Condition category
Mental and Behavioural Disorders
Date applied
18/06/2010
Date assigned
04/08/2010
Last edited
04/08/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs M Eugenia Tello

ORCID ID

Contact details

Avda. de los Pinos
30.
Leganés
28914
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI09/90304

Study information

Scientific title

Cluster randomized trial for evaluate the effectiveness of an implementation strategy of a clinical practice guideline for patients with anxiety disorders

Acronym

GRITA

Study hypothesis

The percentage of patients with a decrease of 2 or more points in the Goldberg Anxiety Scale after 6 months, will be 20% higher in those that were involved in the focused organisational strategy over those that weren’t involved in it.

Ethics approval

The Committee of Ethical Investigation of the 9th Madrid Health Area approved on the 29th of April 2010

Study design

Multicentre cluster randomised 2 arm open label controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Generalised anxiety disorder, panic disorder and panic attacks

Intervention

1. Control group:
1.1. The Clinical Practice Guideline (CPG) will be included on the official working place website
1.2. The CPG will be presented in a formative session of 2 hours of length to which will be invited to assist 1 or 2 members of each one of the 22 Health Centres involved in the study

2. Intervention group:
2.1. They will also receive an special formative session of 2 hours of length focused on the professionals with the protocol of intervention
2.2. They will receive special educational material as information sheets for patients, quick guides, etc.
2.3. A local opinion leader will be chosen on each team as the responsible person for the CPG
2.4. A defined system for reminding, audit and feedback will be developed to give back information about the intermediate results of the study at 3 and 6 months of the beginning.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Variation of 2 or more points in the Goldberg Anxiety Scale
2. Evaluative criteria
2.1. 4 or more affirmative responses in the Anxiety subscale
2.2. 2 or more affirmative responses in the Depression subscale
Outcomes will be measured at baseline, 6 and 12 months.

Secondary outcome measures

1. Compliance with the Guideline recommendations on treatment
2. Information and referrals to Mental Health Services
Outcomes will be measured at baseline, 6 and 12 months in data collecting notebooks

Overall trial start date

15/09/2010

Overall trial end date

15/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients older than 18
2. Diagnosed as generalised anxiety disorder, panic disorder and panic attacks by Diagnostic and Statistical Manual of Mental Disorders 4th edition (text revision) (DSM-IV-TR)
3. Signed informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Sample size adjusted for design effect = 296 (148 in each arm)

Participant exclusion criteria

1. Subjects that have been diagnosed of one of the following types of anxiety:
1.1. Post-traumatic stress disorders
1.2. Acute stress disorders
1.3. drug-related anxiety disorders
1.4. Anxiety disorders due to a medical or a mental illness
2. Subjects not able to read or understand Spanish language
3. Subjects that will not stay living on the Health Area in the next year after their inclusion on the study
4. Institutionalised or immobilised patients

Recruitment start date

15/09/2010

Recruitment end date

15/09/2012

Locations

Countries of recruitment

Spain

Trial participating centre

Avda. de los Pinos, 30.
Leganés
28914
Spain

Sponsor information

Organisation

Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)

Sponsor details

General Sub-Department for the Evaluation and Promotion of Research
(Subdirección General Evaluación y Fomento de la Investigación)
Monforte de Lemos
5
Madrid
28029
Spain

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) - Spanish Ministry of Health Supporting Investigation Department (ref: PI09/90304)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes