Evaluation of Psychotherapeutic Intervention Model in Nursing

Sponsor
Tuğba Aşkan (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06076746
Collaborator
(none)
26
1
2
12
2.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: NIC Psychotherapeutic Intervention(s) for İneffective Coping
  • Behavioral: psychotherapeutic intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel AssignmentParallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
It will not be known by the Outcomes Assessor that the patients are in the experimental or usual treatment group.
Primary Purpose:
Treatment
Official Title:
Evaluation of Psychotherapeutic Intervention Model in Nursing on Patients With Nursing Diagnosis of Ineffective Coping
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Coping [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.

  2. Self esteem [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara Yildirim Beyazit University Ankara Çubuk Turkey 06760

Sponsors and Collaborators

  • Tuğba Aşkan

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tuğba Aşkan, Nurse, Ankara Yildirim Beyazıt University
ClinicalTrials.gov Identifier:
NCT06076746
Other Study ID Numbers:
  • 2022-1081
First Posted:
Oct 11, 2023
Last Update Posted:
Oct 11, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tuğba Aşkan, Nurse, Ankara Yildirim Beyazıt University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2023