anxiety and posttraumatic stress in the period after a loss the relative efficacy of a transdiagnostic individually delivered versus group-based CBT for these types of complicated grief reactions CBTgrief remain unknown Furthermore little evidence exists about the relative cost-effectiveness of individually delivered versus group-based CBTgrief and why and how it works The theory of CBTgrief proposes that it works by targeting three maintaining mechanisms in PGD 1 Insufficient integration of the loss 2 negative loss-related cognitions and 3 depressive and anxious avoidance These maintaining mechanisms have also shown to be statistically associated with depression anxiety and posttraumatic stress in the period after a loss suggesting that different types of complicated grief reactions might share some of the same maintaining mechanisms However this proposed theory of change has yet to be empirically tested as a whole
These knowledge gaps are crucial for the understanding of efficacious and cost-effective treatment formats as well as central treatment mechanisms in the psychological treatment of complicated grief reactions The present study thus aims to examine the relative efficacy of an individually delivered versus group-based CBTgrief by means of a randomized non-inferiority trial Secondary aims include an investigation of the relative cost-effectiveness of individually delivered versus group-based CBTgrief as well as treatment mediators Finally explorative analyses of potential moderators of intervention effects of CBTgrief will be conducted
While Cognitive Behavioural Therapy CBT is a relatively well-documented efficacious treatment for symptoms of PGD depression anxiety and posttraumatic stress in the period after a loss the relative efficacy of a transdiagnostic individually delivered versus group-based CBT for these types of complicated grief reactions CBTgrief remain unknown Furthermore little evidence exists about the relative cost-effectiveness of individually delivered versus group-based CBTgrief and why and how it works The theory of CBTgrief proposes that it works by targeting three maintaining mechanisms in PGD 1 Insufficient integration of the loss 2 negative loss-related cognitions and 3 depressive and anxious avoidance These maintaining mechanisms have also shown to be statistically associated with depression anxiety and posttraumatic stress in the period after a loss suggesting that different types of complicated grief reactions might share some of the same maintaining mechanisms However this proposed theory of change has yet to be empirically tested as a whole
These knowledge gaps are crucial for the understanding of efficacious and cost-effective treatment formats as well as central treatment mechanisms in the psychological treatment of complicated grief reactions The present study thus aims to examine the relative efficacy of an individually delivered versus group-based CBTgrief by means of a randomized non-inferiority trial Secondary aims include an investigation of the relative cost-effectiveness of individually delivered versus group-based CBTgrief as well as treatment mediators Finally explorative analyses of potential moderators of intervention effects of CBTgrief will be conducted
Detailed Description:
Aims of the study
1 Evaluate the relative efficacy of an individually delivered versus group-based CBTgrief
2 Evaluate the relative cost-effectiveness of an individually delivered versus group-based CBTgrief
3 Examine the theoretically proposed treatment mediators of CBTgrief
4 Explore loss-related and sociodemographic characteristics as possible moderators of intervention effects
Primary hypothesis
Group-based CBTgrief will show non-inferiority ie equal efficacy in reducing symptoms of PGD compared to individually delivered CBTgrief at six months follow-up
Secondary hypotheses
1 Group-based CBTgrief will show non-inferiority ie equal efficacy in reducing symptoms of posttraumatic stress depression and anxiety compared to individually delivered CBTgrief at six months follow-up
2 Group-based CBTgrief will be more cost-effective than individually delivered CBTgrief
3 The observed effect of CBTgrief is mediated by changes in theoretically proposed maintaining mechanisms of complicated grief reactions ie insufficient integration of the loss negative loss-related cognitions depressive and anxious avoidance
4 Gender level of education age baseline grief symptom level type of loss circumstances of the loss time since loss and number of additional losses will moderate the observed effects of CBTgrief
5 Additional exploratory analyses include an additional matched comparison group who have not received treatment in order to compare the effect of individual and group-based CBTgrief to a non-treatment group This group will be extracted from a large-scale survey study The Aarhus Bereavement Study NCT03049007 Here it is hypothesized that CBTgrief will have a statistically significant medium size effect on symptoms of PGD at six months follow-up compared to a matched comparison group who did not receive treatment
Design The present study is conducted as a randomized non-inferiority trial of individually delivered versus group-based CBTgrief using block randomization
Participants Participants are recruited from the Danish National Center for Grief DNCG which is a Danish national organization that provide specialized psychological therapy to bereaved individuals who have lost a loved one The therapists at the DNCG will screen and treat bereaved elderly people for complicated grief reactions with CBTgrief at their clinics in Odense and Copenhagen Denmark DNCG identifies participants through consultants local practitioners self-referral and the DNCG grief support line
Assessment points Participants will be assessed at pre- mid- and post-intervention as well as at three and six months follow-up T1-T5 Additionally data on healthcare utilization will be retrieved from the Danish national registers concerning use of health care services such as visits to general practitioners psychologists etc
Sample size A group sample size of 2x64 will enable us to detect non-inferiority between individually delivered and group-based CBTgrief with a non-inferiority of -05 SD on the primary outcome ie symptoms of PGD and a statistical power of 080 The true difference is assumed to be 00 and the one-sided significance level alpha of the test is 0025 Based on an estimated dropout rate of 20 the total number of participants needed to recruit is N160 participants
1 Evaluate the relative efficacy of an individually delivered versus group-based CBTgrief
2 Evaluate the relative cost-effectiveness of an individually delivered versus group-based CBTgrief
3 Examine the theoretically proposed treatment mediators of CBTgrief
4 Explore loss-related and sociodemographic characteristics as possible moderators of intervention effects
Primary hypothesis
Group-based CBTgrief will show non-inferiority ie equal efficacy in reducing symptoms of PGD compared to individually delivered CBTgrief at six months follow-up
Secondary hypotheses
1 Group-based CBTgrief will show non-inferiority ie equal efficacy in reducing symptoms of posttraumatic stress depression and anxiety compared to individually delivered CBTgrief at six months follow-up
2 Group-based CBTgrief will be more cost-effective than individually delivered CBTgrief
3 The observed effect of CBTgrief is mediated by changes in theoretically proposed maintaining mechanisms of complicated grief reactions ie insufficient integration of the loss negative loss-related cognitions depressive and anxious avoidance
4 Gender level of education age baseline grief symptom level type of loss circumstances of the loss time since loss and number of additional losses will moderate the observed effects of CBTgrief
5 Additional exploratory analyses include an additional matched comparison group who have not received treatment in order to compare the effect of individual and group-based CBTgrief to a non-treatment group This group will be extracted from a large-scale survey study The Aarhus Bereavement Study NCT03049007 Here it is hypothesized that CBTgrief will have a statistically significant medium size effect on symptoms of PGD at six months follow-up compared to a matched comparison group who did not receive treatment
Design The present study is conducted as a randomized non-inferiority trial of individually delivered versus group-based CBTgrief using block randomization
Participants Participants are recruited from the Danish National Center for Grief DNCG which is a Danish national organization that provide specialized psychological therapy to bereaved individuals who have lost a loved one The therapists at the DNCG will screen and treat bereaved elderly people for complicated grief reactions with CBTgrief at their clinics in Odense and Copenhagen Denmark DNCG identifies participants through consultants local practitioners self-referral and the DNCG grief support line
Assessment points Participants will be assessed at pre- mid- and post-intervention as well as at three and six months follow-up T1-T5 Additionally data on healthcare utilization will be retrieved from the Danish national registers concerning use of health care services such as visits to general practitioners psychologists etc
Sample size A group sample size of 2x64 will enable us to detect non-inferiority between individually delivered and group-based CBTgrief with a non-inferiority of -05 SD on the primary outcome ie symptoms of PGD and a statistical power of 080 The true difference is assumed to be 00 and the one-sided significance level alpha of the test is 0025 Based on an estimated dropout rate of 20 the total number of participants needed to recruit is N160 participants
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