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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9 May 2022 |
Main ID: |
ACTRN12616000139471 |
Date of registration:
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05/02/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The Chilled Plus Program: Helping Adolescents with Anxiety and Depression.
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Scientific title:
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The Feasibility and Outcome of Internet Delivery of Transdiagnostic Cognitive-Behaviour Therapy for Adolescent Anxiety and Depression |
Date of first enrolment:
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17/10/2014 |
Target sample size:
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120 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12616000139471.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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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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Dr Carolyn Schniering
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Address:
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Department of Psychology
Macquarie University
Sydney, NSW, 2109
Australia |
Telephone:
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+61 02 98506741 |
Email:
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carolyn.schniering@mq.edu.au |
Affiliation:
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Name:
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Dr Jessica Kirkman
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Address:
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Department of Psychology
Macquarie University
Sydney, NSW, 2109
Australia |
Telephone:
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+61 02 9850 6741 |
Email:
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jess.kirkman@mq.edu.au |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Participants must meet DSM-5 criteria for both an anxiety disorder and a depressive disorder.
2. Gender: male and female
3. Age range: 12-17 years
4. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Exclusion criteria: 1. Participants who are at current risk for suicide.
2. Participants who are actively self-harming
3. Participants with unmanaged psychotic symptoms
4. Participants in physically/sexually abusive environments.
5. Participants receiving pharmacological treatment who are not willing to keep medication stable throughout the duration of the study.
6. Participants with bipolar depression.
7. Participants who cannot speak english.
8. Participants with no access to the internet.
Age minimum:
12 Years
Age maximum:
17 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Mental Health - Depression
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Anxiety;Depression; Anxiety Depression
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Mental Health - Anxiety
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Intervention(s)
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The Chilled Plus program is a cognitive behavioural treatment that incorporates the latest research in working with negative emotions. The program consists of 8 online modules accompanied by weekly phone calls with a trained therapist. The treatment targets anxiety and depression symptoms. Modules are released on a weekly basis (adolescents complete one module per week before their phone session). All together there is around 4 hours of work to do each week including the module, completing homework tasks and engaging in the phone calls.
Module one provides psycho-education on the cycle of anxiety and depression, avoidance and managing emotions. It includes videos of people that have stories about their worries and moods (actors), and covers handling suicidal feelings.
Module two explores identifying avoidance patterns, developing goals and exploring values, identifying motivation levels and developing a list of enjoyable activities to begin regularly participating in.
Module three looks at the cost and benefits of avoidance, teaches the steps to goal-directed action to overcome avoidance and introduces the concept of stepladders.
Module four includes a review of the first stepladder created and making a plan for the next steps over the coming weeks. It includes common problems to stepladders and possible solutions. It also teaches new skills to work with negative emotions, and explores developing creative ways to boost motivation.
Module five highlights common thinking mistakes (e.g. catastrophising, filtering, overgeneralising, etc.) made by people with anxious or depressed feelings, teaches the basic steps of realistic thinking and continues with planning the next steps of the adolescents stepladder.
Module six covers di
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Primary Outcome(s)
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Number of diagnoses as measured by the Anxiety Disorders Interview Schedule for Children (ADIS-C; Silverman & Albano, 1996) according to DSM-5 criteria. [Diagnostic interviews will be conducted prior to group allocation, following the 8 week waiting period for the wait list group, immediately following treatment and three months following treatment. ]
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Severity of diagnoses as measured by the Anxiety Disorders Interview Schedule for Children (ADIS-C; Silverman & Albano, 1996) according to DSM-5 criteria. [Diagnostic interviews will be conducted prior to group allocation, following the 8 week waiting period for the wait list group, immediately following treatment and three months following treatment. ]
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Secondary Outcome(s)
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To measure change in symptomatology via the Children's Automatic Thoughts Scale (CATS; Schniering & Rapee, 2002)[Questionnaires will be administered prior to group allocation, following the 8 week waiting period for the wait list group, immediately following treatment and three months following treatment. ]
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To measure change in life interference via the Adolescent Life Interference Scale (ALIS; Schniering et al., 2013).[Questionnaires will be administered prior to group allocation, following the 8 week waiting period for the wait list group, immediately following treatment and three months following treatment. ]
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To measure change in symptomatology via the Short Mood and Feelings Questionnaire (SMFQ; Sharp, Goodyer & Croudace, 2006).[Questionnaires will be administered prior to group allocation, following the 8 week waiting period for the wait list group, immediately following treatment and three months following treatment. ]
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To measure change in symptomatology via the Spence Children's Anxiety Scale (SCAS; Spence, 1998)[Questionnaires will be administered prior to group allocation, following the 8 week waiting period for the wait list group, immediately following treatment and three months following treatment. ]
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To measure change in symptomatology via the Strengths and Difficulties Questionnaire (SD; Goodman, 1997).[Questionnaires will be administered prior to group allocation, following the 8 week waiting period for the wait list group, immediately following treatment and three months following treatment. ]
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Secondary ID(s)
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Nil Known
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Source(s) of Monetary Support
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Australian Rotary Health
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Ethics review
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Status: Approved
Approval date: 20/09/2014
Contact:
Macquarie University Human Ethics Commitee
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Results
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Results available:
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Yes |
Date Posted:
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05/05/2022 |
Date Completed:
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30/04/2017 |
URL:
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