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Completed

NCT Number: NCT04364958

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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders GAD Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Servicio de Evaluación del Servicio Canario de la Salud

Santa Cruz de Tenerife, 38004, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Intervention

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.

Other names: Control

Primary outcomes

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

    Time frame: Change from Baseline at 3 months after intervention

    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.

Secondary outcomes

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

    Time frame: Change immediately after intervention

    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.

  2. Knowledge about the disorder and treatment alternatives

    Time frame: Change immediately after intervention

    A10-item scale will be include to assess patients' knowledge of the disorder and treatments based on the contents of the PtDA.

  3. Treatment preference

    Time frame: Change immediately after intervention

    Assessed with one item with four response alternatives: (pharmacological treatment, psychological treatment, combined pharmacological and psychological treatment, or unsure).

  4. Knowledge about the disorder and treatment alternatives

    Time frame: Change from Baseline at 3 months after intervention

    A10-item scale will be include to assess patients' knowledge of the disorder and

  5. Actual treatment choice

    Time frame: Change from Baseline at 3 months after intervention

    Assessed with one item with four response alternatives: (pharmacological treatment, psychological treatment, combined pharmacological and psychological treatment, or unsure).

  6. Concordance between preference and choice

    Time frame: Change from Baseline at 3 months after intervention

    Assessed by a binary variable (concordant/non-concordant) derived from the congruence between preference and choice.

  7. Decision quality

    Time frame: Change from Baseline at 3 months after intervention

    Assessed by a binary variable (yes/no) defined as a combination of adequate knowledge (≥60% of correct responses) and concordance between values and intention.

  8. GAD symptoms

    Time frame: Change from Baseline at 3 months after intervention

    Assessed with the Generalized Anxiety Disorder questionnaire (GAD-7)

Sponsors and collaborators

Lead sponsor

Servicio Canario de Salud

Other

Registry information

Official study title

The Effectiveness of a Web-based Decision Aid for Patients With Generalized Anxiety Disorder: Protocol for a Randomized Controlled Trial

Acronym: ECA-TAG

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 28, 2020
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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