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

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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder; GAD
• Intervention / Treatment: Other: A web based-Patient Decision Aid (PtDA) (shown on the computer); Other: A web-based fact sheet (one page shown on the computer) with general information on mental health as a part of usual care.

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Santa Cruz de Tenerife, Spain, 38004
    • Servicio de Evaluación del Servicio Canario de la Salud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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.	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 Names: Intervention
Active Comparator: Control group; 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.	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.; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Baseline at 3 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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	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).	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.	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.	Change from Baseline at 3 months after intervention
GAD symptoms	Assessed with the Generalized Anxiety Disorder questionnaire (GAD-7)	Change from Baseline at 3 months after intervention

Collaborators and Investigators

• Sponsor: Servicio Canario de Salud

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2021
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): April 13, 2023

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Web-based intervention; Generalized Anxiety Disorder; Primary Care; Randomized controlled trial; Shared decision making; Patient-centred care; Patient decision aids
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Anxiety Disorders
• Other Study ID Numbers: SESCS_ECA-TAG_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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/).
• IPD Sharing Time Frame: Datasests will become available as of Nov 2020 during all the study until the estimated end date of the recruitment (January 2021) and study complete (August 2021)
• IPD Sharing Access Criteria: The PtDA will be available after the end of the study on the PyDeSalud website (https://www.pydesalud.com/).
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No