Cognitive Behavioural Therapy for Complicated Grief in Older Adults
The Efficacy of Group Versus Individual Cognitive Behavioural Therapy for Complicated Grief Reactions in Old Age: A Randomized Non-inferiority Trial
This study is testing two types of therapy to see which one helps older adults cope better with complicated grief after losing a loved one.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus C) |
| Trial ID | NCT04694807 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two forms of Cognitive Behavioural Therapy (CBT) for older adults experiencing complicated grief reactions after the loss of a loved one. It compares individually delivered CBT to group-based CBT to determine which method is more effective in reducing symptoms of prolonged grief, depression, anxiety, and posttraumatic stress. The study also assesses the cost-effectiveness of each approach and explores various factors that may influence treatment outcomes. Participants must be at least 65 years old and have clinically relevant symptoms of complicated grief.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 65 and above who have lost a loved one at least six months prior and exhibit significant symptoms of complicated grief.
Not a fit: Patients without clinically relevant symptoms of complicated grief or those with severe mental health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective therapeutic options for older adults suffering from complicated grief, improving their mental health and quality of life.
How similar studies have performed: Previous studies have shown that CBT is effective for grief-related symptoms, but this specific comparison of individually versus group-based CBT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aarhus C
- Unit for Bereavement Research, Dept. of Psychology, Aarhus University — Aarhus C, Denmark (Recruiting)
Study contacts
- Study coordinator: Maja O'Connor, PhD
- Email: maja@psy.au.dk
- Phone: +4587165309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.