Decision Aid for Patients With Generalized Anxiety Disorder: Protocol for a Randomized Controlled Trial (ECA-TAG)

Servicio Canario de Salud

Status: Completed

Conditions: GAD; Generalized Anxiety Disorder

Treatments: Other: A web-based fact sheet (one page shown on the computer) with general information on mental health as a part of usual care.; Other: A web based-Patient Decision Aid (PtDA) (shown on the computer)

Study type: Interventional

Funder types: Other

Identifiers

NCT04364958

SESCS_ECA-TAG_001

Details and patient eligibility

About

The main goal of this study is assess the effectiveness of a PtDA for patients with GAD.

Full 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).

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Other: A web based-Patient Decision Aid (PtDA) (shown on the computer)

Control group

Active Comparator group

Description:

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.

Treatment:

Other: A web-based fact sheet (one page shown on the computer) with general information on mental health as a part of usual care.