Generalised Anxiety Disorder Clinical Trial
Official title:
RCT of Sertraline Versus Cognitive Behavioural Therapy for Anxiety Symptoms in People With Generalised Anxiety Disorder Who Have Failed to Respond to Low Intensity Psychological Interventions as Defined by the NICE GAD Guidelines
Generalised Anxiety Disorder (GAD) is common, causes unpleasant symptoms and impairs
people's functioning. It is often chronic and may be accompanied by depression and other
anxiety disorders. It is not currently clear whether medication or psychological therapy
provides better long term outcomes for those not responding to simpler low intensity
treatments so we propose to compare the clinical effectiveness of a pharmacological
treatment (the drug Sertraline) with a Cognitive Behavioural Therapy (CBT) intervention.
Our hypothesis is that in people with GAD who have not responded to low intensity
psychological interventions, CBT will lead to a greater improvement in their GAD symptoms as
measured using the GAD-7 scale at 12 month follow-up than Sertraline.
The investigators propose to undertake a randomised controlled trial (RCT) to compare the
clinical effectiveness in terms of symptoms and function of a pharmacological treatment (the
SSRI Sertraline) prescribed at therapeutic doses, with a manualised psychological
intervention (Cognitive Behavioural Therapy, CBT) delivered by trained psychological
therapists to patients with persistent generalised anxiety disorder (GAD) which has not
improved with low intensity psychological interventions as defined by NICE (the National
Institute for Clinical Effectiveness).
The investigators will recruit people via the Increasing Access to Psychological Therapies
(IAPT) service from up to 15 sites in England. People still scoring highly on an anxiety
measure (GAD-7) despite having received a low intensity psychological intervention will be
given a brief flyer about the trial. Names of those interested in taking part who have given
written consent to having their details released will be passed to the research team and the
IAPT staff will also let the research team know the name of the participant's general
practice, with their permission.
The research team will then contact potential participants offering them an appointment for
an interview/assessment to discuss the study, sending them a patient information sheet to
reach them at least 48 hours beforehand. The study information will explain that the
medication being evaluated, Sertraline, although not currently licensed for GAD was
recommended by NICE on the basis of its effectiveness in clinical trials and that the study
team will be available to clarify any issues arising from this.
At the baseline assessment patients will be asked to give informed consent by a member of
the research team and both medical suitability (as confirmed by fax/secure email from the
GP) and the meeting of other inclusion/exclusion criteria will be checked. Upon confirmation
of eligibility, baseline assessments will be carried out by a member of the research team
and consenting patients randomised to receive either the medication or CBT. The Chief
Investigator or other medically qualified persons within the research team will review all
eligibility information and confirm that the patient is eligible.
Eligible participants will be randomised via an independent web-based computerised system to
one of two interventions. The research team will provide the relevant contact
details/instructions to patients in order to initiate treatment. The trial interventions
consist of: (a) 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. (b) The other intervention is CBT 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. The
primary outcome will be the GAD-7 score measured at 12 months. Participants will also be
asked to complete this outcome measure by postal questionnaire at 3, 6 and 9 months, as well
as a range of secondary outcomes.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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