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Trial registered on ANZCTR


Registration number
ACTRN12613001059752
Ethics application status
Not yet submitted
Date submitted
12/09/2013
Date registered
23/09/2013
Date last updated
3/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Combination treatment of child and adolescent anxiety disorders
Scientific title
Combined Sertraline and cognitive behaviour therapy (CBT) for the remission of anxiety disorders in clinically anxious children and adolescents
Secondary ID [1] 283175 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 290036 0
Condition category
Condition code
Mental Health 290413 290413 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Condition 1: 10 sessions of CBT over 12 weeks + 12 week trial of Sertraline Hydrochloride concurrently

Condition 2: 10 session of CBT over 12 weeks + 12 week trial of placebo medication concurrently

CBT sessions include psychoeducation about anxiety, and skills to manage anxiety. Skills focus on thinking styles and behavioural responses to anxiety. Sessions include both children and parents (less parental involvement for adolescents) and are delivered individually (to each family). 10 sessions are delivered weekly, except for week 9 and 11 where there is a break from CBT sessions. Sessions are approximately 50 minutes in duration.

Sertraline Hydrochloride is administered at dosages ranging from 25 - 200mg - starting with small dosage and being titrated up to a level for maximum tolerance and treatment effects. Administration is via oral capsule and adherence will be monitored via medication diary and pill counts.
Intervention code [1] 287903 0
Treatment: Other
Intervention code [2] 287958 0
Treatment: Drugs
Intervention code [3] 287959 0
Behaviour
Comparator / control treatment
CBT + pill placebo

CBT will be delivered in identical format to the CBT + Sertraline Hydrochloride group. The placebo will be a gelatine capsule with lactose powder.
Control group
Active

Outcomes
Primary outcome [1] 290437 0
Remission of primary anxiety diagnosis assessed via the ADIS-IV C/P
Timepoint [1] 290437 0
Post-Treatment and 6 month follow-up
Primary outcome [2] 290438 0
Remission of any anxiety diagnosis assessed via the ADIS-IV C/P
Timepoint [2] 290438 0
Post-Treatment and 6 month follow-up
Secondary outcome [1] 304518 0
Change on CGI
Timepoint [1] 304518 0
Post-treatment
Secondary outcome [2] 304519 0
Reductions in Clinician Severity Ratings
Timepoint [2] 304519 0
Post-Treatment and 6 month follow-up
Secondary outcome [3] 304520 0
Changes on parent report measures: Spence Children’s Anxiety Scale (Spence, 1998)

Timepoint [3] 304520 0
Post-Treatment and 6 month follow-up
Secondary outcome [4] 304816 0
Changes on parent report measures: Short Mood and Feelings Questionnaire (Angold et al., 1995)
Timepoint [4] 304816 0
Post-treatment and 6 month follow-up
Secondary outcome [5] 304817 0
Changes on parent report measures: The Strengths and Difficulties Questionnaire (Goodman, 1997)
Timepoint [5] 304817 0
Post-treatment and 6 month follow-up
Secondary outcome [6] 304818 0
Changes on parent report measures: Child Anxiety Life Interference Scale (CALIS, Lyneham, et al., in prep)
Timepoint [6] 304818 0
Post-treatment and 6 month follow-up
Secondary outcome [7] 304819 0
Changes on parent report measures: The Paediatric Quality of Life Inventory 4.0 (Varni et al., 2001)
Timepoint [7] 304819 0
Post-treatment and 6 month follow-up
Secondary outcome [8] 304820 0
Changes on child self-report measures: Spence Children’s Anxiety Scale (Spence, 1998)
Timepoint [8] 304820 0
Post-treatment and 6 month follow-up
Secondary outcome [9] 304821 0
Changes on child self-report measures: Short Mood and Feelings Questionnaire (Angold et al., 1995)
Timepoint [9] 304821 0
Post-treatment and 6 month follow-up
Secondary outcome [10] 304822 0
Changes on child self-report measures: Strengths and Difficulties Questionnaire (Goodman, 1997)
Timepoint [10] 304822 0
Post-treatment and 6 month follow-up
Secondary outcome [11] 304823 0
Changes on child self-report measures: The, Child Anxiety Life Interference Scale (CALIS, Lyneham, Abbott & Rapee, in prep)
Timepoint [11] 304823 0
Post-treatment and 6 month follow-up
Secondary outcome [12] 304824 0
Changes on child self-report measures: The Paediatric Quality of Life Inventory 4.0 (Varni, Seid, & Kurtin, 2001)
Timepoint [12] 304824 0
Post-treatment and 6 month follow-up
Secondary outcome [13] 304825 0
Changes on child self-report measures: “How I Feel About Things” (Ollendick & Davis, 2001)
Timepoint [13] 304825 0
Post-treatment and 6 month follow-up

Eligibility
Key inclusion criteria
Primary anxiety diagnosis

Minimum age
7 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Are receiving concurrent pharmacological therapy (other than a stable dose of stimulant medication for ADHD) – especially should not be taking pimozide [for vocal/motor tics] or anti-inflammatory medications.
2. Are receiving concurrent psychological treatment
3. Current MDD, suicidal and/or are self harming.
4. Considered at-risk due to abuse, neglect or extended school refusal
5. Significant learning delays that prevent mainstream class placement (intellectual disabilities).
6. Autism or related disorders (developmental disorders)
7. Eating disorder
8. Substance Use Disorder
9. History of bipolar disorder
10. Psychotic symptoms
11. Participants with a history or current heart, kidney, liver issues, diabetes, glaucoma or epilepsy.
12. Are pregnant
13. Inpatient


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)
Participants self-refer to the clinic or research team, are sent information about the research trial, complete a brief telephone screen and if determined to meeting inclusion but not exclusion criteria from this discussion are sent the treatment consent form and booked in for a diagnostic assessment and complete an online questionnaire battery. Suitability is determined from the diagnostic interview and if suitable participants make payment for treatment and are then randomly allocated to medication condition and booked in for their treatment sessions/appointments. Allocation to condition involves contacting the holder of the allocation schedule who is located at a separate centre (the Pharmacy) and is not involved in assessment or treatment of participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-based random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analyses will be conducted using intention-to-treat and completer models. Multiple imputation will be used to impute missing data. Categorical data will be analysed via chi-squared tests, and continuous data with parametric or equivalent non-parametric tests including mixed linear models.

A sample of 200 participants (100 to each condition) will detect differences in expected improvement for CBT+SSRI of 80% and for CBT+placebo of 60% with power of .8 and significance level of 0.05. Additional participants will need to be recruited in order to achieve 200 participants being randomised to treatment.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287925 0
Government body
Name [1] 287925 0
Australian Research Council
Address [1] 287925 0
Level 2, 11 Lancaster Place
Majura Park ACT 2609
AUSTRALIA
Country [1] 287925 0
Australia
Funding source category [2] 287926 0
University
Name [2] 287926 0
Macquarie University
Address [2] 287926 0
Balaclava Road,
NORTH RYDE
NSW 2109
Country [2] 287926 0
Australia
Primary sponsor type
Individual
Name
Professor Jennifer Hudson
Address
Psychology Department
MACQUARIE UNIVERSITY
NSW 2109
Country
Australia
Secondary sponsor category [1] 286652 0
None
Name [1] 286652 0
Address [1] 286652 0
Country [1] 286652 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289857 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 289857 0
Macquarie University Human Research Ethics Committee
Macquarie University
NSW 2109
Ethics committee country [1] 289857 0
Australia
Date submitted for ethics approval [1] 289857 0
11/09/2013
Approval date [1] 289857 0
Ethics approval number [1] 289857 0

Summary
Brief summary
Building emotional health in childhood sets the platform for a healthy and productive life. Optimising treatment outcome for common emotional disorders (e.g., anxiety disorders) in childhood is an important area of research.

Research using anti-depressant medication in combination with CBT to treat anxiety has been conducted to investigate optimum treatment response. These studies indicate that combination therapy (CBT + anti-depressant medication) has greater efficacy than either treatment alone (March et al., 2004; POTS 2004). Such research provides the opportunity to use empirical data to inform treatment guidelines and enable child/adolescents and their families to receive the most efficacious interventions to reduce anxiety-related impairment and distress. However, research comparing the efficacy of interventions has typically employed a partially blinded approach, where participants are randomly allocated into Pill, Placebo, CBT only or Pill+CBT conditions. This research methodology is limited by the fact that participants receiving the combined CBT and pill treatment are aware that they are receiving two active interventions, so expectancy effects cannot be ruled out as a potential alternative explanation for the comparatively greater response rates found for participants in this condition (Hudson, 2009). Double-blinded research that compares the efficacy of CBT + placebo and CBT + pill conditions in the treatment of child/adolescent anxiety is necessary to clarify the additional benefits of combining medication with the currently recommended first line intervention, CBT.

Additionally, existing research suggesting greater efficacy of combination treatment did not conduct long-term follow-ups. By adding long-term follow-ups the longer-term benefits of combination therapy for anxious children can be determined, and compared to the known long-term benefits of treating anxiety using CBT.

It is expected that combined treatment (CBT + Sertraline) will produce better outcomes than CBT + Placebo condition for children and adolescents with anxiety disorders.
Trial website
www.centreforemotionalhealth.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42790 0
Prof Jennifer Hudson
Address 42790 0
Department of Psychology
Macqaurie University
NSW 2109
Country 42790 0
Australia
Phone 42790 0
+61 2 9850 8668
Fax 42790 0
+61 2 9850 8062
Email 42790 0
jennie.hudson@mq.edu.au
Contact person for public queries
Name 42791 0
Dr Lauren McLellan
Address 42791 0
Department of Psychology
Macquarie University
NSW 2109
Country 42791 0
Australia
Phone 42791 0
+61 2 9850 1463
Fax 42791 0
+61 2 9850 8062
Email 42791 0
lauren.mclellan@mq.edu.au
Contact person for scientific queries
Name 42792 0
Prof Jennifer Hudson
Address 42792 0
Department of Psychology
Macqaurie University
NSW 2109
Country 42792 0
Australia
Phone 42792 0
+61 2 9850 8668
Fax 42792 0
+ 61 2 9850 8062
Email 42792 0
jennie.hudson@mq.edu.au

No data has been provided for results reporting
Summary results
Not applicable