None listed
Conditions
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.
Interventions
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
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.
Sponsors
Professor Jennifer Hudson
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
7 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Primary anxiety diagnosis
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
Outcome results
None listed