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Trial registered on ANZCTR


Registration number
ACTRN12609000229279
Ethics application status
Approved
Date submitted
9/05/2008
Date registered
8/05/2009
Date last updated
8/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized controlled trial of cognitive behaviour therapy to reduce symptoms of complicated grief caused by the loss of a loved one
Scientific title
Randomized controlled trial of cognitive behaviour therapy to reduce symptoms of complicated grief caused by the loss of a loved one
Universal Trial Number (UTN)
Trial acronym
Treating complicated grief
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complicated grief 3133 0
Condition category
Condition code
Mental Health 3296 3296 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive behaviour therapy involves 10 90-minute sessions of group therapy and 4 60-minute sessions of individual therapy over a 10-week period; the 4 individual sessions occur in weeks-3-6 of the treatment program. The therapy includes discussing memories of the deceased, re-appraising beliefs about the loss, and learning activity schedules.
Intervention code [1] 2875 0
Treatment: Other
Comparator / control treatment
Modified cognitive behaviour therapy involves 10 sessions of group therapy and 4 sessions of individual therapy over a 10-week period; the 4 individual sessions occur in weeks-3-6 of the treatment program. Modified cognitive behaviour therapy comprises re-appraising beliefs about the loss, and learning activity schedules.
Control group
Active

Outcomes
Primary outcome [1] 4838 0
Complicated grief, defined as severe grief reactions that persist beyond 6 months after the death of a loved one, and measured by the Inventory of Complicated Grief
Timepoint [1] 4838 0
Administered pretreatment, posttreatment, and 6 months follow-up.
Secondary outcome [1] 7138 0
Posttraumatic stress disorder measured by the Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale.
Timepoint [1] 7138 0
Administered pretreatment, posttreatment, and 6 months follow-up.
Secondary outcome [2] 8165 0
Depression assessed by the Beck Depression Inventory
Timepoint [2] 8165 0
Administered pretreatment, posttreatment, and 6 months follow-up.

Eligibility
Key inclusion criteria
(a) Loss of loved one, (b) Meet criteria for complicated grief, (c) at least 6 months duration
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychosis, substance dependent, suicidal intent

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 were randomly assigned according to a random numbers system administered by an individual who was independent of the study and who worked at a site that was distant from the treatment center.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was conducted by a process of minimization stratified on gender, grief type, and grief total score.
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3372 0
Government body
Name [1] 3372 0
National Health & Medical Research Council
Address [1] 3372 0
GPO Box 1421 Canberra ACT 2601
Country [1] 3372 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
University of New South Wales
Sydney, NSW, 2052
Country
Australia
Secondary sponsor category [1] 3017 0
Hospital
Name [1] 3017 0
Westmead Hospital
Address [1] 3017 0
Westmead Hospital
O'Briens Rd
Westmead, NSW, 2145
Country [1] 3017 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5397 0
University of New South Wales Human Ethics Committee
Ethics committee address [1] 5397 0
University of New South Wales
Sydney, NSW, 2052
Ethics committee country [1] 5397 0
Australia
Date submitted for ethics approval [1] 5397 0
Approval date [1] 5397 0
05/03/2008
Ethics approval number [1] 5397 0

Summary
Brief summary
Patients with complicated grief will be randomly allcoated to a combiantion of group and individual therapy. Patients will receive either 10 sessions of cognitive behaviour therapy with exposure therapy, cognitive behaviour therapy without exposure therapy, or skills training.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28581 0
Address 28581 0
Country 28581 0
Phone 28581 0
Fax 28581 0
Email 28581 0
Contact person for public queries
Name 11738 0
Professor Richard Bryant
Address 11738 0
School of Psychology
University of New South Wales
Sydney, NSW, 2052
Country 11738 0
Australia
Phone 11738 0
61-2-93853640
Fax 11738 0
61-2-93853641
Email 11738 0
r.bryant@unsw.edu.au
Contact person for scientific queries
Name 2666 0
Professor Richard Bryant
Address 2666 0
School of Psychology
University of New South Wales
Sydney, NSW, 2052
Country 2666 0
Australia
Phone 2666 0
61-2-93853640
Fax 2666 0
61-2-93853641
Email 2666 0
r.bryant@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
No Results