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
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
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Sertraline |
| Primary outcome measure | 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 study start date | 01/02/2015 |
| 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 | Both |
| Target number of participants | Planned Sample Size: 360; UK Sample Size: 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
- England
- United Kingdom
Study participating centre
Rowland Hill Street
London
NW3 2PF
United Kingdom
Sponsor information
University/education
Gower Street
London
WC1E 6BT
England
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
Government
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
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.
