Evaluation of a Psychotherapeutic Intervention Model in Nursing

Study 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).

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

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Behavioral: NIC Psychotherapeutic Intervention(s) for Anxiety
* Drug: Psychopharmaceuticals (any drugs prescribed by the psychiatrist)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychotherapeutic Intervention(s) for Anxiety<br>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). | Behavioral: NIC Psychotherapeutic Intervention(s) for Anxiety<br>* Patients will be treated by NIC psychotherapeutic intervention(s) for anxiety (e.g. anxiety reduction) plus psychopharmaceuticals prescribed by their psychiatrist.<br>Drug: Psychopharmaceuticals (any drugs prescribed by the psychiatrist)<br>* Patients will be treated only by psychopharmaceuticals prescribed by their psychiatrist.<br>|
| Active Comparator: Treatment-as-Usual for Anxiety<br>People diagnosed with Anxiety (according to ICNP/NANDA standardized nursing language) will receive treatment as usual for anxiety (psychopharmaceuticals). | Drug: Psychopharmaceuticals (any drugs prescribed by the psychiatrist)<br>* Patients will be treated only by psychopharmaceuticals prescribed by their psychiatrist.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychotherapy, Nursing, Nursing Care, Nursing Model, Randomised Controlled Trial