Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12614000921684 |
Date of registration:
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28/08/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Youth Online Wellbeing Initiative: A randomised controlled trial of online self-help Acceptance and Commitment Therapy for adolescents with anxiety
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Scientific title:
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The efficacy of an online self-help Acceptance and Commitment Therapy intervention for reducing stress and anxiety in adolescents with anxiety |
Date of first enrolment:
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12/09/2014 |
Target sample size:
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168 |
Recruitment status: |
Withdrawn |
URL:
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https://anzctr.org.au/ACTRN12614000921684.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);
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Phase:
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Countries of recruitment
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Australia
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Contacts
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Name:
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Mr Louise Hayes
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Address:
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Orygen Youth Health Research Centre
35 Poplar Road, Parkville, VIC, 3052
Australia |
Telephone:
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+61393423758 |
Email:
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louiseh@unimelb.edu.au |
Affiliation:
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Name:
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Dr Louise Hayes
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Address:
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Orygen Youth Health Research Centre
35 Poplar Road, Parkville, VIC, 3052
Australia |
Telephone:
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+61393423758 |
Email:
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louiseh@unimelb.edu.au |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Sub-clinical levels of anxiety
The ability to understand spoken and written English
Access to a computer with broadband Internet connection
Exclusion criteria: Active suicidality, intellectual disability, illicit substance use
Age minimum:
14 Years
Age maximum:
20 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Anxiety;Stress
;Depression; Anxiety Stress Depression
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Mental Health - Anxiety
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Intervention(s)
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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.
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Primary Outcome(s)
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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.[The SCAS will be administered at pre-intervention (week 0), post-intervention (week 8) and 3 months post-follow up.]
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Valued living, as assessed by the Keyes Psychological Well-being scale. This is a 12-item self-report scale that will be administered online.[The Keyes Psychological Well-being scale will be administered at pre-intervention (week 0), post-intervention (week 8) and 3 months post-follow up. ]
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Secondary Outcome(s)
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Mindfulness, as assessed by the Child and Adolescent Mindfulness Measure. This is a 10-item self-report scale that will be administered online.[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.]
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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.[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.]
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Source(s) of Monetary Support
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beyondblue: the national depression initiative
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Ethics review
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Status: Approved
Approval date:
Contact:
The University of Melbourne Behavioural and Social Sciences HREC
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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