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Trial registered on ANZCTR
Registration number
ACTRN12613000878774
Ethics application status
Approved
Date submitted
1/08/2013
Date registered
7/08/2013
Date last updated
3/08/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
The effectiveness of a guided self-help cognitive behavioural therapy programme for East-Asian students with mild levels of depression and anxiety
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Scientific title
The effectiveness of a guided self-help cognitive behavioural therapy programme on adjustment to university and treatment of mild anxiety and depression in East-Asian students in New Zealand
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Secondary ID [1]
282945
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Nil known
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Universal Trial Number (UTN)
U1111-1143-4922
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
low mood
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anxiety
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sleeping problems
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adjustment problems
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Condition category
Condition code
Public Health
290108
290108
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0
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Health promotion/education
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Mental Health
290150
290150
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0
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Depression
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Mental Health
290151
290151
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The self-help cognitive behavioural therapy (CBT) programme called Living Life to the Full, developed by Dr. Chris Williams of Glasgow University, is used for this study. The workbooks teach key life skills to combat distress, low mood and worry. These skills include stopping vicious thought cycles, problem solving, and goal setting. All participants will go through the individual face-to-face sessions with a paraprofessional, as is the design for low intensity cognitive behavioural programmes. The guided programme will be 1-2 hour sessions per week over 8 weeks. Participants will be assigned homework to put into practice the skills that has been taught, and also the subsequent workbook to read through before the next session. Apart from weekly reminders to complete the homework and meet with the paraprofessional, there are no other strategies used to monitor adherence to the intervention.
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Intervention code [1]
287649
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Treatment: Other
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Intervention code [2]
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Lifestyle
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Intervention code [3]
287651
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Behaviour
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Comparator / control treatment
Repeated measures of health and adjustment scores pre- and post-intervention for each participant
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Increased adjustment as indicated by increased score on Student Adaptation to College Questionnaire (SACQ).
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Assessment method [1]
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Timepoint [1]
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Measured at baseline, Week 4 and Week 8
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Primary outcome [2]
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Increased score on Clinical Outcomes in Routine Evaluation (CORE-10)
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Assessment method [2]
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Timepoint [2]
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At baseline and every week of intervention
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Secondary outcome [1]
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Feedback regarding suitability and modification of programme from semi-structured interview and Client Satisfaction Questionnaire (CSQ-8)
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Assessment method [1]
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Timepoint [1]
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Exit interview post-intervention
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Eligibility
Key inclusion criteria
Low risk, mild levels of depression and anxiety. Participants must be from an East-Asian country (i.e. China, Taiwan, Hong Kong, Japan or Korea) and have been living in New Zealand for no more than 10 years. Recruitment will be targeted at students studying in New Zealand
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
High risk participants will be referred to Health and Counselling service at the university
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants will receive the intervention
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
As this is a preliminary study at Masters level, the sample size will be limited to 12 participants. The within-subject design uses a repeated measures approach.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
12/08/2013
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Actual
16/08/2013
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Date of last participant enrolment
Anticipated
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Actual
8/09/2013
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Date of last data collection
Anticipated
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Actual
16/11/2013
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Sample size
Target
12
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Accrual to date
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Final
11
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Massey University
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Address [1]
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School of Psychology
Massey University
Private Bag 102-904
North Shore Mail Centre
Auckland 0745
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Country [1]
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New Zealand
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Primary sponsor type
Individual
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Name
Kai-Chi Katie Lee
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Address
3/42 Manuka Road
Glenfield
Auckland 0629
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Country
New Zealand
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Secondary sponsor category [1]
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Individual
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Name [1]
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Dr Mei Wah Williams
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Address [1]
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School of Psychology
Massey University
Private Bag 102-904
Auckland 0745
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Country [1]
286452
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Health and Disability Ethics Committee
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Ethics committee address [1]
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1 the Terrace PO Box 5013 Wellington 6011
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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18/07/2013
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Approval date [1]
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24/07/2013
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Ethics approval number [1]
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13/STH/86
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Summary
Brief summary
Most psychological theories and interventions were developed in Euro-American countries, in which the values of individualism, autonomy and independence underline its practice. However, these values are not shared by all cultures, yet it is assumed that what works for one group of people will work for another. With increasing demand for cost-effective interventions, Dr. Chris Williams, of Glasgow University, developed a low intensity CBT programme for use in the community, rather than in clinical settings. The rationale for low intensity CBT is to provide rapid, cost effective, accessible and evidence-based treatment to people with less severe problems. A low intensity intervention, such as a guided self-help approach to CBT, uses simple approaches that are less complex to undertake than formal psychotherapy; contact with people is generally briefer and the low intensity interventions can be delivered by ‘psychological well-being practitioners’ (under clinical supervision). It is yet to be examined whether this programme will be effective when used with East-Asian students as it has been with other population groups. The study attempts to fill the gap, as research have previously been based on Asian Americans and none have examined the effectiveness of low intensity programmes. This study will test the effectiveness of the Living Life to the Full programme, developed by Dr. Chris Williams, in reducing perceived stress and improving life skills in coping with university study and adapting to different culture for East Asian students. Also, feedback regarding the relevance of the programme will be sought and modifications will be considered.
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Trial website
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Trial related presentations / publications
The effectiveness and cultural compatibility of a guided self-help cognitive-behaviour programme for Asian students in New Zealand, New Zealand Journal of Psychology Vol. 46, No. 2, July 2017, p. 23-34.
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Public notes
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Contacts
Principal investigator
Name
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Miss Kai-Chi Katie Lee
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Address
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School of Psychology
Massey University
Private Bag 102-904
Auckland 0745
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Country
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New Zealand
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Phone
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+64 212129994
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Kai-Chi Katie Lee
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Address
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School of Psychology
Massey University
Private Bag 102-904
Auckland 0745
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Country
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New Zealand
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Phone
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+64 212129994
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Kai-Chi Katie Lee
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Address
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School of Psychology
Massey University
Private Bag 102-904
Auckland 0745
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Country
41916
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New Zealand
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Phone
41916
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+64 212129994
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Fax
41916
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Email
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[email protected]
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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
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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