Evaluation of Psychotherapeutic Intervention Model in Nursing

February 4, 2024 updated by: Tuğba Aşkan

Evaluation of Psychotherapeutic Intervention Model in Nursing on Patients With Nursing Diagnosis of Ineffective Coping

This study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing on the nursing diagnosis ineffective coping. For this purpose, validity and reliability studies of the assessment tools will be carried out initially, and then a randomized controlled study will be conducted.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to evaluate the efficacy of the psychotherapeutic intervention model in nursing on patients with nursing diagnosis of ineffective coping (International Classification of Nursing Practices (ICNP)/North American Nursing Diagnostic Association (NANDA)). For this purpose, first of all, validity and reliability studies of "Coping" and "Self-Esteem", which are the results of NOC (Nursing Outcomes Classification), will be conducted, and then a randomized controlled study will be conducted (Turkish version). 200 patients will be included in the validity and reliability phase of the study, which was conducted in a hospital outpatient psychiatric setting in Turkey. The randomized controlled second phase will be carried out, single-blind, nurse-led, with approximately 26 patients with anxiety randomized to intervention (n=13) or control groups (n=13). The usual treatment and care will be compared with the application of the psychotherapeutic intervention model previously developed in nursing.

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Çubuk
      • Ankara, Çubuk, Turkey, 06760

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-64 years old,
  • Literacy,
  • Having applied to the psychiatry outpatient clinic,
  • Being regularly treated in a psychiatry outpatient clinic,
  • Having a medical diagnosis of generalized anxiety disorder,
  • Having at least one of the defining characteristics of the nursing diagnosis of ineffective coping according to the nursing process.

Exclusion Criteria:

  • Medical diagnosis of dementia or psychotic spectrum disorder,
  • Cognitive disorder,
  • Confused state of consciousness
  • Psychomotor agitation,
  • Moderate or severe intellectual disability
  • Expressing suicidal thoughts
  • Suicide attempt in the last month
  • Continuing psychological counseling at the moment.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Intervention(s) for ineffective coping in General Anxiety
Patients with nurse diagnosis of ineffective coping will be treated using Nursing Interventions Classification (NIC) psychotherapeutic intervention(s).
Behavioral: NIC Psychotherapeutic Intervention(s) for İneffective Coping
Patients will be treated by NIC psychotherapeutic intervention(s) for general anxiety (e.g. anxiety reduction, coping enhancement).
Behavioral: psychotherapeutic intervention
Patients will be treated by NIC psychotherapeutic intervention(s) for general anxiety (e.g. anxiety reduction, coping enhancement).
Active Comparator: Treatment-as-Usual for General Anxiety
Patients with nurse diagnosis of ineffective coping will receive the usual treatment for general anxiety.
Behavioral: psychotherapeutic intervention
Patients will be treated by NIC psychotherapeutic intervention(s) for general anxiety (e.g. anxiety reduction, coping enhancement).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coping
Time Frame: Baseline and through study completion, an average of 9 weeks
Nursing Outcomes Classification (Coping (1302)) The scale consists of 19 items. A minimum of 19 and a maximum of 95 points can be obtained from the scale. Increasing scale scores indicate good results.
Baseline and through study completion, an average of 9 weeks
Self esteem
Time Frame: Baseline and through study completion, an average of 9 weeks
Nursing Outcomes Classification (Self-Esteem (1205)) The scale consists of 20 items. A minimum of 20 and a maximum of 100 points can be obtained from the scale. An increase in scale scores indicates good results.
Baseline and through study completion, an average of 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tuğba Aşkan

Investigators

  • Principal Investigator: Tuğba Aşkan, PhD Student, Ankara Yildirim Beyazıt University

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 (Estimated)

May 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

October 8, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 4, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-1081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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