Trial of Sertraline versus CBT for generalised Anxiety

ISRCTN ISRCTN14845583
DOI https://doi.org/10.1186/ISRCTN14845583
EudraCT/CTIS number 2014-004077-16
ClinicalTrials.gov number NCT02347033
Secondary identifying numbers 18345
Submission date
04/02/2015
Registration date
05/02/2015
Last edited
07/07/2016
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Marta Buszewicz
Scientific

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

Study information

Study designRandomised; Interventional; Design type: Treatment
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a patient information sheet
Scientific titleA 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
Study acronymToSCA
Study objectivesA 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(s)14/LO/2105; First MREC approval date 03/12/2014
Health condition(s) or problem(s) studiedTopic: Mental Health; Subtopic: Anxiety; Disease: Anxiety
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Sertraline
Primary outcome measureCurrent 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 measures1. 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 study start date01/02/2015
Completion date08/02/2016
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 360; UK Sample Size: 360
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/07/2015
Date of final enrolment08/02/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

University College London (UK)
University/education

Gower Street
London
WC1E 6BT
England
United Kingdom

ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

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.