Evaluation of a Psychotherapeutic Intervention Model in Nursing
May 12, 2017 updated by: Francisco Miguel Correia Sampaio
Short-term Efficacy Evaluation of a Psychotherapeutic Intervention Model in Nursing on Nursing Diagnosis "Anxiety": A Randomised Controlled Trial
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
133
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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).
|
Patients will be treated by NIC psychotherapeutic intervention(s) for anxiety (e.g.
anxiety reduction) plus psychopharmaceuticals prescribed by their psychiatrist.
Patients will be treated only by psychopharmaceuticals prescribed by their psychiatrist.
|
|
Active Comparator: Treatment-as-Usual for Anxiety
People diagnosed with "Anxiety" (according to ICNP/NANDA standardized nursing language) will receive treatment as usual for anxiety (psychopharmaceuticals).
|
Patients will be treated only by psychopharmaceuticals prescribed by their psychiatrist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
At the beginning of the study (Session 0) and one week after session 5 (approximately 6 weeks after the beginning of the study)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Francisco Sampaio, MSc, Instituto de Ciências Biomédicas Abel Salazar da Universidade do Porto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2016
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
February 5, 2016
First Submitted That Met QC Criteria
October 9, 2016
First Posted (Estimate)
October 12, 2016
Study Record Updates
Last Update Posted (Actual)
May 16, 2017
Last Update Submitted That Met QC Criteria
May 12, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICBAS 1988
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.