Skip to main content
OpenTrials
Completed

NCT Number: NCT02930473

Evaluation of a Psychotherapeutic Intervention Model in Nursing

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

NIC Psychotherapeutic Intervention(s) for Anxiety

Behavioral

Patients will be treated by NIC psychotherapeutic intervention(s) for anxiety (e.g. anxiety reduction) plus psychopharmaceuticals prescribed by their psychiatrist.

Psychopharmaceuticals (any drugs prescribed by the psychiatrist)

Drug

Patients will be treated only by psychopharmaceuticals prescribed by their psychiatrist.

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Francisco Miguel Correia Sampaio

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 12, 2016
Registry last updated
May 16, 2017

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.

Published trials that share one or more normalized conditions with this study.