Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000905965
Ethics application status
Approved
Date submitted
23/08/2011
Date registered
24/08/2011
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Date results provided
16/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial on the effect of a cognitive behavioural bibliotherapy self-help intervention program on increasing resilience in individuals with depression.
Scientific title
A randomised controlled trial on the effect of a cognitive behavioural bibliotherapy self-help intervention program on increasing resilience in individuals with depression.
Secondary ID [1] 262880 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
This trial (ACTRN: 12611000905965) is the parent study of another trial entitled 'Evaluation of a self-help manual for supporting family carers of clients with depression in Thailand: a randomised controlled trial'. (ACTRN12614000774628). ACTRN: 12611000905965 is the trial of people diagnosed with depression, while ACTRN12614000774628 is the trial of their family caregivers.

Health condition
Health condition(s) or problem(s) studied:
Resilience levels of participants with depression 270609 0
Depression levels of participants with depression 270638 0
Psychological distress levels of participants with depression 270640 0
Condition category
Condition code
Mental Health 270776 270776 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group of outpatient participants with a diagnosis of moderate 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 of approximately five minutes’ duration with one of the researchers. They will also continue to receive the standard care and treatment at the outpatient department.

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] 269264 0
Treatment: Other
Intervention code [2] 269265 0
Behaviour
Comparator / control treatment
Control group of outpatient participants with a diagnosis of moderate depression will not be given the cognitive behaviour therapy based bibliotherapy manual, but will continue to receive the standard care and treatment at the outpatient department, plus a short weekly telephone contact of approximately five minutes’ duration from one of the researchers. Standard care and treatment involved attendance at the outpatient department for face-to-face consultations and prescription of antidepressant or a combination of antidepressant and anti-anxiety medication. The duration of control group treatment is eight weeks. Data will be collected at three timepoints: Baseline (Week 0), end of program (Week 8), and 4 weeks follow-up (Week 12).
Control group
Active

Outcomes
Primary outcome [1] 279470 0
Participants with moderate depression who take part in the cognitive behavioural bibliotherapy self-help intervention program as well as continuing to receive standard care and treatment will have greater resilience than those who receive only standard care and treatment. Resilience outcome will be assessed using the following psychometric instrument: Resilience Scale measures the degree of individual resilience (Wagnild & Young, 1993).
Timepoint [1] 279470 0
Baseline (Week 0), completion of the intervention (Week 8), and 4 weeks after completing the intervention (Week 12).
Primary outcome [2] 279506 0
Participants with moderate depression who take part in the cognitive behavioural bibliotherapy self-help intervention program as well as continuing to receive standard care and treatment will have less depressive symptoms than those who receive only standard care and treatment. Depression outcome will be assessed using the following psychometric instrument: Centre for Epidemiologic Studies Depression Scale (CES-D) measures self-reported symptoms associated with depression experienced in the past week (Trangkasombat, Larbboonsarp, & Havanond, 1997). T
Timepoint [2] 279506 0
Baseline (Week 0), completion of the intervention (Week 8), and 4 weeks after completing the intervention (Week 12).
Primary outcome [3] 279507 0
Participants with moderate depression who take part in the cognitive behavioural bibliotherapy self-help intervention program as well as continuing to receive standard care and treatment will have less psychological distress than those who receive only standard care and treatment. Psychological distress outcome will be assessed using the following psychometric instrument: Kessler Psychological Distress Scale (K-10) measures non-specific psychological distress (Kessler et al., 2002).
Timepoint [3] 279507 0
Baseline (Week 0), completion of the intervention (Week 8), and 4 weeks after completing the intervention (Week 12).
Secondary outcome [1] 287706 0
Nil
Timepoint [1] 287706 0
Nil

Eligibility
Key inclusion criteria
(i) diagnosis of moderate depression, (ii) hospital outpatient, (ii) aged 18–60 years, (iv) can read and write Thai, (v) and contactable by telephone at home.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) history of developmental disability or psychosis, and (ii) before entry and during the study: reporting suicidal thoughts/intent.

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 not concealed.
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 table of random numbers. This process was carried out by a second 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
25/01/2008
Date of last data collection
Anticipated
Actual
18/04/2008
Sample size
Target
54
Accrual to date
Final
56
Recruitment outside Australia
Country [1] 3799 0
Thailand
State/province [1] 3799 0
Chiang Mai Province

Funding & Sponsors
Funding source category [1] 269702 0
Self funded/Unfunded
Name [1] 269702 0
Terence McCann & Wallapa Songprakun
Country [1] 269702 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] 268770 0
None
Name [1] 268770 0
Address [1] 268770 0
Country [1] 268770 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271667 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 271667 0
Ethics committee country [1] 271667 0
Australia
Date submitted for ethics approval [1] 271667 0
Approval date [1] 271667 0
09/08/2007
Ethics approval number [1] 271667 0
HRETH 07/155
Ethics committee name [2] 271668 0
Institutional Review Board, Department of Mental Health, Ministry of Public Health, Thailand
Ethics committee address [2] 271668 0
Ethics committee country [2] 271668 0
Thailand
Date submitted for ethics approval [2] 271668 0
Approval date [2] 271668 0
17/10/2007
Ethics approval number [2] 271668 0
IRB 17/2007

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

Contacts
Principal investigator
Name 33048 0
Prof Terence McCann
Address 33048 0
Victoria University
Institute of Health and Sport
McKechnie Street
St Albans
Vic 3021
Country 33048 0
Australia
Phone 33048 0
+61 3 9919 2325
Fax 33048 0
Email 33048 0
[email protected]
Contact person for public queries
Name 16295 0
Terence McCann
Address 16295 0
Victoria University
Institute of Health and Sport
McKechnie Street
St Albans
Vic 3021
Country 16295 0
Australia
Phone 16295 0
+61 3 9919 2325
Fax 16295 0
+61 3 9919 2832
Email 16295 0
[email protected]
Contact person for scientific queries
Name 7223 0
Terence McCann
Address 7223 0
Victoria University
Institute of Health and Sport
McKechnie Street
St Albans
Vic 3021
Country 7223 0
Australia
Phone 7223 0
+61 3 9919 2325
Fax 7223 0
+61 3 9919 2832
Email 7223 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.