Trial from ANZCTR


Trial ID ACTRN12611000905965
Trial Status: Registered
Date Submitted: 23/08/2011
Date Registered: 24/08/2011
Retrospectively registered

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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.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format A randomised controlled trial on the effect of a cognitive behavioural bibliotherapy self-help intervention program on increasing resilience in individuals with depression.
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Secondary ID [1] 262880 0
Nil
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Resilience levels of participants with depression 270609 0
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Depression levels of participants with depression 270638 0
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Psychological distress levels of participants with depression 270640 0
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Condition category: Condition code:
Mental Health Depression
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270776 270776 0 0

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Descriptions 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).
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Treatment: Other 269264 0
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Behaviour 269265 0
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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).
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Control group Active
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Primary Outcome: 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). 279470 0
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Timepoint: Baseline (Week 0), completion of the intervention (Week 8), and 4 weeks after completing the intervention (Week 12). 279470 0
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Primary Outcome: 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 279506 0
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Timepoint: Baseline (Week 0), completion of the intervention (Week 8), and 4 weeks after completing the intervention (Week 12). 279506 0
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Primary Outcome: 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). 279507 0
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Timepoint: Baseline (Week 0), completion of the intervention (Week 8), and 4 weeks after completing the intervention (Week 12). 279507 0
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Secondary Outcome: Nil 287706 0
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Timepoint: Nil 287706 0
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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.
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Minimum age 18 Years
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Maximum age 60 Years
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria (i) history of developmental disability or psychosis, and (ii) before entry and during the study: reporting suicidal thoughts/intent.
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Study type Interventional
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Purpose of the study Educational / counselling / training
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Allocation was not concealed.
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Describe the 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.
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Phase Not Applicable
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Anticipated date of first participant enrolment 20/10/2007
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 54
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Recruitment status Completed
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

Country: Thailand 3799 0
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State/Province: Chiang Mai Province 3799 0
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Funding Source: Self funded/Unfunded 269702 0
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Name: Terence McCann & Wallapa Songprakun 269702 0
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Address: School of Nursing and Midwifery
Victoria University
PO Box 14428
Melbourne
Victoria 8001
269702 0
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Country: Australia 269702 0
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Primary Sponsor University
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Name: Victoria University
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Address: School of Nursing and Midwifery
Victoria University
PO Box 14428
Melbourne
Victoria 8001
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Country: Australia
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Secondary Sponsor: None 268770 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Victoria University Human Research Ethics Committee 271667 0
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Address: Victoria University
PO Box 14428
Melbourne
Victoria 8001
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Country: Australia 271667 0
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Approval Date: 09/08/2007 271667 0
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Submitted Date: 271667 0
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HREC: HRETH 07/155 271667 0
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Ethics Committee name: Institutional Review Board, Department of Mental Health, Ministry of Public Health, Thailand 271668 0
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Address: Department of Mental Health, Ministry of Public Health,
88/20 Tivanond Road, Nonthaburi 11000, Bangkok, Thailand
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Country: Thailand 271668 0
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Approval Date: 17/10/2007 271668 0
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Submitted Date: 271668 0
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HREC: IRB 17/2007 271668 0
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Brief summary The aim of this study was to assess if a self-help manual for participants with moderate depression was effective in strengthening their resilience and reducing symptoms of depression and psychological distress. The study involved two groups: an 'intervention' group who studied the manual, and a 'control' group who did not study the manual.
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Trial website Nil
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Trial related presentations / publications (i) "Effectiveness of a cognitive behavioural bibliotherapy self-help intervention program on individual with depression” at the Victorian and Tasmanian Deans of Nursing and Midwifery, 4th Annual Collaborative Research School for Higher Degree Students in Nursing, 4-5 September 2008, RMIT University, Bundoora, Melbourne, Australia.

(ii) "Evaluation of a cognitive behavioural bibliotherapy self-help intervention program on the promotion of resilience in individuals with depression” at 40th Asia-Pacific Academic Consortium for Public Health Annual Conference, 7-9 November 2008, Renaissance Hotel, Kuala Lumpur, Malaysia.
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Terence McCann
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Address: School of Nursing and Midwifery Victoria University PO Box 14428 Melbourne Victoria 8001
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Country: Australia
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Tel: +61 3 9919 2325
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Email: terence.mccann@vu.edu.au
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Contact person for scientific queries
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Name: Terence McCann
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Address: School of Nursing and Midwifery Victoria University PO Box 14428 Melbourne Victoria 8001
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Country: Australia
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Contact person responsible for updating information
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Name: Terence McCann
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Address: School of Nursing and Midwifery Victoria University PO Box 14428 Melbourne Victoria 8001
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Country: Australia
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Addition Cancer fields
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