Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000307808
Ethics application status
Approved
Date submitted
13/03/2012
Date registered
19/03/2012
Date last updated
10/09/2023
Date data sharing statement initially provided
22/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of Cognitive Behaviour Therapy versus Mindfulness for Adults with Prolonged Grief
Scientific title
Randomised Controlled Trial of Cognitive Behaviour Therapy versus Mindfulness for Adults with Prolonged Grief
Secondary ID [1] 280113 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prolonged Grief 286031 0
Condition category
Condition code
Mental Health 286220 286220 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intervention(s) / exposure*

There are two arms to this trial. Arm 1: CBT. Arm 2: Mindfulness. Therapy is administered once-weekly over 11 weeks on an individual 90 minute basis. CBT includes 11 sessions of education about Prolonged Grief, cognitive restructuring of erroneous beliefs about the loss , and exposure to memories of the death and to avoided situations. Mindfulness involves 11 sessions of learning skills on identifying and managing distress through distraction, mindfulness, labelling emotions, and acceptance of grief distress. The duration of the study for any participant will conclude after a 6-month follow-up assessment, resulting in participation duration of 9 months.
Intervention code [1] 284444 0
Behaviour
Intervention code [2] 284445 0
Treatment: Other
Comparator / control treatment
Mindfulness involves 11 sessions of learning skills on identifying and managing distress through distraction, mindfulness, labelling emotions, and acceptance of grief distress. The duration of the study for any participant will conclude after a 6-month follow-up assessment, resulting in participation duration of 9 months.
Control group
Active

Outcomes
Primary outcome [1] 286695 0
Prolonged Grief symptoms, as measured by the Prolonged Grief -13 inventory.
Timepoint [1] 286695 0
Pretreatment, posttreatment, 6-Month Follow-up
Secondary outcome [1] 296479 0
Depression, as measured by the Beck Depression Inventory
Timepoint [1] 296479 0
Pretreatment, posttreatment, 6-Month Follow-up
Secondary outcome [2] 426549 0
Anxiety, as measured by the Beck Depression Inventory
Timepoint [2] 426549 0
Pretreatment, posttreatment, 6-Month Follow-up
Secondary outcome [3] 426550 0
Quality of Life as measured by the WHOQOL BREF.
Timepoint [3] 426550 0
Pretreatment, posttreatment, 6-Month Follow-up
Secondary outcome [4] 426551 0
Maladaptive appraisals as measured by the Grief Cognitions Scale.
Timepoint [4] 426551 0
Pretreatment, posttreatment, 6-Month Follow-up

Eligibility
Key inclusion criteria
Adults who have lost a loved one more than six months ago and satisfy the criteria for Prolonged Grief
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe suicidal intent, psychotic, substance dependent

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 treatment seeking adults who respond to advertising in Sydney, Australia. Participants will be randomly allocated according to a random numbers system administered by an individual who is independent of the study and who works at a site that is distant from the treatment centre.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be conducted by a process of minmization stratified on gender and severity of grief levels.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2012
Actual
29/12/2012
Date of last participant enrolment
Anticipated
31/12/2021
Actual
31/10/2022
Date of last data collection
Anticipated
30/09/2022
Actual
3/07/2023
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20850 0
Westmead Hospital - Westmead

Funding & Sponsors
Funding source category [1] 284876 0
Government body
Name [1] 284876 0
National Health and Medical Research Council
Country [1] 284876 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Anzac Parade, Kensington, Sydney, NSW, 2052
Country
Australia
Secondary sponsor category [1] 283755 0
Hospital
Name [1] 283755 0
Westmead Hospital
Address [1] 283755 0
O'Brien's Road, Westmead, NSW, 2145
Country [1] 283755 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286869 0
Western Sydney Local Health District HREC
Ethics committee address [1] 286869 0
Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Ethics committee country [1] 286869 0
Australia
Date submitted for ethics approval [1] 286869 0
16/03/2012
Approval date [1] 286869 0
09/10/2012
Ethics approval number [1] 286869 0
HREC/12/WMEAD/99

Summary
Brief summary
The rationale of the study is to evaluate the relative efficacies of Cognitive Behaviour Therapy and Mindfulness in reducing the symptoms of prolonged grief. This study compares the relative effectiveness of (a) Cognitive Behaviour Therapy, and (b) Mindfulness. It is hypothesised that both arms training will lead to grief symptom reduction but that Cognitive Behaviour Therapy will lead to greater symptom reduction at follow-up.
Trial website
NA
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33898 0
Prof Richard Bryant
Address 33898 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 33898 0
Australia
Phone 33898 0
+61 405375874
Fax 33898 0
Email 33898 0
[email protected]
Contact person for public queries
Name 17145 0
Professor Richard Bryant
Address 17145 0
School of Psychology
University of New South Wales
Sydney, NSW, 2052
Country 17145 0
Australia
Phone 17145 0
61-2-93853640
Fax 17145 0
61-2-93853641
Email 17145 0
[email protected]
Contact person for scientific queries
Name 8073 0
Professor Richard Bryant
Address 8073 0
School of Psychology
University of New South Wales
Sydney, NSW, 2052
Country 8073 0
Australia
Phone 8073 0
61-2-93853640
Fax 8073 0
61-2-93853641
Email 8073 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 independent participant data of primary and secondary outcomes will be shared.
When will data be available (start and end dates)?
On publication of the trial results.
Available to whom?
Researchers wishing to conduct re-analyses.
Available for what types of analyses?
IPD and meta-analyses
How or where can data be obtained?
Obtained from principal investigator ([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.