BereavementNCT04694807
Cognitive Behavioural Therapy for Complicated Grief Reactions in Old Age
A study testing Group-based Cognitive Behavioural Therapy for Complicated Grief Reactions and Individually delivered Cognitive Behavioural Therapy for Complicated Grief Reactions in people with Bereavement and Prolonged Grief Disorder, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Bereavement, Prolonged Grief Disorder, Depression
- What is being tested?
- Group-based Cognitive Behavioural Therapy for Complicated Grief Reactions and Individually delivered Cognitive Behavioural Therapy for Complicated Grief Reactions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Apr 2021to 31 May 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years (older adult).
- Lost a loved one (e.g., spouse, partner) ≥ 6 months ago.
- Clinically relevant symptoms of one or more types of complicated grief reactions (i.e. symptoms of prolonged grief (PG-13 ≥ 29), depression (CESD-10 ≥ 10), anxiety (GAD-7 ≥ 10), and/or posttraumatic stress (PCL ≥ 31)).
Who cannot join
- No clinically relevant symptoms of one or more types of complicated grief reactions (i.e. symptoms of prolonged grief, depression, anxiety and/or posttraumatic stress).
- No informed consent given.
- Insufficient Danish proficiency.
- Inability to transport oneself to the clinic.
- Severe psychopathology (e.g., schizophrenia).
- Severe cognitive impairment (e.g., Alzheimer's disease).
- Substance abuse.
- Acute suicidal ideation.
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 Efficacy of Group Versus Individual Cognitive Behavioural Therapy for Complicated Grief Reactions in Old Age: A Randomized Non-inferiority Trial
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.
Read the detailed description
Aims of the study:
- Evaluate the relative efficacy of an individually delivered versus group-based CBTgrief.
- Evaluate the relative cost-effectiveness of an individually delivered versus group-based CBTgrief.
- Examine the theoretically proposed treatment mediators of CBTgrief.
- Explore loss-related and sociodemographic characteristics as possible moderators of intervention effects.
Primary hypothesis:
Group-based CBTgrief will show non-inferiority (i.e., equal efficacy) in reducing symptoms of PGD compared to individually delivered CBTgrief at six months follow-up.
Secondary hypotheses:
- Group-based CBTgrief will show non-inferiority (i.e., equal efficacy) in reducing symptoms of posttraumatic stress, depression, and anxiety compared to individually delivered CBTgrief at six months follow-up.
- Group-based CBTgrief will be more cost-effective than individually delivered CBTgrief.
- The observed effect of CBTgrief is mediated by changes in theoretically proposed maintaining mechanisms of complicated grief reactions (i.e. insufficient integration of the loss; negative loss-related cognitions; depressive and anxious avoidance).
- 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.
- 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 -0.5 SD on the primary outcome, i.e. symptoms of PGD, and a statistical power of 0.80. The true difference is assumed to be 0.0 and the one-sided significance level (alpha) of the test is 0.025. Based on an estimated dropout rate of 20% the total number of participants needed to recruit is N=160 participants.
- Being tested
- Group-based Cognitive Behavioural Therapy for Complicated Grief Reactions, Individually delivered Cognitive Behavioural Therapy for Complicated Grief Reactions
- Medical subject headings
- Prolonged Grief Disorder, Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based Cognitive Behavioural Therapy for Complicated Grief ReactionsBehavioural
Also called Group CBTgrief
CBTgrief is a transdiagnostic psychotherapeutic treatment for complicated grief reactions, i.e., symptoms of prolonged grief disorder as well as post-loss depression, anxiety, and posttraumatic stress. The treatment manual is developed by Professor Paul A. Boelen. CBTgrief includes methods such as psycho-education, homework, exposure, alteration of grief-related negative automatic thoughts, behavioural activation, and goal-oriented work. CBTgrief consists of 12 sessions with a session duration of 2.25 hours for the group format.
Group-based CBTgrief will follow the same content and exercises for each session as individually delivered CBTgrief.
Individually delivered Cognitive Behavioural Therapy for Complicated Grief ReactionsBehavioural
Also called Individual CBTgrief
CBTgrief is a transdiagnostic psychotherapeutic treatment for complicated grief reactions, i.e., symptoms of prolonged grief disorder as well as post-loss depression, anxiety, and posttraumatic stress. The treatment manual is developed by Professor Paul A. Boelen. CBTgrief includes methods such as psycho-education, homework, exposure, alteration of grief-related negative automatic thoughts, behavioural activation, and goal-oriented work. CBTgrief consists of 12 sessions with a session duration of 1 hour for the individually delivered format.
Individually delivered CBTgrief will follow the same content and exercises for each session as group-based CBTgrief.
| Study group | Role | What they receive |
|---|---|---|
| Group-based Cognitive Behavioural Therapy | Experimental | A group delivered treatment format of CBTgrief (12 sessions). Receives: Behavioral: Group-based Cognitive Behavioural Therapy for Complicated Grief Reactions |
| Individually delivered Cognitive Behavioural Therapy | Active comparator | An individual delivered treatment format of CBTgrief (12 sessions). Receives: Behavioral: Individually delivered Cognitive Behavioural Therapy for Complicated Grief Reactions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of prolonged grief disorder
Changes in symptoms of prolonged grief disorder will be measured with Prolonged Grief Disorder-13 (PG-13; Prigerson et al., 2009). Higher total scores indicate higher symptom level (minimum value: 11; maximum value: 57).
Measured: From baseline (T1) to post-intervention (T3; up to one week after the 12th session) and to six months follow-up (T5).
Secondary outcomes (11)
Depressive symptoms
Changes in depressive symptoms will be measured with Center for Epidemiologic Studies Short Depression Scale (CESD-10; Andresen, Malmgren, Carter, \& Patrick, 1994). Higher total scores indicate higher symptom level (minimum value: 0; maximum value: 30).
Measured: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
Anxiety symptoms
Changes in anxiety symptoms will be measured with Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams, \& Löwe, 2006). Higher total scores indicate higher symptom level (minimum value: 0; maximum value: 21).
Measured: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
Posttraumatic stress symptoms
Changes in posttraumatic stress symptoms will be measured with Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) (PCL; Ashbaugh, Houle-Johnson, Herbert, El-Hage, \& Brunet, 2016; Weathers et al., 2013). Higher total scores indicate higher symptom level (minimum value: 0; maximum value: 80).
Measured: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
Quality adjusted life years
Changes in quality adjusted life years will be assessed with 5Q-5D-5L (EuroQol Research Foundation, 2019) and used in order to evaluate cost-effectiveness.
Measured: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
Functional impairment
Changes in functional impairment will be measured with Sheehan Disability Scale (SDS; Leon, Olfson, Portera, Farber, \& Sheehan, 1997). Higher total scores indicate greater functional impairment (minimum value: 0; maximum value: 30).
Measured: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
Loneliness
Changes in loneliness will be measured with Three-Item Loneliness Scale (TILS; Hughes, Waite, Hawkley, \& Cacioppo, 2004). Higher total scores indicate greater loneliness (minimum value: 3; maximum value: 9).
Measured: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
Mental and physical function
Changes in mental and physical function will be measured with 12-Item Short Form Health Survey (SF-12; Ware, Kosinski, \& Keller, 1996).
Measured: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
Social support
Changes in social support will be measured with Crisis Social Support scale (CSS; Joseph, Andrews, Williams, \& Yule, 1992). Higher total scores indicate higher level of support (minimum value: 7; maximum value: 49).
Measured: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
Well-being
Changes in well-being will be measured with the five-item WHO Well-Being Index (WHO-5; Heun, Bonsignore, Barkow, \& Jessen, 2001). Higher total scores indicate higher well-being (minimum value: 0; maximum value: 100).
Measured: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
Symptoms of prolonged grief disorder (at three months follow-up)
Changes in symptoms of prolonged grief disorder will be measured with Prolonged Grief Disorder-13 (PG-13; Prigerson et al., 2009). Higher total scores indicate higher symptom level (minimum value: 11; maximum value: 57).
Measured: From baseline (T1) to three months follow-up (T3).
Symptoms of ICD-11 prolonged grief disorder
Changes in symptoms of ICD-11 prolonged grief disorder (i.e. the 11th revision of the International Classification of Diseases definition) will be measured by mapping questionnaire items from Prolonged Grief Disorder-13 (PG-13; Prigerson et al., 2009); Inventory of Complicated Grief Revised (ICG-r; Prigerson \& Jacobs, 2001); Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5; Ashbaugh et al., 2016; Weathers et al., 2013).
Measured: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start23 Apr 2021
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BereavementStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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 with a 1:1 allocation ratio to individually delivered versus group-based CBTgrief at the clinic in Copenhagen, and with a 1:2 allocation ratio to individually delivered versus group-based CBTgrief at the clinic in Odense. Randomization is conducted by an independent employee at the Danish National Center for Grief (DNCG). The allocation will take place after completion of baseline questionnaire (T1).
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Utrecht University, The Danish National Center for Grief
- Responsible party
- Sponsor
- Investigators
- Maja O'Connor, PhD, Study director, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694807
- Sponsor's protocol ID
- 35880
- Status last verified
- Aug 2025
- First submitted
- 16 Dec 2020
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Komischke K, Boelen PA, Maccallum F, O'Connor M. Group Vs Individual Grief-Focused Cognitive Behavioral Therapy for Older Adults: A Randomized Clinical Trial. JAMA Psychiatry. 2026 Mar 1;83(3):229-237. doi: 10.1001/jamapsychiatry.2025.4106.
PubMed 41533372
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Group Versus Individual Cognitive Behavioural Therapy for Complicated Grief Reactions in Old Age: A Randomized Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT04694807
- Acronym / sponsor ID
- 35880
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Utrecht University, The Danish National Center for Grief
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 5 Jan 2021 (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.
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.
Detailed description
Aims of the study:
- Evaluate the relative efficacy of an individually delivered versus group-based CBTgrief.
- Evaluate the relative cost-effectiveness of an individually delivered versus group-based CBTgrief.
- Examine the theoretically proposed treatment mediators of CBTgrief.
- Explore loss-related and sociodemographic characteristics as possible moderators of intervention effects.
Primary hypothesis:
Group-based CBTgrief will show non-inferiority (i.e., equal efficacy) in reducing symptoms of PGD compared to individually delivered CBTgrief at six months follow-up.
Secondary hypotheses:
- Group-based CBTgrief will show non-inferiority (i.e., equal efficacy) in reducing symptoms of posttraumatic stress, depression, and anxiety compared to individually delivered CBTgrief at six months follow-up.
- Group-based CBTgrief will be more cost-effective than individually delivered CBTgrief.
- The observed effect of CBTgrief is mediated by changes in theoretically proposed maintaining mechanisms of complicated grief reactions (i.e. insufficient integration of the loss; negative loss-related cognitions; depressive and anxious avoidance).
- 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.
- 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 -0.5 SD on the primary outcome, i.e. symptoms of PGD, and a statistical power of 0.80. The true difference is assumed to be 0.0 and the one-sided significance level (alpha) of the test is 0.025. Based on an estimated dropout rate of 20% the total number of participants needed to recruit is N=160 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Block randomization with a 1:1 allocation ratio to individually delivered versus group-based CBTgrief at the clinic in Copenhagen, and with a 1:2 allocation ratio to individually delivered versus group-based CBTgrief at the clinic in Odense. Randomization is conducted by an independent employee at the Danish National Center for Grief (DNCG). The allocation will take place after completion of baseline questionnaire (T1).
| Arm | Type | Receives |
|---|---|---|
| Group-based Cognitive Behavioural Therapy | Experimental | Behavioral: Group-based Cognitive Behavioural Therapy for Complicated Grief ReactionsA group delivered treatment format of CBTgrief (12 sessions). |
| Individually delivered Cognitive Behavioural Therapy | Active comparator | Behavioral: Individually delivered Cognitive Behavioural Therapy for Complicated Grief ReactionsAn individual delivered treatment format of CBTgrief (12 sessions). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥ 65 years (older adult).
- Lost a loved one (e.g., spouse, partner) ≥ 6 months ago.
- Clinically relevant symptoms of one or more types of complicated grief reactions (i.e. symptoms of prolonged grief (PG-13 ≥ 29), depression (CESD-10 ≥ 10), anxiety (GAD-7 ≥ 10), and/or posttraumatic stress (PCL ≥ 31)).
Key exclusion criteria (8 listed)
- No clinically relevant symptoms of one or more types of complicated grief reactions (i.e. symptoms of prolonged grief, depression, anxiety and/or posttraumatic stress).
- No informed consent given.
- Insufficient Danish proficiency.
- Inability to transport oneself to the clinic.
- Severe psychopathology (e.g., schizophrenia).
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 |
|---|---|---|
| Group-based Cognitive Behavioural Therapy for Complicated Grief ReactionsAlso: Group CBTgriefCBTgrief is a transdiagnostic psychotherapeutic treatment for complicated grief reactions, i.e., symptoms of prolonged grief disorder as well as post-loss depression, anxiety, and posttraumatic stress. The treatment manual is developed by Professor Paul A. Boelen. CBTgrief includes methods such as psycho-education, homework, exposure, alteration of grief-related negative automatic thoughts, behavioural activation, and goal-oriented work. CBTgrief consists of 12 sessions with a session duration of 2.25 hours for the group format. Group-based CBTgrief will follow the same content and exercises for each session as individually delivered CBTgrief. | Behavioural | Group-based Cognitive Behavioural Therapy |
| Individually delivered Cognitive Behavioural Therapy for Complicated Grief ReactionsAlso: Individual CBTgriefCBTgrief is a transdiagnostic psychotherapeutic treatment for complicated grief reactions, i.e., symptoms of prolonged grief disorder as well as post-loss depression, anxiety, and posttraumatic stress. The treatment manual is developed by Professor Paul A. Boelen. CBTgrief includes methods such as psycho-education, homework, exposure, alteration of grief-related negative automatic thoughts, behavioural activation, and goal-oriented work. CBTgrief consists of 12 sessions with a session duration of 1 hour for the individually delivered format. Individually delivered CBTgrief will follow the same content and exercises for each session as group-based CBTgrief. | Behavioural | Individually delivered Cognitive Behavioural Therapy |
Primary outcome
Symptoms of prolonged grief disorder
Time frame: From baseline (T1) to post-intervention (T3; up to one week after the 12th session) and to six months follow-up (T5).
Changes in symptoms of prolonged grief disorder will be measured with Prolonged Grief Disorder-13 (PG-13; Prigerson et al., 2009). Higher total scores indicate higher symptom level (minimum value: 11; maximum value: 57).
11 secondary outcomes
Depressive symptoms
Time frame: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
Anxiety symptoms
Time frame: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
Posttraumatic stress symptoms
Time frame: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
Quality adjusted life years
Time frame: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
Functional impairment
Time frame: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
Loneliness
Time frame: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
Mental and physical function
Time frame: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
Social support
Time frame: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
Well-being
Time frame: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
Symptoms of prolonged grief disorder (at three months follow-up)
Time frame: From baseline (T1) to three months follow-up (T3).
Symptoms of ICD-11 prolonged grief disorder
Time frame: From baseline (T1) to post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), and six months follow-up (T5).
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 22 Aug 2025.
- Derived from this study: PubMed 41533372Komischke K, Boelen PA, Maccallum F, O'Connor M. Group Vs Individual Grief-Focused Cognitive Behavioral Therapy for Older Adults: A Randomized Clinical Trial. JAMA Psychiatry. 2026 Mar 1;83(3):229-237. doi: 10.1001/jamapsychiatry.2025.4106.
- Link to the research unit's websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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, 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 Group-based Cognitive Behavioural Therapy for Complicated Grief Reactions and Individually delivered Cognitive Behavioural Therapy for Complicated Grief Reactions in people with Bereavement and Prolonged Grief Disorder, 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 8 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 22 Aug 2025. 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?
Symptoms of prolonged grief disorder (time frame: From baseline (T1) to post-intervention (T3; up to one week after the 12th session) and to six months follow-up (T5).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04694807, which also lists 1 linked publication.
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 22 Aug 2025.