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Trial registered on ANZCTR


Registration number
ACTRN12609000064202
Ethics application status
Approved
Date submitted
5/11/2008
Date registered
23/01/2009
Date last updated
25/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial on the effect of problem-solving based bibliotherapy in improving general wellbeing and lowering distress in primary caregivers of family members with first-episode psychosis.
Scientific title
A randomised controlled trial on the effect of problem-solving based bibliotherapy in improving general wellbeing and lowering distress in primary caregivers of family members with first-episode psychosis.
Secondary ID [1] 743 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General wellbeing for caregivers of first episode psychosis care recipients 3929 0
Coping levels for caregivers of first episode psychosis care recipients 3930 0
Distress levels for caregivers of first episode psychosis care recipients 3931 0
Expressed emotion for caregivers of first episode psychosis care recipients 3932 0
Experience of caregiving 3933 0
Condition category
Condition code
Mental Health 4213 4213 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This involves the intervention group of primary caregivers reading a problem-solving based bibliotherapy manual. The manual contains five modules which focus on improving the primary caregivers' wellbeing, equipping them to support the care recipient, and strengthening the care givers' ability to access and get the best out of support services. By reading the manual it is anticipated the caregivers will acheive better general wellbeing and have a lower level of distress. The intervention lasts for five weeks. Data will be collected at three timepoints: Baseline, end of program, and 10 weeks follow-up.
Intervention code [1] 3647 0
Treatment: Other
Comparator / control treatment
Control group of primary caregivers will not be given the self-help manual but will continue to receive the standard support for caregivers. The standard support is the basic information that is given to families when the care recipient commences treatment. The duration of control group treatment is five weeks. Data will be collected at three timepoints: baseline, end of five weeks, and 10 weeks follow-up (same as intervention group).
Control group
Active

Outcomes
Primary outcome [1] 5017 0
Primary caregivers who complete the problem-solving based bibilotherapy program will have better general wellbeing and coping, greater problem solving ability, and lower distress at 10-week follow-up than at baseline. Outomes will be assessed using the following psychometric instruments:
(i) Short Form Health Survey (SF) - 12 (Version 2) (Ware et al. 1996), a 12-item instrument developed as a generic measure of perceived health status.
(iii) Ways of coping (WOC) (MacCarthy et al. 1989), provides information about coping style. Respondents are requested to rate the coping behaviour they have used during the previous four weeks.
(iv) Kessler Psychological Distress plus Scale (K-10 plus) will be used to measure non-specific psychological distress.
(v) Social Problem Solving Inventory (Short Version) (D'Zurilla et al. 1990), a 25-item instrument that measures social problem solving ability.
Timepoint [1] 5017 0
Baseline (Week 0), completion of program (Week 5), and 10 weeks after completing program (Week 15).
Primary outcome [2] 5018 0
Primary caregivers who complete the problem-solving based bibilotherapy program will have better general wellbeing and coping, greater problem solving ability, and lower distress less at 10-week follow-up compared with the control group who will continue to receive the standard approach to caregivers of individuals with with first-episode psychosis. Outomes will be assessed using the following psychometric instruments:
(i) Short Form Health Survey (SF) - 12 (Version 2) (Ware et al. 1996), a 12-item instrument developed as a generic measure of perceived health status.
(iii) Ways of coping (WOC) (MacCarthy et al. 1989), provides information about coping style. Respondents are requested to rate the coping behaviour they have used during the previous four weeks.
(iv) Kessler Psychological Distress plus Scale (K-10 plus) will be used to measure non-specific psychological distress.
(v) Social Problem Solving Inventory (Short Version) (D'Zurilla et al. 1990), a 25-item instrument that measures problem solving ability.
Timepoint [2] 5018 0
Baseline (Week 0), completion of program (Week 5), and 10 weeks after completing program (Week 15).
Secondary outcome [1] 8465 0
Primary caregivers who complete the problem-solving based bibilotherapy program will have a more favourable experience of caregiving, and a lower level of expressed emotion at 10-week follow-up than at baseline. Outomes will be assessed using the following psychometric instruments:
(i) Experience of Caregiving Inventory (ECI) (Szmukler et al. 1996), a 66-item instrument which measures caregivers' appraisal of their caregiving experience.
(ii) Family Questionnaire (Wiedemann et al. 2002), a 20-item self-report instrument, which assesses the level of expressed emotion in a family. Expressed emotion is a type of negative communication involving excessive criticism and emotional over-involvement directed at a patient by family members.
Timepoint [1] 8465 0
Baseline (Week 0), completion of program (Week 5), and 10 weeks after completing program (Week 15).
Secondary outcome [2] 8466 0
Primary caregivers who complete the problem-solving based bibilotherapy program will have a more favourable experience of caregiving, and a lower level of expressed emotion at 10-week follow-up compared with the control group who continue to receive the standard approach to caregivers of individuals with first-episode psychosis. Outomes will be assessed using the following psychometric instruments:
(i) Experience of Caregiving Inventory (ECI) (Szmukler et al. 1996), a 66-item instrument which measures caregivers' appraisal of their caregiving experience.
(ii) Family Questionnaire (Wiedemann et al. 2002), a 20-item self-report instrument, which assesses the level of expressed emotion in a family. Expressed emotion is a type of negative communication involving excessive criticism and emotional over-involvement directed at a patient by family members.
Timepoint [2] 8466 0
Baseline (Week 0), completion of program (Week 5), and 10 weeks after completing program (Week 15).

Eligibility
Key inclusion criteria
1. Primary caregiver/s to a family member or friend (aged 15-24 years) diagnosed with first episode psychosis.
2. Has never been provided with specialist family interventions to support them in their care giving role.
3. Able to read, write and communicate in conversational English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Caregiver with severe mental illness.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation list will be drawn up by the Principal Investigator, with block randomisation, and given to Co-Invesitagor 3 who is responsible for recruitment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/09/2008
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
17/04/2010
Date of last data collection
Anticipated
Actual
31/07/2010
Sample size
Target
120
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 4112 0
Charities/Societies/Foundations
Name [1] 4112 0
Australian Rotary Health Research Fund
Country [1] 4112 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Rotary Health Research Fund
Address
PO Box 3455
Parramatta
NSW 2124
Country
Australia
Secondary sponsor category [1] 3703 0
None
Name [1] 3703 0
Address [1] 3703 0
Country [1] 3703 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6186 0
Melbourne Health Research Ethics Committee
Ethics committee address [1] 6186 0
Ethics committee country [1] 6186 0
Australia
Date submitted for ethics approval [1] 6186 0
Approval date [1] 6186 0
04/06/2008
Ethics approval number [1] 6186 0
2008.23
Ethics committee name [2] 6187 0
Victoria University Human Research Ethics Committee
Ethics committee address [2] 6187 0
Ethics committee country [2] 6187 0
Australia
Date submitted for ethics approval [2] 6187 0
Approval date [2] 6187 0
19/05/2008
Ethics approval number [2] 6187 0
HRETH 08/84

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

Contacts
Principal investigator
Name 29098 0
Prof Terence McCann
Address 29098 0
Victoria University
Institute of Health and Sport
St Albans Campus
McKechnie Street
St Albans
Vic 3021
Country 29098 0
Australia
Phone 29098 0
+61 3 9919 2325
Fax 29098 0
Email 29098 0
[email protected]
Contact person for public queries
Name 12255 0
Terence McCann
Address 12255 0
School of Nursing and Midwifery
Victoria University
PO Box 14428
Melbourne
Vic 8001
Country 12255 0
Australia
Phone 12255 0
+61 3 99192325
Fax 12255 0
+61 3 99192832
Email 12255 0
[email protected]
Contact person for scientific queries
Name 3183 0
Terence McCann
Address 3183 0
School of Nursing and Midwifery
Victoria University
PO Box 14428
Melbourne
Vic 8001
Country 3183 0
Australia
Phone 3183 0
+61 3 99192325
Fax 3183 0
+61 3 99192832
Email 3183 0
[email protected]

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 83329-(Uploaded-29-10-2018-09-46-28)-Basic results summary.docx
Plain language summaryNo
Study results articleYes McCann, T. V., Lubman, D. I., Cotton, S. M., Murph... [More Details]
Study results articleYes Cotton, S. M., McCann, T. V., Gleeson, J. F., Cris... [More Details]
Study results articleYes McCann, T. V., & Lubman, D. I. (2014) Qualitative ... [More Details]
Study results articleYes McCann, T. V., Cotton, S., & Lubman, D. I. (2017) ... [More Details]

Documents added automatically
No additional documents have been identified.