Effectiveness of an implementation strategy of Clinical Practice Guideline for patients with anxiety disorders in Primary Care

ISRCTN	ISRCTN83365316
DOI	https://doi.org/10.1186/ISRCTN83365316
Protocol serial number	PI09/90304
Sponsor	Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
Funder	Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) - Spanish Ministry of Health Supporting Investigation Department (ref: PI09/90304)

Submission date: 18/06/2010
Registration date: 04/08/2010
Last edited: 29/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs M Eugenia Tello
Scientific

Avda. de los Pinos, 30.
Leganés
28914
Spain

Study information

Primary study design	Interventional
Study design	Multicentre cluster randomised 2 arm open label controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Cluster randomized trial for evaluate the effectiveness of an implementation strategy of a clinical practice guideline for patients with anxiety disorders
Study acronym	GRITA
Study objectives	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(s)	The Committee of Ethical Investigation of the 9th Madrid Health Area approved on the 29th of April 2010
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	15/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	296
Key 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
Key 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
Date of first enrolment	15/09/2010
Date of final enrolment	15/09/2012

Locations

Countries of recruitment

Spain

Study participating centre

Avda. de los Pinos, 30.

Leganés
28914
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/12/2011	29/12/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

29/12/2020: Publication reference added.