Trial of Sertraline Versus Cognitive Behaviour Therapy for Generalised Anxiety

Summary

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.

Conditions

• Generalised Anxiety Disorder

Interventions

DRUG

Sertraline

Sertraline will be prescribed by the patients' GP, starting at 25mg daily for 1-2 weeks and increasing to 50mg daily if tolerated. The GP should review the patient within the first 2 weeks, checking for acceptability, concordance and any side-effects, with further reviews at 6 and 12 weeks. We expect the usual treatment dose to be 50 to 100mg daily, although some may require 150mg. We will suggest that the GPs use their usual procedures to review the patient's progress, asking about and noting functional change as well as clinical improvement. Minimal improvement after 12 weeks at a maximal tolerated dose should prompt consideration of change of treatment. If there has been an adequate therapeutic benefit there should be further review at 26 and 52 weeks.

BEHAVIORAL

Cognitive Behavioural Therapy

CBT will consist of 14 (+ / - 2) weekly 50-minute sessions and will cover 6 treatment modules: psychoeducation and worry awareness training; re-evaluation of the usefulness of worry; uncertainty recognition and behavioural exposure; problem-solving training; written exposure; and relapse prevention. Sessions will be digitally recorded and a random 10% assessed for quality (fidelity to the manual and therapist competence) by an independent external assessor according to pre-specified criteria. Patient consent for this will be obtained as part of obtaining informed consent.

Sponsors & Collaborators

• NHS Health Technology Assessment Programme

  collaborator OTHER

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• University College, London

  lead OTHER

Principal Investigators

• Marta Buszewicz · University College, London

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-31

Primary Completion

2016-02-29

Completion

2016-02-29

Countries

• United Kingdom

Study Locations