Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000921684
Ethics application status
Approved
Date submitted
11/07/2014
Date registered
28/08/2014
Date last updated
6/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Youth Online Wellbeing Initiative: A randomised controlled trial of online self-help Acceptance and Commitment Therapy for adolescents with anxiety
Scientific title
The efficacy of an online self-help Acceptance and Commitment Therapy intervention for reducing stress and anxiety in adolescents with anxiety
Secondary ID [1] 284968 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 292461 0
Stress
 292462 0
Depression 292463 0
Condition category
Condition code
Mental Health 292775 292775 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ACT online assisted self-help online intervention will comprise 2 components: 1) working through weekly material from the ACT adolescent self-help book, Get Out of Your Mind and Into Your Life for Teens: A guide to living an extraordinary life. Content includes, normalisation of anxiety, acceptance of emotions, defusion of thoughts, developing self awareness, mindfulness, and valued action; and 2) an online platform that will contain video, audio and reading material, weekly comments and prompts from therapists, with the ability for participants to receive and send private messages to therapists.
There will be 2 ACT treatment arms. The first will be the online self-help program described. The second ACT condition will receive the same two components as Condition A, plus five additional telephone support sessions with a trained ACT therapist to support their use of the program (an initial 30-minute introductory call at the start of the study, and four 10-minute fortnightly support telephone calls). The approximate time commitment is 1 hour per week over an 8 week intervention period.
Intervention code [1] 289796 0
Treatment: Other
Comparator / control treatment
A standard assisted self-help intervention will be an active control condition comprising two components: 1) CBT written self-help material, as published by beyondblue, with content including psychoeducation on anxiety, problem solving, exposure, relaxation skills, goal setting; and 2) an online platform with equal capacity for video, audio, and reading material, and messaging between participants and therapists as Condition A; however the therapeutic model will be changed to standard CBT.
Control group
Active

Outcomes
Primary outcome [1] 292624 0
Anxiety, as assessed by the Spence Children's Anxiety Scale (SCAS). The SCAS is a 45-item self-report scale linked to DSM-IV anxiety disorders. The SCAS will be administered online.
Timepoint [1] 292624 0
The SCAS will be administered at pre-intervention (week 0), post-intervention (week 8) and 3 months post-follow up.
Primary outcome [2] 292625 0
Valued living, as assessed by the Keyes Psychological Well-being scale. This is a 12-item self-report scale that will be administered online.
Timepoint [2] 292625 0
The Keyes Psychological Well-being scale will be administered at pre-intervention (week 0), post-intervention (week 8) and 3 months post-follow up.
Secondary outcome [1] 309363 0
Mindfulness, as assessed by the Child and Adolescent Mindfulness Measure. This is a 10-item self-report scale that will be administered online.
Timepoint [1] 309363 0
The Child and Adolescent Mindfulness Measure will be administered at the beginning of the intervention (week 1), mid intervention (week 4), post-intervention (week 8), and 3-month post intervention follow-up.
Secondary outcome [2] 309364 0
Psychological flexibility, as assessed by the Avoidance and Fusion Questionnaire for Youth (AFQ-Y). This is an 8-item self-report scale that will be administered online.
Timepoint [2] 309364 0
The AFQ-Y will be administered at the beginning of the intervention (week 1), mid intervention (week 4), post-intervention (week 8), and 3-month post intervention follow-up.

Eligibility
Key inclusion criteria
Sub-clinical levels of anxiety
The ability to understand spoken and written English
Access to a computer with broadband Internet connection
Minimum age
14 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active suicidality, intellectual disability, illicit substance use

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



The people analysing the results/data
Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
12/09/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
168
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 289587 0
Charities/Societies/Foundations
Name [1] 289587 0
beyondblue: the national depression initiative
Country [1] 289587 0
Australia
Primary sponsor type
University
Name
Orygen Youth Health Research Centre, the University of Melbourne
Address
35 Poplar Road, Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 288271 0
None
Name [1] 288271 0
Address [1] 288271 0
Country [1] 288271 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291322 0
The University of Melbourne Behavioural and Social Sciences HREC
Ethics committee address [1] 291322 0
Level 1, 780 Elizabeth Street The University of Melbourne Vic. 3010
Ethics committee country [1] 291322 0
Australia
Date submitted for ethics approval [1] 291322 0
Approval date [1] 291322 0
15/05/2014
Ethics approval number [1] 291322 0
1441479

Summary
Brief summary
The current study aims are: 1) to determine the efficacy of ACT wherever they are to reduce anxiety and improve valued living for adolescents with anxiety; 2) to identify the level of program intensity (therapist support) required to achieve positive program outcomes; 3) to determine the mechanisms of change surrounding the intervention that are critical to program outcomes; and 4) to determine consumer acceptability, satisfaction, and geographical reach of an assisted online self-help mode of delivery.

t is hypothesised that 1) adolescents who receive the ACT online program will show greater improvements in anxiety and valued than adolescents in the active control group; 2) adolescents who receive the ACT online program plus telephone support will show greater improvements in anxiety and valued living than adolescents who receive both ACT and control online self-help programs; and 3) that the mechanisms of change for the ACT conditions will be increased post intervention psychological flexibility and mindfulness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49894 0
Dr Louise Hayes
Address 49894 0
Orygen Youth Health Research Centre
35 Poplar Road, Parkville, VIC, 3052
Country 49894 0
Australia
Phone 49894 0
+61393423758
Fax 49894 0
Email 49894 0
[email protected]
Contact person for public queries
Name 49895 0
Mr Louise Hayes
Address 49895 0
Orygen Youth Health Research Centre
35 Poplar Road, Parkville, VIC, 3052
Country 49895 0
Australia
Phone 49895 0
+61393423758
Fax 49895 0
Email 49895 0
[email protected]
Contact person for scientific queries
Name 49896 0
Dr Louise Hayes
Address 49896 0
Orygen Youth Health Research Centre
35 Poplar Road, Parkville, VIC, 3052
Country 49896 0
Australia
Phone 49896 0
+61393423758
Fax 49896 0
Email 49896 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.