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

Servicio Canario de Salud73 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Generalized Anxiety Disorder GAD

Interventions

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

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

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Servicio de Evaluación del Servicio Canario de la Salud

Santa Cruz de Tenerife, Spain

Outcomes

Primary Outcomes

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.

Time frame: Change from Baseline at 3 months after intervention

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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).

Time frame: 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

Time frame: 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).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.