Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000453684p
Ethics application status
Submitted, not yet approved
Date submitted
6/04/2023
Date registered
2/05/2023
Date last updated
2/05/2023
Date data sharing statement initially provided
2/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Augmented Psychological Treatment for Prolonged Grief
Scientific title
Randomised Controlled Trial of a Standard Cognitive Behaviour Treatment versus Augmented Cognitive Behaviour Treatment on Prolonged Grief Disorder in Adults
Secondary ID [1] 309404 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prolonged Grief Disorder 329637 0
Condition category
Condition code
Mental Health 326560 326560 0 0
Anxiety
Mental Health 326561 326561 0 0
Depression
Mental Health 326562 326562 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 325839 0
Behaviour
Intervention code [2] 325840 0
Treatment: Other
Comparator / control treatment
Augmented 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, and relapse prevention. The comparator differs from the intervention by providing training in emotion tolerance skills and positive affect awareness. 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.
Control group
Active

Outcomes
Primary outcome [1] 334407 0
Prolonged grief as measured by Prolonged Grief -13 Scale
Timepoint [1] 334407 0
Pretreatment (week 0), posttreatment (week 12 post-baseline), primary follow-up (week 38 post-baseline, primary endpoint), additional follow-up (week 120 post-baseline).
Secondary outcome [1] 420540 0
Depression as measured by the Beck Depression Inventory.
Timepoint [1] 420540 0
Pretreatment (week 0), posttreatment (week 12 post-baseline), primary follow-up (week 38 post-baseline), additional follow-up (week 120 post-baseline).
Secondary outcome [2] 420541 0
Posttraumatic stress disorder as measured by the Clinician Administered PTSD Scale.
Timepoint [2] 420541 0
Pretreatment (week 0), posttreatment (week 12 post-baseline), primary follow-up (week 38 post-baseline), additional follow-up (week 120 post-baseline).
Secondary outcome [3] 420542 0
Maladaptive appraisals as measured by the Posttraumatic Cognitive Inventory.
Timepoint [3] 420542 0
Pretreatment (week 0), posttreatment (week 12 post-baseline), primary follow-up (week 38 post-baseline,), additional follow-up (week 120 post-baseline).
Secondary outcome [4] 420543 0
Suicidality as assessed with the Suicidal Ideation Attributes Scale
Timepoint [4] 420543 0
Pretreatment (week 0), posttreatment (week 12 post-baseline), primary follow-up (week 38 post-baseline), additional follow-up (week 120 post-baseline).
Secondary outcome [5] 420544 0
Health related quality of life as measured using Australian Quality of Life
Timepoint [5] 420544 0
Pretreatment (week 0), posttreatment (week 12 post-baseline), primary follow-up (week 38 post-baseline), additional follow-up (week 120 post-baseline).

Eligibility
Key inclusion criteria
• Meet Prolonged Grief Disorder (PGD) criteria (as measured by the PGD-13 Scale)
• Aged at least 18 years
• Sufficient English language comprehension
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Current psychosis
• Imminent suicidal risk
• Current substance dependence (but not abuse)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be adults meeting criteria for PTSD. Participants wishing to participate will be randomly allocated according to a random numbers system administered by an individual who independent of the trial and who works at a site that is independent from the trial centre.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will focus primarily on intent-to-treat analysis. Using SPSS version 24, hierarchical linear mixed models (HLM) will be used to study differential effects of each treatment condition because this method effectively handles missing data by calculating estimates of trajectories. For the follow-up analyses between the two conditions, analyses will focus on linear time effects, treatment conditions, and interactions. Fixed effects parameters were tested with the Wald test (t-test, p <.05, two-sided) and 95% confidence intervals. Cohen’s (d) effect size was calculated for all analyses. The primary outcome measure will be the PG-13. The primary outcome timepoint will be the 6 months assessment.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/05/2023
Actual
Date of last participant enrolment
Anticipated
20/04/2026
Actual
Date of last data collection
Anticipated
17/07/2028
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313599 0
Government body
Name [1] 313599 0
National Health and Medical Research Council (NHMRC)
Country [1] 313599 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Anzac Pde, Kensington, NSW, 2052
Country
Australia
Secondary sponsor category [1] 315388 0
None
Name [1] 315388 0
Address [1] 315388 0
Country [1] 315388 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312775 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 312775 0
Ethics committee country [1] 312775 0
Australia
Date submitted for ethics approval [1] 312775 0
13/04/2023
Approval date [1] 312775 0
Ethics approval number [1] 312775 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125870 0
Prof Richard Bryant
Address 125870 0
School of Psychology
Matthews Building
Anzac Pde, Kensington
University of New South Wales
NSW 2052
Country 125870 0
Australia
Phone 125870 0
+61293854640
Fax 125870 0
Email 125870 0
[email protected]
Contact person for public queries
Name 125871 0
Richard Bryant
Address 125871 0
School of Psychology
Matthews Building
Anzac Pde, Kensington
University of New South Wales
NSW 2052
Country 125871 0
Australia
Phone 125871 0
+61293854640
Fax 125871 0
Email 125871 0
[email protected]
Contact person for scientific queries
Name 125872 0
Richard Bryant
Address 125872 0
School of Psychology
Matthews Building
Anzac Pde, Kensington
University of New South Wales
NSW 2052
Country 125872 0
Australia
Phone 125872 0
+61293854640
Fax 125872 0
Email 125872 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the de-identified individual participant data and related data dictionaries are available
When will data be available (start and end dates)?
Data will be available following publication of the study outcomes. There is no end date for when this data will be available.
Available to whom?
Researchers wishing to conduct re-analyses of the data after approval from the Chief Investigator
Available for what types of analyses?
Meta-analyses or re-analyses of subgroups
How or where can data be obtained?
By emailing the Principal Investigator (email: [email protected]).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.