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

NCT04364958 | Completed

• 1 other identifier: SESCS_ECA-TAG_001
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Decisional conflict regarding the treatment for Generalized Anxiety Disorder, measured by the Decisional Conflict Scale (DCS)

  Change immediately after intervention

• Knowledge about the disorder and treatment alternatives

  Change immediately after intervention

• Treatment preference

  Change immediately after intervention

• Knowledge about the disorder and treatment alternatives

  Change from Baseline at 3 months after intervention

• Actual treatment choice

  Change from Baseline at 3 months after intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

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)

Control group

ACTIVE COMPARATOR

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.

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).

Also known as: Intervention

Intervention group

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.

Also known as: Control

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Servicio Canario de Salud: lead

Study Sites (1)

Servicio de Evaluación del Servicio Canario de la Salud

Santa Cruz de Tenerife, 38004, Spain

Location

Related Publications (2)

• 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.

  PMID: 40628665 DERIVED

• 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.

  PMID: 33303445 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Methods

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Lilisbeth Perestelo Perez, PhD

  Servicio de Evaluacion del Servicio Canario de la Salud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Services Researcher

Model Details: Assignment

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: May 7, 2021
• Primary Completion: November 30, 2022
• Study Completion: April 13, 2023
• Last Updated: April 18, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• 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)
• Access Criteria: The PtDA will be available after the end of the study on the PyDeSalud website (https://www.pydesalud.com/).

Locations

ES (1)