ToSCA: Trial of Sertraline versus CBT for generalised Anxiety

• Research type

  Research Study

• Full title

  A Phase IV randomised controlled trial of the selective serotonin reuptake inhibitor Sertraline versus Cognitive Behavioural Therapy for anxiety symptoms in people with Generalised Anxiety Disorder (GAD) who have failed to respond to low intensity psychological interventions as defined by the NICE GAD guidelines

• IRAS ID

  155078

• Contact name

  Irwin Nazareth

• Sponsor organisation

  University College London Joint Research Office

• Eudract number

  2014-004077-16

• ISRCTN Number

  ISRCTN14845583

• Clinicaltrials.gov Identifier

  NCT02347033

• Clinicaltrials.gov Identifier

  14/LO/2105, REC reference

• Duration of Study in the UK

  4 years, 0 months, 0 days

• Research summary

  Background: Randomised trial of the medication Sertraline versus Cognitive Behavioural Therapy (CBT) for people with Generalised Anxiety Disorder (GAD) not responding to low intensity psychological treatments.
  
  Methods: We will recruit people aged 18 and above via the Improving Access to Psychological Therapies (IAPT) service from 15 English sites. Those potentially eligible and interested will be sent the patient information sheet (PIS) and asked to give permission for their GP to be contacted to check they are medically suitable to participate. They will be informed that Sertraline, although not having current marketing authorisation for GAD, is recommended by NICE as the first-line medication because of its effectiveness in clinical trials. They will be invited to meet a researcher to answer any queries before giving informed consent if they agree to be assessed against trial inclusion/exclusion criteria and entered if eligible. The researcher will check there are no medical reasons they cannot participate and that they also meet the other eligibility criteria. If eligible they will be asked to complete brief questionnaires assessing associated depression, social functioning and quality of life.

  Interventions: Randomisation via an independent computerised system to:
  (a) Sertraline prescribed by their GP according to current clinical guidelines. We will recommend that participants should be reviewed up to 6 times in 12 months and asked to take medication for a year unless they have significant adverse events, or
  (b) CBT delivered by trained high intensity IAPT therapists. They will provide 14-16 weekly sessions of a manualised GAD specific treatment.

  Outcomes: Participants will be monitored at baseline, 3, 6, 9 and 12 months for generalised anxiety using the self-report HADS-A questionnaire, as well as depressive symptoms and quality of life. Other secondary outcomes include other anxiety symptoms, social functioning and use of health and social care at baseline and 12 months.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  14/LO/2105

• Date of REC Opinion

  3 Dec 2014

• REC opinion

  Favourable Opinion