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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
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
Secondary ID [1] 282945 0
Nil known
Universal Trial Number (UTN)
U1111-1143-4922
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low mood 289766 0
anxiety 289767 0
sleeping problems 289768 0
adjustment problems 289769 0
Condition category
Condition code
Public Health 290108 290108 0 0
Health promotion/education
Mental Health 290150 290150 0 0
Depression
Mental Health 290151 290151 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287649 0
Treatment: Other
Intervention code [2] 287650 0
Lifestyle
Intervention code [3] 287651 0
Behaviour
Comparator / control treatment
Repeated measures of health and adjustment scores pre- and post-intervention for each participant
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290144 0
Increased adjustment as indicated by increased score on Student Adaptation to College Questionnaire (SACQ).
Timepoint [1] 290144 0
Measured at baseline, Week 4 and Week 8
Primary outcome [2] 290145 0
Increased score on Clinical Outcomes in Routine Evaluation (CORE-10)
Timepoint [2] 290145 0
At baseline and every week of intervention
Secondary outcome [1] 304015 0
Feedback regarding suitability and modification of programme from semi-structured interview and Client Satisfaction Questionnaire (CSQ-8)
Timepoint [1] 304015 0
Exit interview post-intervention

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
High risk participants will be referred to Health and Counselling service at the university

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants will receive the intervention
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/08/2013
Actual
16/08/2013
Date of last participant enrolment
Anticipated
Actual
8/09/2013
Date of last data collection
Anticipated
Actual
16/11/2013
Sample size
Target
12
Accrual to date
Final
11
Recruitment outside Australia
Country [1] 5259 0
New Zealand
State/province [1] 5259 0
Auckland

Funding & Sponsors
Funding source category [1] 287721 0
University
Name [1] 287721 0
Massey University
Country [1] 287721 0
New Zealand
Primary sponsor type
Individual
Name
Kai-Chi Katie Lee
Address
3/42 Manuka Road
Glenfield
Auckland 0629
Country
New Zealand
Secondary sponsor category [1] 286452 0
Individual
Name [1] 286452 0
Dr Mei Wah Williams
Address [1] 286452 0
School of Psychology
Massey University
Private Bag 102-904
Auckland 0745
Country [1] 286452 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289680 0
Health and Disability Ethics Committee
Ethics committee address [1] 289680 0
Ethics committee country [1] 289680 0
New Zealand
Date submitted for ethics approval [1] 289680 0
18/07/2013
Approval date [1] 289680 0
24/07/2013
Ethics approval number [1] 289680 0
13/STH/86

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

Contacts
Principal investigator
Name 41914 0
Miss Kai-Chi Katie Lee
Address 41914 0
School of Psychology
Massey University
Private Bag 102-904
Auckland 0745
Country 41914 0
New Zealand
Phone 41914 0
+64 212129994
Fax 41914 0
Email 41914 0
kc.katie.lee@gmail.com
Contact person for public queries
Name 41915 0
Kai-Chi Katie Lee
Address 41915 0
School of Psychology
Massey University
Private Bag 102-904
Auckland 0745
Country 41915 0
New Zealand
Phone 41915 0
+64 212129994
Fax 41915 0
Email 41915 0
kc.katie.lee@gmail.com
Contact person for scientific queries
Name 41916 0
Kai-Chi Katie Lee
Address 41916 0
School of Psychology
Massey University
Private Bag 102-904
Auckland 0745
Country 41916 0
New Zealand
Phone 41916 0
+64 212129994
Fax 41916 0
Email 41916 0
kc.katie.lee@gmail.com

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.