Cognitive Behavioural Therapy for Complicated Grief Reactions in Old Age

Depression Clinical Trial

Official title:

The Efficacy of Group Versus Individual Cognitive Behavioural Therapy for Complicated Grief Reactions in Old Age: A Randomized Non-inferiority Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04694807
• Other study ID #: 35880
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2023
• Source: University of Aarhus
• Contact: Maja O'Connor, PhD
• Phone: +4587165309
• Email: maja[@]psy.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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 (i.e., 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 (i.e., 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 (i.e. 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 -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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Age = 65 years (older adult).

2. Lost a loved one (e.g., spouse, partner) = 6 months ago.

3. 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)).

Exclusion Criteria:

1. 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).

2. No informed consent given.

3. Insufficient Danish proficiency.

4. Inability to transport oneself to the clinic.

5. Severe psychopathology (e.g., schizophrenia).

6. Severe cognitive impairment (e.g., Alzheimer's disease).

7. Substance abuse.

8. Acute suicidal ideation.

Related Conditions & MeSH terms

• Anxiety
• Bereavement
• Depression
• Posttraumatic Stress Disorder
• Prolonged Grief Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Group-based Cognitive Behavioural Therapy for Complicated Grief Reactions
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 Reactions
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.

Locations

Country	Name	City	State
Denmark	Unit for Bereavement Research, Dept. of Psychology, Aarhus University	Aarhus C

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	The Danish National Center for Grief, Utrecht University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mediator: Insufficient integration of the loss	Changes in the integration of the loss will be measured with Experienced Unrealness Scale (EUS; Boelen, 2010). Higher total scores indicate greater sense of unrealness (minimum value: 5; maximum value: 40).	Baseline (T1), mid-intervention (T2; immediately after the 6th session), post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), six months follow-up (T5).
Other	Mediator: Negative loss-related cognitions	Changes in grief-related cognitions will be measured with Grief Cognitions Questionnaire (GCQ; Boelen & Lensvelt-Mulders, 2005). Higher total scores indicate higher levels of negative loss-related cognitions (minimum value: 0; maximum value: 90).	Baseline (T1), mid-intervention (T2; immediately after the 6th session), post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), six months follow-up (T5).
Other	Mediator: Avoidance behaviors	Changes in avoidance behaviors will be measured with Depressive and Anxious Avoidance in Prolonged Grief Questionnaire (DAAPGQ; Boelen & van den Bout, 2010). Higher total scores indicate higher levels of avoidance behaviors (minimum value: 9; maximum value: 63).	Baseline (T1), mid-intervention (T2; immediately after the 6th session), post-intervention (T3; up to one week after the 12th session), three months follow-up (T4), six months follow-up (T5).
Other	Mediator: Therapeutic alliance	Changes in the therapeutic alliance will be measured with Working Alliance Inventory - Short Form (WAI-SF; Horvath & Greenberg, 1989; Tracey & Kokotovic, 1989).	Mid-intervention (T2; immediately after the 6th session), post-intervention (T3; up to one week after the 12th session).
Other	Mediator: Therapeutic group processes	Changes in therapeutic group processes will be measured with Therapeutic Factors Inventory - Short Form (TFI-SF; Joyce, MacNair-Semands, Tasca, & Ogrodniczuk, 2011).	Mid-intervention (T2; immediately after the 6th session), post-intervention (T3; up to one week after the 12th session).
Other	Healthcare utilization costs	Data about visits to general practitioners, psychologists etc. delivered by the Danish Health Data Authority.	Baseline (T1) to six months follow-up (T5).
Other	Moderator: Circumstances of the loss	Data about circumstances of the loss (e.g., traumatic, non-traumatic) will be explored as a possible moderator.	Measured at baseline (T1).
Other	Moderator: Type of loss	Data about type of loss (e.g., spouse, child) will be explored as a possible moderator.	Measured at baseline (T1).
Other	Moderator: Time since loss	Data about time since loss will be explored as a possible moderator.	Measured at baseline (T1).
Other	Moderator: Baseline grief symptom level	Grief symptom level prior to intervention will be measured with Prolonged Grief Disorder-13 (PG-13; Prigerson et al., 2009) and explored as possible moderator.	Measured at baseline (T1).
Other	Moderator: Number of additional losses	Data about number of additional losses will be explored as a possible moderator.	Measured at baseline (T1).
Other	Moderator: Sociodemographic characteristics (e.g., gender, age, level of education)	Data about gender, age, level of education will be explored as possible moderators.	Measured at baseline (T1).
Primary	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).	From baseline (T1) to post-intervention (T3; up to one week after the 12th session) and to six months follow-up (T5).
Secondary	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).	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).
Secondary	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).	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).
Secondary	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).	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).
Secondary	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.	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).
Secondary	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).	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).
Secondary	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).	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).
Secondary	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).	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).
Secondary	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).	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).
Secondary	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).	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).
Secondary	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).	From baseline (T1) to three months follow-up (T3).
Secondary	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).	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).

External Links

•   Link to the research unit's website