Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001072707
Ethics application status
Approved
Date submitted
24/09/2013
Date registered
25/09/2013
Date last updated
25/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Reach Out Rise Up: a 10 week text package for young people with mild to moderate depression and anxiety: A pilot study
Scientific title
‘Reach Out, Rise Up’:The efficacy of text messaging in an intervention
package for anxiety and depression severity in young people
Secondary ID [1] 283294 0
NIL
Universal Trial Number (UTN)
U1111-1146-4676
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 290177 0
Anxiety 290178 0
Condition category
Condition code
Mental Health 290562 290562 0 0
Depression
Mental Health 290563 290563 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Youthline is planning to extend the use of our online text platform infrastructure to pilot a programme to provide evidence-based therapeutic text support specifically designed for young people who come through Youthline’s telephone helpline or who contact Youthline’s clinical services presenting with mild to moderate anxiety and/or depression.

Young people will be offered the option of the text package following an assessment along with other standard options i.e. face to face counselling, information or referral.

The young people who consent to participating in the pilot will receive text messages for ten weeks includes three groups of text messages a week:

1. Monday 4pm: Psycho-educational message (to give young people a better understanding of their symptoms and help them to gain a sense of perspective on what they are experiencing)
2. Tuesday 4pm: Weekly challenge (to give them practical and achievable challenges each week based on evidence based Cognitive Behavioural Therapy principles for improving their feelings)
3. Friday 4pm: Inspirational message (to keep them motivated and to learn from the wisdom of others)

Following the ten weeks all young people will be contacted by the researcher to complete a follow up assessment and to ask the participants about their experience using an evaluation questionnaire
Intervention code [1] 288017 0
Treatment: Other
Intervention code [2] 288018 0
Behaviour
Comparator / control treatment
There is no control group however half the paticipants will receive a support person who calls them once a week for 15-30 minutes for the 10 week period to encourage and support them through the weekly challenges.
Control group
Active

Outcomes
Primary outcome [1] 290585 0
Reduction in GAD-7
Timepoint [1] 290585 0
Following 10 week text package
Primary outcome [2] 290586 0
Reduction in PHQ-9 score
Timepoint [2] 290586 0
Following 10 week text package
Secondary outcome [1] 304847 0
NIL
Timepoint [1] 304847 0
NIL

Eligibility
Key inclusion criteria
Mild to moderate depression and/or anxiety
Can read English
Minimum age
12 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
High risk (to self, others or from others) youth as determined through assessment.
Young people with severe anxiety or depression.
Non english speaking.

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)
Particpation is voluntary
Particpants are allocated to two treatment groups (one supported and one text only) based on their order of enrollment i.e odd enrollments to one group even to the other.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
PHQ-9 and GAD-7 score comparisons pre and post.
Evaluation quesionnaire post

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/10/2013
Actual
24/01/2014
Date of last participant enrolment
Anticipated
Actual
24/04/2014
Date of last data collection
Anticipated
Actual
31/07/2014
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 5440 0
New Zealand
State/province [1] 5440 0
Auckland

Funding & Sponsors
Funding source category [1] 288030 0
Government body
Name [1] 288030 0
Ministry of Social Development
Country [1] 288030 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Youthline Auckland Charitable Trust
Address
13 Maidstone St
Grey Lynn
Auckland 1021
Country
New Zealand
Secondary sponsor category [1] 286747 0
None
Name [1] 286747 0
Address [1] 286747 0
Country [1] 286747 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289952 0
Health and Disability Ethics Committee
Ethics committee address [1] 289952 0
Ethics committee country [1] 289952 0
New Zealand
Date submitted for ethics approval [1] 289952 0
27/09/2013
Approval date [1] 289952 0
28/11/2013
Ethics approval number [1] 289952 0

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

Contacts
Principal investigator
Name 43250 0
Miss Amber Davies
Address 43250 0
Youthline Auckland Charitable Trust
13 Maidstone St
Grey Lynn
Auckland 1021
Country 43250 0
New Zealand
Phone 43250 0
+64 21535688
Fax 43250 0
Email 43250 0
[email protected]
Contact person for public queries
Name 43251 0
Amber Davies
Address 43251 0
Youthline Auckland Charitable Trust
13 Maidstone St
Grey Lynn
Auckland 1021
Country 43251 0
New Zealand
Phone 43251 0
+64 21535688
Fax 43251 0
Email 43251 0
[email protected]
Contact person for scientific queries
Name 43252 0
Paul McBride
Address 43252 0
Youthline Auckland Charitable Trust
13 Maidstone St
Grey Lynn
Auckland 1021
Country 43252 0
New Zealand
Phone 43252 0
+64 93614168
Fax 43252 0
Email 43252 0
[email protected]

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.