Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000767808
Ethics application status
Approved
Date submitted
11/06/2012
Date registered
19/07/2012
Date last updated
19/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The National Suicide Call Back Service Carers and Bereaved Online Counselling Pilot: A Clinical Controlled Trial.
Scientific title
A clinical controlled trial of online synchronous chat versus telephone based counselling to reduce psychological distress in people who are bereaved by suicide and people who are carers for someone who is at risk of suicide.
Secondary ID [1] 280651 0
None
Universal Trial Number (UTN)
U1111-1131-6478
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complicated grief 286671 0
Perceived carer burden 286672 0
Condition category
Condition code
Mental Health 286966 286966 0 0
Other mental health disorders
Mental Health 286967 286967 0 0
Depression
Mental Health 286968 286968 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The clinical controlled trial will comprise two sub-studies corresponding to the two populations of interest, namely carers and those bereaved by suicide. Participants within the experimental group of each sub-study will choose to undertake a six week program of counselling with a single Suicide Call Back Service counsellor through online, synchronous, text-based chat. Participants in the control group of each sub-study will choose to receive the same six-week counselling program through telephone. The counselling sessions will be delivered once per week for six weeks. Each counselling session will be 1 hour in duration. The counselling intervention delivered in each sub-study is the same; it is only the sample that differs between sub-studies (Sub-study 1 = comprising carers only; Sub-study 2 = comprising bereaved individuals only).
Intervention code [1] 285054 0
Treatment: Other
Intervention code [2] 285303 0
Lifestyle
Intervention code [3] 285304 0
Behaviour
Comparator / control treatment
Participants in the control group of each sub-study will choose to undertake a six session program of counselling with a single Suicide Call Back Service counsellor through telephone. Each counselling session for both the experimental group and the control group will be 50 minutes in duration to ensure that participants groups are matched on length of exposure time to counsellors. The control group differs from the experimental group only in terms of the modality through which therapy is delivered, namely telephone (control) versus online synchronous chat (experimental).
Control group
Active

Outcomes
Primary outcome [1] 287305 0
Carers study: Perceived level of carer burden as indexed by the Zarit Burden Interview.
Timepoint [1] 287305 0
Participants will be asked to complete clinical assessments at four testing times: directly prior to engaging in their first Suicide Call Back Service counselling session (T1); following the completion of their final Suicide Call Back Session counselling session (T2); six months following the completion of therapy (T3); and twelve months following the completion of therapy (T4).
Primary outcome [2] 287306 0
Bereaved study: Level of complicated grief as indexed by the Inventory of Complicated Grief - Revised Version.
Timepoint [2] 287306 0
Participants will be asked to complete clinical assessments at four testing times: directly prior to engaging in their first Suicide Call Back Service counselling session (T1); following the completion of their final Suicide Call Back Session counselling session (T2); six months following the completion of therapy (T3); and twelve months following the completion of therapy (T4).
Secondary outcome [1] 297872 0
All participants' level of depression will be assessed and indexed by the Beck Depression Inventory - 1996 Revision (BDI-II).
Timepoint [1] 297872 0
Participants will be asked to complete clinical assessments at four testing times: directly prior to engaging in their first Suicide Call Back Service counselling session (T1); following the completion of their final Suicide Call Back Session counselling session (T2); six months following the completion of therapy (T3); and twelve months following the completion of therapy (T4).
Secondary outcome [2] 297873 0
All participants' level of anxiety will be assessed using the Hospital Anxiety Depression Scale (HADS).
Timepoint [2] 297873 0
Participants will be asked to complete clinical assessments at four testing times: directly prior to engaging in their first Suicide Call Back Service counselling session (T1); following the completion of their final Suicide Call Back Session counselling session (T2); six months following the completion of therapy (T3); and twelve months following the completion of therapy (T4).

Eligibility
Key inclusion criteria
Potential participants will be either currently caring for someone who is at risk of suicide, or bereaved by suicide.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants who are assessed as being at risk of suicide will be excluded from the trial. However, these participants will be offered treatment through the Suicide Call Back Service standard counselling programs and additionally provided with referrals to local mental health services as appropriate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited through the SCBS intake team, following either self-referral or referral from their treating health professional. Additionally, information advertising and describing the proposed study will be placed on the Suicide Call Back Service website.

Potential participants will be required to complete a screening questionnaire prior to participating in the study. Potential participants who are assessed as being at risk of suicide will be excluded from the trial and offered telephone counselling through the Suicide Call Back Service and appropriate referrals to local mental health services.

All participants will be required to register personal details, including full name, address, phone numbers, email address and contact details for their primary healthcare provider. This mandatory registration process for participation in the proposed study is intended to mitigate clinical risk, and to ensure that appropriate interventions may be facilitated if warranted. This mandatory registration process is inline with best practice guidelines for clinical trials of online therapy, and resembles closely the registration process for the larger Suicide Call Back Service telephone counselling service.

Participants will choose to receive a program of counselling from the Suicide Call Back Service by telephone or through online chat.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285654 0
Self funded/Unfunded
Name [1] 285654 0
Crisis Support Services
Country [1] 285654 0
Australia
Primary sponsor type
Individual
Name
Christopher Groot
Address
Crisis Support Services/The University of Melbourne
PO Box 2335
Footscray
VIC 3010
Country
Australia
Secondary sponsor category [1] 284269 0
University
Name [1] 284269 0
The University of Melbourne
Address [1] 284269 0
Psychological Sciences,
The University of Melbourne
Parkville Campus, Victoria, 3010
Country [1] 284269 0
Australia
Other collaborator category [1] 276858 0
Individual
Name [1] 276858 0
Garry Thomson
Address [1] 276858 0
Crisis Support Services
PO Box 2335
Footscray
VIC 3010
Country [1] 276858 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287430 0
The University of Melbourne, Behavioural and Social Sciences Human Ethics Sub Committee
Ethics committee address [1] 287430 0
Ethics committee country [1] 287430 0
Australia
Date submitted for ethics approval [1] 287430 0
Approval date [1] 287430 0
17/05/2012
Ethics approval number [1] 287430 0
1237501.1

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

Contacts
Principal investigator
Name 34295 0
Address 34295 0
Country 34295 0
Phone 34295 0
Fax 34295 0
Email 34295 0
Contact person for public queries
Name 17542 0
Christopher Groot
Address 17542 0
Crisis Support Services/The University of Melbourne
PO Box 2335
Footscray
Vic 3011
Country 17542 0
Australia
Phone 17542 0
+61 03 8371 2808
Fax 17542 0
Email 17542 0
cgroot@crisissupport.org.au
Contact person for scientific queries
Name 8470 0
Christopher Groot
Address 8470 0
Crisis Support Services/The University of Melbourne
PO Box 2335
Footscray
Vic 3011
Country 8470 0
Australia
Phone 8470 0
+61 03 8371 2808
Fax 8470 0
Email 8470 0
cgroot@crisissupport.org.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.