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Trial registered on ANZCTR


Registration number
ACTRN12611000903987
Ethics application status
Approved
Date submitted
21/08/2011
Date registered
24/08/2011
Date last updated
24/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomized controlled trial of online versus clinic-based cognitive behaviour therapy (CBT) for adolescent anxiety
Scientific title
A comparison of the effects of online versus clinic-based delivery of CBT in reducing anxiety disorders and anxiety symptoms among clinically anxious adolescents
Secondary ID [1] 262885 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety disorders among adolescents 270614 0
Condition category
Condition code
Mental Health 270781 270781 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The program comprised ten, one-hour online youth sessions and five, online one-hour parent sessions completed over a 12-week period. Booster sessions were completed at one- and three-months following treatment for both the young person and their parent(s). Standard CBT anxiety management strategies were used including: psychoeducation, relaxation training, recognition of the physiological symptoms of anxiety, cognitive strategies of coping self-talk and cognitive restructuring, graded exposure, problem solving, and self-reinforcement. Parent sessions also taught anxiety management skills, in addition to parenting strategies to empower parents to help their child implement anxiety management skills.

The content, length and number of session activities in the Internet program replicate those of the clinic-based version. Sessions are designed to be engaging, interactive, and age-appropriate. Eye-catching graphics, sounds, games and quizzes are used to maintain the youths’ level of interest. Information is presented through interactive exercises and followed by quizzes that check for correct understanding and provide personalized corrective or positive feedback through pop up messages. The content of the intervention is designed to meet the developmental and cognitive level of youths, with age-appropriate scenarios, examples, and activities (example situations include school exams, job interviews, dating, and oral presentations).
The program is (minimally) therapist-assisted, rather than self-help. Each family is assigned an online therapist (BRAVE Trainer) who monitors their progress through the program and provides brief email feedback following each session. At no stage did any participants have face-to-face contact with their therapist and all other contact (i.e., email or phone) was minimal. Clinician contact was restricted to brief, weekly emails and a short, 15-minute mid-program telephone call to assist in exposure hierarchy development. Most other contact with the ‘online therapist’ was computer generated. Client responses to all session and homework activities are stored in an administrator section of the program and can be viewed by the therapist to guide the content of the weekly email. In addition, automated computer-generated emails are sent on behalf of the online therapist to congratulate participants for completion of sessions and personalized emails are sent to provide feedback about responses to quiz tasks. Personalized automated reminder emails are sent to advise when the next session is available for completion, or to provide prompts if not completed by the due date. The first session also includes a picture of the therapist, and some brief biographical information about them, to which the client responds by providing information about themselves.
Intervention code [1] 269239 0
Behaviour
Intervention code [2] 269256 0
Treatment: Other
Comparator / control treatment
Online CBT (with minimal therapist assistance) was compared with clinic-based CBT. The clinic-based intervention mirrored the internet delivered program outlined above in terms of therapy content, strategies, and number of sessions. The clinic program comprised ten, one-hour youth sessions and five, one-hour parent sessions completed over a 12-week period. Sessions for both parent and young person are conducted face-to-face with the therapist in the clinic. Booster sessions were completed at one- and three-months following treatment for both the young person and their parent(s), again face-to-face in the clinic. Standard CBT anxiety management strategies were used including: psychoeducation, relaxation training, recognition of the physiological symptoms of anxiety, cognitive strategies of coping self-talk and cognitive restructuring, graded exposure, problem solving, and self-reinforcement. Parent sessions also taught anxiety management skills, in addition to parenting strategies to empower parents to help their child implement anxiety management skills.

The online and clinic formats of treatment were compared with a 12-week wait list control condition.
Control group
Active

Outcomes
Primary outcome [1] 279474 0
Primary outcome measures is "blind", independent clinical diagnostic interview for anxiety disorders and clinician serverity rating of diagnosis using Anxiety Disorders Interview Schedule for DSM-IV: Child and Parent versions.
Timepoint [1] 279474 0
Pre-treatment
12-weeks
6-month follow-up
12-month follow-up
Primary outcome [2] 279475 0
The Children's Global Assessment Scale. (CGAS: Schaffer et al., 1983).
Timepoint [2] 279475 0
Pre-treatment
12-weeks
6-month follow-up
12-month follow-up
Secondary outcome [1] 287710 0
Parent and child survey of anxiety symptoms using Spence Children's Anxiety Scale (Spence, 1998)
Timepoint [1] 287710 0
Pre-treatment
12-weeks
6-month follow-up
12-month follow-up
Secondary outcome [2] 287711 0
Internalizing problems using the Child Behaviour Checklist and Youth Self-Report form - Achenbach
Timepoint [2] 287711 0
Pre-treatment
12-weeks
6-month follow-up
12-month follow-up
Secondary outcome [3] 287712 0
Treatment satisfaction ratings completed by adolescents and parents, consisting of eight items, each measured on a five-point Likert scale (1 = not at all, 5 = very much).
Timepoint [3] 287712 0
12-weeks (post-treatment)
Secondary outcome [4] 287713 0
Predictors of therapy outcome include:
- working alliance (Working Alliance Inventory - Short Form)
- motivation (short rating scale developed by the researchers)
- types of anxiety disorders (from ADIS-C/P)
- compliance (operationalized for example as the percentage of therapy session and homework tasks completed by the participant by 6-month follow-up)
- family factors including
* parental relationship quality Quality of Marriage Index (Norton, 1983)
* parental anxiety and depression (DASS-21; Lovibond & Lovibond, 1995)
* family environment factors (Family Adaptability and Cohesion Evaluation Scale Version III (FACES-III; Olson et al., 1985).
Timepoint [4] 287713 0
Working alliance after session 3
Compliance with therapy tasks in each session
Family factors prior to commencement of treatment

Eligibility
Key inclusion criteria
Primary diagnosis of SAD, SoP, GAD or SP,
be aged between 12 and 18 years,
access to a computer and the internet at home,
able to read and write English at an age-appropriate level.
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
primary diagnosis of the following (ie. if greater severity than other anxiety disorders)
- panic disorder (PD),
- obsessive compulsive disorder (OCD)
- post-traumatic stress disorder (PTSD)
- depression
Or pervasive developmental disorder or specific learning disorder, self harm, severe conduct disorder

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)
Random assignment of participants to conditions was conducted using a computer generated random number sequence. The clinician who made the judgement regarding acceptance into the trial was not aware of the condition to which the client would subsequently be allocated to, thus allocation was concealed.
Clinical interviewers were independent and blind to allocated condition
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence, for allocation of participants to one of three conditions
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Mixed model, 4 repeated measures, 3 conditions.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269711 0
Government body
Name [1] 269711 0
NHMRC
Country [1] 269711 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
University of Queensland St Lucia
Brisbane
Queensland
QLD 4067
Country
Australia
Secondary sponsor category [1] 268750 0
University
Name [1] 268750 0
Macquarie University
Address [1] 268750 0
Balaclava Rd
North Ryde
Sydney
New South Wales 2109
Country [1] 268750 0
Australia
Secondary sponsor category [2] 268751 0
University
Name [2] 268751 0
Griffith University
Address [2] 268751 0
Nathan Campus
Kessels Rd
Nathan
Brisbane
Queensland 4111
Country [2] 268751 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271673 0
Macquarie University
Ethics committee address [1] 271673 0
Ethics committee country [1] 271673 0
Australia
Date submitted for ethics approval [1] 271673 0
01/01/2006
Approval date [1] 271673 0
24/02/2006
Ethics approval number [1] 271673 0
HE24FEB2006-R04438
Ethics committee name [2] 271674 0
Griffith University
Ethics committee address [2] 271674 0
Ethics committee country [2] 271674 0
Australia
Date submitted for ethics approval [2] 271674 0
01/12/2007
Approval date [2] 271674 0
17/12/2007
Ethics approval number [2] 271674 0
PSY-10-07-HREC
Ethics committee name [3] 271690 0
University of Queensland Behavioural and Social Sciences Ethical Review Committee
Ethics committee address [3] 271690 0
Ethics committee country [3] 271690 0
Australia
Date submitted for ethics approval [3] 271690 0
01/12/2004
Approval date [3] 271690 0
17/12/2004
Ethics approval number [3] 271690 0
2004000768

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

Contacts
Principal investigator
Name 33052 0
Address 33052 0
Country 33052 0
Phone 33052 0
Fax 33052 0
Email 33052 0
Contact person for public queries
Name 16299 0
Professor Sue Spence
Address 16299 0
Griffith University Nathan Campus
Kessels Rd
Brisbane
QLD 4111
Country 16299 0
Australia
Phone 16299 0
+61 7 37355447
Fax 16299 0
+61 7 37357507
Email 16299 0
[email protected]
Contact person for scientific queries
Name 7227 0
Professor Sue Spence
Address 7227 0
Griffith University Nathan Campus
Kessels Rd
Brisbane
QLD 4111
Country 7227 0
Australia
Phone 7227 0
+61 7 37355447
Fax 7227 0
+61 7 37357507
Email 7227 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

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No documents have been uploaded by study researchers.

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