Evaluation of a Psychotherapeutic Intervention Model in Nursing

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Behavioral: NIC Psychotherapeutic Intervention(s) for Anxiety; Drug: Psychopharmaceuticals (any drugs prescribed by the psychiatrist)

• Registration Number: NCT02930473
• Lead Sponsor: Francisco Miguel Correia Sampaio

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).

Study Timeline

• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-10-09
• Study First Posted: 2016-10-12
• Study Start: 2016-11
• Primary Completion: 2017-04
• Status Verified: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-05-12
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychotherapeutic Intervention(s) for Anxiety	NIC 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).
Psychotherapeutic Intervention(s) for Anxiety	Psychopharmaceuticals (any drugs prescribed by the psychiatrist)	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).
Treatment-as-Usual for Anxiety	Psychopharmaceuticals (any drugs prescribed by the psychiatrist)	People diagnosed with "Anxiety" (according to ICNP/NANDA standardized nursing language) will receive treatment as usual for anxiety (psychopharmaceuticals).

Primary Outcome Measures

Name	Time	Method
Change in the Level of Anxiety (NOC outcomes "Anxiety Level" and "Anxiety Self-Control" - Portuguese version)	At the beginning of the study (Session 0) and one week after session 5 (approximately 6 weeks after the beginning of the study)