None listed
Conditions
Brief summary
This study addresses the question of whether an augmented version of a psychological intervention (Cognitive Behaviour Therapy combined with augmentation strategies; CBT/A) to reduce severity of Prolonged Grief Disorder (PGD) more than standard CBT. CBT/A is a novel extension of the gold standard treatment of Prolonged Grief by providing training in emotion tolerance skills and positive affect awareness. The key question of the study is the extent to which this modification to CBT can promote better outcomes relative to standard CBT. This study hypothesises that CBT/A will result in greater reductions in Prolonged Grief than CBT at 6 months following treatment. Participants with PGD will be randomized to 11 sessions of standard CBT or Augmented CBT.
Interventions
There are two arms to this trial that were designed specifically for this trial. Arm 1 (intervention): Cognitive Behaviour Therapy. Arm 2 (comparator): Augmented Cognitive Behaviour Therapy. Cognitive Behaviour Therapy is administered on an individual basis on a once-weekly basis by a clinical psychologist either face-to-face or remotely via Zoom. Therapy comprises individual 60-minute sessions administered over 11 weeks. The intervention instructs participants on the following stress coping str
There are two arms to this trial that were designed specifically for this trial. Arm 1 (intervention): Cognitive Behaviour Therapy. Arm 2 (comparator): Augmented Cognitive Behaviour Therapy. Cognitive Behaviour Therapy is administered on an individual basis on a once-weekly basis by a clinical psychologist either face-to-face or remotely via Zoom. Therapy comprises individual 60-minute sessions administered over 11 weeks. The intervention instructs participants on the following stress coping strategies: psychoeducation, exposure to memories of the loss, reframing of maladaptive thoughts, strategies in emotion tolerance, and relapse prevention. Treatment adherence will be assessed by checklist completed by therapists. The duration of the study for any participant will conclude after a 2-year follow-up assessment, resulting in participation duration of 124 weeks.
Sponsors
UNSW Sydney
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Meet Prolonged Grief Disorder (PGD) criteria (as measured by the PGD-13 Scale) • Aged at least 18 years • Sufficient English language comprehension
Exclusion criteria
• Current psychosis • Imminent suicidal risk • Current substance dependence (but not abuse)
Outcome results
None listed