Trial of Sertraline Versus Cognitive Behaviour Therapy for Generalised Anxiety (ToSCA)
Generalised Anxiety Disorder
About this trial
This is an interventional treatment trial for Generalised Anxiety Disorder focused on measuring Sertraline, Selective Serotonin Reuptake Inhibitor (SSRI), Cognitive Behavioural Therapy (CBT), Increasing Access to Psychological Therapies (IAPT)
Eligibility Criteria
Inclusion Criteria:
- Aged 18 or above
- Positive score of 10+ on GAD-7
- Primary diagnosis of GAD as diagnosed on MINI
- Failure to respond to NICE defined low intensity psychological interventions
Exclusion Criteria:
- Inability to complete questionnaires due to insufficient English or cognitive impairment;
- Current major depression
- Other comorbid anxiety disorder(s) of more severity or distress to the participant than their GAD;
- Significant dependence on alcohol or illicit drugs;
- Comorbid psychotic disorder, bipolar disorder;
- Treatment with antidepressants in past 8 weeks or any high intensity psychological therapy within past 6 months;
- Currently on contraindicated medication: monoamine oxidase Inhibitors within the past 14 days or pimozide;
- Patients with poorly controlled epilepsy;
- Known allergies to the Investigational Medicinal Product (IMP) or excipients;
- Concurrent enrolment in another Investigational Medicinal Product trial;
- Severe hepatic impairment;
- Women who are currently pregnant or planning pregnancy or lactating
- Patient on anti-coagulants
- History of bleeding disorders
Sites / Locations
- Camden & Islington (with Kingston)
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Sertraline
Cognitive Behavioural Therapy (CBT)
The pharmacological arm of the trial is the Selective Serotonin Reuptake Inhibitor (SSRI) Sertraline, prescribed at a daily dose of between 25 and 150mg by the patient's general practitioner (GP). If the medication is well tolerated and associated with reported clinical improvement we are asking the patients in this arm to continue taking it for 12 months.
The psychological therapy arm of the trial is Cognitive Behavioural Therapy (CBT) delivered by high intensity psychological therapists from local IAPT services. They will provide 14 to 16 sessions of a manualised treatment developed specifically for use in GAD and will be trained in its delivery.