Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000580673
Ethics application status
Approved
Date submitted
21/09/2005
Date registered
4/10/2005
Date last updated
4/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Project Lighten Up
Scientific title
Therapeutic Family Involvement (TFI) in the Management of Persistent Clinical Depression: Psycho-education, Family Support and Multi-Family Group Intervention.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment-Resistant Depression 707 0
Condition category
Condition code
Mental Health 784 784 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised control study which compares usual treatment for Depression (control condition) with a usual treatment plus multi-family group intervention (treatment condition). The intervention is a 15-session fortnightly family group involving 6 families.
Intervention code [1] 660 0
Treatment: Other
Comparator / control treatment
Usual treatment
Control group
Active

Outcomes
Primary outcome [1] 996 0
The study measures changes to level of Depression.
Timepoint [1] 996 0
Using pre and post measures at a 9 month interval.
Primary outcome [2] 997 0
The study measures changes to family functioning.
Timepoint [2] 997 0
Using pre and post measures at a 9 month interval.
Primary outcome [3] 998 0
The study measures changes to recovery management.
Timepoint [3] 998 0
Using pre and post measures at a 9 month interval.
Primary outcome [4] 999 0
The study measures changes to quality of life.
Timepoint [4] 999 0
Using pre and post measures at a 9 month interval.
Primary outcome [5] 1000 0
The study measures changes to service evaluation.
Timepoint [5] 1000 0
Using pre and post measures at a 9 month interval.
Secondary outcome [1] 1887 0
Qualitative analysis (using grounded theory methodology) will be conducted with data collected from treatment group-interviews at the conclusion of the intervention. The analysis will focus on the effective elements of multi-family group involvement.
Timepoint [1] 1887 0

Eligibility
Key inclusion criteria
1) A diagnosis of Depression (greater than 17 on Hamilton Depression Inventory) which has been resistant to standard medical treatment delivered for at least one year. 2) The availability of a significant other to take part 3) The absence of moderate to severe psychatric conditions other than depression.
Minimum age
35 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Anxiety

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)
total referrals for a phase are mixed and selected from an opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
control and treatment group are selected blindly on an alternating basis
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/05/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 868 0
Charities/Societies/Foundations
Name [1] 868 0
BeyondBlue Centre of Excellence
Country [1] 868 0
Australia
Primary sponsor type
University
Name
The Bouverie Centre, Latrobe University
Address
Country
Australia
Secondary sponsor category [1] 732 0
Charities/Societies/Foundations
Name [1] 732 0
Western Division of General practice
Address [1] 732 0
Country [1] 732 0
Australia
Secondary sponsor category [2] 733 0
Hospital
Name [2] 733 0
ISIS primary care
Address [2] 733 0
Country [2] 733 0
Australia
Secondary sponsor category [3] 734 0
Hospital
Name [3] 734 0
Djerriwarrh health Service
Address [3] 734 0
Country [3] 734 0
Australia
Secondary sponsor category [4] 735 0
Hospital
Name [4] 735 0
Melbourne health
Address [4] 735 0
Country [4] 735 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2130 0
ISIS brimbank
Ethics committee address [1] 2130 0
Ethics committee country [1] 2130 0
Australia
Date submitted for ethics approval [1] 2130 0
Approval date [1] 2130 0
Ethics approval number [1] 2130 0
Ethics committee name [2] 2131 0
Djerriwarrh Health Service (melton)
Ethics committee address [2] 2131 0
Ethics committee country [2] 2131 0
Australia
Date submitted for ethics approval [2] 2131 0
Approval date [2] 2131 0
Ethics approval number [2] 2131 0
Ethics committee name [3] 2132 0
MidWest primary mental health team
Ethics committee address [3] 2132 0
Ethics committee country [3] 2132 0
Australia
Date submitted for ethics approval [3] 2132 0
Approval date [3] 2132 0
Ethics approval number [3] 2132 0
Ethics committee name [4] 2133 0
Western Division of General Practice
Ethics committee address [4] 2133 0
Ethics committee country [4] 2133 0
Australia
Date submitted for ethics approval [4] 2133 0
Approval date [4] 2133 0
Ethics approval number [4] 2133 0

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

Contacts
Principal investigator
Name 35696 0
Address 35696 0
Country 35696 0
Phone 35696 0
Fax 35696 0
Email 35696 0
Contact person for public queries
Name 9849 0
Dr Grace Couchman
Address 9849 0
The Bouverie Centre
50 Flemington St
Flemington VIC 3031
Country 9849 0
Australia
Phone 9849 0
+61 3 93769844
Fax 9849 0
+61 3 93769890
Email 9849 0
g.couchman@latrobe.edu.au
Contact person for scientific queries
Name 777 0
Dr Colin Riess
Address 777 0
The Bouverie Centre
50 Flemington St
Flemington VIC 3031
Country 777 0
Australia
Phone 777 0
+61 3 93769844
Fax 777 0
+61 3 93769890
Email 777 0
c.riess@latrobe.edu.au

No information has been provided regarding IPD availability


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.