Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000139471
Ethics application status
Approved
Date submitted
2/02/2016
Date registered
5/02/2016
Date last updated
5/05/2022
Date data sharing statement initially provided
5/05/2022
Date results information initially provided
5/05/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Chilled Plus Program: Helping Adolescents with Anxiety and Depression.
Scientific title
The Feasibility and Outcome of Internet Delivery of Transdiagnostic Cognitive-Behaviour Therapy for Adolescent Anxiety and Depression
Secondary ID [1] 287848 0
Nil Known
Universal Trial Number (UTN)
U1111-1176-3545
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 296734 0
Depression 296735 0
Condition category
Condition code
Mental Health 296974 296974 0 0
Anxiety
Mental Health 296975 296975 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 different types of coping strategies and problem solving, as well as assertiveness training and how to handle teasing and bullying.

Module seven looks at how to overcome loneliness, how to build relationships, how to deal with family problems and further review of the next steps on the adolescents stepladders.

Module eight addresses what to do if things go wrong and symptoms reappear and looking to the future (e.g. further goal setting). It concludes with videos of the same people from module one talking about their lives since they used the skills in the program.

Each module requires participants to complete worksheets, monitor their thoughts, feelings and actions and complete personal projects (e.g. stepladder practice, mindfulness practice, etc..).

The phone calls with the adolescents occur once a week over the 8 week program and last for 25 minutes. The weekly phone calls with parents last 10 minutes, with the exception of Weeks 1, 5 and 8 consisting of 30 minute phone calls. These phone calls occur after the adolescents phone call. The aim of the calls with the adolescent is for the therapist to support the adolescent, help them problem solve any difficulties they might be experiencing in the program and to provide them with someone to talk to if things are difficult. The 10 minute phone calls with parents aims to provide a check in on how the child is going and how they are progressing with the program and to answer any questions the parents have around how best to support their child. The parents may also present questions from the content provided in the parent companion.

Treatment adherence for adolescents is monitored via data collected from the treatment website on login times, worksheet completion and pages viewed. Treatment adherence for clinicians is monitored via weekly supervision and the recording of all sessions for independent review to ensure treatment fidelity.
Intervention code [1] 293407 0
Behaviour
Intervention code [2] 293408 0
Treatment: Other
Comparator / control treatment
A wait list control group is being utilised in the current study. Following the completion of an 8 week waiting period the participant receives the intervention.
Control group
Active

Outcomes
Primary outcome [1] 296810 0
Number of diagnoses as measured by the Anxiety Disorders Interview Schedule for Children (ADIS-C; Silverman & Albano, 1996) according to DSM-5 criteria.
Timepoint [1] 296810 0
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.
Primary outcome [2] 297228 0
Severity of diagnoses as measured by the Anxiety Disorders Interview Schedule for Children (ADIS-C; Silverman & Albano, 1996) according to DSM-5 criteria.
Timepoint [2] 297228 0
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.
Secondary outcome [1] 319422 0
To measure change in symptomatology via the Short Mood and Feelings Questionnaire (SMFQ; Sharp, Goodyer & Croudace, 2006).
Timepoint [1] 319422 0
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.
Secondary outcome [2] 320411 0
To measure change in symptomatology via the Spence Children's Anxiety Scale (SCAS; Spence, 1998)
Timepoint [2] 320411 0
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.
Secondary outcome [3] 320412 0
To measure change in symptomatology via the Children's Automatic Thoughts Scale (CATS; Schniering & Rapee, 2002)
Timepoint [3] 320412 0
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.
Secondary outcome [4] 320413 0
To measure change in symptomatology via the Strengths and Difficulties Questionnaire (SD; Goodman, 1997).
Timepoint [4] 320413 0
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.
Secondary outcome [5] 320414 0
To measure change in life interference via the Adolescent Life Interference Scale (ALIS; Schniering et al., 2013).
Timepoint [5] 320414 0
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.

Eligibility
Key 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.
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) was utilised.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study will consist of two groups: Active treatment and wait-list condition each of which will include approximately 60 treatment completer participants. Sixty subjects per group post treatment corresponds to a power of .85 at p = .05, 2-tailed for a moderately small effect size of .25, which is conservative power.

Analysis plan: differences between groups will be examined using hierarchical mixed models containing random intercept and random slope terms as well as fixed effects for treatment received.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/10/2014
Date of last participant enrolment
Anticipated
31/07/2016
Actual
30/10/2016
Date of last data collection
Anticipated
Actual
30/04/2017
Sample size
Target
120
Accrual to date
Final
91
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 292524 0
Charities/Societies/Foundations
Name [1] 292524 0
Australian Rotary Health
Country [1] 292524 0
Australia
Primary sponsor type
Individual
Name
Dr Carolyn Schniering
Address
Department of Psychology,
Macquarie University,
Sydney. NSW. 2109
Australia
Country
Australia
Secondary sponsor category [1] 291550 0
Individual
Name [1] 291550 0
Dr Ron Rapee
Address [1] 291550 0
Department of Psychology,
Macquarie University,
Sydney. NSW. 2109
Australia
Country [1] 291550 0
Australia
Secondary sponsor category [2] 291551 0
Individual
Name [2] 291551 0
Dr Danielle Einstein
Address [2] 291551 0
Department of Psychology,
Macquarie University,
Sydney. NSW. 2109
Australia
Country [2] 291551 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294312 0
Macquarie University Human Ethics Commitee
Ethics committee address [1] 294312 0
Macquarie University,
Sydney. NSW. 2109
Australia
Ethics committee country [1] 294312 0
Australia
Date submitted for ethics approval [1] 294312 0
10/09/2014
Approval date [1] 294312 0
20/09/2014
Ethics approval number [1] 294312 0
5201300828

Summary
Brief summary
Adolescents with a combination of anxiety and depression have especially severe symptoms that can cause major impact on their lives. While we already have good treatments for teenagers with either anxiety or depression alone, there are no good treatments currently available for adolescents with both problems. This trial will evaluate the effects of a new treatment for adolescents with mixed anxiety and depression that teaches them new ways of thinking, acting, and feeling. It is delivered over the internet and is assisted by 8 sessions with a therapist over the telephone. Adolescents will be randomly allocated to either receive the new treatment (called Chilled Plus) or to wait for 8 weeks (after which these adolescents will also get the program). We expect that those adolescents who immediately enter the program will show large reductions in anxiety and depression and improvements in quality of life.
Trial website
chilledplus.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61466 0
Dr Carolyn Schniering
Address 61466 0
Department of Psychology
Macquarie University
Sydney, NSW, 2109
Country 61466 0
Australia
Phone 61466 0
+61 02 98506741
Fax 61466 0
Email 61466 0
carolyn.schniering@mq.edu.au
Contact person for public queries
Name 61467 0
Dr Jessica Kirkman
Address 61467 0
Department of Psychology
Macquarie University
Sydney, NSW, 2109
Country 61467 0
Australia
Phone 61467 0
+61 02 9850 6741
Fax 61467 0
Email 61467 0
jess.kirkman@mq.edu.au
Contact person for scientific queries
Name 61468 0
Dr Carolyn Schniering
Address 61468 0
Department of Psychology
Macquarie University
Sydney, NSW, 2109
Country 61468 0
Australia
Phone 61468 0
+61 02 98506741
Fax 61468 0
Email 61468 0
carolyn.schniering@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent was not obtained from participants in this early trial.


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
SourceTitleYear of PublicationDOI
EmbaseOnline treatment of adolescents with comorbid anxiety and depression: A randomized controlled trial.2022https://dx.doi.org/10.1016/j.jad.2022.05.072
N.B. These documents automatically identified may not have been verified by the study sponsor.