Trial of Sertraline versus CBT for generalised Anxiety

Phase 4

Completed

• Conditions: Topic: Mental Health; Subtopic: Anxiety; Disease: Anxiety; Mental and Behavioural Disorders

• Registration Number: ISRCTN14845583
• Lead Sponsor: niversity College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-05
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. Aged 18 or above
2. Gender: Male or female
3. Positive score of 10+ on GAD-7
4. Primary diagnosis of GAD as diagnosed on the Mini-International Neuropsychiatric Interview (M.I.N.I.)
5. Failure to respond to NICE defined step 1 and 2 low intensity psychological interventions for GAD

Exclusion Criteria

1. Inability to complete questionnaires due to insufficient English or cognitive impairment
2. Current major depression
3. Other comorbid anxiety disorder(s) of more severity or distress to the participant than their GAD
4. Significant dependence on alcohol or illicit drugs
5. Comorbid psychotic disorder, bipolar disorder
6. Treatment with antidepressants in past 8 weeks or any high intensity psychological therapy within past 6 months
7. Currently on contraindicated medication: monoamine oxidase Inhibitors within the past 14 days or pimozide.
8. Patients with poorly controlled epilepsy
9. Concurrent enrolment in another IMP (medication) trial
10. Women who are currently pregnant or planning pregnancy or lactating
11. Severe hepatic impairment
12. Patient on anti-coagulants
13. History of a bleeding disorder

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 06/07/2016:<br>HADS-A measured at 12 months. This is the 7-item anxiety component of the HADS (Hospital Anxiety and Depression Scale) a very widely used 14-item scale that can be self-administered. It has a high validity and reliability and the anxiety and depression components have been assessed separately as primary outcomes. <br><br>Previous primary outcome measures:<br>GAD-7; Timepoint(s): A 7-item self-complete questionnaire with very good sensitivity (89%) and specificity (82%) for GAD

Secondary Outcome Measures

Name	Time	Method
1. Employment and Social Care questionnaire (ESC)<br>2. Euroquol (EQ-5D)<br>3. Hamilton Anxiety Rating Scale (HAM-A)<br>4. Health Service Outcomes<br>5. Patient acceptability measure (CSQ)<br>6. Patient Health Questionnaire (PHQ-9)<br>7. Patient preference rating scale<br>8. Work and Social Adjustment Scale (WSAS)