Clinical trial NCT04364958: Decision Aid for Patients With Generalized Anxiety Disorder: Protocol for a Randomized Controlled Trial
Official title: The Effectiveness of a Web-based Decision Aid for Patients With Generalized Anxiety Disorder: Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Servicio Canario de Salud
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assignment
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Decisional conflict regarding the treatment for Generalized Anxiety Disorder, measured by the Decisional Conflict Scale (DCS)
timeFrame: Change from Baseline at 3 months after intervention
Secondary outcomes:
measure: Decisional conflict regarding the treatment for Generalized Anxiety Disorder, measured by the Decisional Conflict Scale (DCS)
timeFrame: Change immediately after intervention
measure: Knowledge about the disorder and treatment alternatives
timeFrame: Change immediately after intervention
measure: Treatment preference
timeFrame: Change immediately after intervention
measure: Knowledge about the disorder and treatment alternatives
timeFrame: Change from Baseline at 3 months after intervention
measure: Actual treatment choice
timeFrame: Change from Baseline at 3 months after intervention
measure: Concordance between preference and choice
timeFrame: Change from Baseline at 3 months after intervention
measure: Decision quality
timeFrame: Change from Baseline at 3 months after intervention
measure: GAD symptoms
timeFrame: Change from Baseline at 3 months after intervention
Other outcomes:
Locations:
city: Santa Cruz de Tenerife
country: Spain
facility: Servicio de Evaluación del Servicio Canario de la Salud
Study officials:
affiliation: Servicio de Evaluacion del Servicio Canario de la Salud
name: Lilisbeth Perestelo Perez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perestelo-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.