Evaluation of a Psychotherapeutic Intervention Model in Nursing

NCT02930473 | Completed

• 1 other identifier: ICBAS 1988
• Study Type: interventional
• Target: 133
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety

Keywords

Psychotherapy; Nursing; Nursing Care; Nursing Model; Randomised Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Psychotherapeutic Intervention(s) for Anxiety

EXPERIMENTAL

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)

Treatment-as-Usual for Anxiety

ACTIVE COMPARATOR

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

NIC Psychotherapeutic Intervention(s) for Anxiety BEHAVIORAL

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

Psychotherapeutic Intervention(s) for Anxiety

Psychopharmaceuticals (any drugs prescribed by the psychiatrist) DRUG

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

Psychotherapeutic Intervention(s) for Anxiety; Treatment-as-Usual for Anxiety

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old;
• Nursing Diagnosis "Anxiety" (according to ICNP/NANDA standardized nursing language) - assessment using NOC outcome "Anxiety Level" (Portuguese version);
• Elementary education (completed).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Francisco Miguel Correia Sampaio: lead

Related Publications (1)

• 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.

  PMID: 29288510 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Psychotropic Drugs

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Francisco Sampaio, MSc

  Instituto de Ciências Biomédicas Abel Salazar da Universidade do Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: RMN, MSc, PhD Student

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: October 12, 2016
• Study Start: November 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share