Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000542190
Ethics application status
Approved
Date submitted
2/04/2019
Date registered
5/04/2019
Date last updated
3/03/2023
Date data sharing statement initially provided
5/04/2019
Date results provided
3/03/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Eclipse - A support group for people who have attempted suicide
Scientific title
Evaluation of the Lifeline Eclipse Project, a non-clinical support group for people who have attempted suicide to reduce future suicidality.
Secondary ID [1] 297866 0
Nil known
Universal Trial Number (UTN)
U1111-1231-0398
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attempted suicide 312240 0
Condition category
Condition code
Mental Health 310787 310787 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Eclipse Group curriculum is a adapted for Australia from the Didi Hirsch support group for people who have attempted suicide, available through the Suicide Prevention Resource Centre (https://www.sprc.org/resources-programs/manual-support-groups-suicide-attempt-survivors). The group consists of an 8 week closed non-clinical support group for people who have attempted suicide with psycho-educational components and safety planning. The intervention is delivered by Lifeline staff at each site who have been trained in the facilitation of the group. The group sessions run for 1.5 - 2 hours, once per week, for 8 weeks. The evaluation is embedded in the delivery of the program, with data being collected by the facilitators at pre- and post-group. Two further data collection timepoints occur when the researchers conduct a focus group at 1 month post-group and individual, in-depth interviews at 6 months post-group. The trial sites for this evaluation are Port Macquarie, Gordon, Macarthur, Bathurst. Multiple groups may be run at each site during the trial period.
Intervention code [1] 314099 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319632 0
The primary outcome measure is suicidal ideation. This is measured by the Suicidal Ideation Attributes Scale (SIDAS).
Timepoint [1] 319632 0
Immediately post-intervention (T1)
Primary outcome [2] 319646 0
The primary outcome measure is suicidal ideation. This is measured by the Suicidal Ideation Attributes Scale (SIDAS).
Timepoint [2] 319646 0
6 months post intervention (T3)
Secondary outcome [1] 368940 0
The secondary outcome measure is resilience. This is measured by the Resilience Appraisal Score (RAS).
Timepoint [1] 368940 0
Immediately post intervention (T1)
Secondary outcome [2] 369011 0
The secondary outcome measure is resilience. This is measured by the Resilience Appraisal Score (RAS).
Timepoint [2] 369011 0
6 months post intervention (T3)
Secondary outcome [3] 377420 0
The secondary measure is Psychological distress. This is measured by Patient Health Questionnaire (PHQ-9), Interpersonal Needs Questionnaire (INQ-15)
Timepoint [3] 377420 0
Immediately post intervention, 1 and 6 month follow up
Secondary outcome [4] 377421 0
Suicide-related coping via the Suicide-Related Coping Scale
Timepoint [4] 377421 0
Immediately post group, 1 month and 6 month follow up

Eligibility
Key inclusion criteria
Prior suicide attempt/s, over 18 years, proficient in English, ability to physically attend weekly groups
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently suicidal

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/03/2018
Date of last participant enrolment
Anticipated
1/11/2022
Actual
1/11/2022
Date of last data collection
Anticipated
31/12/2022
Actual
31/12/2022
Sample size
Target
65
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302389 0
Charities/Societies/Foundations
Name [1] 302389 0
Lifeline Research Foundation
Country [1] 302389 0
Australia
Primary sponsor type
University
Name
University of New England
Address
Elm Ave, Armidale, NSW 2351
Country
Australia
Secondary sponsor category [1] 302280 0
None
Name [1] 302280 0
Address [1] 302280 0
Country [1] 302280 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303062 0
University of New England Human Ethics Committee
Ethics committee address [1] 303062 0
Ethics committee country [1] 303062 0
Australia
Date submitted for ethics approval [1] 303062 0
01/08/2016
Approval date [1] 303062 0
12/09/2016
Ethics approval number [1] 303062 0
HE16-195

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

Contacts
Principal investigator
Name 92330 0
Prof Myfanwy Maple
Address 92330 0
School of Health University of New England NSW 2351 Elm Ave, Armidale NSW 2351
Country 92330 0
Australia
Phone 92330 0
+61 2 6773 3661
Fax 92330 0
Email 92330 0
[email protected]
Contact person for public queries
Name 92331 0
Myfanwy Maple
Address 92331 0
School of Health University of New England NSW 2351 Elm Ave, Armidale NSW 2351
Country 92331 0
Australia
Phone 92331 0
+61 2 6773 3661
Fax 92331 0
Email 92331 0
[email protected]
Contact person for scientific queries
Name 92332 0
Myfanwy Maple
Address 92332 0
School of Health University of New England NSW 2351 Elm Ave, Armidale NSW 2351
Country 92332 0
Australia
Phone 92332 0
+61 2 6773 3661
Fax 92332 0
Email 92332 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Any researcher with a methodologically sounds reason for request

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified individual data

What types of analyses could be done with individual participant data?
• to achieve purposes of request

When can requests for individual participant data be made (start and end dates)?
From:
following publication of main results for five years

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• via email to principal researcher ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


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.