NCT02347033

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

1.5 years

First QC Date

January 16, 2015

Last Update Submit

July 8, 2016

Conditions

Generalised Anxiety Disorder

Keywords

SertralineSelective Serotonin Reuptake Inhibitor (SSRI)Cognitive Behavioural Therapy (CBT)Increasing Access to Psychological Therapies (IAPT)

Outcome Measures

Primary Outcomes (1)

  • GAD-7

    A 7 item self-complete questionnaire with very good sensitivity (89%) and specificity (82%) for Generalised Anxiety Disorder (GAD).

    GAD-7 score at 12 months

Secondary Outcomes (18)

  • GAD-7

    GAD-7 score at 3 months

  • GAD-7

    GAD-7 score at 6 months

  • GAD-7

    GAD-7 score at 9 months

  • HAM-A

    HAM-A score at 12 months

  • Patient Health Questionnaire (PHQ-9)

    PHQ-9 score at 3 months

  • +13 more secondary outcomes

Other Outcomes (6)

  • Health service outcome - General practitioner (GP) contacts

    GP contacts at 12 months

  • Health service outcome - Practice nurse contacts

    Practice nurse contacts at 12 months

  • Health service outcome - referrals to secondary care medical services

    Referrals to secondary care medical services at 12 months

  • +3 more other outcomes

Study Arms (2)

Sertraline

ACTIVE COMPARATOR

The pharmacological arm of the trial is the Selective Serotonin Reuptake Inhibitor (SSRI) Sertraline, prescribed at a daily dose of between 25 and 150mg by the patient's general practitioner (GP). If the medication is well tolerated and associated with reported clinical improvement we are asking the patients in this arm to continue taking it for 12 months.

Drug: Sertraline

Cognitive Behavioural Therapy (CBT)

ACTIVE COMPARATOR

The psychological therapy arm of the trial is Cognitive Behavioural Therapy (CBT) delivered by high intensity psychological therapists from local IAPT services. They will provide 14 to 16 sessions of a manualised treatment developed specifically for use in GAD and will be trained in its delivery.

Behavioral: Cognitive Behavioural Therapy

Interventions

SertralineDRUG

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.

Also known as: SSRI
Sertraline
Cognitive Behavioural TherapyBEHAVIORAL

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.

Also known as: CBT
Cognitive Behavioural Therapy (CBT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 or above
  • Positive score of 10+ on GAD-7
  • Primary diagnosis of GAD as diagnosed on MINI
  • Failure to respond to NICE defined low intensity psychological interventions

You may not qualify if:

  • Inability to complete questionnaires due to insufficient English or cognitive impairment;
  • Current major depression
  • Other comorbid anxiety disorder(s) of more severity or distress to the participant than their GAD;
  • Significant dependence on alcohol or illicit drugs;
  • Comorbid psychotic disorder, bipolar disorder;
  • Treatment with antidepressants in past 8 weeks or any high intensity psychological therapy within past 6 months;
  • Currently on contraindicated medication: monoamine oxidase Inhibitors within the past 14 days or pimozide;
  • Patients with poorly controlled epilepsy;
  • Known allergies to the Investigational Medicinal Product (IMP) or excipients;
  • Concurrent enrolment in another Investigational Medicinal Product trial;
  • Severe hepatic impairment;
  • Women who are currently pregnant or planning pregnancy or lactating
  • Patient on anti-coagulants
  • History of bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Camden & Islington (with Kingston)

London, WC1X 2DN, United Kingdom

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

SertralineCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Marta Buszewicz

    University College, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 27, 2015

Study Start

August 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

July 11, 2016

Record last verified: 2016-07

Locations

GB(1)