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
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
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
NCT ID
NCT02930473
First Posted
February 5, 2016
Last Updated
May 12, 2017
Sponsor
Francisco Miguel Correia Sampaio
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
Learn more about this trial
Evaluation of a Psychotherapeutic Intervention Model in Nursing
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