Trial of Sertraline versus CBT for generalised Anxiety
| ISRCTN | ISRCTN14845583 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14845583 |
| ClinicalTrials.gov (NCT) | NCT02347033 |
| Clinical Trials Information System (CTIS) | 2014-004077-16 |
| Protocol serial number | 18345 |
| Sponsor | University College London (UK) |
| Funder | National Institute for Health Research |
- 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
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
Scientific
University College London
Department of Primary Care & Population Science Upper Third Floor
Rowland Hill Street
London
NW3 2PF
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | ToSCA |
| Study objectives | 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(s) | 14/LO/2105; First MREC approval date 03/12/2014 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Sertraline |
| Primary outcome measure(s) |
Current primary outcome measures as of 06/07/2016: |
| Key secondary outcome measure(s) |
1. Employment and Social Care questionnaire (ESC) |
| Completion date | 08/02/2016 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 360 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2015 |
| Date of final enrolment | 08/02/2016 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Rowland Hill Street
London
NW3 2PF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
