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CompletedNCT02930473Updated May 16, 2017

Evaluation of a Psychotherapeutic Intervention Model in Nursing

An interventional study of NIC Psychotherapeutic Intervention(s) for Anxiety and Psychopharmaceuticals (any drugs prescribed by the psychiatrist) in Anxiety, sponsored by Francisco Miguel Correia Sampaio. Completed. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2017-05-16.

Sponsored by Francisco Miguel Correia Sampaio · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
133
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
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Study 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.

Read the 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).

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Conditions studied

  • Anxiety

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Keywords

  • Psychotherapy
  • Nursing
  • Nursing Care
  • Nursing Model
  • Randomised Controlled Trial
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In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 133 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

This is the only study on the registry with Francisco Miguel Correia Sampaio as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
133 participants (actual)

Study arms

  • 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).

    Behavioral: NIC Psychotherapeutic Intervention(s) for Anxiety · Drug: Psychopharmaceuticals (any drugs prescribed by the 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).

    Drug: Psychopharmaceuticals (any drugs prescribed by the psychiatrist)

Interventions

  • BehavioralNIC Psychotherapeutic Intervention(s) for Anxiety

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

  • DrugPsychopharmaceuticals (any drugs prescribed by the psychiatrist)

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

06

What researchers measure

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)

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 29288510 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02930473
Lead sponsor
Francisco Miguel Correia Sampaio
Responsible party
Francisco Miguel Correia Sampaio (RMN, MSc, PhD Student, Universidade do Porto) — Sponsor-investigator
First posted
Oct 12, 2016
Start date
Nov 2016
Primary completion
Apr 2017
Completion
May 2017
Last update
May 16, 2017

Study contacts

Francisco Sampaio, MSc
principal investigator · Instituto de Ciências Biomédicas Abel Salazar da Universidade do Porto

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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