NCT04364958

Decision Aid for Patients With Generalized Anxiety Disorder: Protocol for a Randomized Controlled Trial

The Effectiveness of a Web-based Decision Aid for Patients With Generalized Anxiety Disorder: Protocol for a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Servicio Canario de Salud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Generalized Anxiety Disorder
• GAD

Interventions

Type	Name	Description
OTHER	A web based-Patient Decision Aid (PtDA) (shown on the computer)	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).
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 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.

Timeline

• Start date: 2021-05-07
• Primary completion: 2022-11-30
• Completion: 2023-04-13
• First posted: 2020-04-28
• Last updated: 2023-04-18

Locations

1 site across 1 country: Spain