Generalized Anxiety DisorderECA-TAGNCT04364958
Decision Aid for Patients With Generalized Anxiety Disorder: Protocol for a Randomized Controlled Trial
A study testing A web based-Patient Decision Aid (PtDA) (shown on the computer) in people with Generalized Anxiety Disorder and GAD, run by Servicio Canario de Salud at 1 site in Spain.
Trial summary
The main goal of this study is assess the effectiveness of a PtDA for patients with GAD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder, GAD
- What is being tested?
- A web based-Patient Decision Aid (PtDA) (shown on the computer)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSpain
- Study dates
- 7 May 2021to 13 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥ 18 years) with a diagnosis of GAD (ICD-10 or DSM-V codes: 300.02; F41.1), with a score ≥8 in the GAD-7 questionnaire, with ability to speak and read Spanish, and who accept to participate and sign the informed consent
Who cannot join
- Patients with a primary diagnosis other than GAD, a score <8 in the GAD-7, those with significant physical or mental disability that prevents from completion of study activities or those participating in other trials related with GAD treatment or education, will be excluded
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servicio de Evaluación del Servicio Canario de la Salud
Santa Cruz de Tenerife, 38004
About this study
Official title: The Effectiveness of a Web-based Decision Aid for Patients With Generalized Anxiety Disorder: Protocol for a Randomized Controlled Trial
The main goal of this study is assess the effectiveness of a PtDA for patients with GAD.
Read the detailed description
Background: Patients with Generalized Anxiety Disorder (GAD) have concerns and needs about their health and the health care they receive. Patient decision aids (PtDAs) are tools that assist patients in making health decisions, when there is uncertainty about treatment choice, incorporating their personal preferences and values about the available treatment options. PtDAs can improve shared decision-making (SDM) and lead to better treatment outcomes. The aim of this study is to evaluate the effectiveness of a web-based PtDA for patients with GAD in primary care.
Methods and analysis: The general study design comprises two stages: i) Development of a web-based PtDA for patients with GAD, derived from an evidence-based Clinical Practice Guideline and, ii) Assessment of the effectiveness of the PtDA employing in a randomised controlled trial (RCT) design, in primary care centres of Tenerife (Spain). This RCT will be carried out with 156 patients with GAD with a score ≥8 in the GAD-7 questionnaire, comparing the PtDA to usual care (fact sheet with general information on mental health). Patients will review the PtDA accompanied by a researcher. Post-intervention survey will be administered immediately after the intervention.
The primary outcome will be decisional conflict (immediately after intervention and 3 months after intervention).
Secondary outcomes will include knowledge about GAD and its treatment (immediately after intervention and 3 months after intervention), treatment preference (immediately after intervention), actual treatment choice (3 months after intervention), concordance between preferred and chosen (3 months after intervention) decision quality with the decision-making process (3 months after intervention), and GAD symptoms (3 months after intervention).
- Conditions
- Generalized Anxiety Disorder, GAD
- Being tested
- A web based-Patient Decision Aid (PtDA) (shown on the computer), A web-based fact sheet (one page shown on the computer) with general information on mental health as a part of usual care.
- Keywords
- Generalized Anxiety Disorder, Patient decision aids, Patient-centred care, Randomized controlled trial, Shared decision making, Web-based intervention, Primary Care
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A web based-Patient Decision Aid (PtDA) (shown on the computer)Other
Also called Intervention
Patient decision aids (PtDAs) are tools that assist patients in making health decisions, when there is uncertainty about treatment choice, incorporating their personal preferences and values about the available treatment options. This PtDA will include information about GAD symptoms, diagnosis, causes, and benefits and risks associated to psychological and pharmacological treatments for GAD (based on the Clinical Practice Guidelines-GAD). It will also include a values clarification exercise, in which patients will have to rate the importance attributed to the different aspects of treatments (e.g., mode of administration, benefits, risks, time to improvement, probability of relapse).
A web-based fact sheet (one page shown on the computer) with general information on mental health as a part of usual care.Other
Also called Control
Patients in the control group will receive a fact sheet (one page) with general information on mental health as a part of usual care provided by the Canary Islands Health Service.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients who agree participant and will sign the informed consent, will complete the baseline assessment. Then, those allocated to the intervention group will review the web-based PtDA (shown on the computer), with the help of a researcher if necessary, and then will fill the questionnaires assessing the outcome measures in the same web interface. Receives: Other: A web based-Patient Decision Aid (PtDA) (shown on the computer) |
| Control group | Active comparator | Patients allocated to the control group will receive a web-based fact sheet (one page shown on the computer) with general information on mental health as a part of usual care, and they will also complete the same questionnaires. Receives: Other: A web-based fact sheet (one page shown on the computer) with general information on mental health as a part of usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional conflict regarding the treatment for Generalized Anxiety Disorder, measured by the Decisional Conflict Scale (DCS)
DCS includes 16 items and five subscales: feeling informed, clear values about benefits or risks, support, uncertainly and effective decision. Scores are transformed to a 0-100 scale, with higher scores indicating more conflict.
Measured: Change from Baseline at 3 months after intervention
Secondary outcomes (8)
Decisional conflict regarding the treatment for Generalized Anxiety Disorder, measured by the Decisional Conflict Scale (DCS)
CS includes 16 items and five subscales: feeling informed, clear values about benefits or risks, support, uncertainly and effective decision. Scores are transformed to a 0-100 scale, with higher scores indicating more conflict.
Measured: Change immediately after intervention
Knowledge about the disorder and treatment alternatives
A10-item scale will be include to assess patients' knowledge of the disorder and treatments based on the contents of the PtDA.
Measured: Change immediately after intervention
Treatment preference
Assessed with one item with four response alternatives: (pharmacological treatment, psychological treatment, combined pharmacological and psychological treatment, or unsure).
Measured: Change immediately after intervention
Knowledge about the disorder and treatment alternatives
A10-item scale will be include to assess patients' knowledge of the disorder and
Measured: Change from Baseline at 3 months after intervention
Actual treatment choice
Assessed with one item with four response alternatives: (pharmacological treatment, psychological treatment, combined pharmacological and psychological treatment, or unsure).
Measured: Change from Baseline at 3 months after intervention
Concordance between preference and choice
Assessed by a binary variable (concordant/non-concordant) derived from the congruence between preference and choice.
Measured: Change from Baseline at 3 months after intervention
Decision quality
Assessed by a binary variable (yes/no) defined as a combination of adequate knowledge (≥60% of correct responses) and concordance between values and intention.
Measured: Change from Baseline at 3 months after intervention
GAD symptoms
Assessed with the Generalized Anxiety Disorder questionnaire (GAD-7)
Measured: Change from Baseline at 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start7 May 2021
- Primary completion30 Nov 2022
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assignment
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servicio Canario de Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilisbeth Perestelo-Perez, Servicio Canario de Salud
- Investigators
- Lilisbeth Perestelo Perez, PhD, Principal investigator, Servicio de Evaluacion del Servicio Canario de la Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364958
- Sponsor's protocol ID
- SESCS_ECA-TAG_001
- Acronym
- ECA-TAG
- Status last verified
- Oct 2022
- First submitted
- 24 Apr 2020
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and analysed during the current study will be available from the corresponding author on reasonable request. The PtDA will be available after the end of the study on the PyDeSalud website (https://www.pydesalud.com/).
Publications
Ramos Garcia V, Rivero-Santana A, Penate-Castro W, Alvarez-Perez Y, Del Mar Trujillo-Martin M, Gonzalez-Pacheco H, Santos-Alvarez A, Duarte-Diaz A, Del Cura-Gonzalez MI, Perestelo-Perez L. Effectiveness of a web-based decision aid for patients with Generalised Anxiety Disorder in Spain: a randomised controlled trial. BMJ Health Care Inform. 2025 Jul 8;32(1):e101185. doi: 10.1136/bmjhci-2024-101185.
PubMed 40628665Perestelo-Perez L, Rivero-Santana A, Ramos-Garcia V, Alvarez-Perez Y, Duarte-Diaz A, Torres-Castano A, Trujillo-Martin MDM, Del Pino-Sedeno T, Gonzalez-Gonzalez AI, Serrano-Aguilar P. Effectiveness of a web-based decision aid for patients with generalised anxiety disorder: a protocol for a randomised controlled trial. BMJ Open. 2020 Dec 10;10(12):e039956. doi: 10.1136/bmjopen-2020-039956.
PubMed 33303445
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Web-based Decision Aid for Patients With Generalized Anxiety Disorder: Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04364958
- Acronym / sponsor ID
- ECA-TAG / SESCS_ECA-TAG_001
- Conditions
- Generalized Anxiety Disorder, GAD
- Keywords
- Generalized Anxiety Disorder, Patient decision aids, Patient-centred care, Randomized controlled trial, Shared decision making, Web-based intervention, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Servicio Canario de SaludUniversity, hospital or other
- Study start
- 7 May 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this study is assess the effectiveness of a PtDA for patients with GAD.
Detailed description
Background: Patients with Generalized Anxiety Disorder (GAD) have concerns and needs about their health and the health care they receive. Patient decision aids (PtDAs) are tools that assist patients in making health decisions, when there is uncertainty about treatment choice, incorporating their personal preferences and values about the available treatment options. PtDAs can improve shared decision-making (SDM) and lead to better treatment outcomes. The aim of this study is to evaluate the effectiveness of a web-based PtDA for patients with GAD in primary care.
Methods and analysis: The general study design comprises two stages: i) Development of a web-based PtDA for patients with GAD, derived from an evidence-based Clinical Practice Guideline and, ii) Assessment of the effectiveness of the PtDA employing in a randomised controlled trial (RCT) design, in primary care centres of Tenerife (Spain). This RCT will be carried out with 156 patients with GAD with a score ≥8 in the GAD-7 questionnaire, comparing the PtDA to usual care (fact sheet with general information on mental health). Patients will review the PtDA accompanied by a researcher. Post-intervention survey will be administered immediately after the intervention.
The primary outcome will be decisional conflict (immediately after intervention and 3 months after intervention).
Secondary outcomes will include knowledge about GAD and its treatment (immediately after intervention and 3 months after intervention), treatment preference (immediately after intervention), actual treatment choice (3 months after intervention), concordance between preferred and chosen (3 months after intervention) decision quality with the decision-making process (3 months after intervention), and GAD symptoms (3 months after intervention).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: A web based-Patient Decision Aid (PtDA) (shown on the computer)Patients who agree participant and will sign the informed consent, will complete the baseline assessment. Then, those allocated to the intervention group will review the web-based PtDA (shown on the computer), with the help of a researcher if necessary, and then will fill the questionnaires assessing the outcome measures in the same web interface. |
| Control group | Active comparator | Other: A web-based fact sheet (one page shown on the computer) with general information on mental health as a part of usual care.Patients allocated to the control group will receive a web-based fact sheet (one page shown on the computer) with general information on mental health as a part of usual care, and they will also complete the same questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult (≥ 18 years) with a diagnosis of GAD (ICD-10 or DSM-V codes: 300.02; F41.1), with a score ≥8 in the GAD-7 questionnaire, with ability to speak and read Spanish, and who accept to participate and sign the informed consent
Key exclusion criteria (1 listed)
- Patients with a primary diagnosis other than GAD, a score <8 in the GAD-7, those with significant physical or mental disability that prevents from completion of study activities or those participating in other trials related with GAD treatment or education, will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A web based-Patient Decision Aid (PtDA) (shown on the computer)Also: InterventionPatient decision aids (PtDAs) are tools that assist patients in making health decisions, when there is uncertainty about treatment choice, incorporating their personal preferences and values about the available treatment options. This PtDA will include information about GAD symptoms, diagnosis, causes, and benefits and risks associated to psychological and pharmacological treatments for GAD (based on the Clinical Practice Guidelines-GAD). It will also include a values clarification exercise, in which patients will have to rate the importance attributed to the different aspects of treatments (e.g., mode of administration, benefits, risks, time to improvement, probability of relapse). | Other | Intervention group |
| A web-based fact sheet (one page shown on the computer) with general information on mental health as a part of usual care.Also: ControlPatients in the control group will receive a fact sheet (one page) with general information on mental health as a part of usual care provided by the Canary Islands Health Service. | Other | Control group |
Primary outcome
Decisional conflict regarding the treatment for Generalized Anxiety Disorder, measured by the Decisional Conflict Scale (DCS)
Time frame: Change from Baseline at 3 months after intervention
DCS includes 16 items and five subscales: feeling informed, clear values about benefits or risks, support, uncertainly and effective decision. Scores are transformed to a 0-100 scale, with higher scores indicating more conflict.
8 secondary outcomes
Decisional conflict regarding the treatment for Generalized Anxiety Disorder, measured by the Decisional Conflict Scale (DCS)
Time frame: Change immediately after intervention
Knowledge about the disorder and treatment alternatives
Time frame: Change immediately after intervention
Treatment preference
Time frame: Change immediately after intervention
Knowledge about the disorder and treatment alternatives
Time frame: Change from Baseline at 3 months after intervention
Actual treatment choice
Time frame: Change from Baseline at 3 months after intervention
Concordance between preference and choice
Time frame: Change from Baseline at 3 months after intervention
Decision quality
Time frame: Change from Baseline at 3 months after intervention
GAD symptoms
Time frame: Change from Baseline at 3 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 40628665Ramos Garcia V, Rivero-Santana A, Penate-Castro W, Alvarez-Perez Y, Del Mar Trujillo-Martin M, Gonzalez-Pacheco H, Santos-Alvarez A, Duarte-Diaz A, Del Cura-Gonzalez MI, Perestelo-Perez L. Effectiveness of a web-based decision aid for patients with Generalised Anxiety Disorder in Spain: a randomised controlled trial. BMJ Health Care Inform. 2025 Jul 8;32(1):e101185. doi: 10.1136/bmjhci-2024-101185.
- Derived from this study: PubMed 33303445Perestelo-Perez L, Rivero-Santana A, Ramos-Garcia V, Alvarez-Perez Y, Duarte-Diaz A, Torres-Castano A, Trujillo-Martin MDM, Del Pino-Sedeno T, Gonzalez-Gonzalez AI, Serrano-Aguilar P. Effectiveness of a web-based decision aid for patients with generalised anxiety disorder: a protocol for a randomised controlled trial. BMJ Open. 2020 Dec 10;10(12):e039956. doi: 10.1136/bmjopen-2020-039956.
- Individual participant dataSharing planned: Yes. The datasets used and analysed during the current study will be available from the corresponding author on reasonable request. The PtDA will be available after the end of the study on the PyDeSalud website (https://www.pydesalud.com/).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lilisbeth Perestelo Perez, PhD principal investigator
Servicio de Evaluacion del Servicio Canario de la Salud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A web based-Patient Decision Aid (PtDA) (shown on the computer) in people with Generalized Anxiety Disorder and GAD, run by Servicio Canario de Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional conflict regarding the treatment for Generalized Anxiety Disorder, measured by the Decisional Conflict Scale (DCS) (time frame: Change from Baseline at 3 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04364958, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.