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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 information initially 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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Address [1] 269702 0
Victoria University
Institute of Health and Sport
McKechnie Street
St Albans
Vic 3021
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
Victoria University
PO Box 14428
Melbourne
Victoria 8001
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
Department of Mental Health, Ministry of Public Health,
88/20 Tivanond Road, Nonthaburi 11000, Bangkok, Thailand
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
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.
Trial website
Nil
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.
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
terence.mccann@vu.edu.au
Contact person for public queries
Name 16295 0
Prof 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
terence.mccann@vu.edu.au
Contact person for scientific queries
Name 7223 0
Prof 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
terence.mccann@vu.edu.au

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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 29 0
Songprakun, W., & McCann, T. V. (2012) Evaluation of a bibliotherapy manual for reducing psychological distress in people with depression: A randomised controlled trial. Journal of Advanced Nursing, 68(12), 2674-2684. doi: 10.1111/j.1365-2648.2012.05966.x. Date of publication: 1st March 2012.
Attachments [1] 29 0
Publication date and citation/details [2] 157 0
Songprakun, W., & McCann, T. V. (2012) Effectiveness of a self-help manual on the promotion of resilience in individuals with depression: A randomised controlled trial. BMC Psychiatry, 12:12, 1-10. doi:10.1186/1471-244X-12-12. Date of publication: 16th February 2012.
Attachments [2] 157 0
Publication date and citation/details [3] 158 0
Songprakun, W., & McCann, T. V. (2012) Evaluation of a cognitive behavioural bibliotherapy manual for reducing depression: A randomised controlled trial. Journal of Psychiatric and Mental Health Nursing, 19, 647-653. doi: 10.1111/j.1365-2850.2011.01861.x. Date of publication: 20th January 2012.
Attachments [3] 158 0
Publication date and citation/details [4] 159 0
Songprakun, W., & McCann, T. V. (2015) Using bibliotherapy to assist people to recover from depression in Thailand: Relationship between resilience, depression and psychological distress. International Journal of Nursing Practice, 21, 716-724. doi: 10.1111/ijn.12250. Date of publication: 12th March 2014.
Attachments [4] 159 0
Publication date and citation/details [5] 161 0
McCann, T.V., Songprakun, W. & Stephenson, J. (2017). Effectiveness of a guided self-help manual in strengthening resilience in people diagnosed with moderate depression and their family caregivers in Thailand: a randomised controlled trial. Issues in Mental Health Nursing. 38(8), 655-662. doi: 10.1080/01612840.2017.1313913. Date of publication: 4th May 2017.
Attachments [5] 161 0
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
Aim
The aims of the study were to evaluate if individuals diagnosed with moderate depression who took part in a cognitive behavioural bibliotherapy self-help intervention programme, as well as continuing to receive standard care, would have greater resilience and lower levels of depression and psychological distress than those who receive only standard care.

Background information
The prevalence of depression in Thailand is increasing markedly, and depression is projected to become the major mental health problem in the country. One way to help in this situation is to use bibliotherapy. Most bibliotherapy studies of depression have taken place in developed countries, in particular, Australia, UK and the US; none have been undertaken in Thailand and other Asian countries.

Method
An RCT was used to evaluate the effectiveness of an 8-week modularised self-help intervention program in promoting resilience in people living in the community with moderate depression. Participants were recruited through the outpatients’ department at Suan Prung Psychiatric Hospital, Chiang Mai, Thailand. Data were collected using the Resilience Scale, Centre for Epidemiologic Studies Depression Scale, and Kessler Psychological Distress Scale. Data were collected at baseline, at the end of intervention, and four weeks after the completion of the intervention.

Participant characteristics
The majority of participants were female (73%, n=41), and most were married or in de facto relationships (64.3%, n=36). Their average age was 42.13 years, ranging from 18 to 58 years. The duration of their illness was between 3 and 13 months for the intervention group and 5 and 18 months for the control group. Most (83.9%, n=47) were prescribed a combination of antidepressant (the majority were prescribed SSRIs) and anti-anxiety medications, while a small proportion (17.9%, n=10) received a combination of specialised psychological therapy and medications. Approximately 80% (n=44) of participants attended the psychiatric outpatients’ department at the hospital on a monthly or more frequent basis, while the remainder attended less frequently.

Key results
The findings showed there were statistically significant differences between the intervention and the control group in their resilience, depression and psychological distress levels. The participants who completed the self-help manual achieved greater resilience and lower levels of depression and psychological distress than the control group.

Limitations
First, recruitment through clinicians at the outpatients’ department might have resulted in an atypical sample of participants with depression. Second, the assessor of the outcome measures was not blinded to participant allocation to groups. In our opinion, while this did not have an adverse effect on the findings, it is, nonetheless, a potential limitation. Third, generalisabilty of the findings is limited to individuals who have some reading and writing capability, and bibliotherapy may not be appropriate for everyone with moderate depression, especially those who lack energy and have poor concentration.