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

NCT ID: NCT04364958

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-07
• Study Completion Date: 2023-04-13

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).

Conditions

Generalized Anxiety Disorder; GAD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Intervention; Control

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Servicio Canario de Salud

OTHER

Sponsor Role: lead

Responsible Party

Lilisbeth Perestelo-Perez

Health Services Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lilisbeth Perestelo Perez, PhD

Role: PRINCIPAL_INVESTIGATOR

Servicio de Evaluacion del Servicio Canario de la Salud

Locations

Servicio de Evaluación del Servicio Canario de la Salud

Santa Cruz de Tenerife, , Spain

Countries

Spain

References

Ramos Garcia V, Rivero-Santana A, Penate-Castro W, Alvarez-Perez Y, Del Mar Trujillo-Martin M, Gonzalez-Pacheco H, Santos-Alvarez A, Duarte-Diaz A, Del Cura-Gonzalez MI, Perestelo-Perez L. Effectiveness of a web-based decision aid for patients with Generalised Anxiety Disorder in Spain: a randomised controlled trial. BMJ Health Care Inform. 2025 Jul 8;32(1):e101185. doi: 10.1136/bmjhci-2024-101185.

Reference Type: DERIVED

PMID: 40628665 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33303445 (View on PubMed)

Other Identifiers

SESCS_ECA-TAG_001

Identifier Type: -

Identifier Source: org_study_id