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Evaluation of a Psychotherapeutic Intervention Model in Nursing

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NIC Psychotherapeutic Intervention(s) for Anxiety
Psychopharmaceuticals (any drugs prescribed by the psychiatrist)
Sponsored by
Francisco Miguel Correia Sampaio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Psychotherapy, Nursing, Nursing Care, Nursing Model, Randomised Controlled Trial

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-64 years old;
  • Nursing Diagnosis "Anxiety" (according to ICNP/NANDA standardized nursing language) - assessment using NOC outcome "Anxiety Level" (Portuguese version);
  • Elementary education (completed).

Exclusion Criteria:

  • Psychiatric diagnosis of dementia or psychotic spectrum disorder;
  • Being in therapy provided by a psychologist (at the moment of the session 0);
  • Cognitive impairment (assessment using Mini-Mental State Examination);
  • Moderate or severe intellectual disability;
  • Confusional state;
  • Psychomotor agitation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Psychotherapeutic Intervention(s) for Anxiety

    Treatment-as-Usual for Anxiety

    Arm Description

    People diagnosed with "Anxiety" (according to ICNP/NANDA standardized nursing language) will be treated using Nursing Interventions Classification (NIC) psychotherapeutic intervention(s) for anxiety (plus psychopharmaceuticals).

    People diagnosed with "Anxiety" (according to ICNP/NANDA standardized nursing language) will receive treatment as usual for anxiety (psychopharmaceuticals).

    Outcomes

    Primary Outcome Measures

    Change in the Level of Anxiety (NOC outcomes "Anxiety Level" and "Anxiety Self-Control" - Portuguese version)

    Secondary Outcome Measures

    Full Information

    First Posted
    February 5, 2016
    Last Updated
    May 12, 2017
    Sponsor
    Francisco Miguel Correia Sampaio
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02930473
    Brief Title
    Evaluation of a Psychotherapeutic Intervention Model in Nursing
    Official Title
    Short-term Efficacy Evaluation of a Psychotherapeutic Intervention Model in Nursing on Nursing Diagnosis "Anxiety": A Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2016 (Actual)
    Primary Completion Date
    April 2017 (Actual)
    Study Completion Date
    May 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Francisco Miguel Correia Sampaio

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing on the nursing diagnosis "Anxiety". A randomised controlled trial will be carried out to do so.
    Detailed Description
    This study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing on nursing diagnosis "Anxiety" (according to International Classification for Nursing Practice (ICNP)/North American Nursing Diagnoses Association (NANDA) standardized nursing language). A randomised controlled trial will be carried out to do so. In a single-blinded nurse-led 6 months controlled trial, conducted at a hospital outpatient setting in Portugal, approximately 60 patients with anxiety will be randomised to the intervention (n=30) or control groups (n=30). The objective is to compare the outcomes associated with "treatment-as-usual" and the benefits of implementing the psychotherapeutic intervention model in nursing previously developed (5 sessions), which will be evaluated using Nursing Outcomes Classification (NOC) outcomes "Anxiety Level" and "Anxiety Self-Control" (Portuguese version).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety
    Keywords
    Psychotherapy, Nursing, Nursing Care, Nursing Model, Randomised Controlled Trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    133 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Psychotherapeutic Intervention(s) for Anxiety
    Arm Type
    Experimental
    Arm Description
    People diagnosed with "Anxiety" (according to ICNP/NANDA standardized nursing language) will be treated using Nursing Interventions Classification (NIC) psychotherapeutic intervention(s) for anxiety (plus psychopharmaceuticals).
    Arm Title
    Treatment-as-Usual for Anxiety
    Arm Type
    Active Comparator
    Arm Description
    People diagnosed with "Anxiety" (according to ICNP/NANDA standardized nursing language) will receive treatment as usual for anxiety (psychopharmaceuticals).
    Intervention Type
    Behavioral
    Intervention Name(s)
    NIC Psychotherapeutic Intervention(s) for Anxiety
    Intervention Description
    Patients will be treated by NIC psychotherapeutic intervention(s) for anxiety (e.g. anxiety reduction) plus psychopharmaceuticals prescribed by their psychiatrist.
    Intervention Type
    Drug
    Intervention Name(s)
    Psychopharmaceuticals (any drugs prescribed by the psychiatrist)
    Intervention Description
    Patients will be treated only by psychopharmaceuticals prescribed by their psychiatrist.
    Primary Outcome Measure Information:
    Title
    Change in the Level of Anxiety (NOC outcomes "Anxiety Level" and "Anxiety Self-Control" - Portuguese version)
    Time Frame
    At the beginning of the study (Session 0) and one week after session 5 (approximately 6 weeks after the beginning of the study)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18-64 years old; Nursing Diagnosis "Anxiety" (according to ICNP/NANDA standardized nursing language) - assessment using NOC outcome "Anxiety Level" (Portuguese version); Elementary education (completed). Exclusion Criteria: Psychiatric diagnosis of dementia or psychotic spectrum disorder; Being in therapy provided by a psychologist (at the moment of the session 0); Cognitive impairment (assessment using Mini-Mental State Examination); Moderate or severe intellectual disability; Confusional state; Psychomotor agitation.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Francisco Sampaio, MSc
    Organizational Affiliation
    Instituto de Ciências Biomédicas Abel Salazar da Universidade do Porto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29288510
    Citation
    Sampaio FMC, Araujo O, Sequeira C, Lluch Canut MT, Martins T. A randomized controlled trial of a nursing psychotherapeutic intervention for anxiety in adult psychiatric outpatients. J Adv Nurs. 2018 May;74(5):1114-1126. doi: 10.1111/jan.13520. Epub 2018 Jan 25.
    Results Reference
    derived

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    Evaluation of a Psychotherapeutic Intervention Model in Nursing

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