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Clinical Trials/NCT02930473
NCT02930473
Completed
Not Applicable

Short-term Efficacy Evaluation of a Psychotherapeutic Intervention Model in Nursing on Nursing Diagnosis "Anxiety": A Randomised Controlled Trial

Francisco Miguel Correia Sampaio0 sites133 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
NIC Psychotherapeutic Intervention(s) for Anxiety
Conditions
Anxiety
Sponsor
Francisco Miguel Correia Sampaio
Enrollment
133
Primary Endpoint
Change in the Level of Anxiety (NOC outcomes "Anxiety Level" and "Anxiety Self-Control" - Portuguese version)
Status
Completed
Last Updated
8 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
May 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Francisco Miguel Correia Sampaio
Responsible Party
Sponsor Investigator
Principal Investigator

Francisco Miguel Correia Sampaio

RMN, MSc, PhD Student

Universidade do Porto

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.

Arms & Interventions

Psychotherapeutic Intervention(s) for Anxiety

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).

Intervention: NIC Psychotherapeutic Intervention(s) for Anxiety

Psychotherapeutic Intervention(s) for Anxiety

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).

Intervention: Psychopharmaceuticals (any drugs prescribed by the psychiatrist)

Treatment-as-Usual for Anxiety

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

Intervention: Psychopharmaceuticals (any drugs prescribed by the psychiatrist)

Outcomes

Primary Outcomes

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)

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