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 werent 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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list