Plain English Summary
Background and study aims
Everyone experiences worry and anxiety now and then, but for some people it’s difficult to control these feelings. These people may develop a condition called generalized anxiety disorder(GAD). People who have GAD feel anxious most days, which can lead to a number of debilitating mental and physical symptoms. This study will compare the effectiveness of Sertraline, a drug that increases the activity and levels of certain chemicals in the brain that may help people with GAD and Cognitive Behavioural Therapy (CBT) for anxiety symptoms for people with GAD.
Who can participate?
Adults (aged 18 and over) who have failed to respond to “low intensity” psychological interventions delivered by an Increasing Access to Psychological Therapies Service (IAPT) will be invited to participate.
What does the study involve?
After an initial assessment, participants are randomly allocated into one of two groups. Those in group 1 are treated with Sertraline for a year. Those in group 2 receive 14-16 CBT sessions. All participants are assessed for GAD 12 months after starting the study.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
A number of IAPT services in the UK
When is the study starting and how long is it expected to run for?
February 2015 to January 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Marta Buszewicz
Trial website
Additional identifiers
EudraCT number
2014-004077-16
ClinicalTrials.gov number
NCT02347033
Protocol/serial number
18345
Study information
Scientific 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
Acronym
ToSCA
Study hypothesis
A phase IV randomised controlled multi-centre 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 delivered by an Increasing Access to Psychological Therapies Service (IAPT).
Ethics approval
14/LO/2105; First MREC approval date 03/12/2014
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Topic: Mental Health; Subtopic: Anxiety; Disease: Anxiety
Intervention
1. Cognitive Behavioural Therapy: CBT will be delivered by high intensity therapists from local IAPT services. They will provide 14 to 16 sessions of a manualised treatment developed for use in GAD and will be trained in its delivery.
2. Sertraline: The medication sertraline prescribed by their GP according to a trial protocol matching current clinical recommendations and within a dosage between 25 and 150mg daily. We will ask GPs to review patients regularly (at least 6 times in 12 months) and patients to take the medication for a year unless they have significant adverse effects. Side-effects will be regularly monitored.
Follow Up Length: 12 month(s); Study Entry : Single Randomisation only
Intervention type
Drug
Phase
Phase IV
Drug names
Sertraline
Primary outcome measures
Current primary outcome measures as of 06/07/2016:
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.
Previous primary outcome measures:
GAD-7; Timepoint(s): A 7-item self-complete questionnaire with very good sensitivity (89%) and specificity (82%) for GAD
Secondary outcome measures
1. Employment and Social Care questionnaire (ESC)
2. Euroquol (EQ-5D)
3. Hamilton Anxiety Rating Scale (HAM-A)
4. Health Service Outcomes
5. Patient acceptability measure (CSQ)
6. Patient Health Questionnaire (PHQ-9)
7. Patient preference rating scale
8. Work and Social Adjustment Scale (WSAS)
Overall trial start date
01/02/2015
Overall trial end date
08/02/2016
Reason abandoned
Participant recruitment issue
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 360; UK Sample Size: 360
Participant 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
Recruitment start date
01/07/2015
Recruitment end date
08/02/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
Department of Primary Care & Population ScienceUpper Third Floor
Rowland Hill Street
London
NW3 2PF
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary