Condition category
Mental and Behavioural Disorders
Date applied
04/02/2015
Date assigned
05/02/2015
Last edited
07/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

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

Contact information

Type

Scientific

Primary contact

Dr Marta Buszewicz

ORCID ID

Contact details

University College London
Department of Primary Care & Population Science Upper Third Floor
Rowland Hill Street
London
NW3 2PF
United Kingdom

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

Sponsor information

Organisation

University College London (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes

06/07/2016: the following changes were made to the trial record: 1. The trial closed early because of recruitment difficulties. 2. The recruitment start date was changed from 01/02/2015 to 01/07/2015. 3. The recruitment end date and overall trial end date were changed from 31/01/2017 to 08/02/2016.