Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000774628
Ethics application status
Approved
Date submitted
2/07/2014
Date registered
21/07/2014
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Date results information initially provided
23/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a self-help manual for supporting family carers of clients with depression in Thailand: a randomised controlled trial.
Scientific title
Effect of a self-help manual for supporting family carers of clients with depression in Thailand, on resilience, expressed emotion and experience of caregiving: a randomised controlled trial.
Secondary ID [1] 284903 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
This trial (ACTRN: 12614000774628) is the sub-study of another trial entitled 'A randomised controlled trial on the effect of a cognitive behavioural bibliotherapy self-help intervention program on increasing resilience in individuals with depression' (ACTRN: 12611000905965). ACTRN: 12611000905965 is the trial of people diagnosed with depression, while ACTRN 12614000774628 is the trial of their family caregivers.

Health condition
Health condition(s) or problem(s) studied:
Experience of caregiving in carers of individuals with depression 292364 0
Resilience in carers of individuals with depression 292366 0
Expressed emotion in caregivers of depression care recipients 292368 0
Condition category
Condition code
Mental Health 292686 292686 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This involves the intervention group of primary carers of individuals with depression reading a cognitive behaviour therapy based bibliotherapy manual; 'The Good Mood Guide: A Self-Help Manual for Depression,' plus a short weekly telephone contact, for 8 weeks, of approximately five minutes’ duration with one of the researchers. Adherence was also assessed through the weekly telephone calls, whereby the researcher asked a standardised set of questions about the content of the specific module. Answers to these questions enabled the research to ascertain complicance with the readings.

The manual contains eight modules, each module containing reading, writing and activities to be completed over a one-week time-frame. Each module takes approximately 1-2 hours per week to complete. The entire program was designed to be completed in eight weeks. By reading the manual, it is anticipated that participants will have an increase in their resilience. Data will be collected at three timepoints: Baseline (Week 0), end of program (Week 8), and 4 weeks follow-up (Week 12).
Intervention code [1] 289722 0
Behaviour
Intervention code [2] 289723 0
Treatment: Other
Comparator / control treatment
The control group of primary caregivers will not be given the self-help manual but will continue to receive standard family support (standard outpatient support group) as well as a short weekly telephone call of approximately five minutes’ duration from a researcher. The duration of control group intervention is eight weeks. Data will be collected at three timepoints: Baseline (Week 0), completion of the intervention (Week 8), and 4 weeks after completing the intervention (Week 12).
Control group
Active

Outcomes
Primary outcome [1] 292530 0
To assess if there is any difference in the level of resilience of carers who complete the guided-help manual, at 12-week follow-up, compared to a control group who continue to receive only the standard care approach to caregivers of individuals with depression.

Resilience assessed using the following psychometric instrument: Resilience Scale measures the degree of individual resilience (Wagnild & Young, 1993). It contains 25 items rated on a 7-point Likert scale, with scores ranging from 25 to 175; higher scores reflecting greater resilience.
Timepoint [1] 292530 0
Data will be collected at three timepoints: Baseline (Week 0), end of program (Week 8), and 4 weeks follow-up (Week 12).
Primary outcome [2] 292609 0
To assess if there is any difference in the experience of caring of carers who complete the guided self-help manual, at 12-week follow-up, compared to a control group who continue to receive only the standard care approach to caregivers of individuals with depression.

Caregiving experience assessed using the following psychometric instrument: Experience of Caregiving Inventory (ECI) (Szmukler et al. 1996), a 66-item instrument which measures caregivers' appraisal of their caregiving experience.
Timepoint [2] 292609 0
Data will be collected at three timepoints: Baseline (Week 0), end of program (Week 8), follow-up (Week 12)
Primary outcome [3] 292610 0
To assess if there is any difference in the level of expressed emotion of carers who complete the guided self-help manual, at 12-week follow-up, compared to a control group who continue to receive only the standard care approach to caregivers of individuals with depression.

Level of expressed emotion assessed using the following psychometric instrument: 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 [3] 292610 0
Data will be collected at three timepoints: Baseline (Week 0), end of program (Week 8), follow-up (week 12)
Secondary outcome [1] 309161 0
Nil
Timepoint [1] 309161 0
Nil

Eligibility
Key inclusion criteria
a) main family support person to a Thai national diagnosed with moderate depression ((F32.1), ICD-10 classification) receiving outpatient treatment at Suan Prung Psychiatric Hospital, (b) aged 18–60 years, (c) able to read and write Thai, and (d) had a working telephone at home.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently receiving treatment for 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 was concealed. Allocation, which was off-site, was carried out by a researcher who was not directly involved in the recruitment process for the study. Randomisation was then emailed to the researcher allocating participants to intervention and control groups in Thailand.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were randomly assigned to either the intervention or the control group by means of independent random allocation, using a computer generated randomisation list. This process was carried out by a researcher who was not directly involved in the recruitment process for the study.
Masking / blinding
Open (masking not 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
20/10/2007
Actual
20/10/2007
Date of last participant enrolment
Anticipated
Actual
8/02/2008
Date of last data collection
Anticipated
Actual
2/05/2008
Sample size
Target
54
Accrual to date
Final
54
Recruitment outside Australia
Country [1] 6189 0
Thailand
State/province [1] 6189 0
Chiang Mai Province

Funding & Sponsors
Funding source category [1] 289531 0
Self funded/Unfunded
Name [1] 289531 0
Terence McCann & Wallapa Songprakun
Country [1] 289531 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Victoria University
Institute of Health and Sport
McKechnie Street
St. Albans
Vic 3021
Country
Australia
Secondary sponsor category [1] 288218 0
None
Name [1] 288218 0
Address [1] 288218 0
Country [1] 288218 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291269 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 291269 0
Victoria University
PO Box 14428
Melbourne
Victoria 8001
Ethics committee country [1] 291269 0
Australia
Date submitted for ethics approval [1] 291269 0
Approval date [1] 291269 0
09/08/2007
Ethics approval number [1] 291269 0
HRETH 07/155
Ethics committee name [2] 291270 0
Institutional Review Board, Department of Mental Health, Ministry of Public Health, Thailand
Ethics committee address [2] 291270 0
Department of Mental Health, Ministry of Public Health,
88/20 Tivanond Road, Nonthaburi 11000, Bangkok, Thailand
Ethics committee country [2] 291270 0
Australia
Date submitted for ethics approval [2] 291270 0
Approval date [2] 291270 0
17/10/2007
Ethics approval number [2] 291270 0

Summary
Brief summary
The aim of this study was to assess whether a self-help manual for caregivers of individuals with depression was effective in strengthening their resilience, reducing expressed emotion and improving their experience of caregiving. The study involved two groups: an 'intervention' group who studied the manual, and a 'control' group who did not study the manual.
Trial website
Nil
Trial related presentations / publications
Publications are pending.
Public notes

Contacts
Principal investigator
Name 49614 0
Prof Terence McCann
Address 49614 0
Victoria University
Institute of Health and Sport
McKechnie Street
St. Albans
Vic 3021
Country 49614 0
Australia
Phone 49614 0
+61 3 9919 2325
Fax 49614 0
Email 49614 0
[email protected]
Contact person for public queries
Name 49615 0
Prof Terence McCann
Address 49615 0
Victoria University
Institute of Health and Sport
McKechnie Street
St. Albans
Vic 3021
Country 49615 0
Australia
Phone 49615 0
+61 3 9919 2325
Fax 49615 0
Email 49615 0
[email protected]
Contact person for scientific queries
Name 49616 0
Prof Terence McCann
Address 49616 0
Victoria University
Institute of Health and Sport
McKechnie Street
St. Albans
Vic 3021
Country 49616 0
Australia
Phone 49616 0
+61 3 9919 2325
Fax 49616 0
Email 49616 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval was not obtained to make IPD available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes McCann, T.V., Songprakun, W. & Stephenson, J. (201... [More Details]
Study results articleYes McCann, T. V., Songprakun, W., & Stephenson, J. (2... [More Details]
Study results articleYes McCann, T. V., Songprakun, W., & Stephenson, J. (2... [More Details]
Study results articleYes McCann, T. V., Songprakun, W., & Stephenson, J. (2... [More Details]

Update to Study Results
Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomized controlled trial of guided self-help for improving the experience of caring for carers of clients with depression.2015https://dx.doi.org/10.1111/jan.12624
N.B. These documents automatically identified may not have been verified by the study sponsor.